sleep apnea

  • Philips Suspends U.S. Sales of Breathing Machines After Recall

    Original Post | New York Times

    Under a settlement with regulators, the company must revamp some operations before resuming sales of its CPAP and ventilator devices in the United States.

    Philips Respironics announced on Monday that it would halt sales of all of its breathing machines in the United States after reaching a settlement with the Food and Drug Administration over continuing problems with the devices.

    Millions of the company’s ventilators and CPAP machines, used to ease breathing at night, were recalled after reports that they blew bits of foam and potentially toxic gases into consumers’ airways.

    Under the settlement, Philips said it would have to meet a list of standards in a “multiyear” plan before it could resume business in the United States. The company said further details would be disclosed when the agreement was finalized in court. But it added that it would continue to repair existing devices and provide service for people using them.

    The company initially began the recall of millions of devices in June 2021 and paused sales of new sleep therapy machines to the United States, according to Steve Klink, a spokesman for Philips. At the time, the company and the F.D.A. cited the potential for serious injury or permanent impairment from the potentially cancer-causing chemicals emitted from the devices.

    The company has since released results of additional testing, saying the devices were “not expected to result in appreciable harm to health in patients,” and it said it was continuing to conduct tests. The F.D.A. has pushed back on some of the company’s updated claims, and at one point called them “unpersuasive.” Philips has also faced continuing scrutiny and undertaken more recalls in its attempts to upgrade the devices.

    Dr. Jeff Shuren, director of the F.D.A.’s device division, said the agency could not comment until the agreement was finalized and filed with the court.

    The initial recall affected about 15 million breathing machines produced since 2006, though roughly five million were still in circulation in mid-2021.

    With replacements not immediately available, the recall caused confusion and upset for many doctors and patients. Many struggled to weigh the risk of continuing to use a faulty device against the peril of sleeping with impaired breathing.

    Millions of people suffer from sleep apnea, or interrupted breathing, which is associated with elevated rates of strokes, heart attacks and possible cognitive decline. Recalled machines included CPAP, or continuous positive airway pressure, machines; BiPap devices; and ventilators.

    Philips, which is based in Amsterdam, disclosed that it had reached an agreement, or a consent decree, that was brokered with the U.S. Justice Department and the F.D.A., along with the announcement of its fourth-quarter earnings. The company said it wrote down about 363 million euros related to the cost of completing the settlement requirements. Its stock, which trades in the United States, was down about 7 percent Monday morning.

    The company said it would continue to sell its products in other countries.

    Thousands of patients have since sued Philips, claiming that the machines led to a wide range of respiratory and other ailments, including allegations of deaths from lung cancer. In September, the company reached a $479 million settlement with plaintiffs that was meant to cover the financial losses related to repairing or replacing the machines. Litigation over illnesses and medical costs is still pending.

    Christina Jewett covers the Food and Drug Administration. She is an award-winning investigative journalist and has a strong interest in how the work of the F.D.A. affects the people who use regulated products. More about Christina Jewett

  • From Caffeine to Screens: Everyday Habits That Might Be Ruining Your Sleep

    A peaceful night’s sleep often remains an elusive dream for many, with daily habits being significant culprits. The subtle interplay of what we consume, our digital indulgence, and even our bedtime activities can significantly influence the quality of our slumber.

    What Habits Could Ruin Your Sleep?

    Take caffeine, for example. Renowned as a morning pick-me-up, caffeine does more than just jolt you awake. Research suggests that caffeine can linger in your system for 3 to 5 hours, potentially disrupting the sleep cycle. To circumvent this, consider wrapping up your caffeine consumption by early afternoon. If you’re hankering for a warm drink later on, herbal tea, notably devoid of caffeine, could be your go-to.

    Then there’s the omnipresent screen. The blue light emitted from our beloved devices is notorious for meddling with our melatonin production, a hormone pivotal for sleep. Frequent screen interaction, particularly in the twilight hours, could spell sleep trouble. Employing blue light filters on gadgets or designating the hour before bed as screen-free could pave the way for better rest.

    Late-night munching, though seemingly harmless, brings its set of sleep challenges. Certain foods, notably those rich in spice or acid, can potentially disrupt sleep. In case of late-night hunger pangs, foods like bananas or almonds, known to promote sleep, might be apt choices.

