DC Medical Malpractice & Patient Safety Blog

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.

If you're facing a hip or knee replacement, today's story in the New York Times is a fresh reminder of something we patient safety mavens see over and over with new drugs and devices: the new ones often work no better, and sometimes worse, than older versions on the market for a long time. But it takes much longer for the safety track record to develop for the new devices, and meantime billions in profits have been pulled down.

Barry Meier of the Times is on top of this story, as he is on so many of the ongoing troubles in the medical device industry.

The new study finds that new technology in hip and knee replacements, such as metal-on-metal hip joints, don't turn out to last any longer than their older cousins. Many Americans who have had early failures of new hip replacements can attest to that.

Another interesting angle is the source of the study: an Australian patient registry. We don't have such mandatory registries in the United States. When all patients are entered into a common database, it's easier to pick up early warning signals of safety issues.

A new study in BMJ , the British medical journal, has revived interest in the issue of the kind of materials best used for hip replacements.

Problems have long been reported from many quarters when metal is used to refashion both sides of the ball-and-socket hip joint. We wrote about one manufacturer’s defective product last year.

The trouble comes when the metal parts abrade each other, releasing tiny bits of metal into the surrounding tissue. Essentially, it’s metal poisoning, called metallosis, characterized by pain and inflammation that impedes the ability to walk.

In 2009, the FDA initiated a comprehensive evaluation of approved implants. And in May, the agency requested more information from metal hip replacement manufacturers to quantify and address the problem.

Now, the FDA-sponsored study results in BMJ “do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional metal on polyethylene or ceramic on polyethylene bearings.”

That means earlier technology, which used ceramic or, essentially, plastic, are just as effective as the latest technology—metal. Although metal conferred no advantage, the study showed, it was burdened with more problems that not only left patients uncomfortable and mobility-challenged, but possibly at a greater likelihood of needing follow-up surgery.

Many lawsuits have been filed involving metal-on-metal hip implants.

The study examined 3,139 hip-implant patients and data from more than 830,000 operations worldwide. “Evidence on implant revision did not favor metal on metal implants,” researchers wrote.” There is limited evidence regarding comparative effectiveness of various hip implant bearings, and the results do not indicate any advantage for metal on metal or ceramic on ceramic implants compared with traditional bearings.”

More than 700,000 joint replacements are performed every year in the Unites States; about 270,000 are hip replacements, and that number is expected to double over the next decade. The cost of the procedure is expected to rise as well.

Joint replacement, the study notes, is a generally successful operation that addresses a significant health issue. The recent popularity of metal is due in part because it enables the use of larger femoral heads (top of the thigh), which supposedly reduces the risk of dislocation and improves the functional outcomes in younger patients. But its use for older patients, according to one study, was popular as well, with 1 in 3 such patients receiving metal-on-metal implants.

Hip replacement surgery can be a godsend for people suffering from this degenerating joint problem. But if you’re scheduled for the procedure, ask your surgeon which device he or she is planning to use, and research its history. If it’s a metal-on-metal device, at least seek a second opinion.

Last week, the New York Times summed up pretty well what a lot of people have been thinking: “Poorly designed, hard-to-use computerized health records are a threat to patient safety, and an independent agency should be set up to investigate injuries and deaths linked to health information technology, according to a federal study…”

The paper was referring to “Health IT and Patient Safety: Building Safer Systems for Better Care," a report by the Institute of Medicine (IOM) calling for greater oversight of health-care technologies.

The U.S. Department of Health and Human Services (HHS) requested the IOM to evaluate electronic health records in the first place out of concern that some such products raised safety risks for patients. Practitioners were wondering if the boom in digital record-keeping is fostering a rash of medical errors thanks to balky, difficult or malfunctioning technology.

The report doesn’t decry the move – for reasons of both cost and care efficiency – from paper to electronic records, it just emphasizes that oversight must be part of the deal: “To achieve better health care, a robust infrastructure that supports learning and improving the safety of health IT is essential. Proactive steps must be taken to ensure that health IT is developed and implemented with safety as a primary focus. If appropriately implemented, health IT can help improve health care providers’ performance, better communication between patients and providers, and enhance patient safety, which ultimately may lead to better care for Americans.”

The IOM said an investigative agency -- like the National Transportation Safety Board, which investigates airline accidents and examines safety issues -- should be established for health-care technology. And that it should include tracking the safety performance of electronic health records.

So far, such efforts have yielded mixed results: There are tales of success, such as hospitals that use computerized, bar-coded prescription systems, but also tales of patient harm, such as delayed treatment due to lost data and/or problems with human-computer communication.

The IOM advised the Department of Health and Human Services (HHS) to devise a plan within 12 months to monitor patient safety risks associated with health IT, and to report on that progress every year. If, within a year, such progress is insufficient, the scientists’ group said the FDA should regulate these technologies, and that the agency should start planning for that now.

