DC Medical Malpractice & Patient Safety Blog

Harm caused during robotic surgery has led to numerous malpractice lawsuits against surgeons who use the high-tech devices and product liability actions against manufacturers who make them. Last week we wrote about the statement from the American College of Obstetricians and Gynecologists advising caution in robotic use for hysterectomies.

Intuitive Surgical Inc., according to a story on Bloomberg.com, manufactured robots used in 367,000 U.S. operations last year. The company has been sued for putting patients at risk because it allegedly sold the devices to doctors without training them sufficiently in their use.

“At least 10 lawsuits have been filed over the last 15 months,” says the Bloomberg story, “alleging injuries from robot surgery, and almost all cite Intuitive’s training regimen.”

Among the adverse outcomes resulting from robotic surgery are tearing internal tissue and burning internal organs.

One patient at the wrong end of the robotic knife was Fred E. Taylor. His widow, Josette Taylor, sued Intuitive for complications Fred suffered after prostate surgery. He died four years later, partly, she claims, from “woefully inadequate” company training “designed to give surgeons a false sense of confidence.”

Taylor’s cancerous prostate gland was removed in 2008. It was his doctor’s first unsupervised surgery using the Intuitive device, according to the lawsuit. He lost 15 cups of blood during the 13-hour procedure. He suffered kidney failure, brain damage, permanent incontinence and a 1-inch tear in his rectum, the suit charges.

As Bloomberg reports, Scott Bildsten, the doctor who performed the surgery, had done about 100 prostate removals via the standard method, without any complications. Bildsten had done only two supervised robotic prostate removals before Taylor’s. Intuitive provided the overseeing physician and the hospital paid the fees.

The robots, called the Da Vinci system, cost about $1.5 million each, says Bloomberg, and nearly 1,400 U.S. hospitals have them. Remarkably, there is no universal, prescribed guideline for training the people who use them, unlike the standards for many other sophisticated surgical procedures. Many hospitals depend Intuitive for this instruction. But its priority, of course, is selling, not teaching.

“Sales reps should have nothing to do with credentialing,” Dr. David Penson, a urologist, told Bloomberg. “Of course they are going to do whatever they can to get that guy out there and using their equipment.”

Last year, says Bloomberg, robots and related products generated most of Intuitive’s $2.2 billion in revenue.

The FDA approved the robotic device in 2000. Documents obtained by Rick Friedman, Taylor’s attorney, showed that Intuitive told the agency then that it would design a 70-question quiz and a three-day training course for all operating-room personnel. But only months after the robot hit the market, Intuitive put a marketing official—not a medical professional—in charge of training. Off- site training was cut to one day and the test questions were cut to 10.

Documents from the Taylor complaint include Intuitive emails about training from marketing officials and sales personnel. One, from 2009, was by a company clinical sales representative. It told one hospital that had suggested that new robot surgeons have at least five supervised procedures was “on the high side” and might have “some unintended consequences.”

What the rep might have meant, it seems, is that such careful oversight would cost $15,000 per urologist. The email said a similar requirement “slowed down” development of robotic surgery at another hospital. When the first hospital indicated it would “most likely” lower its requirement, the rep was congratulated in another company email, Bloomberg reports: “… [N]ice job on taking charge and ownership of your programs.”

Another company email by a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries. Translation: We’re about numbers, not safety. We’re about sales, not outcomes.

Myriam Curet, Intuitive’s chief medical advisor, told Bloomberg that company training includes an online quiz, practice simulators and a one-day course at Intuitive’s headquarters in Northern California and 14 hospitals across the country. Doctors new to the procedure are supposed to observe at least one robot operation and perform mock operations with their team. Most hospitals require the first few operations be supervised by an expert, Curet said.

But there’s no credentialing, there’s no regulated oversight; it’s up to doctors to decide how much training they need, Curet said. “We cannot require anything.”

Which is why several parties might share responsibility for a tragedy like Taylor’s. People, like institutions, don’t always do the right thing without being required to do so. We’re not moved by Intuitive’s argument to have the Taylor lawsuit dismissed: “…[C]redentialing and privileging for performing surgery at a hospital is solely the responsibility of the hospital. It is not the responsibility of a medical device manufacturer like Intuitive.”

Tellingly, the hospital where Taylor underwent surgery didn’t dispute that Taylor suffered complications. It settled the case for an undisclosed amount.

The FDA shares responsibility for robotic device misuse and poor patient outcomes—it first required that Intuitive submit the Da Vinci for approval in its most rigorous device review category. That’s reserved for products that aren’t seen as equivalent to anything already on the market (otherwise, devices can qualify for a faster approval).

But in spring 2000, the FDA reversed that decision and moved the robot into a less stringent category. By July 2000, it was approved for marketing. The earlier three-day training program simply wasn’t required. The agency left the training the details “to the discretion of Intuitive Surgical,” said one official in a statement.

Like Josette Taylor, we are left to wonder—who guards the guards?

If you or a loved one is scheduled for surgery your doctor wants to perform robotically, ask:

• Why is a robotic procedure preferable to traditional surgery?


• What are the risks of each approach?


• How many robotic surgeries have you performed with this device? (One expert told Bloomberg that it can take 200 operations to be proficient at robotic prostate cancer surgery; the Mayo Clinic says it can 90 procedures to be proficient in gynecological surgery.)


• Ask how long the hospital has had the robotic equipment—some hospitals feel pressured to use expensive technology as much as possible to recoup costs, even if their staffs haven’t been adequately trained.

Sometimes, reality is lost in the love for medical device technology. Just because something’s new doesn’t mean it’s better. A recent statement by the president of the American College of Obstetricians and Gynecologists advises caution when it comes to robotic surgery for hysterectomies.

Dr. James T. Breeden states, “Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.”

As in other surgeries, patients are given general anesthesia for robotic surgery. The surgeon uses a computer to direct a robotic arm in the control of tiny instruments inserted through small surgical incisions. An endoscope—a thin tube with a camera at the end—enables the surgeon to see magnified, three-dimensional images on a monitor.

We’ve noted some of the harms of robotic surgery, including tearing internal tissue and burning internal organs, and that in some procedures, their outcomes are no better than those of traditional surgery.

Lawsuits are rising against surgeons who commit malpractice with robotic machines and against the manufacturers who make them.

As Breeden points out, outcomes are directly associated with a surgeon’s skill, not just the tools he or she uses. Skill comes with years of training and practice, and any new technology comes with increased complications while the learning curve is mastered.

“Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons,” Breeden says. “While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes.

Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.”

Because the incisions are smaller and the procedure less invasive, robotic hysterectomy usually means shorter hospitalization, less discomfort and faster recovery compared with other approaches. But, often, a hysterectomy can be performed vaginally, without any abdominal incision. That’s the least invasive and least expensive option. “Based on its well-documented advantages and low complication rates, this is the procedure of choice whenever technically feasible,” Breeden says.

When vaginal hysterectomy isn’t possible, laparoscopic hysterectomy is the second least invasive and costly option for patients. That involves a smaller abdominal incision than total abdominal hysterectomy (TAH).

Both vaginal and laparoscopic procedures require fewer days of hospitalization and shorter recovery than TAH, and they have proven records for excellent outcomes and cost efficiencies.

But hospitals spend a lot of money on fancy robotic technology, and many surgeons are like kids with the latest Game Boy—as the saying goes, when you’re a hammer, everything looks like a nail.

Even if safety weren’t a consideration—and it always should be the primary concern—robotic hysterectomy should be scrutinized for its expense, Breeden says. Robots cost more than $1.7 million, and have $125,000 in annual maintenance costs.

Breeden refers to a recent study in the Journal of the American Medical Association (JAMA) finding that the percentage of hysterectomies performed robotically jumped in the last three years from less than 1 in 100 to 1 in 10. They were more than $2,000 more expensive for the patient and showed no demonstrable benefit.

“Aggressive direct-to-consumer marketing of the latest medical technologies may mislead the public into believing that [robotic hysterectomy is] the best choice,” Breeden says. “Our patients deserve and need factual information about all of their treatment options, including costs, so that they can make truly informed health-care decisions. Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated.”

Cost concerns aside, patients must consider safety. As reported by AboutLawsuits.com, an increasing number of lawsuits have been filed resulting from the use specifically of the da Vinci robotic device.

Bloomberg News told the story of one patient. Uterine growths were removed with a da Vinci robot, described by her gynecologist as “the latest, greatest” technique available.

Five weeks later, she felt something pop while she was using the toilet, and glanced down to see her intestine protruding from her vagina. The vaginal wound had failed to heal properly. Four years later, Blooomberg reports, the 41-year-old has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life.

“It didn’t help me one bit, the robot,” she told the news site. “It forever changed my life for the worse.”

Robot systems made by Intuitive Surgical Inc., including the da Vinci, are linked to at least 70 deaths since 2009, says Bloomberg.

“Many of the complaints allege that a potential cause of the da Vinci problems is a lack of training provided for doctors who use the device, particularly at smaller hospitals where there is not a large volume of procedures,” AboutLawsuits notes. “In addition, lawsuits indicate that many hospitals feel pressured by competition and marketing to buy a da Vinci, and then doctors are encouraged to use the machine as often as possible to help the hospital recoup costs.”

Those are not compelling reasons for patients to agree to undergo the robotic knife.

Two treatments are proven to lengthen the lives of women with ovarian cancer, but only 1 in 3 patients gets them, according to a new study. It's no mystery why. The old rule for better health care -- experience, experience, experience -- is proven out again.

Ovarian cancer is a bone-scary diagnosis because of its dismal prognosis. But the understandable fright causes many women to make illogical moves when they reach out for care: First, they often look to a familiar face for treatment, such as the obstetrician who birthed their children (who usually is qualified on paper to take out ovaries, but lacks big-time experience with ovarian cancer). Second, they think they have to get surgery in a matter of days, not weeks, and that leads them to grab onto whatever surgeon can see them first.

These are mistakes that can shorten lives. The two treatments that are shown to lengthen life of ovarian cancer patients are:

* Debulking surgery.

* Chemotherapy delivered directly to the inside of the abdomen, called intraperitoneal (IP) chemo.

The best advice for women with a new diagnosis of ovarian cancer is to get to a "center of excellence" for cancer treatment, and to make sure the surgery is done by a gynecologic oncologist. That's a gynecologist with extra training in women's cancers of the reproductive organs.

Also, make sure the surgeon does ovarian debulking surgeries at least about once a month, or a dozen times a year. The operation often takes six or more hours, and it's necessary to have a surgeon with the skill, experience and meticulous patience to take out all visible signs of the cancer from inside the lower abdomen.

The seeds of cancer are scattered like Rice Krispies, and the best result is for those women who get all visible cancer removed by the surgeon, and then get the pelvis washed out with IP chemo.

Read more about this in a takeout in the New York Times by Denise Grady.

If you're a patient facing serious heart surgery -- a transplant or a valve replacement, say, anything that requires surgeons to stop the heart from beating while they repair it -- you want the most skilled, experienced hands working inside your chest. All other things being equal, nobody wants a part-time doctor working on them.

But what if you could have "America's Doctor," Mehmet Oz, operate on you?

Before he became a television celebrity, Dr. Oz was an accomplished surgeon at New York-Presbyterian Hospital. He still is. He operates there every Thursday, and recently showed New Yorker writer Michael Specter what the inside of someone's chest looks like when the heart is completely stilled for intricate surgery. It created an arresting scene for Specter's profile of Oz, which he called, "The Operator." (You'll understand why the title is a double entendre when you read the piece, which you can find here.)

The reporter posed a hard question to Eric Rose, the surgeon who trained Oz:

I asked if he would place his confidence in a heart surgeon, no matter how gifted, who operated just once a week, as Oz does. “Well,” he replied, “in general you want a surgeon who lives and breathes his job, somebody who is above all devoted to that.” Again he mentioned Oz’s experience, but when I asked if he would send a patient to Oz for an operation, he looked uncomfortable. “No,” he said. “I wouldn’t. In many respects, Mehmet is now an entertainer. And he’s great at it. People learn a lot, and it can be meaningful in their lives. But that is a different job...."

Celebrity has a magnetic attraction. We all want to be around people who are famous and who dazzle us with their intelligence and personality. But does celebrity mix with surgery, where the surgeon's skills stay up-to-date only with constant practice?

No, it just doesn't.

UPDATE: John McKiggan, a top malpractice lawyer in Halifax, Canada, has written a blog on the same subject, pointing to the research on the number of hours of practice -- typically 10,000 -- that it takes someone in any field to become truly proficient. John says he would also decline Dr. Oz, and he notes that many hospitals have their own version of Dr. Oz, not a TV personality perhaps, but a senior surgeon who has taken on other duties that may have left him or her a bit rusty with the knife.

Bottom line: It pays to know in advance your surgeon's current work load and experience.

In 2010, Johnson & Johnson recalled an all-metal hip implant device because of a high failure rate and because the grinding of its components released tiny bits of metal that damaged tissue and bone. The company conducted an internal review of the device in 2011 that showed the implant would fail within five years in about 4 in 10 patients.

Only now, as reported by the New York Times, is that information coming to light.

J&J’s report is among hundreds of internal company documents, says The Times, expected to become public as the first of more than 10,000 lawsuits by patients who got the implant, the Articular Surface Replacement (ASR), went to trial yesterday.

Hip implants made of metal and plastic instead of the metal-on-metal design of the ASR often last for 15 years before they wear out, according to The Times. They can fail prematurely for a variety of reasons, but not at the rate of the recalled device. A premature replacement rate would be about 1 in 100 after a year, and 5 in 100 after five years.

J&J never released the dismal five-year failure results for the ASR. “But at the same time that the medical products giant was performing that analysis,” says The Times, “it was publicly playing down similar findings from a British implant registry about the device’s early failure rate.”

We’ve written about the problematic history of metal-on-metal hip implants, and the new disclosure about hidden company documents once again puts Johnson & Johnson’s DePuy Orthopaedics division in the hot seat: What did company officials know about the device’s problem before its recall? What actions did they take or fail to take?

How many more failures of this shoddy device are about to occur? How many more patients who had the surgery are facing more painful and expensive surgeries to replace it?

As The Times reports, last year J&J took a $3 billion charge so that money could be reserved for patients and lawyers involved in the upcoming product liability lawsuits. DePuy, The Times says, has offered to cover the cost for patients to correct the problems.

That’s nice, but, really, if the company knew of the high potential for such problems and did nothing to address them before they harmed thousands of people, is that really much consolation?

The discovery last week of the internal report is only a tiny bit of what will become public knowledge if the company doesn’t settle, and the lawsuit proceeds to trial. Plaintiffs’ lawyers have been preparing for two years, and who knows what other ugly secrets J&J was protecting.

Approximately 93,000 people around the world have received an ASR; more than 31,000 of them live in the U.S. Some 7,000 separate ASR lawsuits have been consolidated in a federal court in Ohio, and another 2,000, says The Times, have been consolidated in a California state court.

The California case that brought the internal report to light involved a cancer patient who might not live much longer. The paper said DePuy has settled some ASR cases before trial, and it may do so in his.

Cold comfort, indeed. But a testimonial, at least, to the power of lawsuits to unlodge secrets of corporate wrongdoing.

The authors of an unsettling study recently published in The Lancet concluded that thousands of people have had kidneys removed unnecessarily because doctors misdiagnosed their disease.

As interpreted in a story on ScienceDaily.com, 1 in 5 people with kidney tumors, which are common in patients with a genetic disorder known as tuberous sclerosis complex (TSC), had a kidney removed; 4 in 10 had some kind of surgical procedure. But according to the researchers, a proper diagnosis could have prompted treatment that involved neither surgery nor kidney removal.

TSC, according to the National Institutes of Health, is characterized by the growth of numerous noncancerous (benign) tumors that can occur in the skin, brain, kidneys and other organs. Sometimes they lead to significant health issues, including developmental problems.

According to ScienceDaily, TSC affects about 40,000 people in the U.S.; as many as 7 or 8 in 10 develop kidney problems because its multiple tumors compress normal renal tissue. That can lead to kidney failure, bleeding and shock.