    But Wait, There’s More

    Alcohol, contrary to popular belief, isn’t the sleep ally it’s made out to be. While it might propel you into slumber initially, it notably compromises sleep quality, especially the NREM and REM phase, vital for memory and mood regulation. Moderating alcohol intake or consuming it well before bedtime could better your sleep odds.

    Engaging in rigorous physical activity late in the evening or succumbing to stress-laden thoughts can keep sleep at bay. The adrenaline surge post an intense workout can push sleep away, while stress can send the mind into an overdrive. Positioning workouts earlier in the day and carving out pre-bed relaxation routines can be beneficial.

    Lastly, the ambiance of your sleep quarters wields considerable influence. Studies emphasize the correlation between optimal room temperature and enhanced sleep quality. Moreover, noise can disturb sleep, impeding its depth and quality. Fine-tuning room temperature and possibly integrating tools like white noise machines can make a tangible difference.

    Better Habits is Better Sleep

    In sum, our day-to-day habits silently script our sleep narrative. Tweaking these can be a step towards improved sleep and, by extension, heightened well-being. For those keen on further sleep enhancement, exploring specialized sleep solutions or engaging with experts can provide tailored recommendations.

    Footnotes:

    [1]: Clark, I., & Landolt, H. P. (2017). Coffee, caffeine, and sleep: A systematic review of epidemiological studies and randomized controlled trials. Sleep Medicine Reviews, 31, 70-78.

    [2]: Gooley, J. J., Chamberlain, K., Smith, K. A., Khalsa, S. B. S., Rajaratnam, S. M. W., Van Reen, E., … & Lockley, S. W. (2011). Exposure to room light before bedtime suppresses melatonin onset and shortens melatonin duration in humans. The Journal of Clinical Endocrinology & Metabolism, 96(3), E463-E472.

    [3]: St-Onge, M. P., Mikic, A., & Pietrolungo, C. E. (2016). Effects of diet on sleep quality. Advances in Nutrition, 7(5), 938-949.

    [4]: Ebrahim, I. O., Shapiro, C. M., Williams, A. J., & Fenwick, P. B. (2013). Alcohol and sleep I: effects on normal sleep. Alcoholism: Clinical and Experimental Research, 37(4), 539-549.

    [5]: Stutz, J., Eiholzer, R., & Spengler, C. M. (2019). Effects of evening exercise on sleep in healthy participants: A systematic review and meta-analysis. Sports Medicine, 49(2), 269-287.

    [6]: Okamoto-Mizuno, K., & Mizuno, K. (2012). Effects of thermal environment on sleep and circadian rhythm. Journal of Physiological Anthropology, 31(1), 1-9.

    [7]: Basner, M., & McGuire, S. (2018). WHO environmental noise guidelines for the European region: A systematic review on environmental noise and effects on sleep. International Journal of Environmental Research and Public Health, 15(3), 519.

    February 6, 2024

  • Doctors’ Group Warns Sleep and Sound Machines May Be Too Loud for Kids

    Original Article | Good Morning America

    The American Academy of Pediatrics is warning parents and caregivers that excessive exposure to loud noises can be detrimental to children, and sound machines can cause more harm to children than previously thought.

    In a statement released Saturday, the AAP said: “What families may not realize is that children are exposed to potentially harmful noise from infancy and that the effects are cumulative over a lifetime.”

    ABC News medical correspondent Dr. Darien Sutton told “Good Morning America” that millions of children are at risk of some form of hearing loss.

    “One of the reasons why is because children have smaller ear canals. That exposes them to intensification of that higher frequency sound and [makes] them at risk for damage,” Sutton explained.

    According to one study published in BMJ Global Health in 2022, more than 1 billion young people are at risk of hearing loss around the world due to unsafe high listening volumes. The AAP cited another study that estimated 60% of adolescents listened to music and audio that was greater than the maximum recommended daily noise intake of 85 decibels averaged over eight hours, a standard that is also for adults and not children.

    “The average volume that kids listen to music at is 70 to 100 [decibels],” Sutton said. “That’s the upper limit of normal or the range for most of our headphone outputs.”