The IOM report is big on transparency. It is the government’s job to ensure that the private sector demonstrates concern for consumers by freely exchanging information about product use, “including details relating to patient safety.” You can’t establish a body of knowledge and develop a functioning market of safe products if you don’t share details of their risks.

This is thwarted today by the common practice of including nondisclosure clauses in contracts with vendors of IT health products. Such provisions impede efforts to improve safety by discouraging users from sharing information.

The report notes that clauses that limit liability (known as “hold harmless”) also undermine best-product practice by shifting liability “from the vendor to the users when an adverse event occurs.” As the story in The Times said, “Such language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.”

No one wants to stifle technological developments or the will to manage health care more efficiently. The key, as the IOM says, is to foster innovation without compromising safety.

As if there aren’t enough things to think about when a medical device is implanted into your body, here’s a new, 21st-century concern: hacking!

As reported on AboutLawsuits.com, Medtronic, the manufacturer of the Paradigm insulin pump, is investigating the cybersecurity of the drug delivery device used by diabetics in lieu of daily injections. The concern is that the pumps could be hacked, and reprogrammed to overdose patients with insulin.

McAfee, a name known among computer users for its security software, identified the flaw, and indicated that the problem might not be limited to this particular piece of equipment. As medical devices increasingly rely on wireless technology for delivering meds such as antibiotics, chemotherapy and anesthesia, their software could be vulnerable to outsiders less concerned with medicine than life-threatening havoc.

So far, Medtronic has reported no hacking problems among its 200,000-some insulin pump patients.

But FDA warnings are nothing new to Medtronic; we recently wrote about problems with another of its infusion pumps, and a couple of years ago a Paradigm model was recalled.

But, really, hacking?

All-metal hip implants are proving to be a brewing epidemic of injury to patients: the failure rate is much higher than metal-plus plastic or ceramic hip implants, and now, doctors are finding that the metallic debris from wear and tear incites an immune reaction from the body that causes tissue damage.

When tiny fragments of metal wear off of the hip, the body responds by having scavenger cells gobble up the metal. These cells can chew the metal into smaller fragments, but those fragments include electrically charged ions, which can trigger damage to surrounding tissue and early implant failure.

Read more in this article by the New York Times' Barry Meier, who owns this failed hip implant story.

The Food and Drug Administration has received more complaints about defective metal-on-metal hip implants in the last six months than in the total previous four years combined, according to a report in the New York Times.

The defect complaints mainly concern the DePuy (Johnson & Johnson) A.S.R. hip implant device but also include the Zimmer Durom cup.

Reader comments to the Times include many who raise these questions:

* Why is there no national registry of devices implanted in the human body, to make it easier to catch up with defect issues before they become widespread? Other countries have this.

* Why does the FDA not mandate independent testing of permanent devices like hip implants before they are marketed? Why do the manufacturers control all the testing?

* Why couldn't the FDA foresee the issues with metal-on-metal hip implants which had been forecast in the medical literature for many years?

My take: Our system of regulating medical devices is badly flawed and in need of a big overhaul. This is the same conclusion reached recently by an independent panel of the Institute of Medicine.

The latest report from the prestigious Institute of Medicine -- about the nonsensicality of the current system where dangerous medical devices can get approved for sale with a grandfathering process called 510-k -- prompted this letter to the editor that summed it all up:

The problems are not new. They reflect an underfinanced and underpowered Food and Drug Administration, successful efforts by the device industry to block or blunt regulation, and the industry’s relationships with corruptible surgeons and members of Congress.

In the current ideological climate, we will hear a great deal about the dangers of “overregulation.” One must hope that the F.D.A. will be allowed to pay more attention to the Institute of Medicine than the onslaught from industry lawyers and lobbyists.

The author is HENRY GREENSPAN, who teachers ethics, politics and regulation at the University of Michigan, writing in the New York Times.

It's another science-versus-commerce face-off.

Last Friday, the Institute of Medicine released a report commissioned by the FDA that proposes a vastly different and more rigorous approval process for medical devices. In the wake of several recent, well-publicized recalls of devices causing grievous injury, such as hip implants, the report has generated attention well beyond the medical-regulatory nerd community.

As the IOM, an arm of the National Academy of Sciences, explained, "Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process.... Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective. Other policymakers and patients, as well as the medical-device industry, have asserted that the process has become too burdensome and time-consuming and that it is delaying important new medical devices from entering the market."

So the FDA asked the IOM to answer two questions:

• Does the current 510(k) process protect patients optimally and promote innovation in support of public health?


• If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process optimally?

The answers? No, and (we're paraphrasing here) you need a makeover.

"The IOM finds that the current 510(k) process is flawed right from its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process ... the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle."

Before the report was released, the medical device industry issued a pre-emptive strike. As reported in the New York Times, the industry called the report biased, and claimed that a greater regulatory burden would retard innovation, cost jobs and harm patients. "An official of a group that represents surgeons who implant hips and other artificial joints," the paper reported, "has also voiced support for a recent filing by a pro-business organization that challenged the scientific report’s credibility and argued that the F.D.A. was statutorily required to ignore it."

