Millions 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.”
The devices, which many people may be familiar with due to advertising blitzes, particularly on television cable channels, address a major patient need, the newspaper said:
“Without treatment [with the devices], sleep apnea sufferers can go on to develop serious long-term conditions such as high blood pressure, stroke, diabetes and heart problems. Untreated sleep apnea is also a major cause of road traffic accidents, due to sleep deprivation, according to a 2018 study in BMC Medicine. Nearly 24 million people in the U.S. suffer from moderate or severe sleep apnea, according to a 2019 study in The Lancet Respiratory Medicine, although most are undiagnosed.”
The federal Food and Drug Administration, the Wall Street Journal reported, pushed for the Royal Phillips recall, labeling the action with the agency’s “most serious classification, meaning there is a reasonable probability that using the device could lead to serious health issues.”
The FDA website includes this information, explaining the recall:
“The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices … due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. If you use one of these affected devices … talk to your health care provider to decide on a suitable treatment for your condition …”
The FDA goes on to warn about the sound-dampening foam’s risks:
“To date, Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue, though the cause of the symptoms cannot be definitively linked. The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver. The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects. The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone. To date, there have been no reports of death as a result of these issues.”
Sleep specialists, including at the Mayo Clinic, say they have been overwhelmed by patient calls. Doctors are trying to sort out with individuals the seriousness of their sleep disorders, the risks of discontinuing for even short periods the treatment with the devices, and possible arrangements to secure replacements, notably from a Royal Philips competitor. That firm says it is trying to assist patients, but it has detected significant price increases in its own product, as consumers scramble to buy up substitute devices.
The supplies of CPAP and BiPaP machines has been hit, however, by shortages associated with the coronavirus pandemic, company officials told the New York Times and the Wall Street Journal. Components for the devices have gotten harder to source, globally, and ventilation devices altogether have become scarcer due to demand created by coronavirus patient care.
Patients are growing frustrated and angry that Royal Philips, aside from accepting online registration of potentially problem machines, has not explained in detail to the FDA or customers how or how soon devices will be fixed or replaced. The company says it is working overtime to increase supplies and it is trying to triage complaints, so patients in greatest need get help quickly.
The situation for patients is further complicated by health care middlemen. Doctors, in many cases, prescribe breathing devices for patients but the orders for the machines are fulfilled by “durable medical equipment suppliers,” or DMEs, the Wall Street Journal reported. This can add yet another layer of bureaucracy, besides insurers, for patients to deal with as they try to get devices fixed or replaced, especially with urgency.
In my practice, I see not only the harm that patients suffer while seeking medical services, but also the damage that can be inflicted on them and their loved ones by defective and dangerous devices, notably those of the medical kind.
The Royal Philips recall offers yet another case in which regulators themselves, the public, politicians, and regulators need to scrutinize the effectiveness of the FDA as a watchdog over Big Pharma and the growing medical device industry. The FDA has received sustained, justified criticism that it has grown too pro-business and lax in its regulation of industries that, among other things, fund its operations (a Republican idea) and provide, regrettably, lucrative havens for experts to land after their public service.
The Biden Administration has raced in its first year in office to reverse many of the detrimental, pro-business oversight of federal agencies, with the Federal Trade Commission, at long last, ending its long foot-dragging and ordering the recall of tiny, powerful magnets that imperiled kids, and the Environmental Protection Agency, reversing policy and banning a farm pesticide that critics say threatened neurologic damage to youngsters.
Here’s hoping that sleep apnea patients get the help they need with defective devices — and fast, with minimal harm. We have much work to do to ensure that federal agencies work, first and foremost, for the people and not wealthy corporations, and that makers of prescription drugs and medical devices put on the market products that are safe, effective, and affordable.