    “Now, noise above 70 [decibels] for prolonged periods of time can cause damage. Noise at 100, which is the maximum, can cause damage in minutes. And noise over 120 can cause immediate harm,” Sutton continued. “So it’s important to pay attention to those volume settings [and] keep them at least 60 to 70% total.”

    With sound machines, often used to lull infants and children to sleep, the AAP warns that they are often too loud for healthy listening.

    “The AAP recommends that parents and caregivers consider that if an environment sounds too loud for an adult, it probably is too loud for a child. ‘Too loud’ can mean having to raise your voice to speak with someone just an arm’s length away,” the pediatricians’ group said.

    “The Academy of Pediatrics recommends, for example, that nurseries have a volume maximum of around 50 decibels,” Sutton said. “That’s a volume that you and I can speak at without raising our voice. Most of these machines go above that. So if you’re going to use them, turn that volume down, place it away from the bed at least seven feet and make sure that you give limits.”

    Signs of hearing loss in children

    • Early speech and language delays
    • No reaction or a startled reaction to loud noises
    • Trouble hearing at schools

    Sutton recommended parents pay attention to their child’s communication.

    “It’s about paying attention to that communication. If you’re finding that your child is speaking loudly, having difficulties with pronunciation, if you’re finding that they’re not reacting to loud noises — these are all some of the reasons why you should get them checked, their hearing checked, because it can help with their learning comprehension and, of course, reduce their risk long-term,” Sutton said.

  • Five Weird Signs of Sleep Apnea

    Original Article | By Sandee Lamotte CNN

    Sign up for CNN’s Sleep, But Better newsletter series. Our seven-part guide has helpful hints to achieve better sleep.CNN — 

    If you snore the house down, you may be suffering from obstructive sleep apnea, or OSA — a potentially dangerous condition in which people stop breathing for 10 seconds or more at a time.

    The condition has been linked to smaller brain volume, damage to the white matter communication pathway in the brain and even a three times higher risk of dying from any cause. If left untreated, obstructive sleep apnea puts you at higher risk for hypertension, heart disease, type 2 diabetes, depression and even an early death, according to the American Academy of Sleep Medicine.

    Yet even if you’re a rock star at snoring, you may not know you have obstructive sleep apnea unless someone tells you about your nocturnal roars. That’s why it’s important for partners and friends to speak up and encourage snorers to get professional help.

    But what if you have an odd or quirky symptom besides snoring? You and your loved ones may have no idea that you are in danger, and the condition could go undiagnosed for years.

    “Greater than 30 million people have sleep apnea in the United States, yet it’s often underdiagnosed or misdiagnosed,” said sleep specialist and pulmonologist Dr. Raj Dasgupta, an associate professor of clinical medicine at the University of Southern California’s Keck School of Medicine.

    “It’s really misdiagnosed in women versus men because women may not present with the classic, heroic snoring that men often show,” he said.

    Here are five weird signs of obstructive sleep apnea to watch for, according to Dasgupta.

    Headache as a result of sleep apnea

    Night sweats

    There are many reasons people may sweat at night. It could be too hot, especially with the persistent heat waves in the past few years due to the climate crisis. Certain medications can cause night sweats, as can cancer, thyroid issues, the flu and bacterial infections, and the onset of menopausal symptoms, according to the Mayo Clinic.

    But research has shown that about 30% of people with obstructive sleep apnea have reported night sweats, Dasgupta said.

    “It’s because your body isn’t getting enough oxygen you fall into this sympathetic fight-or-flight mode, which triggers night sweats,” he said. “The research showed people with OSA that had night sweats were also more likely to have really low oxygen levels on top of having obstructive sleep apnea.”

    Sleep apnea can cause you to wake up tired, have difficulty regulating emotions and suffer from brain fog, experts say.

    Frequent awakenings

    Many people get up at night to empty their bladders — it can be caused by alcohol overindulgence, diabetes, edema, high blood pressure, certain medications, pregnancy, prostate issues and even drinking too many fluids before bed, according to the Cleveland Clinic.

    But getting up at least two times a night to urinate — which is called nocturia — can also be a sign of obstructive sleep apnea, Dasgupta said.