As lead author Dr. John Bissler, a nephrologist (kidney specialist) who co-directs the Tuberous Sclerosis Clinic at Cincinnati Children’s Hospital Medical Center, told ScienceDaily, "I can't tell you how many times I've heard from patients who say their doctors told them a kidney looks bad, is full of tumors, isn't working and has to come out. But you can do studies on these patients and find out that they have normal kidney function. The kidney looks bad, but it works. Doctors are unfamiliar with tuberous sclerosis, so when they see tumors, they think it's renal cell carcinoma [a type of kidney cancer], perform surgeries trying to help, but before long the kidney is gone. This approach is unnecessary. …”

As many as 8 in 10 TSC patients experience tumor growth on vital organs called angiomyolipomas, or AMLs. A drug called Afinitor (everolimus) can shrink them. The FDA approved everolimus last year to treat noncancerous kidney tumors that don’t require immediate surgery for patients with TSC. It had been approved previously as an antirejection drug for organ transplant patients.

Bissler’s study involved 118 TSC patients at 24 treatment centers in 11 countries. Within a few months, everolimus substantially reduced the size of angiomyolipoma tumors in more than 4 in 10 people. Tumor reduction lasted an average of more than five months.

Traditionally, treatment for AMLs was arterial embolization, which uses a catheter to block the artery and stop blood flow to the tumor. That procedure, however, also can damage healthy tissue.

Studies in the 1990s determined the cause of TSC to be two defective genes. When they malfunction, a protein in the cell triggers uncontrolled tumor cell and blood vessel growth. With the discovery, everolimus attracted interest as a treatment for TSC.

The science is evolving, and like all difficult medical disorders, there’s no single approach that works for everybody. But for people with TSC who may be facing surgery, it makes sense to seek the opinion of a specialist in this disorder, and to inquire about drug treatment.

Side effects of everolimus range from the annoying—dry mouth, dry skin—to the serious—seizures, irregular heartbeat, swelling of the lips and tongue... For a complete description of the drug’s indications and possible harms, link here.

A couple of months ago, we posted a blog about surgical errors, specifically when the operating teams leave tools inside the patient. That’s an example of what’s known in the medical biz as a “never event.” That means it’s a mistake, a malpractice event, for which there is never any excuse and that should never happen.

Researchers from John Hopkins University School of Medicine published a story this month in the journal Surgery that disclosed that never events occur with shocking regularity. Leaving tools inside a wound, operating on the wrong body part or even the wrong body happen about 500 times a year. The researchers estimated that 80,000 never events occurred in U.S. hospitals between 1990 and 2010.

They said their estimates probably are on the low side.

The study said that malpractice claims were paid for 9,744 never events; payments totaled $1.3 billion. More than 6 in 100 never-event patients died, more than 32 in 100 suffered permanent injury and nearly 60 in 100 were temporarily injured.

According to the Washington Post, about half of those cases involved objects left inside the patient (usually sponges, as our story earlier this year noted). The other half were cases of the wrong body part being operated on, and 17 were people who weren’t supposed to have that surgery at all.

And those were only the cases for which claims were paid; if a patient didn’t experience or didn’t report harm, they weren’t represented in the study.

The Post said the study indicates which doctors are more likely to be involved with a never event—those who had been the defendant in prior malpractice claims. The data also showed that younger doctors were more likely to settle malpractice claims for never events.

Our friends at Pop Tort, the unfiltered civil justice blog sponsored by the Center for Justice & Democracy, remind us that only a tiny percentage of people injured by malpractice in this country file lawsuits, and the Johns Hopkins study assumed that 12 in 100 errors result in indemnity payments. Some people say only 3 in 100 such patients file claims. (Pop Tort refers readers to the Center’s resource, “Briefing Book, Medical Malpractice: By the Numbers.”)

As Pop Tort points out, the $1.3 billion paid out doesn’t include the additional health-care costs for the affected patients, most whom never file suit.

Although fining hospitals more severely for never events is a popular notion, Pop Tort proffers its own solution: “What if hospitals and medical societies stopped spending millions of dollars a year lobbying to limit the recovery to malpractice victims [see our post about malpractice “reform,”] and devoted that money instead to patient care? And how about a law that would double every jury award when a ‘never event’ caused the injury--a meaningful penalty where the money goes to the person actually injured (instead of a fine, where the money goes who knows where?) And stop demonizing injured patients and their attorneys. That would be a start.”

We applaud that approach, but more immediate solutions to the problem of never events, as the Washington Post noted, involve better hospital leadership and communication. “Hospitals that have implemented checklists have seen success in increasing communication between health-care providers. Others have reviewed their policies to see where patients might be slipping between the cracks, and made improvements that way.”

As the researchers wrote in Surgery, “We trail behind other high-risk industries that have used systematic approaches to successfully identify and reduce sentinel errors. Strategies used in other complex systems such as aviation may help provide a blueprint to examine both the individual and the institutional factors that contribute to these preventable and costly events.”

The health and medicine watchdog HealthNewsReview.org recently laid bare how regulatory absence can poison what’s supposed to be an objective, scientific analysis of the suitability of a surgical procedure.

In excerpting an article that has been accepted for future publication in Arthritis Care & Research, HealthNewsReview shows the wide cracks in how the FDA approves some medical devices. Known as the 510(k) expedited review process, the exercise allows certain devices to be approved for sale “without formal testing in clinical trials as long as they confer low or moderate risk to patients and are structurally similar to a previously approved device.”

We’ve examined how devices are approved by the FDA, and how nonsensical the 510(k) process can be. On its face, an expedited process has merit. Many people otherwise without treatment for their medical problems can receive relief faster when bureaucracy gets out of the way. But speed doesn’t always result in good medicine.

As the journal article points out, a “previously approved” device might have been approved under 510(k), “leading to daisy chains of approved devices going back for decades, most of which have not undergone rigorous premarket assessment in human subjects.”

And lax regulation invites conflicts of interest. Using a hypothetical example, the writers demonstrate how, because surgeons have few constraints on their choice of medical device, “many are able to decide for themselves when they wish to begin using newer models.”

In the authors’ scenario, a surgeon, Dr. Jones, reviews a total hip replacement procedure with the patient, a man in his 50s. Dr. Jones makes sure he understands his options, and the patient signs the surgical consent form. Everything seems kosher but, although the risks and benefits of total hip replacement were detailed, shouldn’t the patient have participated in the decision about which implant device to use?

The authors say that without regulatory demand, not all the evidence must be presented that would fully inform the patient about technical considerations and the surgeon’s personal beliefs and possible conflicts of interest.

What if Dr. Jones has received consulting fees from the manufacturer of one of the devices under consideration? As the authors note, “Orthopedists who receive industry support express, on average, a greater sense of shared goals and priorities with their vendors and sales representatives than surgeons who don’t.”

Doesn’t the patient deserve to know that?

Doctors with financial interests in medical devices aren’t limited to orthopedics—the industry is rife with cross-pollination of science and commerce in all manner of devices and drugs. Among the most active players are pharmaceutical manufacturers and the doctors they pay for research, consulting, speaking, travel and entertainment to (see our post).

Patients can’t make a fully informed decision about surgery unless they’re offered a clear, complete picture of all aspects of the procedure. To that end, the article authors suggest that for their hypothetical hip-replacement, “the informed consent process … be enriched with a greater focus on shared decision-making. This would include discussing the choice of implant and other technical decisions that may affect the outcome of the procedure, in addition to disclosing any relevant financial relationships. We note the challenge of providing patients with easily digestible information that helps them make decisions consistent with their own values.”

Yes, it’s challenging. But it’s necessary and only fair, for this and any surgical procedure.

Two studies about how hospitals care for patients confirm the wisdom of researching the facilities where you’re considering having an inpatient procedure, and for enlisting a strong patient advocate to act on your behalf once you’ve been admitted.

In our Better Health Care newsletter, we've addressed how to find the best hospitals and the importance of having someone to protect your interests while you’re hospitalized.

As reported on ScienceDaily.com, patients treated in “magnet” hospitals—or those recognized for their nursing excellence—recorded lower death rates than those in nonmagnet hospitals. The study, by the University of Pennsylvania School of Nursing, involved four states and 564 hospitals. The designation of “magnet” is conferred by the American Nurses Credentialing Center, and recognizes high-quality patient care, advanced nursing education and nursing innovation.

Approximately 400 U.S. health-care facilities are recognized as magnet hospitals, or about 8 in 100. The University of Pennsylvania study studied hospitals in California, Florida, Pennsylvania and New Jersey, representing more than 20 in 100 annual hospitalizations. Nearly 100,000 registered nurses were included in the study, which was published in the journal Medical Care.

Researchers analyzed data from 56 magnet and 508 nonmagnet hospitals with a focus on differences for surgical patients in the odds of mortality and “failure to rescue.” That term indicates measures taken to prevent adverse events, such as hospital-acquired infection, cardiac arrest, shock, etc. According to the Agency for Healthcare Research and Quality (AHRQ), this measure can signal the quality of monitoring, the effectiveness of actions taken once early complications are recognized, or both. The Pennsylvania researchers determined that magnet hospitals had 14 percent lower odds of death, and 12 percent lower odds of failure to rescue.

The study’s authors concluded that “Magnet recognition identifies existing quality and stimulates further positive organizational behavior that improves patient outcomes.”

Another study of interest to potential hospital patients was reported in the Annals of Surgery. It suggested that medical mistakes often are made during the postoperative care of patients who have undergone major elective surgery, putting them at risk for serious complications. Researchers found that patients at teaching hospitals routinely experience as many as five procedural mistakes during their recovery.

The most common of these errors are receiving the wrong drugs or drugs delivered the wrong way, and being given incorrect instructions, test results or diagnoses.

According to a story on Aboutlawsuits.com, more than half of what are known as “process failures” result in serious harm to patients; most, it appears, can be prevented.

The study was unusual in that its focus was what happens after, not during, surgery. The researchers investigated a large gastrointestinal surgery center and observed patients from the day after surgery until they were discharged. In 659 days of observed post-op care, there were 256 process failures. In more than 8 in 10 of those cases, the failure was preventable; in half of the cases, patients suffered harm as a result of the failure.

“Interventions to prevent process failures will improve the reliability of surgical postoperative care,” the study authors concluded, “and have the potential to reduce hospital stay.”

To find a magnet hospital, check out the resources of the American Nurses Credentialing Center.

This is part 2 of my talk to the American College of Surgeons about medical malpractice and how attorneys for injured patients can work together with organized medicine to make for better, safer care (and fewer lawsuits as a result). (Click here for part 1.)

I want to tell some very short stories about clients of mine where we had to bring malpractice lawsuits against their surgeons. You see the view in these kinds of symposiums from 40,000 feet. Here is the view from sea level.

Mike Wood, backhoe operator:

Mike Wood lost the median nerve controlling his left hand when a surgeon talked him into doing a procedure to open a blocked subclavian artery (under the shoulder blade) that was causing absolutely no symptoms. Instead of the standard approach through the groin or elbow, for percutaneous balloon access, the surgeon chose his own technique through the brachial plexus, cutting down through the tissue in the armpit, retracting the nerves, putting a catheter in the brachial artery and going upstream to unblock the subclavian. Mike Wood woke up in intense pain in the hand and he couldn't use first three digits. Another surgeon six weeks later found the median nerve swollen and dead in brachial area – a few millimeters from the suture that marked where the artery had been penetrated, and the area of damage matched the width of the retractor that must have pulled too hard and too long on the nerve.

Two vascular surgeons testified in defense at trial. They could cite no literature advocating the brachial plexus cut-down for what was supposed to be a non-invasive percutaneous (through the skin) balloon procedure, and they could cite no one they knew who did it this way. Nor did they unblock subclavian arteries this way. But they told the jury it was still OK.

They also testified about the indications for surgery. Despite the lack of any symptoms, and the lack of any support in the surgical literature for doing this surgery when the patient has no symptoms of pain in the arm or dizziness from the arm trying to grab blood flow from one of the arteries going up the back of the neck to the brain, they also said surgery was absolutely okay to do because of the possibility of future symptoms.

To me, Mr. Wood's case shows hows how overwhelming the case must be to win. And how the defense even defends the indefensible.

Another case: Jaime Vargas, bus mechanic:

Gall bladder removal: The surgeon cut off the common bile duct (the connection from the liver to the intestines), failed to recognize what he had done for two days, and worse, he did his own roux-en-Y repair and made the arm going to the liver so short the patient got a series of infections in the new bile duct, eventually destroyed the liver and he died.

The surgeon had no explanation for the initial injury: Still, the case was defended by two surgeons, who said the operator had done nothing wrong in failing to convert to open surgery or failing to do x-ray of the bile ducts to make sure he was cutting in the right place. Eventually this case settled shortly before trial, but only after Mr. Vargas had died from liver failure.

One more quick example: Billy Boone, home builder:

An ENT did surgery to clean out a benign growth behind his ear from his mastoid cavity, called cholesteatoma. Seventeen years before, another surgeon had done the same surgery, and had left a small hole in the base of his skull, but no injury. In the new surgery, the surgeon stuck an instrument through that hole into the base of his brain's temporal lobe. The operative report was silent about this. Only evidence was a CT scan two days post-op, done after patient complained of trouble reading the newspaper and retrieving names of close friends. CT scan showed a pencil diameter tract of air going from the base of the skull into the brain parenchyma, surrounded by a pool of blood.

The defense strategy was deny and defend. They couldn’t really say what had happened, but it had nothing to do with the surgery.

We won the trial, but the case went all the way to the highest court of Maryland. [Blog readers can find the decision here.]

I'm proud to say we made new law in Maryland for patients: giving them a right to know up front if their surgeon lacks experience in the type of surgery he proposes to do.

The Wood, Vargas and Boone cases had this in common – lack of experience by the surgeons.

Dr. Goldberg was a general ENT, not a neuro-otologist, no experience in revision mastoidectomies.

Wood’s surgeon was a cardiothoracic surgeon, not vascular, and had done this procedure once or twice before.

Vargas’s surgeon had been trained in the era of open gall bladder surgeries and was doing this laparascopically, which he had done maybe half a dozen before. More important, on the bile duct repair, he had done one previous in his entire life. A forty-five minute drive from this hospital was Johns Hopkins in Baltimore, which has full-time biliary surgeons who would not have made the basic error of the too-short roux-en-y arm that killed the patient.

American medicine has financial incentives that encourage inexperienced surgeons to not refer patients to better qualified surgeons. In fee for service medicine, the surgeon loses any fee if he refers the case out.

One legal reform could go a long way toward fixing this. If surgeons were employees of their hospitals, and not independent contractors, the employer would have both the muscle and the financial incentives to better supervise individual practitioners. It’s called enterprise liability.

• Enterprise liability: make the hospital (clinic, HMO, etc.) liable for everyone practicing within their institution, even “independent contractors.” This provides an incentive for meaningful peer review, meaningful institutional guidelines and enforcement. Lowers litigation expenses – one defendant, one set of attorneys. It also allows for more equitable spreading of the costs of insurance: instead of high-risk specialists being personally on the line for insurance premiums, the hospital can decide how to fairly allocate the costs of its coverage for all members of the surgical staff.

• Enterprise liability is already the rule in military and veterans’ health care. In fact, individual surgeons are immune from lawsuit. The patient must sue the federal government as the sole defendant.

Outside the government, medical practice is becoming more corporatized. Here in Washington, D.C., Johns Hopkins now owns two of our major hospitals. George Washington University has been buying up doctors’ group practices. Enterprise liability fits into a trend that’s already happening.

• A related concept is enterprise notice. Avoid patients having to sue all providers by letting them put on notice everyone, stop the statute of limitations clock, and add defendants later if discovery shows them to be culpable.

Let me turn to some of the other legal reforms you have been talking about today.

Here is one program that trial lawyers like me have no problem with, as long as it’s done in an even-handed and fair way. That is: Early offer/apology programs, or what I call "be open and honest with the patient."

