Articles Posted in Medical Device Safety

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.

fdanulogo-300x126Critics are slamming the federal Food and Drug Administration for dropping the ball in informing the U.S. officials who run the Medicare, Medicaid, and veterans’ health programs about crucial regulatory decisions, leading the federal government apparently to pay hundreds of millions of dollars for patients to get a defective heart device and potentially to pay billions of dollars for a prescription medication targeted at Alzheimer’s but with questionable evidence of its effectiveness.

FDA officials insist that they acted in patients’ best interests when they posted on an agency website, along with thousands of other public communications, a warning letter issued to the maker of the HeartWare Ventricular Assist Device, or HVAD. That missive told the device maker HeartWare — and later its acquiring company Medtronic — that the FDA found serious problems with the HVAD tied to patient injuries and deaths.

The FDA eventually would amass “thousands of reports of suspicious deaths and injuries and more than a dozen high-risk safety alerts from the manufacturer,” ProPublica, the Pulitzer Prize-winning investigative new site found. “One horrifying device failure after another” led HVAD’s maker to halt the manufacture of the supposed life-sustaining heart pump. The firm has agreed to a long-term plan to deal with the calamity of patients who now cannot have the defective device removed.

califf-150x150Robert Califf, a cardiologist and President Biden’s “new” nominee to head the federal Food and Drug Administration, is a familiar face around the agency and Washington, D.C.

Califf served as the FDA commissioner before — winning U.S. Senate confirmation and holding the important post for the last year of the Obama presidency.

He is 70 and has long history in academic medical research and running clinical trials, including consulting for Big Pharma and giving his foes queasiness about his ability to run the nation’s top overseer of prescription medications and medical devices, as well as food quality and safety.

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