Articles Posted in Medical Device Safety

Operating_theatreIf the time in a doctor’s office or the hospital isn’t  frightening enough already for most patients, some recent publications by MDs in prominent, peer-reviewed medical journals may ramp up that anxiety to new heights: Just who is skulking around, with institutional blessing, when you’re getting your medical care? And what role are these official-looking people playing?

A tip of the hat to Morning Rounds, the daily newsletter from the health news site Stat, for pointing out a newly published study on PLOS One that details how sales people for surgical device makers conduct themselves when they are routinely allowed into operating rooms. They are gowned, often wear badges like hospital staff, and they consult with the surgical team, as doctors allow. They bring laser pens that they use to point out instruments and anatomical features. They never touch patients or handle any part of the surgery.

But, the study notes that the sales reps:

barcode-b4d283303a1a8ec1667da9a9cf3325b8They may seem like a cryptic pile of digits on devices that most of us might never see but will have in us, sometimes in life-saving fashion. But “unique identification numbers,” emblazoned on everything from hip implants to pacemakers, may offer a ne safety check on a burgeoning aspect of health care. They also have gotten a major boost from the federal Medicare agency.

The Wall Street Journal has reported that the agency, after years of resistance, has agreed with the federal Food and Drug Administration and patient safety advocates that the makers of medical devices should put the identifying numbers on their products, and that this information also should be recorded in patient records, particularly the new electronic versions. To be sure, this is one  step in a long regulatory process.

But experts say it could be a big advance, allowing them to better detect flawed equipment, bad processes or practices, and other situations involving medical devices and harming patients’ health and safety. Some regulators and advocates for the device makers had fought this step for some time now. They contend that it adds to costs, and it hasn’t yet demonstrated a return for the investment.

FDA logoCongressional overseers of the federal agency that regulates drugs and medical devices have gotten red-flag warnings about problems at the Food and Drug Administration, including: two separate calls for improvements from lawmakers’ top watchdog; and an eyebrow-raising corruption case brought against an agency official by U.S. prosecutors and securities enforcement authorities.

As Stat, the health news site, has reported, the Government Accountability Office has criticized the FDA in reports, saying the regulatory agency has failed to plan how it will keep up with rapid advancements in medical science. Stat observes of the studies by GAO, Congress’ watchdog:

One report notes that the FDA lacks goals, targets, and time frames for keeping up with scientific advances—and also fails to track the money it spends on these efforts. The other finds fault with the FDA’s strategic plan, which is supposed to speed approvals of drugs and devices, especially combination medical products, such as heart stents that also deliver blood thinners to prevent clots.

2003-huntington-memorial-hospital-1125The damage from dirty examination scopes won’t stop, with a public health agency in Pasadena, Calif., blasting a respected hospital for failing to report 16 infections that resulted in 11 deaths.

Huntington Hospital may have violated California laws by not informing officials of the outbreak of infections of drug-resistant Pseudomonas aeruginosa. The problems may have surfaced as early as 2013 and ran through 2015. City health inspectors, instead, discovered big problems during a surprise, spot-check of their local hospital last August.

In fact, the institution−the anchor of a large health care system that serves a big swath of suburban Los Angeles−emerges from the inspectors’ report badly sullied, with what is described as a “top to bottom” failure of patient safety procedures.

Here are some fast takes on some developments in health worth watching:

Good news: Birth rates among teen moms have declined to historic lows, falling most sharply (by almost half) for blacks and Hispanics, the federal Centers for Disease Control and Prevention has reported. Many factors may have contributed to this important trend, including greater access by the young to contraception and shifting mores and behaviors that lead to teens having less sex. Even with this positive news about declining teen birth rates, those for blacks and Hispanic still are double those for whites. Taking care of young parents and their kids costs the country an estimated $9 billion annually. Teen moms and their kids suffer short- and long-term health and social well-being consequences, experts say.

Back-PainQuestions on a common, painful back procedure: When U.S. patients appear to suffer “degenerative disc disease,” a condition around which a $40 billion industry has sprouted, their doctors more than 70,000 times annually subject them to a painful, costly procedure called provocative discography. Materials are injected under pressure into several discs─both those suspect and some as experimental controls─as a diagnostic technique. But new research shows this invasive procedure has no proven benefit and may lead to faster degeneration of the injected discs, says HealthNewsReview.org, a health information watchdog site. The site asks why this study, praised by experts it quotes, was ignored by media. The study potentially opens the door to further, needed inquiry about questionable, costly, painful, and potentially ineffective care given for the millions who suffer from back pain, site experts write.