Here are the essential elements I see for fairness in an early offer/apology program:

• Mandatory participation of all hospital staff, including non-employee physicians, in any apology program. Why? If not, patient who knows this is an “early offer/apology” hospital might think that failure to be approached means whatever happened to them was not a preventable compensable error.

• Right to hire own attorney: Advise patient in writing before any meeting. Encourage lawyer presence. No signing away legal rights without consult from independent counsel. Why? This is not a “full employment for lawyers” program but simply an evening of the scales concept. The hospital will have its own legal counsel, whether present in the room with patient meetings, or just behind the scene. Patients need their own counsel. Period. Any counsel must be completely independent from the hospital, not on any ‘favored attorneys’ list. This will ultimately protect hospital from later accusations of undue influence or fraud.

• Protect apologies from use in court but not facts of what went wrong.

• Stop clock on legal deadline for filing suit till end of talks between hospital and patient.

• Offer fair compensation.

• No penalties for patients who decline early offers.

This follows my simple litmus test: what would you want for a family member hurt by another medical provider that you’re not connected to.

Bottom line on early offers: Your institutions can do all of this now. You don’t need any laws passed to be open, honest and fair with your patients.

Let me speak to a couple of other reforms you have talked about today:

First, clinical practice guidelines, which you are calling "safe harbor" provisions.

• What you may not know is: We already use these in court, and the current system works well: Practice guidelines can be admitted into evidence by either side, with a sponsoring expert to explain. This is the rule under Federal Rule of Evidence 803-18 and similar rules in all states I know of except Minnesota.

• Allowing practice guidelines as “evidence” but not conclusive lets both sides explain to the fact finder why the guideline should or should not be given weight, based on:
– Relevance to this patient.
– Bias and conflicts of interest in the formulation of the guideline.
– Scientific evidence for the guideline.
– Guidelines that are conflicting, vague or otherwise wrong for this patient.

• The proposal for "safe harbor" guidelines as a One-way street – guidelines can exonerate but never implicate a doctor’s liability – is obviously unfair. You wouldn’t want that for a family member injured by medical care.

• If medicine really requires customized attention to individual patients, then guidelines will never be conclusive. If guidelines were conclusive in actual medical practice, that would turn doctors from the thinking professionals that they are now, into mere technicians. So why would you want conclusive guidelines in law that you would not want in medical practice.

• Last point on practice guidelines: I challenge people to show me a case where a doctor proved adherence to a relevant clinical guideline and still lost the case. I would not prosecute the case against that doctor and doubt if any sane colleague would.

Finally, health courts. I’ve already mentioned that having schedules of injury payments is a bureaucratic style solution that does not fit the way we typically work in America. Other problems:

First, there is no evidence of any unfair tilt in the current system toward patients. Quite the opposite.

Why does it happen over and over that indefensible cases go all the way to trial and even appeal, as in the cases of Mr. Wood and Mr. Boone.

Are juries biased? Absolutely yes. But not the way some of you might think. I wrote a book a few years ago about how patients can get better medical care so they never need the services of lawyers like me. And towards the end of the book – after I detailed a lot of common sense ways that patients can better participate in their own health care and improve its quality – I had a short passage about jury trials that I’m going to boil down here:

Seven studies over the past three decades have compared the outcome of jury trials with the private evaluations by the insurance company of their own doctors’ performance. The studies have been remarkably consistent: Even where doctor reviewers have rated the medical care “indefensible” or “poor,” plaintiffs win at trial no more than 50 percent of the time. When the doctor reviewers have rated the care “defensible,” the juries overwhelmingly agree, and vote for the defendant doctors 80 to 90 percent of the time. When different reviewers disagree about the quality of the care, and so the case is rated “unclear” or “a tossup,” the defendants still win around 70 percent of the time. Note the logical pattern in the research: As the evidence of negligence becomes more clear, the victim win rate goes up. But it almost never gets higher than 50 percent, even in the “indefensible” cases. Juries have a very heavy thumb on the scales of justice favoring the doctor defendant.

How are “indefensible” cases defended? For starters, juries never hear about the “indefensible” evaluations. Those are tucked into a very private file back at the insurance company headquarters. A skilled lawyer is hired to defend the case and is set loose to find an expert witness willing to defend the care. … the jury never hears about the turn-downs. For all the jury can see, the plaintiff has an expert, and the defense has an expert, and they’re both pretty glib, and so the benefit of the doubt goes to the doctor, who, after all, was only trying to help his patient.

So those of you who want to do away with juries and have professional fact finders or even “health courts”– just a friendly word of advice – be careful what you wish for. Any reasonably neutral decision maker will return verdicts for patients far more often than happens in our current 50 state system. You might want to look at what happens in federal courts with life-appointed judges from both political parties, who decide malpractice cases without a jury in lawsuits against government hospitals like the Veterans hospitals and military hospitals. The plantiff’s win rate before judges is considerably higher than for malpractice cases tried to juries, according to the U.S. Bureau of Justice Statistics.

More problems with health courts:

• First: Shift from negligence to preventability as the legal standard solves no problems. Fault is embedded in the idea that the harm could have been avoided. If we compensate all harms in hospitals, even non-preventable ones, the system loses all connection to accountability for doing poor job.

• Second: Who are we trying to help? Shouldn’t it be the patients who suffered the worst harms? Why would we shift to a system that in essence reduces payments to worst injured in order to fund payments for lesser injured? Patients with minor injuries can take care of themselves. It’s the crippled, maimed, paralyzed, brain-damaged patients, and family members of those killed, who need a system that tries to bring some measure of justice to what’s happened to them.

Let me wrap up:

I started this talk with the idea that both the leadership of surgeons and patient advocate attorneys want the same thing: to improve safety, reduce medical errors and have fewer injured patients knocking on my door and other attorneys.

We know that concerted safety reform efforts can have a dramatic impact on lowering malpractice payouts. Look at this slide that shows what happened at New York Presbyterian Hospital when they had a multi-year effort to reform the safety of their baby deliveries.

This is from a study published in 2011 in the American Journal of Obstetrics and Gynecology.

They not only dramatically cut their payouts, more important, they had a lot fewer “sentinel events,” which means many more healthy babies.

This is just one program in one hospital. Safety reform is something you can do even without the cooperation of the plaintiff’s bar. If you don’t like lawyers, that could be your best revenge, by making medicine safer and cutting down on our business.

To me and attorneys who do the kind of work I do, the statistics are stunning, but numbers themselves are not really the point. (Here are a few more pictures of my clients. There are many more.)

The point is that these are real human beings.

There are many more patients and many more stories just like these.

Their lives were broken by preventable medical events.

They need to be treated honestly and fairly by our compensation system.

They want us to pay it forward. To help make sure the same thing doesn’t happen to other people.

That’s the challenge for your and my professions.

(Click here for part 1 of my talk to the surgeons.)

I was honored to be invited to speak the other day to a leadership conference of the American College of Surgeons about medical malpractice. They assured me I could leave my bullet-proof vest at home, and true to their word, the assembled surgeons were cordial and asked excellent questions. Even better, they told me how helpful it was to hear from an attorney for injured patients and how they plan to do it again.

I spoke about how patient safety efforts could make for better care and greatly reduce the need for patients to come calling at my office. And I highlighted how the surgeons, mulling over possible "reforms" in the civil justice system in how malpractice cases are decided, ought to consider what I said should be the litmus test of fairness:

Is this reform something you would advocate if the tables were turned, and instead of speaking for doctors you were advocating for a family member injured by care at some medical institution other than your own?

Here are excerpts from my talk:

I feel honored to be here. You might see me as an adversary. After all, I have sued many of your member surgeons. In fact, I think we are natural allies. And I think the more we recognize how closely allied the leaders of the American surgeons are with attorneys who represent injured patients, the better we can make progress in our shared goals.

What do we both want? Your profession and mine both want high quality surgical care for all patients – where the right patient gets the right operation at the right time, done in the right way, by the right surgeon.

We both know that ideal cannot always be met. When things go wrong, when patients get hurt through no fault of their own, when looking back we can see the patient’s injury was entirely preventable, then I hope that we share two more goals:

First, to learn lessons so it doesn’t happen again – so the individuals involved in causing the harm are held accountable if they’ve done something wrong, and to hold the system accountable if it’s done something wrong, and to fix it. That means retraining, educating, coming up with new checklists and protocols. Malpractice cases can provide a powerful tool for re-education and reform. Injured patients know this already when they come see people like us. I hear so many of them say: “The money is not so important. I just don’t want the same thing to happen to somebody else.”

Second goal: to fix the harm to the individual patient. In the kinds of tragic injuries that I and other patient advocates work with – the patient’s health cannot be restored. So our civil justice system uses money as a poor but necessary substitute – to compensate the patient with money for what cannot be replaced in kind.

“Compensate” comes from a Latin word meaning: to weigh one thing against another – literally to balance things out. That’s what justice does.

Yours is an ancient and esteemed profession. Every day, surgeons across America cure disease, relieve pain, and make lives better.

I see what we attorneys for injured patients do as another form of healing – helping to restore broken lives to some measure of independence and dignity. Helping to balance things out.

Part of the legal healing process that health care providers should want to encourage is restoring the patient’s trust in their own doctors and nurses. Trust is a vital ingredient in health care. When injured patients are treated fairly in the legal system, it helps restore their trust.

...

About our American civil justice system, I feel the same way that Winston Churchill felt about the democratic form of government: Democracy, he said, is definitely the worst form of government … “except for all those other forms that have been tried from time to time.” Likewise, the civil justice system is easy to criticize. It’s too expensive, it takes too long to reach resolution, it can be emotionally difficult on all the participants.

But it’s not broken. And like other democratic institutions, nothing better has been invented for the fair resolution of disputes. Our system is fair to the participants, in several fundamental ways. I can think of at least three.

First, our justice system is even-handed. The same rules apply to both sides.

Second, our justice system respects the uniqueness of each human litigant. There are no pre-fab boxes that people are stuffed into. On the patient’s side, that means you get to try to prove the full dimensions of the injury, with no artificial barriers like one-size-fits-all damages caps, or set schedules of payments like so much for an eye, so much for a brain. On the health care provider’s side, it means proving what was unique to the care in your case that might justify the care and explain the injury.

Third, our justice system respects and maximizes the freedom of the litigants. Each side runs its own lawsuit. Each litigant hires whatever lawyer he wants, pays him whatever they negotiate, hires whatever expert witnesses they want, and then they present their cases in a courtroom presided over by a professional judge trained in neutrality, and usually decided by a jury drawn from a cross-section of the community.

[To be continued in my next blog post; click here to read it.]

Even when surgery is necessary, it’s scary. Common patient concerns include anesthesia, operating on the wrong body part, infection, and surgical stuff left inside your body after you are closed up. All these prospects are fairly remote, except for the risk of infection. But then you read a story like the one recently published in the New York Times and you wonder if you’ll ever consent to being cut open.

Four years after undergoing a hysterectomy, Sophia Savage experienced extreme pain and vomiting. A CT scan found that a surgical sponge, an artifact of her hysterectomy, had lodged in her abdomen. She underwent another operation to remove it, but it had adhered to her bladder and other viscera, and caused an infection that required the removal of a large segment of intestine.

Savage sued the original hospital and won $2.5 million in damages. But that award has been appealed, and her health has declined seriously. Unable to work, Savage has bowel problems, anxiety and depression. It’s a sad coincidence that nursing was her own former profession.

According to The Times, 4,000 cases of so-called “retained surgical items” occur every year in the U.S. Most of the items left behind are the gauzelike sponges used to absorb blood. A long operation might require dozens of them.

Failing to remove these infectious time bombs, experts say, is the result of surgical teams using a clunky method to account for their use. Usually, a surgical nurse keeps a manual count of sponges used, but an OR can be chaotic, and it’s easy to miscount. In 4 out of 5 cases in which sponges were left behind, the surgical team had declared them all accounted for.

Despite efforts by groups such as the Association of periOperative Registered Nurses and the American College of Surgeons many hospitals, The Times says, haven’t updated their procedures.

So patients are left at risk, Dr. Verna C. Gibbs, professor of surgery at the University of California, San Francisco, told The Times.

“In most instances, the patient is completely helpless,” said Gibbs, who is also the director of NoThing Left Behind, a national surgical patient safety project. “We’ve anesthetized them, we take away their ability to think, to breathe, and we cut them open and operate on them. There’s no patient advocate standing over them saying, ‘Don’t forget that sponge in them.’ I consider it a great affront that we still manage to leave our tools inside of people.”

Although sponges account for about 2 in 3 retained items, post-surgical patients are carrying around all sorts of stuff: clamps, scalpels, even scissors. But they’re easier to spot in a surgical cavity than balled-up, blood-soaked sponges, which are more likely to be left behind during abdominal operations and in overweight patients.

Technology to the rescue! Sponges can be tracked via radio-frequency tags, which are about the size of a grain of rice. As reported on PubMed.gov, one study reviewed 2,285 cases in which sponges were tracked using a system called RF Assure Detection, which alerts the team at the end of an operation if any sponges remain inside the patient. In this study, 23 forgotten sponges were recovered from nearly 3,000 patients. The cost was about $10 per procedure.

Another tracking system employs bar code technology. Every sponge is scanned before use and again when it’s retrieved.

But as effective as electronic tracking can be fewer than 1 in 100 hospitals use it, Dr. Berto Lopez, chief of the safety committee at West Palm Hospital in West Palm Beach, Fla., told The Times. His advocacy of the technology comes from personal experience: He was sued in 2009 for leaving a sponge inside a patient. Two nurses had assured him that all sponges had been accounted for, but they weren’t. Now he won’t operate in any hospital that does not use electronic tracking.

Depressingly, Lopez believes hospitals resist electronic tracking because they don’t want to spend the 10 bucks.

But Gibbs, of NoThing Left Behind, believes technology should augment manual counting, not replace it. Some hospitals, she told The Times, use inexpensive “counter bags” in which each sponge has its own compartment. If a compartment is empty at the end of an operation, a sponge is missing. Then the electronic tracking system can help find it.

Gibbs also believes that counting sponges should not be the responsibility of only nurses: Everyone in an operating room must share accountability. “Technology is but an aid,” Gibbs told the Times. “The way that safety problems are corrected and fixed is by changing the culture of the O.R.”

If you or a loved one is scheduled for surgery, inquire about the hospital’s procedures about retained surgical items. The hospital’s patient advocate and/or your surgeon should be willing to discuss it. Ask if there is a technological tracking procedure as well as a manual count. If you are not satisfied with the response, you might consider other hospital options.

To read about some surgical mistakes that proved to be learning opportunities, see our blog “Medical Mistakes that Led to a Greater Good.”

A disturbing story published last week in the New York Times raised anew questions about how profit sometimes is the primary consideration in performing medical procedures. Following a major hospital chain’s paper trail, The Times told a story of widespread overuse of cardiology resources with serious implications for patient safety.

In 2010, Stephen Johnson, the chief ethics officer of HCA, the largest for-profit hospital chain in the U.S, received a letter from a former nurse at a Florida hospital claiming that a doctor there was performing heart procedures on patients who didn’t need them. A two-month internal investigation confirmed the charge in a confidential memo by Johnson. The doctor was slapped on the wrist, but the nurse lost his job. That decision, Johnson said in the memo, was because he blew the whistle on the cardiologist.

“But the nurse’s complaint,” The Times reported, “was far from the only evidence that unnecessary — even dangerous — procedures were taking place at some HCA hospitals, driving up costs and increasing profits.”

According to The Times, Medicare reimburses hospitals about $10,000 for a cardiac stent—a tiny tube that holds an artery open. But recently, doctors have been less eager to implant stents, preferring drugs to treat blockages.

Another invasive test, cardiac catheterization, which Medicare reimburses at about $3,000, is used to diagnose blocked arteries. A long, thin, flexible tube (the catheter) is inserted into a blood vessel in the arm, groin, or neck and threaded to the heart, where it is used to inject dye into the heart's blood vessels to take x-ray pictures.

Even if necessary, these procedures pose a range of risks from infection, nerve damage, pain to death. Cardiologists generally don’t operate on coronary arteries unless they show at least 70 percent blockage. (See our story about unnecessary surgery here.)