    “One study found about 50% of patients with OSA had nocturia, and they noted that treatment for the sleep disorder did cut back on awakenings,” he said.

    Nevertheless, frequent nighttime urination is not commonly asked about in screening questionnaires on sleep apnea in primary provider offices, Dasgupta said.

    Teeth grinding

    Grinding or clenching teeth while sleeping is called bruxism, and it too may be a sign of obstructive sleep apnea, Dasgupta said.

    “Certainly, anxiety and other factors can cause bruxism, but a common cause is obstructive sleep apnea,” he said. “There’s a theory on why — the airway becomes obstructed, so the muscles in the mouth and jaw move to try to free the blocked airway. That’s not been proven, but it is an interesting hypothesis.”

    Most people who grind or clench their teeth use a mouthguard suggested by their dentist for protection, but it won’t protect the jaw, Dasgupta said.

    “So, a person might also develop TMJ (dysfunction), which is pain in the temporomandibular joint, and that may also lead to other issues, such as headaches,” he said.

    Morning headaches

    Studies have found a link between having obstructive sleep apnea and waking up with a headache, Dasgupta said.

    “They typically occur daily or most days of the week and may last for several hours after awakening in the morning,” he said. “The cause of the headaches is not well-established and may be multifactorial.”

    Headaches caused by obstructive sleep apnea don’t appear to lead to nausea or increased sensitivity to light and sound. Instead, they seem to be a pressing sensation on both sides of the forehead that lasts about 30 minutes, according to a June 2015 study.

    Depression, fatigue and insomnia

    Some symptoms of obstructive sleep apnea can disguise themselves as issues of mental health, brain fog or other sleep problems, Dasgupta said.

    “Sleep affects our ability to think, react, remember and solve problems,” he said. “Women especially have a tendency to underreport atypical symptoms such as insomnia, fatigue and depression.”

    If obstructive sleep apnea awakens you, it may be hard to go back to sleep. A person may suspect insomnia, not realizing that a different issue may be triggering the awakenings.

    Symptoms of daytime fatigue include a lack of motivation to accomplish everyday tasks, a lack of productivity at work, memory problems and a low interest in being social, Dasgupta said. Those are also signs of depression, so if the sleep issues aren’t brought up at a health visit, the underlying cause may be missed.

  • Dangers of Uncontrolled Sleep Apnea

    Original Article | JohnsHopkins.org

    You’ve probably heard that regular exercise and a heart-healthy diet are the most important things you can do for your cardiovascular health. As it turns out, though, the quality of sleep you receive is also critical to your heart’s wellbeing. 

    In particular, undiagnosed sleep apnea is directly tied to an increased risk in cardiovascular and metabolic health. The scariest part? You might not even know you have this very common problem.

    “Sleep apnea happens when upper airway muscles relax during sleep and pinch off the airway, which prevents you from getting enough air. Your breathing may pause for 10 seconds or more at a time, until your reflexes kick in and you start breathing again,” explains Jonathan Jun, M.D. , a pulmonary and sleep medicine specialist at the Johns Hopkins Sleep Disorders Center.

    Sleep apnea occurs in about 3 percent of normal weight individuals but affects over 20 percent of obese people, Jun says. In general, sleep apnea affects men more than women. However, sleep apnea rates increase sharply in women after menopause. Sleep apnea is often linked to heart disease and metabolic issues like diabetes.

    What are the signs of sleep apnea?

    There are two kinds of sleep apnea: obstructive sleep apnea and central sleep apnea. Obstructive sleep apnea happens when air can’t flow into or out of the nose or mouth, although you’re trying to breathe. Central sleep apnea happens when the brain fails to send the right signals to your muscles to make you start breathing. (This type is less common.)

    “Sleep apnea may be noticed more by the bed partner than by the sleeper,” says Jun. “Your bed partner might notice that your breathing pauses, or they may complain of your loud snoring.”

    That said, snoring itself—though annoying—isn’t the same as sleep apnea. Snoring is just the vibration sound created by airway resistance. You can snore loudly and not have sleep apnea, and you may even have sleep apnea without much snoring.

    People with sleep apnea might also suffer from unexplained fatigue and mood swings, because their breathing interruptions continually wake them and prevent them from settling into a deep, nourishing sleep.

