Articles Posted in Medical Device Safety

US_Congress_02It’s almost 1,000 pages,   culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the 21st Century Cures Act, a sweeping measure that some say could affect American health care as much as the Affordable Care Act aka Obamacare?

After the bitterly divisive presidential campaign, House members surprised many with their swift consideration of the health funding bill, which passed 392-26. Congressional leaders then crowed about how they can work together and how the legislation will help. The act now has moved to the Senate for consideration. Senators, notably Massachusetts Democrat Elizabeth Warren, have been far more critical of components of the measure, particularly how Big Pharma and device-makers may benefit.

I’ve written how Congress, around this time last year, provided holiday cheer by approving the framework of the 21st Century Cures Act, an omnibus bill that took a year for funding details to get worked out. Because the legislation covers so many health areas and still must be acted on by the Senate and signed by the president, it still needs wary watching. Lobbyists for many different causes already have had a field day on this bill, and they will continue to do so.

prof-Madris-glasses-crop-2Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices−from heart valves to drug pumps−the federal Food and Drug Administration all too often has served as an industry lap cat offering late, lax oversight in reporting safety woes, a new report finds. The Minneapolis Star-Tribune and former agency official Madris Tomes (photo right) deserve credit for blowing the whistle on the gaping bureaucratic loophole that lets device makers report problems almost at their leisure, and to do so in a way that hides issues from public view.

By law, the paper says, makers are supposed to file safety incident reports with the FDA within 30 days of occurrence. But the agency not only fails to enforce that requirement, it has created a process of Orwellian double-speak, allowing “retrospective reporting.” Device makers in this process tell the agency about hundreds of thousands of safety incidents, sometimes years after they occurred. Further, the FDA allows the companies to detail the incidents, in some cases tens of thousands of them, in confidential reports. The only notice the public gets is via terse summaries, “marker reports,” of the much longer documents.

Tomes, since leaving the agency, has created a search engine, Device Events, that helps outsiders track agency information on medical devices’ performance. Using that tool, it still took Star-Tribune reporters almost a year to pry from the FDA information barely hinted at in marker reports.

heatercoolerPost-op heart surgery patients who experience night sweats, muscle aches, weight loss, fatigue, or unexplained fever should contact their doctors, stat, federal officials say. They’re warning that a medical device, designed to keep organs and blood at a constant temperature, was contaminated with nontuberculous mycobacterium (NTM). Officials already have confirmed more than two dozen NTM infections in open heart patients, and thousands more may be at risk.

The federal Centers for Disease Control and Prevention flagged the potential patient risks linked to the Stöckert 3T, temperature-regulating surgical devices made by LivaNova PLC (formerly Sorin Group Deutschland GmbH).

Temperature-regulating devices are common in the 250,000 open heart surgeries performed annually in hospitals, officials say, and 60 percent of the procedures involve the German-made model. NTM infections may not develop immediately, and some cases were confirmed as many as four years after surgery. They typically are not fatal but can be problematic for immune-compromised patients, such as many open heart patients are. They respond well to antibiotics if detected.

ICUThe spots in hospitals where patients in the direst shape receive specialized treatment are themselves in need of urgent care, experts say, explaining that antiquated intensive care units (ICUs)

contribute to needless harm. But how exactly to yank them and the therapies they provide into the 21st century?

Usha Lee McFarling, a Pulitzer Prize winner, examines ICU reforms for the online health news site Stat, finding that these crucial and “heroic” hospital facilities fundamentally have changed little in a half century, although they now are jammed with new technology and devices. They serve almost 6 million Americans in grave condition, but in them, she says, “studies show serious and sometimes fatal medical errors are routine. And a recent review published in the journal Critical Care found no major advances in ICU care since the field’s inception in the 1960s.”

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.

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