Articles Posted in Medical Device Safety

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.

fdabreastimplantFederal regulators have toughened the requirements for surgeons and medical device makers to inform women in detail about rising risks associated with breast implants, which also now will carry the government’s sternest warning — a “black box” label cautioning about the products’ potential harms.

The implant alarms, announced after years of complaints by patients, include the Food and Drug Administration’s counseling women that implants carry significant complications and should not be considered long-lasting products, secure for extended periods after surgery. The agency also ordered manufacturers to disclose ingredients used to make the devices.

The FDA, which is seeking public comment on its new oversight, has issued a 22-page document that describes how doctors and makers should discuss with patients the risks of implants.

boseaids-e1634953901247-150x150Millions of Americans soon may be able to buy much cheaper devices to help them with their mild to moderate hearing loss and avoid costly hearing aids prescribed by specialists.

It took far too long for this big step to occur, and consumers won’t see its full benefits for a bit still.

But the Food and Drug Administration, by issuing a new, draft hearing device regulation, took a major step in helping ordinary folks, as Congress intended with bipartisan legislation passed in 2017.

vuse-117x300The federal Food and Drug Administration has infuriated health and anti-smoking advocates by handing Big Tobacco a major first — the agency’s seal of approval for an e-cigarette as a way for consumers to reduce or stop harmful use of burning tobacco cigarettes.

The decision allowing RJ Reynold’s Vuse product (shown, left) to stay on public markets is the latest in a series of disastrous actions by the agency, putting a smoking alternative for adults ahead of the health and safety of young people, critics said. They repeated their contention that  with bungled oversight on alternative delivery devices and the vaping fad, the FDA has opened the way for a new generation to get addicted to toxic nicotine and lethal tobacco items.

Erika Sward, national assistant vice president for advocacy at the American Lung Association, told the New York Times this of the FDA ruling allowing an e-cigarette delivering high levels of nicotine:

Back-Pain-300x188As the nation rapidly grays, not only are middle-aged and older patients undergoing increasing numbers of knee, hip, ankle, and shoulder surgeries, back operations also have spiked — and a significant number of these procedures may be unwarranted and harmful.

Spinal surgery is a booming business for orthopedic surgeons and hospitals, with  Wall Street analysts forecasting, according to one report, that the “sales of spinal surgery implants, instruments, pharmaceuticals and other novel treatments for chronic and disabling back pain will … rise from $10 billion in 2020 to $14 billion -$ 16 billion by 2030.”

While rising numbers of patients, starting around age 42, complain of back pain and many eventually seek surgical relief, skepticism and concern may be deserved for the common, costly, and lucrative spinal fusion surgery, Modern Healthcare, an industry trade publication reported in its Oct. 5 edition.

chartgfrresults-300x197Medical specialists and researchers have taken a big step in recognizing that how they diagnose black patients with kidney disease may be racially biased and harmful to a group that already and disproportionately suffers the illness’s harms.

Doctors now should jettison race-based adjustments in equations used in a crucial and fundamental test to assess kidney function, according to studies and editorials published in the New England Journal of Medicine, the American Journal of Kidney Diseases, and the Journal of the American Society of Nephrology.

As the New York Times reported, this step will “affect hundreds of millions of kidney function tests performed yearly in hospitals and outpatient settings, both for acutely ill patients and as part of routine screening blood tests. By one estimate, one million Black Americans might be treated earlier for kidney disease if the diagnostic equation were not adjusted for race.”

bugatti-300x118If big hospitals really want to keep surgeons happy and provide them with greater comfort during procedures, why not build giant, sanitary glass garages next to operating rooms and let docs park their Bentleys, Lamborghinis, and Bugattis there for ogling and maybe even to take a break under the vehicles’ hoods?

Okay, maybe we’re being a bit too snarky.  Yet that hyperbolic scenario just might be cheaper and more medically justifiable than the sustained embrace by specialists and profit-seeking institutions of fancy robotic surgical devices costing more than $1 million annually — and for which patients, ultimately, pay. Here’s what the New York Times reported of yet another published meta-analysis of dozens of studies on the devices and their outcomes found:

“Surgical procedures performed with the aid of a robot is sometimes marketed as the ‘best’ form of surgery. But a recent review of 50 randomized controlled trials, testing robot-assisted surgeries against conventional methods for abdominal or pelvic procedures, suggests that while there may be some benefits to robotic surgery, any advantages over other approaches are modest … Some surgeons believe that these robots allow more precision during the operation, shorter recovery time, and generally better clinical outcomes for patients. But the review found that in many ways, compared outcomes from the robotic and conventional procedures showed little difference.

cpaprecall-300x139Millions of patients with serious, diagnosed sleep disorders now are wrestling with a daytime nightmare: Medical devices designed to help them avoid damage from their conditions have been recalled for major and concerning defects.

But consumers complain that they’re getting poor and too little information about their health options until the device maker more fully addresses the products’ problems.

The manufacturer under regulatory and consumer fire is Royal Philips NV, which has recalled its “devices known as CPAP and BiPaP machines,” the Wall Street Journal reported, adding that the products “gently push air into the lungs and are primarily used to treat sleep apnea.”

medscrewsuw-171x300Patients, regulators, hospitals, and doctors themselves need to open their eyes and ask tougher questions about the eyebrow-raising trend occurring among a specialized set of “sawboneses” — orthopedists and neurosurgeons.

Hundreds of them are profiting handsomely, not on their  medical skills  but rather their investments in and relationships with surgical hardware. The specialists also are increasingly reliant, in dubious fashion, on medical device salespeople.

Fred Schulte, an investigative reporter with the independent, nonpartisan Kaiser Health News service, has written a pair of detailed news articles raising yet more questions about medical devices, specifically the $3 billion that floods a peculiar pipeline between those who operate on patients’ backs, knees, hips, and shoulders and the companies that provide the surgical hardware for the procedures.

fdahvad-230x300The federal Food and Drug Administration too often fails to protect patients from defective and dangerous medical devices because it lets manufacturers self-police themselves, cozies up to companies rather than trying to compel safety fixes, and inadequately informs the public and medical community about problem products.

If that sounds like too broad and harsh an indictment of poor performance by a purported watchdog agency, just read the deep dig by ProPublica, the Pulitzer Prize-winning investigative journalism site, into the FDA’s record with the HeartWare Ventricular Assist Device, or HVAD.

ProPublica details the unacceptable actions that put thousands of patients at risk with a heart pump that cost $80,000, required major surgery, and that the FDA knew had significant problems but still allowed highly vulnerable people to have implanted. As reporter Neil Bedi found:

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