Although The Times’ story focused only on HCA, a story published last week by ProPublica, an independent investigative organization, said that the practice of inflating the need for cardiac procedures is widespread.

ProPublica referred to a study published last year in the Journal of the American Medical Association that found that only half of 144,000 nonemergency heart catheterizations were appropriate.

"It's presented in the media as if it's an aberrancy, when actually it's the rule," Dr. David Brown, an interventional cardiologist and professor of medicine at SUNY-Stony Brook School of Medicine told ProPublica. "The medical system is addicted to the revenues that it generates."

Last year, Medicare spent nearly $1 billion on the procedures that boost revenues for doctors and hospitals but cost taxpayers, raise insurance premiums and put patients at risk—about 3 in 100 patients experience serious complication.

Since 2002, HCA itself had uncovered evidence that some cardiologists at several of its Florida hospitals were unable to prove the need for many of the procedures they were performing. To justify them, according to internal HCA documents, doctors wrote inflated medical reports to make it seem as though they were necessary.

Approximately half of one HCA hospital’s cardiac catheterizations—about 1,200—were deemed to have been performed on patients without significant heart disease, according to a 2010 confidential review.

At one hospital, a 44-year-old man who came to the emergency room complaining of chest pain suffered a punctured blood vessel and a near-fatal irregular heartbeat after a doctor performed a procedure that an outside expert later suggested might have been unnecessary. The patient had to be revived.

In another incident at the same hospital, a woman with no significant heart disease went into cardiac arrest after a vessel was cut when a cardiologist inserted a stent. She was hospitalized for several days.

Last month, the U.S. attorney’s office requested information on reviews assessing the medical necessity of interventional cardiology services provided at 10 of HCA’s hospitals. The Justice Department, according to the Associated Press, also will review billing and medical records at 95 HCA hospitals.

HCA declined to provide evidence that it had alerted Medicare, Medicaid or private insurance companies of its findings, or that it reimbursed them for any procedures the company determined had been unnecessary, never mind that such action is required by law.

HCA told The Times that it took the steps necessary to improve patient care, and that “significant actions were taken to investigate areas of concern, to bring in independent reviewers, and to take action where necessary.”

But HCA declined to show that it had ever notified patients, who might have been entitled to compensation from the hospital for any harm. And some of the doctors accused in the reviews of performing unnecessary procedures still practice at HCA hospitals.

How “significant” can its actions have been?

The Times reviewed hospital communications and concluded that rather than asking whether patients had been harmed or whether regulators needed to be contacted, hospital officials asked for information on how the physicians’ activities affected the hospitals’ bottom line.

Maybe that’s because HCA is less concerned about doing no harm than in recouping expenses for its chronic bad behavior. In 2000, HCA settled one in a series of huge Medicare fraud cases with the Justice Department that tallied $1.7 billion in fines and repayments, mostly concerning charges of overbilling.

Only two years after that fraud settlement, HCA started uncovering the “questions regarding the medical necessity of some of the procedures” that remain problematic.

Today, the surgeon who inserted a cardiac stent after the whistle-blowing nurse (and others) had seen no blockages in the images of the patient’s artery continues to practice at the same HCA hospital. This, despite the fact that an outside heart specialist found problems with 13 of the 17 cases the surgeon performed, including unwarranted cardiac catheterizations and patients who were needlessly subjected to multiple procedures.

To learn more about options for treating coronary problems, visit the website of the Informed Medical Decisions Foundation.

Routine screening for prostate cancer has been in the news a lot lately, and attention was renewed recently when the U.S. Preventive Services Task Force recommended that the PSA test be canceled for most men. Those experts concluded that only one life is saved for every 1,000 people screened over a 10-year period, that the rate of false positives is high and the side effects of treating them and cancers that are growing so slowly as to present little threat are unacceptable.

A new study published in the New England Journal of Medicine looked at surgery for early-stage prostate cancer patients and concluded much the same, as reported in the Los Angeles Times. “Most patients diagnosed with early-stage prostate cancer will live just as long if they simply watch their cancers rather than have them surgically removed.”

The problem with surgery as the default response to early-stage cancer is that the side effects are often worse than the disease—specifically, wound infection, urinary incontinence and sexual dysfunction. The study did find a slight benefit of surgery for patients with higher risk early cancers, including those whose blood levels of prostate-specific antigen (PSA) measure above 10 nanograms per milliliter or who had larger tumors whose cells appeared abnormal.

But for most men, "The trial gives us results that we have been waiting for in urology for quite some time," Mark S. Litwin, chairman of the UCLA department of urology, told the L.A. Times. "It confirms many of the recent reports that men with prostate cancer, by and large, can be safely managed with close monitoring."

That’s known as “watchful waiting,” and it’s rapidly being accepted as best practice for most patients with prostate concerns.

About half of the study subjects, who were tracked for about 10 years, died during the course of the study. Most of those deaths were not from prostate cancer, the authors noted, reinforcing the notion that more men die with prostate cancer than from it. Prostate disease affects 1 in 6 men.

The likelihood of death from any cause was the same for patients who had surgery and those who didn't.

Because only 1 in 10 of the study participants was younger than 60, its conclusions don’t necessarily apply to them. So for young patients, the jury is still out.

Outpatient surgery is an increasingly popular medical option, thanks to the cost of inpatient care and the expanding capability of outpatient facilities. More than 6 in 10 surgical procedures are conducted on a same-day-to-home basis. They include operations for cancer, orthopedic and gastrointestinal problems and plastic surgery.

But as we recently wrote in a related post, ambulatory care centers lack the rigorous oversight that is standard protocol for hospitals.

Now, a new study published in The Annals of Surgery raises the flag of concern that outpatient procedures carry a higher risk of life-threatening blood clots than similar inpatient care. Hospital patients undergoing surgery generally are apprised of the possibility of venous thromboembolism (VTE), and how to thwart it. VTE is a blood clot that forms within a vein, usually in the calf in an immobile leg. It's potentially lethal because it can migrate to the lungs (pulmonary embolism, or PE) and impede the ability to breathe, sometimes fatally.

Unlike inpatients, people who under go outpatient surgery often are not warned to watch for signs of VTE, according to the study’s authors. Less than half of outpatient centers have VTE prevention guidelines. Worse, the study showed, even fewer adhere to them.

Approximately 300, 000 Americans die each year from PE each year, most because of a failure of diagnosis rather than unsuccessful treatment. Surgical patients and their caregivers must be aware of VTE symptoms in order to neutralize the threat.

Researchers analyzed a national registry of more than 200,000 outpatient surgeries across the country to design a paradigm to predict a patient’s risk for VTE. Their study showed that 1 in 84 patients at highest risk suffered a dangerous blood clot after surgery. It’s well-known that vein surgery and arthroscopic surgery boost the risk for VTE. Other risk factors include:

• advanced age;


• obesity;


• longer surgery;


• pregnancy;


• active cancer.

“[The] data are in stark contrast to provider and patient expectations that outpatient surgery is a low-risk event,” said Christopher J. Pannucci, a surgeon at the University of Michigan and the the study’s lead author. “It also underscores the importance of evaluating a patient’s individual risk factors as opposed to procedure-type alone.”

The study signaled the need for better screening and prevention of venous thromboembolism especially for people who are obese and/or older than 65. Researchers advised that the informed consent process for outpatient surgery provide clear information about the risk for developing VTE, just as such guidelines are routine for inpatient surgery.

If you are scheduled to undergo same-day surgery, ask for the facility’s patient guidelines for preventing blood clots. If it has none, consider getting treatment elsewhere, or at least consult with your doctor about how to prevent VTE. No one is immune from this potentially lethal but quite preventable condition.

Medical malpractice is a huge problem in blood clot management, as this article on our firm's website discusses. You can read patient safety tips on blood clot prevention in another article here, which talks about the key warning signs of blood clots in the legs, and different warning signs of clots that may have moved to the lungs.

It’s another episode in the continuing drama of technology lust. Device manufacturers love to market their new, advanced and invariably expensive wares, hospitals love to leverage them for marketing and bill-enhancement, and doctors love them like middle-schoolers love the latest version of the iPad.

But the Da Vinci Surgical System continues to rack up a troubling record of patient harm. The robotic device, used in a variety of surgical procedures, enables surgeons looking at 3-D images through eyeholes to maneuver multiple arms with a joystick and perform surgery through tiny incisions. We’ve raised previous concerns about Da Vinci, and its most recent problem reports involve accidental tears and burns to internal organs, according to AboutLawsuits.com. Some of these adverse effects require multiple surgeries to repair, and some its patients have died.

Intuitive Surgical Inc., which manufactures Da Vinci, promotes the robot’s treatment of bladder, colorectal, gynecologic, kidney, prostate and throat cancers. It’s also marketed for coronary artery disease, endometriosis, heavy uterine bleeding, kidney disorders and obesity.

Questions about whether surgeons are being trained adequately in the use of the machine, and whether the higher cost of using it is worthwhile, are growing louder. A recent report by the Office of Medical and Scientific Justice joined the chorus of concern.

Da Vinci is complicated, and the journal Reviews in Urology said it can take 200 cases for some surgeons to become proficient with robotic surgery. Often, patients experience inferior outcomes while their doctors are scaling this learning curve. Some surgeons, the journal reported, simply don’t have patient volume sufficient to master the technique.

At a cost between $1 million and $2 million, the machines are used by hospitals to gain competitive edge, and surgeons may feel pressure to employ Da Vinci before they’re ready. In fact, the Journal of Clinical Oncology suggested that the increased cost of this technology over that of a traditional hysterectomy did not bring a noticeable benefit. The journal also said that women treated for endometrial cancer had about the same complication rates through traditional laparoscopy as they did with Da Vinci surgery, but that Da Vinci cost about $1,300 more.

Lawsuits prompted by the most common problems involve tears and burns to blood vessels, intestines and reproductive organs, complicated by the fact that problems generally aren’t apparent until after surgery, resulting in delayed treatment.

One lawsuit concerns a woman who suffered an artery burn during her hysterectomy. That prompted blood to pump directly into her body cavity, requiring three subsequent emergency surgeries. She died a couple weeks after the initial surgery. The lawsuit claims that Intuitive Surgical failed to adequately research the device or warn patients and the medical community that its use comes with substantial risk of complications and injuries.

Is Da Vinci defective? Is it defective only in less than skilled hands? Is it defective only for some applications?

Maybe lawsuits will answer these questions, maybe not. In the meantime, find out if there is a safer, equivalent means of performing your surgery. If your surgeon is adamant about using the device, ask how many such procedures he or she has performed. Ask how long the hospital has owned the device, and if you can see adverse reports about it. Consult the Manufacturer and User Facility Device Experience (MAUDE), a public database of voluntary reports of adverse events involving medical devices.

Just because your surgeon, your hospital and a manufacturer are excited about technology doesn’t mean it works for everyone.

Most people are aware of the increasing scrutiny of hospital performance in terms of patient safety. Better infection control and attention to readmission rates are among the criteria by which hospitals are measured and, in the case of Medicare, sometimes reimbursed.

But ambulatory facilities don’t fall within traditional hospital oversight, and a recent post on KevinMD by David B. Nash, dean of the Jefferson School of Population Health at Thomas Jefferson University, might raise some helpful consciousness about standards of care at these increasingly popular medical providers.

Ambulatory care facilities provide a range of medical services, including surgery, to outpatients who don’t require overnight care. (See our article, “Same Day Surgery.”)

We reported about one study concerning ambulatory surgery centers, but Nash invokes a report in 2000 by the Agency for Healthcare Research and Quality (AHRQ) noting that very little research actually has been done on medical errors and injuries in ambulatory settings. The AHRQ report made 11 recommendations to stimulate care standards research for ambulatory facilities.

Twelve years later, Nash notes, “almost none” of the recommendations has been implemented. This matters, he says, because a disproportionate and growing number of Americans are receiving care in ambulatory settings. “According to the American Medical Association,” he writes, “300 people are seen in ambulatory settings for every person admitted to a hospital.”

How hospitals care for patients is easier to study than how ambulatory centers do because hospital patients remain hospitalized for a longer period of time. Medical errors such as incorrect medication or the wrong dose of medicine are more difficult to track if the patient isn’t there when the symptoms present or the mistake is realized.

Sharpening the focus on ambulatory quality and safety is challenging because, unlike hospitals, such facilities don’t employ risk managers, compliance officers and chief quality officers to ensure that rules are established and followed. But something must be done, Nash says, because the vulnerability of patients in ambulatory centers was made clear by a recent study of outpatient malpractice claims.

Nash doesn’t say where the study was published, only that in 2009, paid malpractice claims tallied 4,910 for outpatient care and 4,448 for inpatient care. The total amount was higher for inpatient claims, but 2 in 3 of the outpatient claims involved major injury or death.

For the most common outpatient claims:

• 45 in 100 were for diagnostic problems;


• 30 in 100 were for treatment problems; and


• 14 in 100 were for surgical problems.

1. Conduct a large national study on the epidemiology (the incidence, distribution and control of disease in a given population) of ambulatory patient safety using accepted tools to screen for errors and chart reviews to detect harm in large ambulatory care clinics.

2. Identify and pursue an early and easily achievable goal, such as timely follow-up of abnormal test results.

3. Engage patients, their families and community organizations in ambulatory safety improvement efforts.

4. Link the ambulatory safety agenda to high-profile inpatient safety initiatives; for example, in concert with the initiative for reducing hospital readmissions, emphasize and study the role of ambulatory care clinicians in ensuring patient safety before, during and after hospitalizations.

5. Foster the development of a national system of clinics and practices that function as ambulatory safety “laboratories.”

The AHRQ has earmarked $74 million to research ambulatory quality and safety via health information technology, which signals the importance of increased scrutiny. But patients must be proactive as well.

If you intend to seek care from an ambulatory facility, ask to see its infection control procedures. If it doesn’t have one, go elsewhere. Find out if the providers who will treat you are board-certified in their fields. Research the facility’s medical professionals on your state’s medical licensing board’s website to find any complaints that have been lodged (states vary in their ability to track this activity, and in their ability to organize it for public consumption).

If you’re having surgery, find out the status of the surgery center’s license and certification, which enforce standards of care; just because the surgery center looks clean and professional doesn’t mean it meets professional standards. State health agencies keep a list of licenses for same-day surgery centers.

Ask: Who is giving me anesthesia? What are his or her qualifications? Ensure this person is at least a qualified registered nurse anesthetist, even for sedation.

Of course, if your problem is an emergency you might not have time for advance research. But you should always ask questions and persist until you’re satisfied with the answers.

Before your gall bladder surgery, you did everything you were supposed to. You made sure the hospital, lab and surgeon were part of your insurer’s provider network. You cleared the time off from work. You completed all the preliminary lab tests. You bought some cool new pajamas, and brought your own pillow to the hospital.

No wonder you felt sick when you received a whopping bill for anesthesia because the anesthesiologist you never even met was an out-of-network provider.

A recent story from Kaiser Health News (KHN) recounted tales from a New York investigation of patients who had been stung by surprise bills for medical services they either thought they had cleared in advance or had no idea they had incurred. Add to this the fact that insurers are shifting a greater percentage of the cost for out-of-network services to policyholders, and you have a lot of confused, righteously angry people.

Some of the bills were for treatment in an emergency room and others were scheduled medical services, often at in-network facilities. Here’s a sampling:

• A patient had gotten approval for an in-network surgery but received a bill for $7,515 because an out-of-network surgeon assisted.


• A patient requiring reattachment of his finger at an in-network emergency room received a bill for $83,000 bill from the out-of-network plastic surgeon who attended him.


• A surgical patient woke up to find that at least six doctors had signed the chart. None of the names was familiar to the patient, and all had charged for the exam/consultation while the patient was sleeping. Their fees were billed at more than $7,500.

To avoid the unpleasant surprise of an unexpected or unexpectedly large medical bill, do your due diligence in advance if your treatment is not an emergency (and, depending on its nature, possibly even then). Get confirmation from your insurance provider that the people and facilities providing your care are covered under your policy, and at what percentage. Ask your insurance company representative for ways you might be able to lower your costs, and if the company has an online “cost estimator” enabling you to get ballpark figures for both in- and out-of-network care.

