Articles Posted in Medical Device Safety

philipslogo-150x150While critics long have ripped the Food and Drug Administration for its weak oversight of medical devices and its too cozy relationships with their makers, the federal agency and a Dutch global conglomerate have given millions of U.S. consumers a big, infuriating, prolonged exposure to just how bungled the oversight of this industry can be.

As 2022 races to its close, the Wall Street Journal has reported on this costly, inconvenient, and unacceptable mess, as has the New York Times. And now, so has Stat, the science and medical news site, which wrote this about the “flaws in device oversight” as so many regular folks have experienced with the FDA, manufacturer Philips, and CPAP (continuous positive airway pressure) and BPAP or BiPAP (bilevel positive airway pressure) devices:

“The ongoing recall of millions of breathing devices made by Philips has been botched and belabored at nearly every turn: It took more than a decade after users first reported the soundproofing foam in their CPAP and BPAP machines breaking down for Philips to issue a recall. Even after the recall notice was issued, it failed to reach many patients, and many are still waiting on their promised replacement devices or refunds, some of which had to be recalled themselves. More than a year after the recall, the FDA has received more than 90,000 reports about problems with the devices, including 260 … deaths reportedly associated with the products. The [FDA] has pulled out all the stops — including regulatory orders not deployed in decades — to force Philips to contact users about the recall and replace the devices in a timely manner.

pulseoximeter-150x150Until the coronavirus pandemic struck, few regular folks knew about pulse oximeters, much less had one on hand for urgent use. The devices, which fit over a finger, are supposed to give fast readings on the levels of oxygen in patients’ blood — a key measure of their respiratory wellness.

But the devices, whether in relatively inexpensive consumer versions or in medical-grade units used in doctor’s offices, clinics, and hospitals, are far from perfect. They suffer major inaccuracies when used by those with darker skin.

Federal regulators have known about this flaw for years. But at a time when patients, families, doctors, and hospitals relied on the devices routinely to make critical treatment decisions affecting those struggling with likely coronavirus infections, an information chasm opened. Doctors urged people to pop by drug stores and other retailers to pick up the devices, saying that they could be helpful in letting them know when their oxygen levels were dipping in concerning enough fashion that they should seek emergency treatment.

hearing-300x181Is it time for a glimmer of optimism about reducing at least one unacceptably high health care cost?

Say hear, hear then, to the federal Food and Drug Administration’s removing the last regulatory block to consumers with mild to moderate hearing loss buying cheaper, easier to access, over-the-counter (OTC) hearing aids — potentially as soon as this fall.

Hearing some fading Bronx cheers? Those may be for the regulators who plodded to potentially benefit tens of millions of folks, who were forking over $5,000 for pairs of medically prescribed devices that previously also required expensive attention of doctors and audiologists. Patients also were ripped for the costs of this care, which typically was not covered by traditional insurance or Medicare. As the Washington Post reported of the regulatory shift to allow OTC hearing devices:

bankruptcy-300x199They were a tortured part of the opioid abuse and drug overdose crisis. They have become a painful aspect of the push to hold nursing home owners and operators accountable for the shambolic response to the coronavirus pandemic.

And they soon may be an obstacle to military veterans’ attempts to get justice for defective devices that were supposed to protect their hearing.

Bankruptcy courts, the evidence increasingly shows, are at risk of warping their congressional mandate to help struggling enterprises sort out complex business operations. They are instead offering a legal haven to big corporations zealously protecting their profits from civil claims they harmed others.

Abbottlogo-300x77The giant drug maker Abbott and the federal Food and Drug Administration both should hang their heads in shame as more information becomes public as to how they left millions of vulnerable infants hungry and put kids’ health at risk by wrongs involving the manufacture and distribution of a vital foodstuff — baby formula.

Millions of parents have gone into meltdown because of a nationwide shortage of the needed nutrient. It was sparked by the shutdown of Abbott’s formula-producing plant in Michigan, as well as the company’s product recall after babies got sick and died from  infections involving Cronobacter sakazakii bacteria.