If it's not surprising that device manufacturers would object to greater scrutiny and bureacracy, it's highly unusual for any business interest to orchestrate a campaign against a thoroughly vetted recommendation before its report has been published. The IOM, The Times said, "was unaware of a previous instance in which one of its reports, sight unseen, was the target of a similar effort to invalidate it."

Ralph F. Hall, a professor of law at the University of Minnesota who also represents the medical device industry, denied that the pre-publication diss was intended to undermine its message, but only to question the IOM's methods of review. “I could have waited until the report came out,” Hall told The Times. “That seems intellectually less than satisfactory with me.”

So, someone whose professional obligation is to thoughtfully and thoroughly examine circumstances and then carefully apply the law to them is OK with assumptions about something unseen and indictments of a 12-person panel of doctors, lawyers, and academics who did perform the necessary due diligence?

The FDA commissioned the report, but it isn't required to take its advice. In fact, as noted by MedPage Today, Jeffrey Shuren, M.D., and director of the FDA's Center for Devices and Radiological Health, said the agency isn't keen to dump the fast-track approval process for moderate-risk devices. "FDA believes that the 510(k) process should not be eliminated but we are open to additional proposals and approaches for continued improvement of our device review programs," Shuren said.

Still, the agency will invite the public to comment on the report, and hold a public meeting in the next few weeks.

Patient and consumer advocates applaud the IOM report. Diana Zuckerman, president of the National Research Center for Women and Families, told MedPage Today that there are four major problems with the 510(k) process:

• it doesn't require device-makers to submit clinical trials;


• it doesn't mandate inspections of manufacturing facilities;


• it doesn't require post-marketing studies;


• it doesn't give the FDA any authority to rescind approval if the device is found to be unsafe or ineffective.

Most devices, from low-tech tongue depressors to something more complicated, such as pacemakers -- are fast-tracked with 510(k) approval. That requires companies seeking approval for a low-to-moderate risk device to prove that it's substantially similar to another device on the market. Completely new and high-risk devices, such as an implanted heart defibrillator, must provide clinical data demonstrating safety and effectiveness.

As noted in The Times' story, so-called metal-on-metal artificial hips (the subject of much scrutiny and many lawsuits), seemed to work well when tested on mechanical simulators. But they failed when implanted in patients.

No one questions the fact that governmental oversight agencies can be inefficient and slow. But when the use of a product or device presents life-or-death issues, can you be careful enough?

To make your feelings known about the IOM report and to find information about recalled products and devices, contact the FDA's Center for Devices and Radiological Health:

(800) 638-2041; dsmica@fda.hhs.gov

Food and Drug Administration

10903 New Hampshire Avenue

WO66-5429

Silver Spring, MD 20993

That's the sellout price for a spine surgeon. Give or take a few million.

Like police officers, whose thin blue line separates them from “the other,” medical researchers and doctors are loath to diss their fellow professionals. But this week, the code of omerta was breached with a series of critical reports in The Spine Journal about industry-sponsored research in general and the use of a bone growth product in particular.

As noted in the New York Times, “It is extremely rare for researchers to publicly chastise colleagues, and editors of leading medical journals said they could not recall an instance in which a publication had dedicated an entire issue for such a singular purpose.”

At the center of attention is Infuse, a product manufactured by Medtronic that’s used in more than 100,000 spinal fusion surgeries in the U.S. each year to encourage growth of new bone so the spine fusion "takes." The Spine Journal articles claimed that researchers subsidized by Medtronic exaggerated the benefits of Infuse and minimized the risks.

All surgical procedures and all medical products carry some element of risk, large or small. Dumbfoundingly, some of Infuse’s defenders claimed it had no risk. None. Zip. Nil. Uh-huh, and I’m vacationing next month on Jupiter.

In a joint editorial, five doctors wrote, “It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research.”

Objective research and the “do no harm” vow apparently have their price, and for some of the so-called “scientists” championing Infuse, it is $12 million to $16 million—the median amount collected by researchers from Medtronic. Median. That means half got more. Clearly, for Medtronic, corrupting science is a good investment: In the most recent fiscal year, Medtronic earned an estimated $900 million from Infuse.

Infuse was approved by the FDA in 2002 for one type of spinal fusion, and as required, Medtronic reported complications in its use that the agency considered sufficiently significant to require the company to list them on the product label. But, as the New York Times explained, “in reporting on such studies in 13 medical journal articles published during the last decade, researchers whose studies were paid for by Medtronic maintained that Infuse’s use was not tied to any complications.”

In addition to its approved use, Infuse is used for other spinal procedures. The Justice Department, however, has been conducting a criminal investigation to determine whether Medtronic illegally promoted such off-label uses, which the company denies.