    The consequences can be significant, Jun says. “We’re talking about car accidents in the daytime, lost productivity at work, mood swings, waking up feeling groggy and falling asleep in class.”

    Other sufferers might wake up with a dry mouth, since sleep apnea tends to make you breathe with an open mouth, drying out your saliva. Some awaken with a headache, which may be caused by low oxygen or high carbon dioxide levels during sleep.

    How is Weight Control Linked to Sleep Apnea?

    “Weight control is very important. There are many studies showing that losing weight can either completely cure you of sleep apnea or at least make it less severe,” Jun says.


    Sleep apnea, cardiovascular risk and metabolism

    Several studies have shown an association between sleep apnea and problems like type 2 diabetes strokes heart attacks and even a shortened lifespan, says Jun. Why this connection? For one thing, obesity is common in sleep apnea patients, and obesity greatly increases risks of diabetes, stroke and heart attack, he says. “In most cases, obesity is the main culprit behind both conditions,” Jun explains.

    Still, it’s important to note that not everyone with sleep apnea is obese. Furthermore, evidence suggests an independent link between sleep apnea and diabetes. “Our lab and others have shown that sleep apnea is associated with higher risks of diabetes, independent of obesity, and that sleep apnea can increase blood sugar levels,” says Jun.

    For people who are overweight or obese, weight loss is key for treating or avoiding sleep apnea. People who accumulate fat in the neck, tongue and upper belly are especially vulnerable to getting sleep apnea. This weight reduces the diameter of the throat and pushes against the lungs, contributing to airway collapse during sleep.

    Women in particular should be careful as they age. While premenopausal women tend to put on weight in the hips and in the lower body instead of the belly, this shifts with time. Weight begins to accumulate in traditionally “male” areas like the tummy, and this leads to a greater chance of sleep apnea.

    “After menopause, hormones change and women tend to start looking like men in terms of where the weight gets put on. It’s a time to be paying attention to the risks of sleep apnea because women begin to catch up to men in the rates of apnea after menopause,” Jun says.15

    Diagnosing and treating sleep apnea for better health

    It’s important to treat sleep apnea, because it can have long-term consequences for your health. While there have been some high-profile deaths linked to sleep apnea—such as with Judge Antonin Scalia —Jun says that the true risk is from damage done over time.

    Obstructive sleep apnea can range from mild to severe, based on a measurement system called the apnea-hypopnea index (AHI). The AHI measures the number of breathing pauses that you experience per hour that you sleep.

    Obstructive sleep apnea is classified by severity:

    • Severe obstructive sleep apnea means that your AHI is greater than 30 (more than 30 episodes per hour)
    • Moderate obstructive sleep apnea means that your AHI is between 15 and 30
    • Mild obstructive sleep apnea means that your AHI is between 5 and 15

    Whether or not you need treatment for sleep apnea depends on its severity, whether or not you have symptoms such as sleepiness and other health conditions. For example, if you have risk factors for heart disease, your doctor might opt to treat you even for mild sleep apnea. On the other hand, if you have a severe case of sleep apnea, your doctor might insist on treatment even if you’re not sleepy.

    The main choice of therapy is a breathing device called a CPAP, or continuous positive airway pressure machine. A CPAP machine pipes humidified air through the nose, which creates air pressure to keep your throat open while asleep. This prevents pauses in breathing.

    “CPAP is the first-line treatment, and it’s very effective,” Jun says. A recent Johns Hopkins study looked at what happens to metabolism at night when sleep apnea patients don’t wear their CPAP. The study found that the resulting apnea caused a spike in blood sugar, heart rate, blood pressure and stress hormones—a response similar to what might happen if you were asked to get up in front of a crowd to speak. “It’s very similar to that type of a stress response,” says Jun. “I would liken sleep apnea to something like that happening on a nightly basis.”

    CPAP is not the only alternative.

    Many cannot tolerate the CPAP machine and are able to obtain the help they need from a Sleep Apnea Dental Specialist. Their use of an oral appliance has helped hundreds of thousands resolve their medical issues as they pertain to Sleep Apnea.