Visit FAIR Health, a nonprofit organization with a national database of billed medical and dental services. Consumers can estimate and plan their medical and dental expenditures from averages derived from their Zip code, and learn how much is covered by typical insurance plans.

If you receive a medical bill you feel is unfair, contact your state’s consumer affairs department; many offer designated sites for medical billing complaints and resolution.

To avoid insurance and billing errors, see our recent post by linking here.

Surgery with the da Vinci robot to remove a cancerous prostate gland is guaranteed to dazzle the patient with the high-tech wizardry of it all. Problem is the outcomes in side effects that can disable men after prostate surgery -- incontinence and sexual dysfunction -- are no better than with conventional surgery. And the robot costs a lot more.

The latest of several studies to reach the same conclusion about the robot being less than it's cracked up to be is published in the Journal of Clinical Oncology. The authors randomly surveyed men who had had either robot or traditional surgery and found that both had high rates of sexual and urinary complications, with no advantage for the robot.

Dr. Michael Barry and his co-authors questioned whether this might be a case of "gizmo idolatry," the tendency in medicine to adopt new and expensive technology before there is real evidence of improved patient outcomes.

We've written before on our patient safety blog about benefits of the robot being oversold. Another critical issue for patients is the experience of the surgeon; the robot takes a lot more practice to get up to speed and reduce complication rates than does ordinary surgery.

As health care journalist blogger Gary Schwitzer notes, the marketing of the surgical robot gets hyped even more by naive news coverage with headlines like:

* Robot doctor – surgery of tomorrow
* Da Vinci puts magical touch on the prostate
* Cancer survivors meet lifesaving surgical robot
* Robotic surgeon’s hands never tremble
* Da Vinci is code for faster recovery

Once again, the take-home for patients is: Don't be dazzled by technology. What you want is a surgeon with a proven track record. Ask pointed questions, and don't assume that machines work better than experienced hands.

Article first published as Robot Surgery of the Prostate: No Evidence of Better Outcomes for Patients on Technorati.

No surgical patient wants to experience, or remember, the details of their operation, and the drugs given to put patients to sleep generally work nicely to create a blank slate in the mind for anything that happened after the anesthesiologist told the patient to start counting backward. But not always.

As many as 1 in 100 patients reports afterward that he or she was awake during the surgery, and can recount details of what was heard that make it clear it wasn't a dream. The psychic injury is worse because the paralysis that accompanies anesthesia usually means that aware patients can do nothing to signal to the doctor that they can hear what is going on.

Sometimes these patients are psychologically traumatized enough (with post-traumatic stress disorder) that they end up in the office of a malpractice lawyer like me, asking if they have a legitimate claim against the anesthesiologist or the surgeon.

The answer to that question is "Probably not," according to the latest research.

The problem is that while anesthesiologists have a rough idea of which patients are at high risk, nobody knows how to guarantee, or even improve the odds, that "intra-operative awareness" will not occur.

A study published this week in the New England Journal of Medicine assessed two possible ways of cutting the risk of intra-op awareness. One involved monitoring brain waves. The other involved measuring the concentration of anesthetic gases being exhaled by the patient. The study found that neither clearly worked, although there were fewer reports of intra-op awareness in the patients whose anesthetic gas levels were monitored.

You would think that if someone is awake by mistake during surgery, it means they weren't given enough anesthesia. But you would be wrong, according to the experts. Despite decades of research, we don't know that much about consciousness and memory, and their relationship to general anesthesia. And the ability to figure out during surgery who might still be awake when they look asleep is surprisingly rudimentary.

Here's the conclusion of an editorial on the subject that was also published in the NEJM, written by Gregory Crosby, M.D., an anesthesiologist at Brigham & Women's Hospital in Boston:

Monitors are meant to supplement, not supplant, clinical decision making, and depth-of-anesthesia monitors that reduce complex neurobiology to simple numbers are no exception. It is unreasonable to expect any such monitor to unfailingly detect conscious awareness — a specific and still mysterious property of the brain and mind — and neither patients nor physicians should think otherwise. Notwithstanding this and other weaknesses of current devices, a window into the anesthetized brain, albeit a foggy one, may still be useful, in conjunction with information from other monitors ... as a generic, all-purpose index of the brain's response to powerfully sedating drugs. Whether these devices add value in this way remains to be seen, but when minding the mind during sedation and general anesthesia, a little insight into how the brain is reacting is apt to be better than none, especially if it challenges historical ways of gauging anesthetic depth and catalyzes the search for something better.

Article first published as Awake by Mistake During Surgery: A Patient's Nightmare on Technorati.

It was supposed to be a routine hernia operation. But then the surgeon ordered the anesthesiologist to give the patient a blood-thinning drug. The anesthesiologist, who wasn't familiar with the drug, injected the drug directly into the patient's i.v. line, as soon as the surgeon ordered it. That was a double mistake, and it started a cascade of consequences for the patient, who later became our law firm's client.

The legal issue in the medical malpractice lawsuit we filed was: Who was responsible for the misuse of the drug? Just the anesthesiologist, who should have known better than to inject the drug intravenously, and so soon? Or the surgeon too?

That issue was finally resolved this week in our client's favor. Here is what happened.

The too-quick use of the drug Lovenox, which was intended to prevent blood clots in the legs after the surgery, caused bleeding in the spinal cord, with permanent nerve damage for our client. The use of the drug was against the "black box warning" on the drug's official labeling, which said doctors should wait after a spinal anesthetic at least several hours, and also against the official policy of the Washington, DC hospital where the surgery happened.

The anesthesiologist settled out of court on the eve of trial and turned over to the injured patient the anesthesiologist's cross-claim for "contribution" against the surgeon.

The trial court then ruled, after a hard-fought trial, that the surgeon was jointly responsible with the anesthesiologist for the injury.

After a long battle, the District of Columbia Court of Appeals affirmed the trial court's ruling in all respects. You can read the decision on our firm's website here.

A couple of implantable devices recently received new scrutiny with negative results.

Medtronic issued a “medical device correction” about possible diminished battery life of its infusion pump, the SynchroMed II. The device is surgically implanted to deliver painkilling medication.

According to About Lawsuits.com, of 140,000 implants worldwide, 55 were reported to have reduced battery performance. Designed to last 84 months, some batteries failed as early as 48 months. Medtronic issued a caution about the problem in July 2009, and an update earlier this month. And in February, certain models of the SynchroMed infusion pump were recalled thanks to a defective design that could result in an overdose during refill.

Pump failure can result in the return of pain, can cause patients to experience drug withdrawal and, for patients with multiple sclerosis who receive the drug baclofen, can be life-threatening.

The SynchroMed II is not being recalled, nor is it recommended that it be removed. Patients who have the device and whose symptoms reappear, or who hear a device alarm should contact their doctors immediately. For additional information, call Medtronic Patient Services, (800) 510-6735.

For women with pelvic organ prolapse, in which urinary and/or sexual organs droop or slip out of place, surgery is sometimes indicated. The FDA warns that if surgical mesh, rather than stitches, is implanted to strengthen the vagina, the risk of complications including tissue erosion, pain, infection, bleeding and urinary problems is greater. (Sometimes the mesh is implanted through the abdomen, which is not subject to the advisory.)

According to MedPage Today, “the number of adverse events linked to the device has been increasing in recent years.” Between 2008 and 2010, five times as many such events were reported than between 2005 and 2007.

"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," William Maisel, M.D., M.P.H., deputy director of FDA's center for devices and radiological health, said in a statement. "Mesh is a permanent implant--complete removal may not be possible and may not result in complete resolution of complications."

Although the mesh often corrects the anatomical issue, after reviewing reports for a 14-year period of use, the FDA concluded that the greater risk was not accompanied by greater clinical benefit than nonmesh surgery. Its advisory was issued in advance of a committee meeting in September to examine the safety and effectiveness of surgical mesh for the treatment.

As quoted by the McClatchy-Tribune News Service, Diana Zuckerman, president of the National Research Center for Women & Families, said an advisory wasn’t strong enough. “The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available.”

If your doctor has advised surgery to correct pelvic organ prolapse, be sure to discuss the implications of both mesh and stitches.

Generally, a gut-check is an informal, instinctive assessment. But researchers at the University of San Diego Health System took matters literally in studying the impact of gender in major gastrointestinal surgery. They found that women are more likely than men to survive the procedure.

Published in the Journal of Surgical Research, “The Battle of the Sexes: Women Win Out in Gastrointestinal Surgery” examines the major differences that affect treatment success, and aims to create new therapies that improve survivability of surgical patients.

“[M]edical outcomes could be optimized by tailoring therapies based upon each individual’s unique genetic make-up as well as other characteristics. Gender is among the most important traits,” said Carrie Y. Peterson, M.D., lead author of the study. Among the procedures that fell under her scientific knife: stomach, intestinal, liver and pancreatic surgeries.

“The results suggest that female hormones might enhance the immune system -- a process previously shown in animal models and also observed in trauma patients,” said Peterson. “Thus, there is a hope that negating the effects of testosterone or giving estrogen to male patients could be considered part of a treatment plan.”

Other factors that might contribute to higher survivability rates:

• females have more elective operations;


• females have surgery more often in teaching hospitals; and


• when symptoms occur, females seek medical attention sooner than men.

A study examining outcomes of heart and lung transplant surgery has concluded that patients fare essentially the same whether the transplants are performed during the day or at night. Two smaller previous studies – one on kidney transplants and the other on liver transplants – had indicated that patients tended to fare worse if the operations took place in the middle of the night.

The new study, published in the Journal of the American Medical Association, took into account all of the nearly 30,000 heart and lung transplants performed in the United States over 10 years. Researchers were surprised by the results, which indicated that, contrary to conventional wisdom, patient outcomes had little to do with the time of the operation or the fatigue of the surgeon. Rather, they seemed to hinge on the reliability of the surgical team.

Unlike surgeons in other specialties, cardiothoracic surgeons almost always work in the operating room with the same team of highly specialized anesthesiologists, nurses, physician assistants and technicians. The team’s familiarity with and constant repetition of the same complex steps — placing patients on bypass machines, performing certain intraoperative studies, even executing specific suture sequences — may be the key to ensuring consistent performance, whatever the time of day.

When performing a transplant, “the surgeon isn’t doing a complicated operation in the middle of the night with an anesthesiologist who usually staffs gynecology procedures and a nurse who works in the orthopedic operating rooms during the day,” says Dr. Ashish Shah, a co-author of the study and assistant professor of surgery at the Johns Hopkins University School of Medicine. “We need to think about doctors less like airline pilots and more like a part of a special forces military team. Those teams carry out complex tasks at a very high level and under less than ideal physiologic or environmental conditions.”

Source: The New York Times

You can read an abstract of the study here.

Doctors who aren't directly involved in patient safety issues often sail through their careers without much awareness of how commonly errors and malpractice infect hospitals, clinics and medical offices. Then they become patients, and suddenly their world is turned upside down.

Itzhak Brook, M.D., has been a doctor for more than 40 years. He is an infectious disease pediatrician at Georgetown University Hospital in Washington, D.C. Then he got throat cancer a few years ago.

His cancer was successfully removed, but then it came back. He had to have his voice box -- the larynx -- removed, and the throat was reconstructed.

It was then that the errors began to pile up, or, as he puts it, “mistakes occurred at all levels of my care.”

Dr. Brook recorded these incidents before, during and after his surgery:

* Surgeons had failed to timely diagnose the recurrence of his cancer. It was finally observed by an astute resident via a basic procedure that allowed visualization of the pyriform sinus, which was where his tumor was located. Had his experienced surgeons done the same basic procedure, his tumor most likely would have been observed and removed much earlier.

* Surgeons mistakenly removed scar tissue instead of the cancerous lesion. A week after the surgery, pathological studies revealed that the tumor was actually farther down in the pyriform sinus. This error could have been avoided if frozen sections of the lesion itself, not just its margins, had been analyzed in the operating room. As a result, he had to undergo additional surgery to remove the tumor, which was more difficult because of swelling and changes to the surgical site due to the original operation.

* While still in the ICU one day after surgery, he experienced an airway obstruction and couldn’t find his call button, which had fallen on the floor. Though he was only a few feet away from the nurses station, he was unable to get the attention of staff but was ignored. (He couldn’t call out because he no longer had a larynx).

* In what was probably the most serious error, he was fed soft food by mouth far too early, which, following laryngectomy with flap reconstruction, can lead to failure of integration by the flap. It took 16 hours before the feeding was stopped, and only after Dr. Brook brought this to the attention of a senior surgeon. The error occurred because the order to start feeding was in fact intended for another patient.

In addition, nurses and other staff:

Did not clean or wash their hands.

Did not use gloves.

Took oral temperature without placing the thermometer in a plastic sheath.

Used an inappropriately sized blood pressure cuff (which produced alarming readings).

Attempted to administer medications by mouth intended to be given by nasogastric tube.

Dissolved pills in hot water and fed them through the feeding tube (thus irritating the esophagus).

Delivered an incorrect dose of a medication.

Connected a suction machine directly to the port in the wall without a bottle of water.

Forgot to rinse the hydrogen peroxide used for cleaning the tracheal breathing tube (causing
severe irritation).

Did not write down verbal orders.

Fortunately, despite all these errors, Dr. Brook did not suffer any long-term consequences. Still, his experience made him realize that a hospital is the least safe place for patients, and that all hospitalized patients should have a dedicated patient advocate such as a family member or a friend at their bedside.

Dr. Brook writes extensively about his experiences as a throat cancer patient on his blog. He also lectures to medical groups to try to get doctors and nurses to understand the human costs of the epidemic of medical error.

You can also read Dr. Brook’s account of his hospital experiences in the Journal of Participatory Medicine.

It's a new story but an old story too: For-profit spine surgery centers recruit patients with promises of relieving their long-standing back pain with tiny cuts and high-tech lasers. Then comes a string of malpractice lawsuits from patients crippled by the surgery. Then the journalists mount the evidence: Big profits, many operations, little scrutiny from state or federal health regulators, and no evidence the high-tech stuff even works.

Bloomberg News just published this expose of malpractice issues at the Laser Spine Institute, which has surgery centers in Philadelphia, Tampa, Scottsdale and Oklahoma City.

One problem for patients is that there's no FDA for surgeons. Unlike drug companies which have to show scientific evidence that their products work, surgeons can make promises to patients about minimally invasive surgery and show testimonials from satisfied customers that make it all sound irresistible, even with no real scientific proof that their high-tech stuff works any better than what other surgeons offer.

The laser part of the surgery merely substitutes the laser beam for what other surgeons would accomplish with an electrical current. In both cases, the idea is to burn off sensitive nerve endings between the vertebrae. The problem is that no matter what device does the burning, the pain relief tends to be short-lived as the nerve endings grow back.

The other part of the typical surgery at Laser Spine Institute involves removing some of the bones surrounding the spinal cord when those bones have become overgrown and the spinal canal is narrowed and painful. That is standard back surgery. It's different at the Laser Spine Institute only in the doctors operating through smaller holes and viewing the operative site through telescopes (endoscopes) rather than direct vision.

Since the surgery is done at a same-day surgery center, patients are sent home or to hotel rooms afterward, and that can be a huge issue if something goes awry. For example, it's not uncommon that patients start bleeding near the spinal cord after back surgery. This can create a collection of blood near the spine that compresses the nerves and can cause paralysis and damage to nerves controlling bowel and bladder function -- known as cauda equina syndrome.

The Bloomberg article also documents malpractice issues with other for-profit spine surgery outfits that compete with Laser Spine for patients. Those include the Bonati Institute in Hudson, Florida and North American Spine of Dallas.

Another big problem with the business model of these spine outfits, which are competing for an estimated $73 billion that Americans spend annually seeking relief from back pain, is that surgeons are offered a "piece of the action" as investors in the profitability of the surgery center. That means that the more patients they send to surgery, and the bigger and more elaborate the operations they do, the more profit they make.