At this point, Medtronic's credibility, and that of the people who speak for its scientific authority, is thin.

DePuy's now notorious metal-on-metal artificial hip, known as the ASR, was marketed as the next great thing in orthopedics, but actually was a recycled old design that ignored warnings from industry insiders that the all-metal construction was subject to dangerous flaking of metal fragments inside the patient's body.

That's the conclusion of a new takeout on the artificial hip saga from the New York Times' Barry Meier, who has written extensively on the DePuy debacle and other defective products in the medical device world.

The article also discusses a disturbing loophole in FDA regulations that allowed products like the DePuy ASR onto the market with little testing, because the manufacturer could argue that they were close enough to an old design that they should be grandfathered into approval.

“Alarm fatigue” caused by the rising use of monitors is distracting and numbing hospital personnel with deadly results, the Boston Globe reports.

An investigation by the newspaper reveals that more than 200 hospital patient deaths in the U.S. between January 2005 and June 2010 are linked to problems with alarms on patient monitors that track heart function, breathing, and other vital signs.

Typically, the problem isn’t the equipment, but rather the failure by medical personnel to react with urgency or notice the alarm. As monitor use continues to increase, the audible beeps from the machines can become so relentless that nurses become desensitized. How relentless? At a 15-bed unit at Johns Hopkins Hospital in Baltimore, staff documented an average of 942 alarms per day — about 1 critical alarm every 90 seconds.

Nurses said the number of alarms can be so overwhelming that they turn into background noise — although a dozen nurses interviewed by the Globe said they have never seen a nurse purposely ignore an alarm. The problem, says one nurse, is that “everyone who walks in the door gets a monitor. We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

In addition, the devices themselves have flaws that contribute to alarm fatigue. For example, monitors can be so sensitive that alarms go off when patients sit up, turn over or cough. Some studies have found more than 85 percent of alarms are false (i.e. they go off when the patient isn't in danger. Over time this can make nurses less and less likely to respond urgently to the sound.

In many cases, of course, nurses miss alarms warning of problems that aren’t life-threatening. But even the highest-level crisis alarms, which are typically faster and higher-pitched, also may go unheeded.

In one extreme case, a cardiac monitor blared 19 dangerous arrhythmia alarms for nearly 2 hours before staff silenced the alarms temporarily without treating the patient, who died. In other instances, staff have misprogrammed complicated monitors or forgotten to turn them on.

Hospitals that have experienced alarm-related deaths have aggressively addressed the issue, hiring nurses and technicians whose sole job is to monitor the monitors and modifying monitors to make them less sensitive to unimportant changes and less prone to false alarms. But overall, hospitals and the medical device industry have yet to seriously tackle the issue.

Source: The Boston Globe

If you wanted to lobby for a law that wipes out the rights of patients to hold hospitals, drug manufacturers and doctors accountable when they hurt people by carelessness and wrongful conduct, what would you call your group?

"Protect Patients Now!" It has a nice ring, doesn't it?

However, the people behind this campaign, which was launched in Washington to advocate for the H.R. 5 "tort reform" bill in Congress, are anything but patient advocates.

The campaign comes from a group called the Health Coalition on Liability and Access. A list of the coalition's members can be found on its website, and includes:

* Major medical malpractice insurance carriers (Pro Assurance, The Doctors' Company, Medical Protective);

* Doctors' lobbying organizations, especially those who have been active in political efforts to curb lawsuits (the AMA, plus neurosurgeons' and orthopedic surgeons' societies and others);

* Long-time "players" in the legal "reform" space, particularly the American Tort Reform Association, which got much of its seed money from the tobacco industry.

The coalition calls itself a "grassroots advocacy organization" but conspicuously absent from its membership are any of the consumer groups — Consumers Union and Public Citizen, to name two — who have been pushing the medical industry to make health care safer (and thereby solve its lawsuit problem).

H.R. 5 was sent to the floor of the U.S. House of Representatives this week by a party line vote of the House Judiciary Committee. The bill gives special breaks in the form of damage "caps" and other special treatment not only to all physicians, nurses and other individual caregivers, but also to drug manufacturers, nursing homes and hospitals.

The idea of H.R. 5 is that by making the medical industry less legally accountable for the harms it causes, Congress will free up the industry to become safer and provide cheaper care to more Americans.

I did not make that up.

The American Association for Justice (of which I am a member) has an online petition for concerned consumers to send a message to their Member of Congress about this bill.

Article first published as George Orwell Comes to Washington: The "Protect Patients Now" Lobbying Group on Technorati.

Yet more evidence that expensive technology drives treatment decisions in medicine: A new survey of prostate cancer treatment shows that once a hospital invests the $1 million to $2.5 million it takes to get a surgical robot, men in the area start to get a lot more prostate removal surgery than they otherwise would.

Although heavily marketed, robotic surgery has never been proven to reduce the two big risks of prostate removal: incontinence and impotence. And each surgery with a robot is about $2,000 more expensive than those done the traditional way.