    Get the Medical Equipment You Need at Home

    Many studies show that regular use of CPAP or oral devices reduces blood pressure and improves wakefulness during the day. People with sleep apnea who use sleep apnea therapeutic devices also report improved quality of life. In some observational studies that compare people with apnea who seek sleep apnea remedies versus those who don’t, those seeking treatment have lower risk of stroke and heart attack and lower blood glucose, Jun notes.

    If you or your partner has noticed signs of sleep apnea, visit your doctor. A sleep specialist can order a sleep apnea test, which uses equipment to monitor your breathing and oxygen levels while you sleep. Often, you’ll visit a laboratory to spend the night for monitoring. Other times, it’s possible to use a portable, take-home kit. You’ll rest easier knowing the results.

  • CPAP Crisis Creates Chaos for Apnea Victims and Snorers!

    Original Article | The People’s Pharmacy

    Do you know someone who snores and/or stops breathing temporarily? They could have sleep apnea. Why is there a CPAP crisis? Who is at fault?

    According to the AMA“About 30 million people in the United States have sleep apnea, but only 6 million are diagnosed with the condition.” People with sleep apnea may stop breathing many times during the night. These episodes can last a few seconds or as long as a minute or two. They can occur dozens of times an hour. There is a CPAP crisis going on because many patients are having a hard time getting safe CPAP devices. Disclaimer: we do not know who made the CPAP device in the photo. The illustration is not intended as criticism.

    What’s It Like To Suffer Sleep Apnea?

    I have tried holding my breath while timing it with my smart phone stopwatch. It starts to get uncomfortable around 25 seconds and I have to take a breath around 30 seconds. I have a hard time imagining what it would be like to go longer than that.

    Obstructive sleep apnea (OSA) is caused by the collapse of muscles in the throat. This can block the airway. The result is reduced oxygenation of the circulating blood.

    Patients with OSA often suffer from daytime sleepiness and brain fog. That makes them more prone to accidents. They are also more likely to develop hypertension, strokes, irregular heart rhythms or heart attacks.

    Symptoms can include noisy snoring interrupted by gasping or gagging sounds. For a bed partner, this can be scary and/or annoying. It’s hard to sleep when the person nearby is “sawing wood” and intermittently gasping for air. People with OSA may also complain about frequent nighttime trips to the bathroom to pee, morning headaches, daytime irritability and “cotton mouth” upon awakening.

    Treating OSA and the CPAP Crisis:

    To treat sleep apnea, doctors prescribe machines that pump air in a continuous stream that can help keep the airways open. They are called CPAP devices, for continuous positive airway pressure. Some people find the devices noisy and uncomfortable. You have to wear a kind of face mask that pushes air into the throat and lungs.

    Others find the devices improve the quality of their lives. Here is just one of the hundreds of messages we have received on our website:

    Jerry reports that CPAP made a difference:

    “Sleep apnea is a medical condition that can cause frequent nighttime urination. After being diagnosed with severe obstructive sleep apnea, I was treated using CPAP therapy.

    “The very first night after getting my CPAP machine I slept for a full 7 hours. Before treatment, I was waking and passing large amounts of urine every 1-2 hours. My blood pressure went from high to normal, and my heart rate during exercise dropped by 20 heartbeats.”

    The CPAP Crisis Is Creating Chaos:

    Needless to say, people with serious sleep apnea rely on these machines and are well aware that their lives depend on them. Just imagine the panic they might feel if their machines were no longer available.

    That has happened to far too many patients over the last year, as the company that dominates the industry, Philips Respironics, fumbled a recall of faulty CPAP devices.

    Here is what one reader wrote us about the CPAP crisis:

    “My husband has sleep apnea, so he has used a CPAP for over 12 years. Recently his machine stopped working. When he contacted his supplier, he was told his machine had been recalled and he would have to wait for a replacement. They advised him to contact the manufacturer, Philips.

    “He called Philips, and after following the instructions to restart the machine, was told it was not working. That was July 11. We had just gotten home from the ER where we both tested positive for COVID and received infusions. So he has been without his CPAP since then.

    Anxiety interferes with sleep:

    “He is very aware of the dangers of not using the CPAP machine and has been sleeping very uncomfortably since then. I have been anxious as well, just listening to his snoring. Here’s hoping he does not stop breathing, as he used to do before getting the CPAP.