Sure enough, University of Michigan researchers found that surgeons increased their recommendations for back surgery by 87 percent after they became part owners of surgery centers. Their findings were published in the journal Health Affairs last year.

A pioneering new study of the popular liposuction surgery finds that the fat which a surgeon sucks out from one part of the body gets added back in elsewhere by Mother Nature.

The study published in the journal Obesity found that within a year, all the fat suctioned out in a liposuction was regained by the body -- not in the location of the liposuction but in other places such as the upper abdomen and shoulders.

Obesity researchers say that the body "defends" its fat, carefully regulating the total amount of fat in the body. So fat removed by surgery in this respect is no different from fat lost by dieting -- the body's natural mechanism tends toward putting that fact back on.

No one quite knows why liposuction fat doesn't come back in the same place, but researchers told the New York Times it may be due to the way that liposuction disrupts the fishnet structure under the skin where fat cells reside.

Since liposuction has been around since the 1970s, why hasn't a carefully controlled study like this been done before? It has a lot to do with surgeons who rely on anecdote to prove that their methods work, rather than careful statistical studies.

Most breast lumps found in women need to be looked at under the microscope to make sure they're not cancer. But new research says too many women are getting unnecessarily aggressive open biopsies, which produce a scar, when most of them could get enough tissue for sampling with a simple needle stick.

About 1.6 million breast biopsies are done every year in the United States, with about 200,000 of those resulting in a diagnosis of invasive cancer, which requires more treatment. That means that about seven in eight women who undergo biopsy receive the good news of no cancer (or the pre-invasive diagnosis of ductal carcinoma in situ).

Needle biopsy is the gold standard for the initial investigation of most suspicious breast lumps, except for those that a needle cannot reach. It can be done with numbing local anesthetic and a quick needle stick, which sometimes needs to be guided by x-ray imaging when the lump cannot be felt. In that case the needle biopsy is done by a radiologist, not a surgeon.

An open biopsy requires a one-inch incision, which leaves a scar, and must be done with either general anesthesia or sedation. It costs about twice as much as a needle biopsy, both for the surgeon's fee and the hospital's fee. And that could be the economic motivator for the persistently high rates of open biopsies still done in the U.S., according to researchers.

The new study of breast biopsies in Florida found that three in ten were done by the more expensive and scarring open technique, when the rate should be less than one in ten.

A New York Times piece on the new study quoted Dr. Melvin J. Silverstein, a breast cancer surgeon at Hoag Memorial Hospital Presbyterian in Newport Beach, Calif., as saying it was “outrageous” that 30 percent of breast biopsies were done by surgery. The article went on:

He said some of the unnecessary procedures were being performed by surgeons who did not want to lose biopsy fees by sending patients to a radiologist.

“I hate to even say that,” Dr. Silverstein said. “But I don’t know how else to explain these numbers.”

A woman in Napa, Ca., has been awarded $250,000 in a malpractice suit against the surgeon who removed her gallbladder and erroneously cut her hepatic duct. The verdict includes $70,393 for past medical expenses and $179,607 for pain and suffering.

According to court documents, while performing a laparoscopic cholecystectomy (gall bladder removal), the surgeon cut the hepatic duct instead of the cystic duct. The plaintiff’s lawyers argued that the surgeon could have attempted to identify the correct duct before cutting it by taking an x-ray picture -- an intraoperative cholangiogram, which many surgeons routinely perform in conjunction with laparoscopic cholecystectomies.

The surgeon argued unsuccessfully that the technique he used was not only within the standard of care, but was common and typical for surgeons with his training and experience with this procedure, and that injury to the hepatic (common bile) duct is a well-known potential complication of any gallbladder surgery. He also maintained that the patient’s anatomy was abnormal, in that the cystic duct was adherent to and congruent with the hepatic duct, effectively mimicking the cystic duct.

Nearly 500,000 laparoscopic cholecystectomies (commonly referred to as lap choles) are performed in the U.S. every year. In 0.04% (200) of those cases, the common bile duct or the hepatic duct is improperly cut.

Source: Napa Valley Register

Footnote: Nearly all of the time, it is possible for the surgeon to identify the correct structure and cut the connection to the gallbladder. The hepatic duct delivers bile from the liver to the intestines, where it performs life-essential functions in breaking down fats in food.

Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein.

According to the complaint, Mylotec allegedly sold video-guided catheters to Rothstein, even though the catheters were not FDA approved for use with a laser. “Myelotec representatives were present during many of the spinal surgeries conducted in Ohio and knew or should have known that the company was placing patients at risk by promoting and permitting the alteration of its devices for non-FDA approved surgical use,” the complaint says.

Rothstein claims to have pioneered a non-invasive laser spine surgery called AccuraScope. The former patients allege Rothstein’s surgery left them with nerve damage, pain, weakness, numbness, paralysis and incontinence.

Rothstein declared bankruptcy in June 2010. At that time, there were 19 active malpractice cases against him. Previously, he had settled at least three cases and lost two trials, including a $5 million judgment for a Clark County woman who was left with permanent brain damage due to an overdose of pain medication. The bankruptcy case – which is still pending – halted the remaining malpractice cases.

Source: Dayton Daily News

Research shows that a surgeon who has been working for 24 hours is impaired as much as a drunk person in thinking and motor function. So should patients have a right to know if their doctor has been up all night?

Yes, say a group of sleep researchers, who argued for full disclosure of sleep deprivation in a recent article in the prestigious New England Journal of Medicine.

No, responded the American College of Surgeons, whose leaders say it should be up to the individual surgeon to decide if he or she is too tired to operate -- or if the surgeon needs to tell the patient before heading to the OR.

The debate shows that surgeons and hospital administrators are just beginning to consider some basic issues of fatigue and patient safety that in other contexts -- piloting airliners and driving large trucks on interstate highways -- have long been settled.

Surgeons understandably don't want to be subject to the welter of bureaucratic rules that truck drivers and pilots deal with. And patients might not like it either if a surgeon was required to announce that he would be starting their surgery but another doctor would come into finish it because the time would stretch beyond the first doctor's hour limit.

But some sensible limits could easily be put in place. For one, the opportunity for a surgeon to work inhuman hours is created by hospitals who let a surgeon sign up for overnight call, which often results in working all night in the OR, and let the same surgeon schedule elective non-urgent cases for the next day.

Why would a surgeon do this in the first place? The lure of money, as a number of commenters on the New England Journal of Medicine website candidly admitted. Which raises a problem with the American College of Surgeons' idea that surgeons should be left to their good judgment on when and when not to operate. Anyone who schedules back-to-back call nights with elective cases is not showing good judgment in the first place.

Another issue for patient safety is the surgeon who is well rested but inexperienced, for not having gone through sleepless nights filled with surgical cases. Residency training programs are now starting to limit young surgeons to 16-hour days, which many surgeons say is going to result in a generation of rested but green doctors.

The right of informed consent gives at least one answer to the conundrum. Every patient has a right to know what any reasonable patient would want to know going into a surgery. And since we would all pause before submitting to the knife with a surgeon smelling of alcohol, the same right should apply to the less obvious danger of the sleep-deprived surgeon. If a doctor wouldn't want a family member to undergo surgery with that glassy-eyed doctor, then the same right should apply to all patients.

This means patients should be told, and should be given the option of rescheduling or bringing in a fresh replacement to operate. This will be inconvenient for hospital schedulers and may cause some surgeons to lose income. But patients will ultimately be safer for it.

And if hospitals want to minimize patients getting upset for having their plans upended at the last minute, all they have to do is adjust their call schedules to make these up-all-night dilemmas a rare event.

Article first published as Should Patients Have a Right to Know When Their Surgeon Has Been Up All Night? on Technorati.

An orthopedic surgeon who performed the wrong operation on a patient now says he no longer sees any burden in The Joint Commission’s (TJC) Universal Protocol for Preventing Wrong Site, Wrong Procedure and Wrong Person Surgery. And he's gone on the record in a prominent medical journal to confess error and try to help other surgeons do it right.

TJC’s universal protocol recommends that surgeons:

1. Conduct a pre-procedure verification process.

2. Mark the procedure site before the procedure is performed.

3. Perform a time out.

The surgeon, David C. Ring, M.D., was treating a 65-year-old woman whom he had diagnosed 3 months earlier with trigger finger, a common disorder in late adulthood in which a finger or thumb snaps or locks before unlocking (like a trigger), caused by a swollen flexor tendon.

According to Dr. Ring’s own account, the correct arm had been marked at the wrist by the nurse but the planned incision site on the hand was not marked. Dr. Ring performed three other carpal tunnel procedures that day, one of which was performed on a patient who became extremely agitated before and after the procedure, causing the surgeon to vow that the next procedure would be the best carpal tunnel release he’d ever performed. In addition, the patient was moved to another operating room, resulting in a change of personnel which meant the nurse who had had performed the preoperative assessment would not be in the room during the procedure.

About 15 minutes after performing the carpal tunnel procedure, Dr. Ring realized he had performed the wrong surgery. After informing staff, he told the patient about the error, apologized and offered to perform the correct procedure. The patient agreed, and the trigger finger release was performed. Later, the patient’s son informed Dr. Ring that the patient had lost faith in him and would not return for followup care. A financial settlement was negotiated shortly after the event.

Dr. Ring asked that the case be published in the Case Records of the Massachusetts General Hospital to encourage the development and following of procedures that would minimize the risk of such events occurring again.

Source: New England Journal of Medicine

You can view and download a poster of the Universal Protocol here.

Any lingering doubts about the positive effects of comprehensive surgical checklist intervention should vanish following the release of a study conducted in the Netherlands and published in the New England Journal of Medicine.

The Dutch study evaluated the effects of a comprehensive surgical checklist intervention in six regional and tertiary care centers in the Netherlands and involved 11 distinct checklists applied
during different phases of preoperative, intraoperative, and postoperative care completed by
surgeons, anesthesiologists, nurses and other staff.

The checklists included nearly 100 items that address the availability of imaging information, equipment and materials, patient and operative site verification, communication of postoperative instructions between caregivers and discharge instructions. Outcomes improved substantially as a result of this intervention. The proportion of patients with one or more complications fell from 15.4 to 10.6%, while mortality dropped from 1.5 to 0.8%.

A large international study supported by the World Health Organization (WHO) released last year reported similar results, showing that checklists cut surgical morbidity and mortality almost in half. However, not everybody was convinced by the findings of the WHO study, because:

1. The pre-intervention/post-intervention study failed to control for confounding factors, such as the the “surgical Hawthorne effect,” which states that outcomes tend to improve rapidly when surgeons know they are being evaluated.

2. The study’s operating room checklist consisted primarily of common-sense items and processes of care that seemed unrelated to the most common serious complications of surgery, making it implausible for some that improved compliance with these practices could lead to such drastic reductions in morbidity and mortality.

3. Compliance of the eight study hospitals with the checklists had no bearing on the extent of improvement in outcomes. Overall compliance with processes of care on the checklists improved negligibly even in the two hospitals with the greatest reductions in morbidity and mortality, while conversely, the two hospitals with the greatest increase in compliance showed no change in outcomes.

The Dutch study avoided these pitfalls by including hospitals that had already been tracking their surgical outcomes with the same detailed registry for many years, so the results cannot be attributed to the effects of performance feedback.

It also documented a strongly positive relationship between checklist compliance and outcomes, in that patients with incomplete checklists had significantly more complications than those for whom checklists were more fully completed.

Finally, the study included a control group. At five similar hospitals that did not implement the checklist intervention, morbidity and mortality were unchanged during the study period.

An editorial published with the article concluded that surgery checklists now have advanced from a good idea to "standard of care."

Source: New England Journal of Medicine

You can view an abstract of the Dutch study here.

You can view an abstract of an editorial about the Dutch study here.

When Trevor Roberts' leg bones snapped during a high school football game near Wichita, Kansas, he received the standard orthopedic treatment: a resetting of the bones with a titanium rod to hold them in place. So why did he have to have an above-the-knee amputation because of gangrene six days later?

The surgeon who had to remove most of the boy's leg, Dr. Archie Heddings at the University of Kansas Medical Center in Kansas City, told USA Today he thought the health care system had failed Roberts in some way.

Dr. Heddings told the newspaper:

"To me, in all honesty, I think this is a failure of the doctor-hospital system. I don't want to impugn anybody. But ... one of the first things you're supposed to do when there's an open fracture is get tetanus and antibiotics. Then, you take that person to the operating room and you get out all the dirt, you get out all the bone that doesn't have soft tissue attached to it — that's dead bone — and you take out all the dead muscle. And then if there's any question 48 hours later, you take the patient back to the operating room and look at the wound and make sure there's no dead muscle. If there is dead muscle, those bacteria have something they can reproduce in. And they'll ... start wreaking havoc."

From the newspaper's account, the first surgery to put the leg back together occurred at a Wichita hospital on the same Friday night as the injury. The 17-year-old was sent to his home near Lawrence, Kansas on the following Sunday. Then he had a high fever and went to another hospital in Lawrence two days later. It's not clear what happened at that visit, but he didn't get definitive care until two more days when he was back in the Lawrence hospital with another fever and a blistered foot. That brought him to the care of the surgeon in Kansas City who told the young man he had to amputate to save his life.

An investigation is under way to get to the bottom of this sad story.

Read the whole newspaper account by clicking here.

Ambulatory surgery centers (ASCs) that specialize and have high case volumes have better patient outcomes, according to a study by researchers at four U.S. universities.

The researchers found that the more a facility specialized in its services –and the higher its case volume for those services, the higher its patient quality scores. The researchers defined quality performance as the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

To perform the study, which examined potential associations among ASCs organizational strategy, structure and quality performance, the researchers obtained claims data for arthroscopy and colonoscopy procedures performed from 1997 to 2004. “Quality performance” was determined by the likelihood that an ASC patient undergoing surgery would avoid unplanned hospitalization within 30 days after the procedure.

Ambulatory surgery, or outpatient surgery, is provided for patients requiring less than a 24-hour stay. ASCs have become more common across the country because (a) advances in surgical technology and anesthesia have made surgery easier on patients and so consequently more in demand; and (b) the cost of providing the same procedure in an ASC is often considerably less than hospital outpatient surgery.

According to a KNG study, the specialties with the highest percentage of Medicare-certified ASCs in 2007 were ophthalmology (19%) and gastroenterology (18%), followed by pain management (8%), orthopedics (7%) and dermatology (4%). Multiple specialty ASCs comprised 35% of the total.

Source: Medical Care Research and Review

You can view the KNG study here.

Until now, it’s been easier to rate appliances and restaurants than surgeons in most parts of the country, but that should change now that surgeons who perform cardiac bypass surgery are being rated on objective quality measures in Consumer Reports magazine.

The consumer magazine recently published ratings of 221 surgical groups in 42 states online. The same ratings will be available in the October print issue. To date, only a few states, such as New York, compile data-based ratings of physicians.

The data Consumer Reports used to rate the physicians was collected the Society of Thoracic Surgeons, which includes more than 90% of cardiothoracic surgeons in the U.S. in its membership. Physician groups, not individual surgeons, were rated either above average, average or below average based on (a) complication and survival rates; (b) the surgical technique used; and (c) the type of medication(s) the patient was sent home with after surgery.

An article in the New England Journal of Medicine called the move to make this data public “a watershed event in health care accountability.”

The 221 groups rated in Consumer Report represent less than a quarter of physician groups that perform bypass surgery in the U.S., as only surgical groups that allowed their information to be published were rated. Of these, only five were rated below average, which is fortunate, because the gap in treatment between a below-average and an above-average surgical group can be extremely wide; for instance, at an above-average hospital, patients had a 92% chance of receiving the recommended medications when leaving the hospital; at one of the below-average hospitals, patients had only a 24% chance of getting the recommended drug.

For now, the information is available only to people who subscribe to Consumer Reports online and print subscribers. However, STS says it will make the ratings freely available on its web site in a few months.

Source: New York Times
Visit the web site of the Society of Thoracic Surgeons (STS) here.