While Abbott has emphasized that experts have not conclusively linked the bacteria to its formula and the firm has played up its cooperation in a product recall, Robert Califf, the FDA’s chief and a doctor, ripped the company. He told a U.S. House subcommittee that agency inspectors found “egregiously unsanitary” conditions at the drug maker’s plant, the New York Times reported, quoting him, thusly:

babewithbottle-300x293Americans keep suffering the dire consequences of corporations’ relentless pursuit of profits, their stifling of beneficial competition, and their failure to secure the production of their products. These now include desperately needed, specialized baby formula and contrast dyes used in diagnostic imaging studies for seriously ill and injured patients.

A special place in perdition needs to be reserved for those who have put infants at risk of hunger and illness by allowing the feeding crisis to explode and for boobs who are rushing in with finger-snapping, fact-light, and unworkable actions for parents to respond.

Let’s be clear that the formula mess, bad for all families across the country, hits hardest at the working poor and the poor. As the New York Times reported:

philipslogo-150x150Federal officials have ramped up the pressure on a Dutch conglomerate over its expanding but slow recall of sleep apnea breathing devices relied on by millions of increasingly angry U.S. patients.

The Justice Department has issued a subpoena to Royal Philips NV in preparation for an undetermined investigation of the company’s CPAP machines and their recall, a problematic process about which the Food and Drug Administration recently also gave the company a kick, the Wall Street Journal reported:

“Philips said its Respironics division, and some other subsidiaries received the subpoena on April 8 to ‘provide information relating to events leading to the Respironics recall.’ It said it was cooperating with the agency. Philips Chief Executive Frans van Houten told investors … that the company wasn’t aware of any specific allegations. ‘They are preparing an investigation and we just have to accept that,’ he said.”

convictedtennnurse-150x150While nurses deserve patients’ gratitude and the highest praise for the valiant care they have provided during the coronavirus pandemic, a Nashville case has raised tough questions as to whether and when professional caregivers’ medical errors ought to be criminalized.

Prosecutors decided that some mistakes rise to the criminal level, after considering the evidence against RaDonda Vaught, a former nurse involved in a 2017 fatal drug error.

Vaught, who already has been stripped of her nursing license, has been convicted, NPR reported, of “gross neglect of an impaired adult and negligent homicide after a three-day trial … She faces three to six years in prison for neglect and one to two years for negligent homicide as a defendant with no prior convictions, according to sentencing guidelines provided by the Nashville district attorney’s office. Vaught is scheduled to be sentenced May 13, and her sentences are likely to run concurrently, said the district attorney’s spokesperson, Steve Hayslip.”

instruments-300x166While the coronavirus pandemic has forced patients, doctors, and hospitals to curtail crucial tests, procedures and treatments in worrisome fashion, a trend with one kind of medical practice apparently continues apace: The so-called “Zoom boom” in plastic and cosmetic surgeries is still going strong.

Patients, though, soon will get a tough reality TV warning about the damages that can occur in the costly pursuit of beauty.

For the many who have struggled with illness, as well as professional, personal, and economic hardship during the pandemic, it may be distressing to be reminded of the upswing in elective procedures, ostensibly to improve the aesthetics of patients’ faces and other body parts. But the Los Angeles Times interviewed Drs. Jason Litner and Peyman Solieman to learn why they say their Beverly Hills surgical practices with cosmetic procedures have been busier than ever — or as much as the pandemic allows, as Litner reported:

pregnant-300x200Expectant parents have gotten an ugly exposure to a rapacious aspect of modern medicine: Over testing, over diagnosis, and over treatment, specifically with a new, fast-growing high-tech twist.

The grownups — whether over-reaching to safeguard the unborn or in a simply silly way to determine the gender of their hoped-for bundle of joy — are ordering unnecessary, expensive, and too often alarming prenatal genetic blood tests. These rapid exams purport to tell whether a fetus may have the rarest of congenital diseases, the New York Times reported in some admirable digging, triggered by a stack of patients’ surprise medical bills.

Reporters Sarah Kliff and Aatish Bhatia found a big problem with the high-tech prenatal screens: The tests too often are dead flat wrong.

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