    “I have heard that it can take up to a year to get a replacement. Surely, he is not alone in this situation. What is a person with sleep apnea supposed to do? A person at his pulmonologist’s office said they are currently diagnosing new patients with severe sleep apnea. These patients are being placed on waiting lists.

    “To my mind, this situation is similar to not having baby formula available. Apparently, there are currently just two companies in the USA who manufacture CPAP devices. What can patients do without this important appliance? Doctors warn that using the machine every night is of critical importance. What can be done to help so many people in need?

    “I am hoping that sleep apnea patients can soon get the machines they desperately need for a good safe night’s sleep.”

    How Has the FDA Fumbled the CPAP Crisis?

    Our reader is right to compare the situation with CPAP machines to the baby formula shortage. Both result from the FDA’s inadequate oversight. In our opinion, the FDA has fumbled a few too many oversight responsibilities.

    That’s not just our opinion. An article in JAMA Internal Medicine, July 26, 2021 reviewed the FDA’s oversight of MAUDE (Manufacturer and User Facility Device Experience). The agency relies on device manufacturers, distributors, physicians, patients, hospitals and other health care facilities to submit reports of problems. Unfortunately, the FDA only pays attention to deaths, rather than all serious complaints.

    The analysis in JAMA Internal Medicine points out that:

    “For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23%, suggesting that approximately 31,552 reports in our sample had deaths that were classified in other categories.”

    If the FDA ignores serious complaints and overlooks deaths with misleading codes, it risks leaving flawed medical devices on the market long past their “use by” date. You can read more about the agency’s fumbling and bumbling at this link.

    What Went Wrong With CPAP Machines”

    On July 29, 2021, the FDA issued an announcement about problems with Philips Respironics BiPap and CPAP machines.

    On May 19, 2022 the agency updated its warning:

    “Philips Respironics (Philips) voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive airway pressure (CPAP) machines in June 2021 due to potential health risks. The polyester-based polyurethane (PE-PUR) foam used in these medical devices to lessen sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device.”

    The Washington Post reported on July 29, 2022 that:

    “Today, those machines are at the heart of one of the biggest medical device debacles in decades.”

    “If inhaled or swallowed, the emissions could cause headaches, asthma, lung problems and even cancer, the company warned in launching a massive recall. The Food and Drug Administration classified the recall as the most serious type, saying “use of these devices may cause serious injuries or deaths.”

    According to the Washington Post, millions of patients have been left in limbo while they wait for their devices to be repaired or replaced.

    “In May, the FDA announced it had received 21,000 reports, including 124 deaths, concerning the breakdown of the polyester-based polyurethane foam in sleep apnea machines and ventilators during the past year — a sharp increase from 30 the previous decade.”

    How long has the maker of CPAP machines known there was a problem? Why didn’t the FDA discover this problem on its own? What should it do about the CPAP crisis?

    Some Recommendations from The People’s Pharmacy:

    Here are some of our suggestions:

    • 1) The president should invoke the Defense Production Act to increase the manufacture of chips specifically for these medical devices.
    • 2) Philips Respironics should prioritize delivering CPAP machines to people who are most vulnerable. The company should also communicate directly to every patient.
    • 3) The FDA should be more proactive regarding critical medical devices so that a life-threatening shortage of this sort never happens again.

    What Do You Think?

    We would love to read your thoughts about the CPAP crisis in the comment section below. Do you know someone who snores and has obstructive sleep apnea? Have they ever used a CPAP machine? Has their device been recalled? What are they doing now?

    If you think this article has merit, please send it to friends and family. We suspect that someone you know snores, has a sleep apnea and/or has a CPAP-type machine. They (and their health care providers) may not know about the problems with these devices. It’s super easy to share. Just scroll to the top of the page and click on the icons for email, Twitter and Facebook.

    While you are at it, please encourage your contacts to sign up for our free online newsletter. You may have noticed that Google accepts a lot of drug and device ads. Is it any wonder that articles like this disappear almost without a trace? The only way your acquaintances can read our independent voice is to subscribe to our newsletter at this link. Thank you for supporting our work!

    Contact us TODAY! Our oral devices can help.