A new patient safety organization has launched a range of online tools and other resources to reduce abuse of opioids by identifying the risks associated with their use. The materials from the CARES Alliance (Collaborating & Acting Responsibly to Ensure Safety) include several “safe-use” programs, tools and educational materials for patients, caregivers and healthcare providers.

They were developed using Failure Mode and Effect Analysis (FMEA), a scientific methodology that identifies where problems occur in the use of pain medications and the underlying causes of those problems. The FMEA research identified 79 areas where problems occur in the use of opioidsand 290 potential causes of those failures.

Tools now available include clinical materials and risk assessments for physicians, safe-use guides for patients and general education for all groups. The organization also plans to develop additional tools based on the research.

Jeffrey Gudin, MD, a pain management and addition specialist at the Englewood Hospital and Medical Center in Englewood, N.J., says that healthcare professionals need to do a better job of assessing our patients' pain medication needs and of communicating the risks of the medications they prescribe.

"Through the resources of the C.A.R.E.S. Alliance, patients, caregivers and health professionals will have access to information, tools and resources to help them better understand these risks and better ensure that the medications are used properly by only those for whom they are prescribed," he says.

The alliance, which is sponsored by Covidien, the largest producer of prescription pain medications in the U.S., also will work to ensure that patients suffering from chronic pain have access to necessary medications.

Source: Medical News Today
You can obtain tools and other resources here.

Nurse anesthetists have been proven to deliver about as safe and high quality care as physician anesthesiologists, but there's still a key question every patient should ask before being put to sleep by a nurse anesthetist.

"Is there a doctor anesthesiologist nearby in case there's an emergency during my surgery?"

That's the question you need to get answered. In most hospitals and many free-standing surgery centers, the answer will be, "Of course, we wouldn't dream of putting patients to sleep without an anesthesiologist supervising the anesthetists." But in other facilities, particularly same-day surgery centers, the answer will be, "No, we don't think it's necessary."

And that "no" should give you pause.

Anesthesiologists have MD degrees and broad training in medicine. They also spend a lot more years learning anesthesia than nurses who come up through a "CRNA" program (Certified Registered Nurse Anesthetist). It costs about six times as much to train an anesthesiologist as an anesthetist, and the anesthesiologists are paid about double what nurse anesthetists get paid.

If something goes terribly wrong during surgery -- and luckily that's a rare event nowadays, thanks to improvements in anesthesia technology over the last thirty years -- I know who I want nearby. That's an anesthesiologist.

You can read more about this in a series of letters to the editor in the New York Times debating the merits of state governments passing laws that opt their state out of the Medicare requirement that surgery centers have an anesthesiologist supervisor.

I discuss anesthesia and other issues about safe surgery in my book, "The Life You Save."

Healthcare providers need to know more about the efficacy and potency of hydromorphone, a pain killer frequently used as a morphine substitute in post-operative patients, to avoid medication errors and adverse drug reactions (ADR), says an advisory from the Pennsylvania Patient Safety Authority (PPSA).

Researchers hired by PPSA reviewed 1,694 medication error and 937 adverse event reports involving hydromorphone from January 2008 to October 2009. They identified lack of knowledge about hydromorphone potency and the difference in potency between morphine and hydromorphone as the most significant factors causing serious medication errors, particularly when a patient is switched from morphine to hydromorphone.

Hydromorphone is administered in doses that range from 0.4 mg to 2 mg, whereas patients may receive as much as 7-10 mg of morphine. Incorrect dosing may occur when prescribing, dispensing or administering hydromorphone when a physician, pharmacist or nurse confuses hydromorphone and morphine. Other medical errors noted in the study were giving patients the wrong drug and not noting a documented allergy.

Some adverse drug reactions to hydromorphone also may be preventable. The study found that of the 447 reported ADRs involving central nervous system or respiratory effects, 292 (65%) were preventable, and, of these, 205 (70%) resulted from dosing errors.

To reduce the number of medical errors and ADRs involving hydromorphone, the study recommended implementing risk reduction strategies such as constraints and standardization, which focus on system improvement. It also recommended writing hydromorphone with the first five letters capitalized (i.e. HYDROmorphone) to further distinguish it from morphine.

Source: Pennsylvania Patient Safety Authority
You can view the report here.

A long article in the New York Times brings home the dangers of women undergoing disfiguring surgery or radiation for breast cancer they never had. The story is a familiar one to malpractice attorneys but not well enough known to the public: The critical job of determining if breast tissue is cancerous or not is sometimes left in the hands of inexperienced pathologists who are prone to error.

The problem is worse with diagnosis of "ductal carcinoma in situ" (DCIS), an early form of cancer that may or may not progress to truly invasive cancer. The criteria for DCIS are sometimes subtle and not all pathologists agree on them.

What can patients do to protect themselves?

As I write in my book, "The Life You Save," you should never have any kind of cancer surgery without at least one second opinion on the biopsy. You can have a top cancer pathologist review your tissue slides for a cost of at most a few hundred dollars, and it might even be covered by your insurance.

Second, make sure the pathologist who interprets your specimen has enough experience. The College of American Pathologists now says 250 cases a year are the minimum for competence in this field, and it is starting a special certification program for breast cancer pathology.

The Times' article features Monica Long, a nurse in northern Michigan who had disfiguring breast surgery for DCIS, only to learn later that she never had it. She also learned too late that the pathologist at her hospital had only seen 50 cases a year and was not yet certified in any kind of pathology when he gave the reading on her tissue.

Some women get so scared by the diagnosis of DCIS that they have BOTH breasts removed. As previously reported in this blog, having a healthy breast removed does not improve a woman's statistical odds of survival. And as many as two out of three cases of DCIS never progress to full-fledged cancer. But such is the power of the "C" word to frighten people into doing anything -- even undergoing mutilation unnecessarily -- to try to stay alive.

This makes it all the more imperative for the pathology community to develop better criteria for the diagnosis of DCIS, and to improve the certification program so that this scary diagnosis is not made unless it's truly warranted.

The Times' "Well" blog has compelling accounts written in by other patients. Click here to browse them.

Reading these stories compels me to make another point: Unless you are financially destitute, I think it's a bad idea to let insurance coverage drive important medical decisions. If the insurance company won't pay for getting a second reading on the biopsy, scrape up the dough and get it done yourself. You'll be glad you did.

Among other second opinion providers, the Armed Forces Institute of Pathology in Washington, DC, gives second readings at a modest cost.

The greatest fear for any patient in the hospital, and the biggest nightmare for their families, is that something will go wrong suddenly and no one will respond until it's too late. Beeping monitors are no help if their alarms go unheeded. Patient safety experts know that one basic way to keep patients safe and prevent death or injury from malpractice is to have enough nurses on hand.

How many is enough? Nursing leaders got the state of California, after a 10-year fight with the hospital industry, to mandate minimum nurse-to-patient ratios: one nurse for every five post-surgery patients, one nurse for every two intensive care patients, one nurse for every four children in the pediatrics ward.

If you have a family member in the hospital, these numbers are worth keeping in mind. Ask the bedside nurse how many patients he or she is in charge of. And don't let hospital management confuse the issue by pointing out how many aides they have. Aides can plump pillows and give other comfort measures. But only a nurse can recognize when a patient is in peril and give lifesaving treatment.

A new study by a nursing professor at the University of Pennsylvania, Linda Aiken, asserts that mandatory minimum nurse-to-patient ratios like California's could prevent as many as 14 percent of post-surgery deaths in New Jersey hospitals and 11 percent in Pennsylvania.

Another important outcome of ensuring that nurses aren't overwhelmed by too many patients is that nurse burnout and job turnover go down, and overall quality of care improves, according to the study.

Theresa Brown, an oncology nurse in Pittsburgh, has an op-ed piece in the New York TImes asking why bills in Congress to mandate minimums nationally haven't gone anywhere.

Saving money, of course, is the issue. But that's a penny-wise answer. Saving lives can be a lot cheaper in the long run.

Nearly every week, I hear about a patient who had surgery to relieve terrible chronic back pain and ended up far worse off than before. One of the biggest problems is that money motivates surgeons to talk patients into much bigger and more complex operations than they really need -- and then those surgeries result in predictable complications.

The greed allegation sounds a bit harsh, but it comes straight from the top: The Journal of the American Medical Association, in an editorial by a leading Stanford orthopedic surgeon, Eugene Carragee, and in a study carried out by a group of doctors at Oregon Health and Science University led by Dr. Richard Deyo.

The Oregon study found that the rate of complex surgeries for back pain in Medicare patients jumped by 15-fold over a recent five-year period, but there was nothing in the patient population -- like increasingly complicated back deformities -- to justify the increase.

Joanne Silberner of NPR reported:

Deyo says there's no reason to think people suddenly started developing the spinal deformities that justify the complex surgeries. He offers several possibilities for the upswing. "Many surgeons genuinely believe that the more invasive procedures offer some benefits," he says. "But certainly there are important financial incentives at play as well." Surgical fees for simple decompressions are about $600 to $1,000. The complex surgeries earn surgeons as much as 10 times more. He says another possible factor is the tendency for both doctors and patients to go for a new, more expensive approach just because it sounds better.

The problem is that the more complex surgeries carry at least double the risk of a bad outcome, according to the Deyo study.

Most back pain that isn't relieved effectively with medicines or other non-surgical therapies is caused by disk herniation or spinal stenosis. Spinal stenosis is growth of bone near a nerve coming out of the spinal cord which presses on the nerve root and causes pain to radiate down a leg. The vast majority of patients who need back surgery because of spinal stenosis can be benefited from a fairly simple lumbar decompression. This involves removing bone, ligament and facet joint material which is compressing the nerve root. This operation has a high degree of success as it's been developed over the last 20 years.

According to Dr. Carragee's editorial, if the patient also has some deformity of the spine -- front to back or side to side -- the simple lumbar decompression can result in spine instability with increased deformity, so those patients might need a fusion where adjacent vertebrae are fixed together with bone grafts. But even here, simpler techniques get just as good results than more complex procedures that add metal or other instrumentation into the back.

A very small minority of patients, says Dr. Carragee, have spines that are so collapsed and twisted that the spine is unbalanced and tilted forward and the patient has severe pain and poor quality of life. These are the patients who might qualify for the complex surgeries now being done so commonly. Techniques have improved in the last ten years, but the surgeries in these patients still carry a very high complication rate -- 30 to 40 percent. And a lot more patients are getting the complex, multi-level surgeries than is warranted by the medical evidence, according to Dr. Carragee and other researchers.

Consumer Reports has rated spinal surgery as No. 1 on a list of overused tests and treatments.

As quoted by NPR, Dr. Deyo said he would like his study to alter the practice of medicine. "The effect I would hope it would have is to have surgeons and patients choose the least invasive procedure that would accomplish the surgical aim," he says. But he's pessimistic about it, unless there's a change in the financial incentives.

This is yet another area of medicine where it pays for patients to be skeptical and to get multiple opinions. It fits our natural instincts to think that bigger and more elaborate surgeries have a higher likelihood of success, but the human body proves over and over that it prefers minimal interventions.

More and more women with cancer in one breast are now opting to have the other healthy breast removed as well, even though the statistics show survival odds don't improve by having both breasts removed and most patients end up with chests that are numb to sensation.

Peace of mind is cited by many of these cancer patients for their decision.

A new report by Tara Parker-Pope in the New York Times details this trend, and the Times' "Well" blog has a number of interesting comments from women and cancer experts.

As many as three in ten breast cancer surgeries in large urban cancer centers are for preventive removal of the healthy breast, the Times reported.

But what is prevented, exactly?

The only women who get a very slight survival bump from having their healthy breast removed are patients under age 50 who have estrogen-negative cancers that don't respond to drugs like Tamoxifen. For everyone else, there is no real advantage in having the second breast removed. When the second breast gets cancer, as happens sometimes, that is not "spread" from the original cancer but is a new, unrelated cancer.

The real risk that women face from the original cancer is that it has already spread beyond the breast, but removal of the second breast doesn't help that risk.

The most striking evidence of how afraid of cancer women are is with DCIS: ductal carcinoma in situ, which is not even considered true cancer by many experts because it either disappears or never progresses in two-thirds of women. Yet still many women with DCIS are electing to have not just the one breast removed, but both.

Ultimately, this is an intensely personal decision. But it helps to get the true facts first.

Prostate surgery with a robot called "da Vinci" is often sold to patients as the latest and greatest technology and a way to get a better outcome. But on the key long-term complications -- urinary incontinence and erectile dysfunction -- the "minimally invasive" robotic surgery may be no better than traditional surgery, and may be worse if the operator is inexperienced.

A new study in the Journal of the American Medical Association criticizes the benefits of the "minimally invasive" surgery as oversold. The operation does cut the average time in the hospital from three days to two, but brings with it both more short-term complications plus more long-term injuries like impotence.

The lead author is Dr. Jim Hu of Brigham and Women's Hospital in Boston. "There has been rapid adoption of minimally invasive radical prostatectomy, however, outcomes have not been superior," Hu said.

Surgeons are trained to use the robot in a weekend course with the manufacturer. Dr. Hu said that a big part of the problem could be surgeons not getting enough experience with the device. He said he has now done more than 700 robotic prostate surgeries, but "it took several hundred cases before I thought I was doing really well in preserving erectile function and continence."

Articles about the new study can be found here and here

The new study brings home an issue that is discussed at length in Patrick Malone's book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst. Choosing the right surgeon is key to success, and patients need to ask about the surgeon's volume of cases exactly like theirs. For robotic prostate surgery, it's easy to find a surgeon with hundreds of cases. If that's an option, why would anyone settle for a surgeon who has only done a few dozen?

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Pennsylvania continues to lead the nation in showing how public health authorities can cast a little disinfecting sunshine onto the patient safety practices of hospitals.

In its latest report, the Pennsylvania Patient Safety Authority says that in 2008, a total of 194 surgery patients were sewed up with a foreign object still inside them. They have a term for it: RFO, for Retained Foreign Object.

To avoid leaving behind a sponge, needle or other instrument, the nurses and doctors involved in any surgery are supposed to go through a counting ritual. The problem is that the count doesn't always end correctly. In fact, the same Authority reported that last year, there were over 2,000 instances of incorrect counts, which doesn't always mean an object has actually been left behind.

One technique to follow up when there has been a discrepancy in the count is to do an x-ray of the affected area. That should show up any hidden objects.

The RFO problem is expensive for patients and hospitals. According to the Consumer Union Safe Patient Project, the average cost of a hospital stay for the corrective surgery and other problems that come from a retained object is $62,631.

Vertebroplasty is a popular surgical technique for treating patients who suffer "crush" fractures of their vertebrae due to osteoporosis, the loss of bone mass that often comes with old age. Two newly published studies suggest that this procedure is going the way of other medical "fads" that showed early promise but failed to show a real benefit after extensive testing.

Both new studies were published in the New England Journal of Medicine in August 2009, and they found that the surgery was no better than doing nothing at relieving the patients' symptoms. Here is how one put it into perspective for an online publication, Medscape Neurology.

Lead investigator of the second trial, Rachelle Buchbinder, PhD, from Monash University in Malvern, Australia, raised similar concerns to Medscape Neurology. "There have been numerous examples of treatments that have looked promising in noncomparative studies but have subsequently been shown to be no better than placebo, a sham procedure, or standard care."

Dr. Buchbinder cites arthroscopy for osteoarthritis of the knee, bone marrow transplantation for breast cancer, embryonic neurons for severe Parkinson's disease, and from her own work, shock-wave therapy for plantar fasciitis. She suggests that each of these looked promising early on, but didn't do well after rigorous study.

It had previously been argued that performing a randomized placebo-controlledtrial of vertebroplasty is unnecessary and unethical in light of the published results of numerous studies that suggest a benefit. But Dr. Buchbinder said that the take-home message from her trial is that vertebroplasty was no better than a sham procedure for improving pain, function, and quality of life after an osteoporotic spinal fracture.

"Both treatment groups improved by about the same amount," she said. "In view of the known potential adverse effects and no benefit, vertebroplasty should not be used in clinical practice."

The bottom line for patients is that this is just another in a long string of popular medical innovations that failed to pan out, so wise patients should be wary about undergoing any new-fangled treatment before it is of proven benefit.