An excerpt from a New York Times piece on the new study:

One reason for the increase in operations in hospitals that own a surgical robot may be that the technology helps a hospital lure potential surgical patients away from the competition. But the data also suggest that once a hospital obtains a robot, patients who might be candidates for nonsurgical options are more likely to be steered toward robotic surgery instead.

“This may be the medical embodiment of the phrase, ‘If you’re a hammer, everything looks like a nail,’”said the lead study author, Dr. Danil V. Makarov, assistant professor of urology at New York University’s Langone Medical Center. “If you have the technology, it will get used.’’

...

“If you’re a hospital and you get a robot, clearly you want to use it,’’ said Dr. David Penson, a study co-author and director of the Center for Surgical Quality and Outcomes Research at Vanderbilt University. “There are some real pressures here that have nothing to do with science,” he said. “We have this interplay of patients’ fascination with technology coupled with business interests on the part of the hospital and device makers, pushing people to try a new technology perhaps before it’s been fully tested.’’

And here's a good bottom line point for patients, also from the Times article:

“For patients, there are a lot of choices in prostate cancer,’’ said Dr. Makarov. “Knowing that technology can influence both what they want and what their physician may advise them should make them a little more skeptical and maybe make them ask a few more questions.’’

The medical community is waking up to an enormous problem with radiation – mainly X-rays and CT scans — used to diagnose disease and injury. Patients are getting too much radiation, and the excess itself causes injuries, many years down the road, in a big uptick in the risk of cancer.

Even a “routine” CT scan of the abdomen, ordered thousands of times every day in the United States for patients with belly pain, carries a large risk of downstream cancer, just from that single scan.

Dr. Rebecca Smith-Bindman, MD, of the University of California San Francisco, estimates a 20-year-old woman who undergoes a CT scan of the abdomen and pelvis has a one in 250 chance over her lifetime of getting cancer just from that single dose of radiation. This number was in a talk she gave recently at UCSF, as reported by her colleague Bob Wachter, MD, a patient safety expert at UCSF.

More scary statistics are in two articles Dr. Smith-Bindman and her colleagues published in Archives of Internal Medicine in 2009. There, they estimated that a single CT scan of the heart’s arteries (called a CT coronary angiogram, and promoted as being safer than the usual test called a cardiac catheterization) would cause cancer in one in 270 women and one in 600 men who underwent the test at age 40.

One problem is a huge range in the amount of radiation used at different facilities. Dr. Smith-Bindman’s group found a 13-fold variation from the lowest to the highest radiation exposure between scanners running the exact same imaging study.

She blames lax regulation by the Food and Drug Administration and lack of aggressive self-regulation by the medical physicists, working in hospitals, who are supposed to protect patients.

Most patients have no idea of the amount of radiation in one CT scan. It’s estimated to be about 200,000 times more than the radiation you get from going through an airport whole-body scanner, or about 450 times more than a simple chest X-ray.

Once people start to appreciate the risk, they realize that the pretty pictures produces by CT scans can have a very expensive cost down the road. It's something to remember the next time you see a billboard advertising “whole body scans” for healthy checkups, or “virtual colonoscopies” (to pick two examples of the heavily hyped types of CT scans now available).

Article first published as The Coming Cancer Epidemic from Overuse of CT Scans on Technorati.

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk. Only 21 devices (19%) had been approved through the more rigorous premarket approval (PMA) process, which requires clinical testing and inspections. (Eight other devices were exempt from any FDA regulation.)

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Originally, the 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids. It did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. Instead, it only required proof that the device was substantially equivalent in materials, purpose, and mechanism of action to another device that was already on the market, with the previous device serving as the “predicate” device with which the new device would be compared.

This approach was justified as a way to give manufacturers the opportunity to make small improvements on the devices already on the market and to allow companies with new products to compete with very similar devices without using the more extensive PMA process. If the FDA determined that the product was reasonably safe and effective according to the 510(k) review, it was said to be cleared for market rather than approved.

However, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which shifted the regulatory standard to "the least burdensome approach in all areas of medical device regulation." This had the practical effect of making 501(k) the dominant mechanism for new device clearance, with the FDA now reviewing only 1% of medical devices using the more rigorous PMA process.

To decrease the number of high-risk recalls, the study recommends:

1. The FDA fully implements current law that subjects "life-saving and life sustaining" (Class III) devices to the PMA process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

Source: The Los Angeles Times

You can read the complete study here.

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

Patients naturally assume that when a sophisticated metal implant like a hip replacement is surgically placed into their bodies, it must have been thoroughly tested before wide use. The now-recalled DePuy ASR hip replacement shows how wrong that assumption is.

A medical device manufacturer in the United States can cobble together new components into an old, already-approved device, and the new hybrid device is essentially grandfathered into government approval since it in theory closely resembles the old device.

