Articles Posted in Sleep

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.

sidesleep-300x155With millions of patients struggling with long delays in getting replacements for night-breathing devices recalled by their manufacturer over the machines’ potential health risks, a seasoned health journalist has reported an intriguing, personal counterpoint on the growing prevalence of the problem of sleep apnea and its routine, costly, inconvenient care.

Jay Hancock, who has been a senior correspondent for the independent, nonpartisan Kaiser Health News service (KHN) for a decade and has reported on health care, business, finance, and the U.S. State Department for the Baltimore Sun and the Virginian Pilot, penned his piece in admitted self-interest. That’s because he suffered bouts of drowsiness during the day and his wife told him he snored.

He decided to undergo exams to see if he had sleep disorders. Tests gave him a diagnosis of moderate apnea. Because of his journalistic background, he wrote that he decided he needed to learn more, reporting:

We’re barraged by so much health hokum that it’s a relief when common-sense reminders come along about crucial wellness concerns like exercise, diet, and sleep.

Timely information on these issues has been reported by the Washington Post (here on movement myths and here on sleep and weight), the Athletic on a soccer nutritionist’s insights on healthful eating, and the New York Times on exercise and bodily immunity.

Some of the key takeaways:

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.”

dcautowreck2-300x191The nation keeps zooming toward a tragic and preventable fatality measure: Our roads are staying as deadly as they became during the coronavirus pandemic, and 2021 is racing to be one of the most lethal vehicular years in a decade.

As the Washington Post reported of data on the year’s first quarter from the National Highway Traffic Safety Administration:

“The first quarter of 2021 was the deadliest start of a year on the nation’s roads in over a decade, with car crashes killing an estimated 8,730 people from January to March, according to a new estimate from the National Highway Traffic Safety Administration. The numbers indicate that a surge in road deaths that began with the coronavirus pandemic has continued into this year, although they offer some early glimmer of hope that unusually high fatality rates might be beginning to come down. NHTSA said the ongoing high death rate appears to have been caused by drivers continuing to take risks by speeding, getting behind the wheel after drinking or using drugs, and not wearing seat belts. To coincide with the new estimates, NHTSA … released an updated version of a guide to improving highway safety, largely focusing on encouraging more-conscientious behavior on the roads and deterring risk-taking.”

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.”

babysleepers-300x217One of the federal government’s top consumer watchdogs has roused itself from its torpor and, finally, moved to ban what a leading independent group calls “dangerous infant sleepers and other products that do not align with expert medical recommendations for safe sleep.”

As Consumer Reports said of the new orders by the federal Consumer Product Safety Commission (CPSC) regarding devices linked to the deaths of dozens of babies:

“The ruling, which was approved by three of four CPSC commissioners, was years in the making — and was prompted in part by an ongoing CR investigation that has linked inclined sleepers, such as the Fisher-Price Rock ’n Play Sleeper, to at least 94 infant deaths. CR has also tied in-bed sleepers, such as the DockATot and the Baby Delight Snuggle Nest, to at least 12 fatalities. The CPSC has separately tied unregulated ‘flat sleepers’ —such as baby boxes, soft-sided travel beds, and bassinets with no stand —to 11 deaths. All told, that amounts to close to 120 infant deaths connected to one of these hazardous infant sleep products.”

curveflatten-300x175Across the nation, and throughout the DC region, Americans — finally — have started to come to grips with the gravity of a fast-spreading, new respiratory virus’ infections. The novel coronavirus has infected almost 150,000 internationally, killing thousands as part of what now is officially a global pandemic and a national emergency.

Cases of Covid-19 have been detected in Washington, D.C., Virginia, and Maryland, as public health officials have urged the public to increase safeguards against contracting the disease, notably by staying home and practicing not only hygienic measures (washing their hands, covering their coughs and sneezes, and foregoing handshakes and hugs) but also keeping their distance from others.

Businesses have urged their people to work from home. Schools have shut their doors. Concerts, plays, museums, and cultural events and institutions have closed and canceled. Professional and amateur sports have suspended play. Travel, domestic and international, has screeched to a halt. Panic buying has broken out at groceries and big box warehouse stores.

sleeperteen-300x180If millions of young folks in the nation’s largest state seem even sunnier than before, that may be because they are getting a wee bit more needed shut eye: California has become the first state in the nation to order public schools to roll back their start times, so middle school classes generally won’t start before 8 in the morning and high school teaching doesn’t start until after 8:30 a.m.

The rule — pushed by experts and resisted by parents juggling already hectic and conflicting family schedules — will be phased in over three years. It also will be accompanied by yet more research on how teens doze and how sleep can best benefit their rapidly growing minds and bodies.

California’s later start to teens’ schools got a boost from groups like the American Academy of Pediatrics, the California Medical Assn., and the California State Parent Teacher Assn. They cited a growing body of research, including by organizations like the RAND Corporation, tying more sleep from later start times to adolescents’ better school performance and health.

doctired-300x169Will the medical educators finally get that it makes no sense to force residents to toil like field animals? Yet another study, this latest from Harvard experts, finds that keeping residency training hours at more humane levels does not significantly affect quality of patient care, including inpatient mortality.

Let’s be clear: The grueling preparation for MDs is only relatively better than before, capping their training time to 80 hours a week.

Medical educators, hospitals, and doctors themselves have criticized that limit since it was imposed after long study and much argument in the profession by the Accreditation Council for Graduate Medical Education (ACGME), the group that accredits MD training programs.

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