Articles Posted in Medical Device Safety

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, 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.

Twenty-one patients died and at least two dozen others fell ill from infections now linked to a flexible, state-of-the-art scope used in gastrointestinal examinations, even as the medical device’s manufacturer for years kept selling the instrument and failed to alert hospitals about growing dangers, the Los Angeles Times has reported. The paper detailed its findings about a nationwide outbreak that became public only after problems were publicized at a major, Southern California medical center.

The manufacturer, Olympus of Japan, blamed others and improper cleaning for deadly infections tied to its instrument. It also kept hospitals and regulators in the dark about problems with the devices, allowing each of several hospitals involved to think it was the only one having issues, the paper reported. It quoted a gastroenterologist at one affected hospital as saying the company’s silence was “unethical, irresponsible, and dangerous.”

Only after the Times published reports of three Southern California deaths did federal regulators issue a nationwide warning, and investigations in LA, Pittsburgh, and Seattle were tied together. These indicated that, what the manufacturer had called improvements in the scope’s design and had led to a higher costs for the devices, permitted a grimy film to develop in Olympus scopes; this residue harbored patient tissue and deadly microbes that were fatally spread. The company was brought in to see how hospitals tried to clean the scopes, offering no adverse commentary about intensified procedures that ultimately proved inadequate.

Here’s another device you probably don’t need. Or do you?

That’s the question Austin Frakt, who writes for the New York Times, tried to answer for himself when his cardiologist told him that one of his heart’s chambers sometimes pumped when it shouldn’t. The doctor had been “99.9% certain” that it wasn’t worrisome, and doctor advised against additional tests and visits.

But even though he’s a health economist, and knows that many commonly prescribed tests aren’t necessary, Frakt is only human. “As a patient,” he acknowledged in his story in The Times, “I’m not confident I know which ones.”

Earlier this year, both patients and providers were shocked when a rash of hospital patients got seriously ill or died after medical devices used to examine their gastrointestinal tracts infected them because they were not sufficiently cleaned after previous use. 

Now, it seems, inpatients aren’t the only ones who need to worry about contaminated medical instruments — according to an advisory issued by the Centers for Disease Control and Prevention ( CDC) and FDA, a wide range of reusable diagnostic instruments used in doctors’ offices and other outpatient facilities are vulnerable to the same risk of carrying other patients’  bacteria.

And last week, the FDA followed up that notice with a warning that bronchoscopes specifically can transmit infections if not adequately cleaned — 109 such adverse events have been recorded by the agency in the last five years, according to Bronchoscopes are instruments inserted into the mouth or nose and through the windpipe (trachea) to examine the lungs’airways.

In the same week in which the FDA issued warnings to companies whose invasive medical scopes are difficult to disinfect and that have spread deadly infections, another hospital’s infectious outbreak is being investigated for the same type of problem.

As the Los Angeles Times reported last week, Huntington Memorial Hospital in Pasadena, Calif., informed health authorities about the possible link between a small wave of infections and bacteria-trapping Olympus duodenoscopes. That company makes more than 8 in 10 of such devices used in the U.S.

As our blog explained when the first outbreaks were reported earlier this year, duodenoscopes are inserted into and down patients’ throats to view and treat a variety of serious, often life-threatening gastrointestinal problems. Although the FDA cited manufacturers for not reporting infections they knew were occurring because their equipment couldn’t be fully disinfected, the feds continue to allow their use because there are no options for the critically ill people who might benefit from them.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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