As explained by New York Times reporter Barry Meier in a long outtake:

Unlike new drugs, many of which go through a series of clinical trials before receiving approval from the Food and Drug Administration, critical implants can be sold without such testing if a device, like an artificial hip, resembles an implant already approved and used on patients.

That way, manufacturers can rapidly make small changes to a device to improve it. But those simpler procedures have also effectively created a loophole, experts say, that lets producers bundle a component from an unapproved implant into an existing design and sell a device with minimal testing. With the A.S.R., that process unfolded with devastating results.

Read more here.

The Food and Drug Administration has issued Class I recalls of Hospira Symbiq One- and Two-Channel infusers and Medtronic Octopus Nuvo tissue stabilizers.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

The FDA is recalling Hospira’s infusion pump products due to motor encoder failures in the pumping mechanism that causes the infuser to cease operation. Delay or interruption of therapy may result in serious injury or death in: patients receiving critical therapy, pediatric patients, and neonates. The company mailed an “urgent device field correction” to affected customers and issued a recall notification in February 2010. All the affected units were distributed from Dec. 23, 2006 to January 22, 2010.

Medtronic’s Octopus Nuvo tissue stabilizers were manufactured from February 19, 2010 through August 28, 2010 and distributed from March 8, 2010 through September 7, 2010. The device stabilizes and minimizes the motion of selected areas of the beating heart during minimally invasive cardiac procedures while directly visualizing the heart through a small cut in the chest cavity. The FDA ordered the recall because of the possibility that a component of the device could fracture during use and fragments could fall into the patient’s chest cavity and/or damage the heart tissue, causing serious injury or death. Fortunately, no action from patients is required, since any adverse event related to the device would occur at the time of surgery.

Medtronic sent an “urgent medical device recall notice” to its customers on September 14, requesting that they discontinue use of the device, quarantine all unused devices and return unused devices.

Hospira recall source: Bioscience Technology

To view the FDA ruling on Hospira, click here.

Medtronic recall source: Operating Theatre Journal

To view the FDA ruling on Medtronic, click here.

Most consumers are shocked when they learn the reality of the early warning system for defective medical devices and drugs in the United States. Unlike Europe and most other advanced countries, there is no systematic, mandatory national registry of failures to provide an early warning system.

Manufacturers are required to send to the FDA reports of drug adverse reactions and device failures. But the manufacturers have no legal obligation to collect such data in the first place, except in the rare instances when the FDA uses its power to require such on a case-by-case basis.

The DePuy hip replacement recall in August 2010 repeats a familiar pattern. Hip replacement surgeons knew they were experiencing a lot of failures with the DePuy hips, but no one had systematic data, and everyone assumed the manufacturer knew what was up and would report promptly.

In March 2010, the company warned doctors there might be a high failure rate. Then in August, it issued the recall. Now many patients have hired lawyers to pursue lawsuits, but a better warning system might have prevented many of them from getting the defective device installed in the first place.

The New York Times has more here.

For years, patient safety experts have known that medical devices, like tubes that deliver food and drugs to hospitalized patients, need to be designed so that predictable mix-ups don't hurt patients. If a tube is safe if it goes through the nose to deliver food to the stomach, it should not be possible to hook up the same tube to a line that delivers medication to a blood vessel, since that could kill the patient.

But this basic safety philosophy -- which permeates other high-risk industries like aviation and nuclear power -- still hasn't penetrated the medical industry, as a new report in the New York Times documents in distressing detail.

Partly to blame is the U.S. Food and Drug Administration, which could set up uniform rules that would bar as unsafe any medical devices where fatal mix-ups could be easily made by hurried nurses or other caregivers.

The way the agency does its work is the problem. When the FDA has tried to act on a case-by-case basis with an application from a manufacturer for a new product, efforts by FDA safety reviewers to solve the problem have been met with cries from the new manufacturer that it is being unfairly singled out.

Efforts to have industry-wide regulations have met with years of bureaucratic delay and industry resistance.

Here's a quotable quote from former FDA official Dr. Robert Smith:

“F.D.A. could fix this tubing problem tomorrow, but because the agency is so worried about making industry happy, people continue to die.”

When is a radiation overdose not an overdose? When the facility giving the CT scans says so. At least that's what the Food and Drug Administration concluded when it dropped a safety investigation of the Huntsville, Alabama Hospital.

Now the FDA, which monitors radiation safety for the medical industry, is considering re-starting its investigation, once a New York Times reporting team found that the doses of radiation given to patients at the Huntsville Hospital were 13 times the normal dose for this type of scan, called a CT brain perfusion scan. The scan is used to test patients for stroke.

Even a properly done CT brain perfusion scan delivers about 200 times more radiation to a patient's head than a skull X-ray.

According to the Times, the hospital claims it used higher doses to get sharper images.

A quotable quote from the article, the latest in a series about medical radiation overdoses:

“It is absolutely shocking and mind-boggling that this facility would say the doses are acceptable,” said Dr. Rebecca Smith-Bindman, a radiology professor who has testified before Congress about the need for more controls over CT scans.