Problems with medical devices contribute to 3,000 Americans’ deaths annually, research shows, and fixing any one of the problem devices can cost hundreds of millions. So why aren’t government officials doing more and better in regulating them and protecting the public, a New York Times health policy columnist has asked.

This health economist, Austin Frakt, also has zeroed in on possible solutions, some of which have surfaced after a scandal involving diagnostic scopes used in gastroenterological procedures. Those defective and dirty scopes caused infections that have killed at least 21 and sickened dozens at hospitals nationwide, U.S. Senate investigators confirmed in January.

Experts are starting to think that medical devices each must carry distinctive numbers and tags of some kind, and that this information needs to be recorded in health records each time a device is implanted or used. Such a system exists now for medications. It has helped researchers analyze and find problems in drug prescribing.

MarchCoverFBFor anyone who has doubt about how low physicians and hospitals can stoop for a buck, a city magazine has offered a dismal portrait of breathtakingly bad conduct in a $500 million medical fraud. Prosecutors have accused some powerful California politicians of playing a part in this scandal.

The report in Los Angeles magazine details how a Long Beach, Calif., hospital and other area facilities became veritable medical factories where droves of patients, many of them blue-collar workers injured on the job but lucky enough to be covered under federal and state workman’s compensation programs or private insurace, underwent back surgeries.

The magazine says that many of these patients were given spinal fusions (a costly controversial procedure); many of the operations were medically unnecessary. But worse still: A key figure in the case, who has pleaded to federal charges in exchange for his prospective testimony about the powerful pols, got surgeons to use medical hardware he supplied. An array of civil lawsuits assert that these specialized screws, rods, and plates were shoddily manufactured knock-offs. Patients have packed the courts with lawsuits, claiming the metal junk is breaking apart in their bodies, subjecting them to debilitating pain and significant health risks.

Can the sleaze get any worse with the maker of a dirty medical device that investigators say sickened dozens and played a role in killing 21? Sadly, it can. Federal prosecutors say that the  maker of a flexible scope used in endoscopic exams will pay $623.2 million to settle criminal and civil charges over its payment of kickbacks to unnamed physicians and hospitals.

The penalties against Olympus Corp. of Japan were the largest ever levied under U.S. anti-kickback laws. The company, according to the criminal complaint, forked out kickbacks to bring in $600 million in sales of endoscopes and other medical equipment, earning it more than $230 million in gross profits.

Prosecutors did not name the recipients of the kickbacks but said they included:

It’s a short paragraph, fine-print tucked in a 10,000-word document on tobacco product regulations. But these 245 words (see Intended Use Regulations, ง 201.128) have lit up critics of the U.S. Food and Drug Administration. They say officials are trying to pull a fast one, seeking to relax labeling rules for drugs and medical devices. This could make it tougher to hold manufacturers accountable for their products’ harms. The proposed FDA rule change, critics say, relieves companies from providing “adequate labeling” for non-FDA-approved uses of their products that they know about. This applies to detailed explanations inserted with drugs or devices.

Although the change might give companies greater “free speech” in discussing their products and allow for more “off-label” uses, which doctors like, critics decry this alteration. They say the agency needs to get tougher on off-label uses and to force companies to be more rather than less transparent about them

I’ve written, for example, about the abominable practice by some physicians who write prescriptions for powerful anti-psychotic medications for tots; the drugs never have been tested in children. No one will defend this use, though it is increasing and may be a dangerous use of drugs to restrain difficult infants and toddlers. Medical device manufacturers have come under fire when their products were used off-label for unintended uses, resulting in one case in thousands of claims of patient harms.

A U.S. Senate Committee has ripped a medical device maker, hospitals, and federal regulators for their shameful roles in allowing scores of patients to be sickened and some to die due to defects in a flexible, state-of-art scope used in gastrointestinal procedures. The committee’s findings and some other recent reports ought, in particular, to raise lawmakers’ hackles about the cozy relationships between regulators and industry and how these work to the public’s detriment.

I wrote recently about this scandal, uncovered by the Los Angeles Times. The paper’s investigation found three infection outbreaks linked to Olympus scopes and blamed 21 deaths on dirty scopes.

Senate investigators found the situation was far more widespread — with 25 outbreaks — and the conduct of the various parties even more problematic. We already knew that Olympus dissembled throughout the growing crisis. It blamed others for faulty cleaning. It told European customers there might be problems with the devices but failed to warn users in the bigger, more profitable American market. Olympus, though it knew of spreading concerns, sought to persuade affected hospitals that they were alone in their problems. The company moved as slowly as it could in filing incident reports with federal regulators.

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