In a study published this week in The Lancet, a British research team found that surgical stockings given to stroke patients for prevention of blood clots do not work, reports Sam Lister of UK’s Times.

The compression stockings provide graduated pressure and should reduce swelling in the legs. Studies have shown that, for patients immobilized after surgery, these stockings effectively reduce formation of blood clots, which can be deadly when the clots travel up to the heart or lungs and obstruct blood flow.

However, in the new Lancet paper, scientists followed 2,500 stroke patients in Britain, Italy and Australia, and found that the use of compression stockings made no significant difference in the occurrence of DVT (deep vein thrombosis, the blood clots in the deep veins of the legs that can travel to the heart or lungs). Patients who wore the stockings actually suffered additional symptoms that include skin breaks, ulcers and blisters.

The results of the study were also presented at the European Stroke Conference on May 27 in Stockholm. Researchers believe this study conclusively shows compression stockings should not be recommended to stroke patients.

In 2008 alone, more than a million Americans underwent various coronary procedures, including balloon angioplasty and coronary artery bypass surgery. However, while these expensive measures can be lifesaving for some, they do not necessarily do a better job at protecting most people’s hearts than a heart-healthy lifestyle would, Jane Brody writes in the New York Times. Essentially, the surgeries are like “‘doing cosmetic surgery on coronary arteries, making them look pretty, but it’s not treating the underlying biology of these arteries,’” Brody quotes the Miami cardiologist and author, Dr. Michael Ozner.

Dr. Ozner is an advocate of preventive coronary care, which he believes is safer, less costly, and more effective than intervention. Interventional cardiology that involves invasive coronary procedures has become lucrative for hospitals and doctors, costing $60 billion a year in the U.S. But such procedures have not been proven to “prevent heart attacks or coronary mortality in most patients.” Worse, they may even be harmful; Brody quotes a 2006 report revealing that the stents inserted in angioplasty can elevate the chance that “a dangerous clot will form in a coronary artery.”

So how do patients find out whether they are candidates for invasive coronary procedures? Dr. Ozner, who authored “The Great American Heart Hoax,” urges patients to seek an independent second opinion if their doctors recommend surgery to them. He said that “unstable patients” who have symptoms that really warrant surgical interventions are those who are in the middle of a heart attack or those with severe chest pain from minimal exertion. If you do not experience any chest pains or cardiac symptoms, you likely do not need surgery on your heart.

Brody writes in the second of her two columns on coronary care about the alternative treatments of the heart. Many of these preventive measures have been well-established and are widely known: selecting foods that are found in the Mediterranean diet (rich in fish oil, nuts, seeds, vegetables and fruits), maintaining good dental hygiene (gum diseases are linked to chronic inflammation), reducing chronic stress (with adequate sleep and regular relaxation activities), and exercising regularly (only 15 minutes of exercise a day for five days a week can make a lot of difference).

People who follow these tips can reduce their risks for heart problems by up to 50%, while avoiding the costly and risky surgeries that have yet to be proven to prevent coronary deaths.

An international research team has shown that death and complication rates from surgery can be dramatically improved by using simple checklists to make sure that safety measures are taken before, during and after each operation.

The research project, involving nearly 8,000 patients at eight hospitals around the world, was done as part of the World Health Organization's program called Safe Surgery Saves Lives. The results were published in January 2009 in the New England Journal of Medicine.

When the surgical teams at the hospitals used the checklists, they found that death rates were cut in half and non-fatal complications by one-third.

The nineteen items on the surgical safety checklist include basic items like verifying that the team has the correct patient and the correct surgical site, making sure the pulse oximeter (which measures oxygen in the blood) is working, making sure antibiotics have been given within one hour before the start of the surgery to prevent infection, and confirming that x-rays needed for the case are on display in the operating room. One other item on the checklist is to have all members of the surgical team introduce themselves by name and role; this is intended to give permission to lower-status team members to speak up at a later time if they notice something wrong. Click here for the entire checklist from the WHO (which is part of the United Nations).

The Patrick Malone law firm has prosecuted many lawsuits against hospitals where these basic preventive steps were not done and their absence led to tragedy. Examples include non-functioning pulse oximeters, surgery done on the wrong body part, and failing to prepare for known possible risks like heavy bleeding.

Patrick Malone discusses steps that patients can take to make sure their surgeons follow safe practices in his new book, The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst, available at Amazon.

When a doctor knows that his patient would receive better care elsewhere, should he inform the patient and send him to another provider? While this question is yet to be settled among bioethicists and physicians themselves, authors of an article published recently in the journal, Public Library of Science Medicine, think doctors have an ethical obligation to tell patients that better care is available to them, according to the New York Times’ Denise Grady.

Research has shown that facilities that perform high volumes of a certain procedure do it better than those that perform the procedure less frequently. The difference is substantial, especially in surgeries of pancreatic and esophageal cancer, although “the experience of the surgeon and the whole medical team [is] important in any major cancer surgery.”

Only a few courts around the country have decided whether doctors have a legal duty to inform patients that another doctor might have more skill and experience performing a planned surgery. One of them is Maryland's highest court, the Court of Appeals, thanks to a client of Patrick Malone named Billy Boone who suffered brain damage after an ear surgeon punched a hole into Mr. Boone's brain.

Mr. Boone's case shows that surgeons' skills make a difference in much more than cancer surgeries. The Maryland Court of Appeals decided that Boone had a legal right to know that his surgeon did not have extensive experience doing the ear surgery that Mr. Boone underwent.

Mr. Boone had an outpatient surgery in January 2000, to remove a benign growth from the mastoid cavity behind his left ear. Dr. Seth Goldberg, an ear nose throat surgeon, performed this surgery, called a mastoidectomy. Seventeen years before, Mr. Boone underwent the same procedure, in which another surgeon drilled out the same mastoid to remove a cheesy growth of skin debris called a cholesteatoma. Unknown to Boone, the surgeon had become lost at one point during the procedure and drilled a hole in the skull just above the mastoid, near the bottom of the brain's temporal lobe. But nothing happened to his brain, which was protected by the tough fibrous shell below the skull called the dura. Years later, when Dr. Goldberg prepared for the new surgery, he took some CT scan pictures of the bone anatomy and saw the pencil-sized hole in the side of the skull.

Dr. Goldberg's surgery seemed uneventful, but after Boone went home, he developed a short-term memory problem that ruined his ability to do carpentry; worse, he developed a problem controlling his temper that unleashed itself at stressful moments on whoever happened to be nearby. Later, his neurologist explained to the jury that Boone's outbursts could be traced to injury in the limbic system that modulates emotional response.

A CT scan showed that a hole had been poked from the pre-existing skull defect into Boone's brain. A small pocket of air could be seen in the temporal lobe, surrounded by a pool of blood. But it wasn't just air in the brain – it was something slightly denser than air, likely surgical gelfoam which could have made its way there only if Dr. Goldberg had pushed it in to try to stop bleeding after he punched the first hole.

The key moment for Mr. Boone came not in the surgery but a month before, when he sat down with Dr. Goldberg to go over the planned operation. Goldberg never volunteered the key information: that with the hole in the skull from the prior surgery, his surgery would be that much more difficult, could even result in an injury to the brain, and Mr. Boone might benefit from consulting with someone who regularly did "revision mastoidectomies," the technical term for this second go-round. A general ENT doctor who advertised his specialty in facial cosmetic work like nose jobs – he named his professional corporation the "Aesthetic Facial Surgery Center of Rockville" – Goldberg only had done occasional revision mastoid surgeries. His operation on Boone proved he wasn't up to the job. On the witness stand, Goldberg admitted he hadn't discussed with Boone the hole in the skull, the chance of brain damage, or the availability of sub-specialists called neurotologists. For Billy Boone, the jury's vote in his favor, and the Court of Appeals' affirmance of the award, gave him some vindication. For other patients, his win makes it easier to demand the information you need to make a sensible selection among surgeons. Of course, if you asked Billy Boone, he would trade in legal vindication for a healthy brain any day. It's too late for him, but not for the rest of us.

(Click here for more information on the Boone case, and follow this link to Mr. Patrick Malone's closing argument.)

It is instructive and interesting to read about Senator Edward Kennedy's treatment for his brain tumor.

The linked article describes the change in direction between May 20th of this year, when Kennedy's brain cancer was first disclosed and surgery was not discussed as a possible treatment, and two weeks later, when neurosurgeons performed a "successful" surgery on his brain.

Why the change? From the article:

Precisely why Mr. Kennedy’s treatment course changed is not known; he and his doctors are not talking to reporters.

What is known is that a few days after Mr. Kennedy learned he had a malignant brain tumor in the left parietal lobe, he invited a group of national experts to discuss his case.

The meeting on May 30 was extraordinary in at least two ways.

One was the ability of a powerful patient — in this case, a scion of a legendary political family and the chairman of the Senate’s health committee — to summon noted consultants to learn about the latest therapy and research findings.

The second was his efficiency in quickly convening more than a dozen experts from at least six academic centers. Some flew to Boston. Others participated by telephone after receiving pertinent test results and other medical records.

As the article notes, Senator Kennedy called similar conferences of experts when one of his children was diagnosed with bone cancer and the other with lung cancer. He has been known to advise his colleagues in the Senate to use this method when dealing with an illness in the family.

Obviously, powerful senators can do things the rest of us cannot. Again, from the article:

Mr. Kennedy can tap leading doctors for answers in a way few patients could. His celebrity status aside, he has spent a career promoting insurance and other ways to improve the health of Americans. And he has had a track record of being thorough and diligent in researching medical options when relatives or friends have fallen ill.

Nevertheless, despite Kennedy's power and influence, there are ways in which the average person can imitate his example and seek second and third opinions on their medical care:

Several doctors not connected with Mr. Kennedy’s case said in interviews that they admired his resourcefulness in getting more opinions simultaneously. At the same time, these doctors said many average patients gained competent advice, without a command performance, by sending pertinent records to experts for their opinions.

Many patients search the Internet for medical information and ask that their scans and other data be sent electronically or by overnight services.

Then such patients visit, call or write the consultant.

The potential negative consequence of all this opinion-shopping is that people may focus on what they want to hear and disregard everything else. This is partly why the doctors quoted in the article strongly recommend actually meeting physicians whose advise you intend to take (rather than just sending records and receiving written responses). That way the physician can make sure your expectations are realistic and address your specific concerns.

Starting October 1, 2008, Medicare will no longer pay for eight hospital-acquired conditions that could be prevented if hospitals followed the proper guidelines.

Those eight conditions are bed sores, objects left inside the patient during surgery, falls that occur when the patient is in the hospital, blood incompatibility, air embolism, mediastinitis (infection of the area between the lungs, which can happen after a heart bypass surgery), catheter-associated urinary tract infections, and certain bloodstream infections. In addition, several other conditions have been proposed as additions to the list.

The purpose of this change is to provide an incentive for hospitals and health care providers to avoid errors and prevent neglect of patients. If both Medicare and the patient refuse to pay for treatment of a hospital-acquired condition, then the hospital is stuck with the costs, and most hospitals would obviously wish to avoid that.

This is a long-overdue incentive for hospitals to reduce the incidence of these events and injuries which should never happen.

Lasik is a popular laser surgery done on the eyes to correct vision. However, last week Lasik patients went to Washington D.C. to speak to the Food and Drug Administration on harmful side-effects that they experienced as a result of the surgery, including the following:

(1) Severe eye pain

(2) Dry eye

(3) Blurred vision

The effects of intense chronic pain can have a devastating effect on people's lives. One case was particularly extreme. From the article:

Colin Dorrian was in law school when dry eye made his contact lenses so intolerable that he sought Lasik, even though a doctor noted his pupils were pretty large. Both the dry eye and pupil size should have disqualified Dorrian, but he received Lasik anyway -- and his father described six years of eye pain and fuzzy vision before the suburban Philadelphia man killed himself last year.

"As soon as my eyes went bad, I fell into a deeper depression than I'd ever experienced, and I couldn't get out," Gerard Dorrian read from his son's suicide note.

One quoted patient said he was considered a "success" by doctors despite experiencing terrible after-effects:

Matt Kotsovolos, who worked for the Duke Eye Center when he had a more sophisticated Lasik procedure in 2006, said doctors classify him as a success because he now has 20-20 vision. But he said, "For the last two years I have suffered debilitating and unremitting eye pain."

These patients are demanding clearer standards for who can qualify for Lasik, as well as better information from the FDA on how many patients suffer these various side-effects.

A new study shows that heart surgery patients are more likely to die or suffer other problems if they get blood that has been sitting on the shelf for more than two weeks. The study, entitled Duration of Red-Cell Storage and Complications After Cardiac Surgery, was published in this week's New England Journal of Medicine.

From the linked Washington Post article:

A number of hospitals have re-evaluated long-standing practices and taken steps to minimize transfusions. One example: Duke University Medical Center in North Carolina has reduced its use of transfused blood products by 17 percent in the past 3 1/2 years.

Concern about the safety of older blood for cardiac patients is one reason for the change at Duke, said Dr. Sunil Rao, a Duke assistant professor of medicine who runs the cardiac catheterization labs at the Durham VA Medical Center.

If you will require a transfusion in the near future, this would be a good thing to ask your doctor and hospital about to find out their policy.

Out of nineteen industrialized nations, the U.S. has the most deaths that could have been prevented by access to timely, effective medical care.

Ellen Nolte and Martin McKee of the London School of Hygiene and Tropical Medicine performed the study, looking at deaths before the age of seventy-five caused by numerous diseases and complications. They found that France performed the best by this measure--though France, and other countries that ranked higher than the U.S., spends less money on health care than the U.S. does.

Not only was the U.S. the worst in these rankings, but we Americans are also ranked four places lower than we were in the last study (which covered 1997 and 1998). We are getting worse and spending more money.

Rhode Island Hospital has, for the third time this year, done a brain surgery on the wrong side of the patient's head.

The hospital has been fined $50,000 and has received a reprimand from the state Department of Health. In this most recent instance, the patient was 82 years old. Fortunately, the patient was unhurt by the mistake. However, in one of the previous instances of this mistake at this hospital, the patient died as a result.

Rhode Island Hospital has said that it will be conducting a review of its procedures and implementing reforms. One such reform would be to allow nurses greater power in ensuring that procedures are followed correctly. Another would be to mandate better verification of surgery plans, which would require better communication between surgeons and other doctors. These reforms highlight a major factor in averting medical errors: teamwork. The multiple healthcare professionals involved in taking care of a patient need to be empowered to speak up if they see something going wrong. They also need to know what the others are doing, and to make sure that they are not acting contrary to the recommendations and instructions of other healthcare providers. Performing a surgery on the wrong side of the head is only one possible thing that could go wrong in the absence of communication. Another example would be giving a patient medications that, combined with medicine the patient is already taking, could cause problems. Such errors can be minimized through proper communication between healthcare professionals.

For more information: When Surgeons Cut the Wrong Body Part

The risks of plastic surgery have been in the news lately thanks to the death of Donda West, mother of Kanye West. West died following a "tummy tuck," a common plastic surgery operation. At this time, the cause of her death is unclear.

In the wake of her death, the American Society of Plastic Surgeons issued a press release. They emphasize that plastic surgery is generally safe, but offer general suggestions as to what prospective patients should do to reduce their risk.

Research is the number one safety precaution: read studies about the risks and benefits of whatever procedure you are contemplating. Make sure you hear opinions from multiple sources: your primary care physician, your surgeon, medical journals and former patients who have undergone the procedure. Make sure you understand what will be happening to you every step of the way.

Furthermore, be sure to check the credentials of the experts who are giving you advice. The ASPS emphasizes making sure that your surgeon is board-certified and that your outpatient surgery center is accredited.

Most of these are common-sense procedures that ought to be applied to any surgery you may need to undergo. When it comes to plastic surgery, as it is often not part of an emergency procedure, you have the opportunity to take some time and research the risks before assuming them.

More resources:

FAQ from the ASPS on Outpatient Plastic Surgery

Ten Plastic Surgery Risks You Need to Know