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.

The Food and Drug Administration has canceled its policy of giving rubber-stamp approval to marketing of powerful new radiation therapy equipment like linear accelerators. From now on, the manufacturer of the machine is going to have to prove the equipment has proper safety checks to prevent dangerous overdoses of radiation to patients.

The New York Times ran a series in January 2010 that exposed some horrific tragedies that occurred, particularly when hospitals rushed into operation new and complicated equipment without thorough safety checks and training of technicians. The series also showed that the equipment often lacked simple fail-safe devices such as a way of preventing the machine from delivering a walloping overdose of radiation even if one had been inadvertently programmed by a technician.

But since the FDA only has power over manufacturers and not over hospitals themselves, it still will be possible for poorly trained technicians to cause errors that hurt patients by either delivering overdoses or underdoses of radiation.

In a follow-up article, the New York Times' Walt Bogdanich quotes Dr. Howard I. Amols, chief of clinical physics at Memorial Sloan-Kettering Cancer Center in New York, as saying the more serious problems stem from shortcomings in staffing, personnel competency and hospital quality assurance programs:

“I’d also caution that however commendable tougher standards for premarket approval of software may be, its not clear that F.D.A. has the expertise to police this,” Dr. Amols said. “In fact, I’m not sure anybody does. That’s one of the big problems with software. It comes down to a qualified user recognizing that something is amiss.”

While the government regulators are getting their act together, my advice for patients is to always make sure you get radiation therapy at only a leading center that has been doing it for a long time. Make sure the center employs licensed, certified technicians to operate the therapy machines. Don't be dazzled by the new smell and clean look of a spanking-new therapy center. That could be a sign that people aren't well trained yet to keep you safe.

The scandal about injuries to cancer patients from malpractice in radiation therapy has had one beneficial side effect: the Food and Drug Administration is gaining urgency and attention for its new initiative to reduce unnecessary radiation in diagnostic imaging of patients.

Here is a link to the FDA's White Paper on its steps to make sure patients get only the dosage of radiation needed, at the right time and in the right way.

One part of the project is to make it easy for patients to keep track of how much radiation they've had, because accumulated dosing is what causes long-term injuries. The FDA says it is working

to develop and disseminate a patient medical imaging record card.26 FDA will make this card available on our website. While ultimately the best way of tracking a patient’s history of radiation exposure will be to incorporate it into that patient’s paper or electronic medical record, a personal record card will give patients and their caregivers a means, in the short term, of tracking their own medical imaging histories and sharing this information with their physicians. This will help facilitate critical discussions between patients and providers about the best available clinical options.

Time and again in U.S. health care, new technologies are hurried into wide use with little testing, scant training of their human operators, and lack of solid evidence that newer really is better. After the flush of optimism has faded, billions of dollars later, we learn how to judiciously use the new equipment, but only after patients have been hurt or killed by the rush to the new.

The latest example is the deployment of new radiation therapy machines on cancer patients with operators who are not properly trained or credentialed and equipment that has not been tested or calibrated. The New York Times' recent investigative series on the subject prompted one knowledgeable reader, Dr. Joseph Imperato, medical director of the Center for Advanced Radiation Medicine at Lake Forest (Ill.) Hospital. to write this:

To the Editor:

As a radiation oncologist practicing for 25 years, I believe that there is a crucial part of the story of radiation mishaps that has not been mentioned: the “nuclear arms race,” in which people want the newest technologies, without stopping to think about who is operating them.

In the past, academic medical centers were typically the first to obtain and use new technologies. The equipment would be thoroughly vetted and reported on in peer review articles before being accepted and used by the smaller community hospitals.

Now the reverse is true. Small community hospitals often far outpace academic medical centers. One example is the proliferation of proton centers run by for-profit companies. Often the staff has limited knowledge and experience with this extraordinarily complex equipment. And new technologies are often assumed by the public to be better, even though there is often little firm clinical data to support that.

As we struggle as a country to come to grips with health care costs, this is one area where there is great opportunity for savings. Clinical reviews can prevent the proliferation of needlessly expensive technology. What the public must come to grips with is that “new” is not automatically “better.”

See the Times' letters section for more.

In my book, "The Life You Save," I have several chapters that speak to this issue, particularly with new drugs. What patients need to understand is that whatever the technology, the early years of use are in essence a continuation of the testing phase. If you are comfortable with being a guinea pig, that's fine, but very often you can get better, safer care with the tried and true. And if the new technology looks enticing, go with an operator who has the most experience using it, because practice does make perfect.

What can cancer patients do to protect themselves from malpractice in radiation therapy? This urgent question arises from a lengthy series of investigative reports in the New York Times. The articles exposed serious patient injuries that stem from therapists who are overwhelmed and inexperienced, lax regulation and indifference by hospital administrators.

A key part of the problem is that technological sophistication has outrun the ability of the humans running the radiation machines to monitor the safety of the radiation beams they train on patients' bodies.

Another issue is that no central agency is responsible for inspecting the machines and credentialing the people who run them. Depending on the type of radiation involved, the Food and Drug Administration, the Nuclear Regulatory Commission and various state health agencies could have jurisdiction. Or worse, each could claim that someone else has the jurisdiction, and the patient can slip through the cracks.

There is one simple way that patients can take some measure of self-protection. That is to make sure that the radiation therapy center treating you has significant experience, in years not months, with the specific machine being used on you. Too often, hospital administrators buy a fancy new machine, advertise it heavily in glossy brochures, but don't take the time to make sure the machine is properly calibrated and that the medical physicists who operate the machine are fully trained.

You should also ask if the machine treating you has been inspected recently by an independent agency. One federally funded inspection and testing service is the Radiological Physics Center, operated out of MD Anderson Hospital in Houston. It does inspections for any radiation center that wants to receive federal funding for clinical trials. The Center found in 2008 that nearly three in ten hospitals it inspected failed to accurately irradiate a test dummy using IMRT technology.

The Times also found rampant problems with fake credentials among medical physicists, who are in charge of making sure patients get the right dose of radiation. The American Board of Radiology certifies medical physicists in one of three sub-specialties. You can check if a physicist is certified at the umbrella website for all medical board certifications, the American Board of Medical Specialties. Click here to go to the login page to search for a medical physicist's certification. The same page will let you search for whether a doctor is board-certified in any of the ABMS specialties or sub-specialties.

Also, the American Board of Medical Physics runs some certification programs. Its website has lists of diplomates but lacks any searchable database of qualified physicists. So the ABMS website is a better choice.

I recommend that patients ask questions to find out the qualifications of the persons running your radiation treatment program. If they lack certification, why take a chance?

I discuss the certification issue in detail in my book, "The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst." Many of the most egregious cases of malpractice that I have prosecuted for victims' families have involved doctors who lacked basic board certifications. Click here for more information on the kinds of malpractice cases we work on.

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.

Whether or not a patient should get an expensive imaging scan or some other elaborate and expensive test is not always clearcut. But what should be clearcut is that doctors should not have a thumb on the scale when they're balancing harms versus benefits. The balancing ought to be focused entirely on what's in the patient's best interest. The news story about what happened when a group of urologists in Iowa ordered a new CT scanner for their office sheds light on this conflict of interest issue.

According to the article by Shankar Vedantam in the Washington Post, the doctors at Urological Associates in Iowa were ordering fewer than one dozen CT scans per month for their insured patients in the months before their office bought its own CT scanning machine. That number jumped to 55 scans per month soon after the doctors got their own machine and started getting direct insurance payments for its use.

Defenders of the doctor-owned machines say it's more convenient for patients not to have to go to some other building for their scan. That's no doubt true -- if the scan is really needed in the first place. The problem is that self-interest colors the doctor's calculation, whether subtly or blatantly.

You might say "so what," but no test is without its downside, and excessive radiation from unnecessary CT scans can ultimately cause cancer in some patients -- as many as one in one hundred cancers are traced to radiation exposure. Not to mention bankrupting our health care system in the meantime.

Congress is considering outlawing the practice of what is called "self-referral," referring the patient to a test on a machine that the doctor owns. At the least, Congress should make it mandatory that doctors disclose any self-interest they have in testing, so that patients can take it into account in deciding whether they want the test.

I discuss doctor conflicts of interest in Chapter 9 of my new book, "The Life You Save." Chapter 9 is called "The Second Opinion: Always Your First Choice." It explains why you the patient need to understand if your doctor may have some ulterior influence on his or her thinking, and how it's always a good idea to get a second opinion before undergoing any major procedure.

Another reason for careful patients to be skeptical about overly hyped prescription drugs came this week with news about the extent to which articles in important medical journals are "ghost-written" by drug manufacturers.

According to an article in the New York Times by Natasha Singer, newly released papers from lawsuits involving Wyeth's hormone replacement drugs Premarin and Prempro show that over several years, Wyeth repeatedly hired ghost writers who placed 26 articles in 18 prestigious medical journals, all promoting the drugs in the guise of objective analysis by medical experts:

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

The Times article made an interesting comparison to professional baseball's steroids scandal.

“It’s almost like steroids and baseball,” said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. “You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

“The filter is missing when the reader does not know that the germ of an article came from the manufacturer,” said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

The same concern about ghostwriting applies to patients who read literature on the Internet. People can be easily misled if they think an article is truly objective.

My advice, as I write in my book, "The Life You Save," is to rely on truly independent groups like the Medical Letter and Public Citizen's Health Research Group for objective information about drugs.

Some top medical journals like the Journal of the AMA now require authors to fill out detailed forms describing exactly how much input they had into the writing of an article. But many do not have such requirements. Consumer, beware.