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August 17, 2021
By Joshua Brockman | New York Times | NEW YORK (August 17, 2021) -- For three years, Donald Camp has used a breathing device to sleep. He has severe sleep apnea, so without this device, his breathing is obstructed and he gasps for air.
But in June, Mr. Camp and many others began learning that more than a dozen Philips Respironics machines that deliver pressurized air through a mask were recalled because of potential health risks from faulty components. Since then, millions of people in the United States, and their doctors, have been scrambling to find alternatives for those with common sleep disorders, breathing problems and respiratory emergencies.
Last month, the Food and Drug Administration warned of potential health risks that could be “life-threatening, cause permanent impairment and require medical intervention.” The potential harm comes from polyester-based polyurethane foam that dampens sound and vibration in the machines; it can degrade and result in a user’s breathing in chemicals or swallowing or inhaling black debris.
The agency said the possible risks of particulate and chemical exposure from the recalled devices included asthma, skin and respiratory-tract irritation and “toxic and carcinogenic effects” to organs including the kidneys and liver.
The company has to submit a repair-and-replacement program for the flawed components to the F.D.A. In the meantime, there are shortages and backlogged orders, created by delays in the replacements and the use of similar devices in emergency rooms and intensive-care units during the coronavirus pandemic.
Mario Fante, a spokesman for Royal Philips, the parent company of Respironics, estimated that up to two million of the recalled devices were in use in the United States, about half of the global count. These machines are used at home by some of the estimated 24 million Americans with obstructive sleep apnea.
Philips has advised customers with affected devices to register their products and consult their doctors.
Mr. Camp said he did not hear directly from Philips, his doctor or the medical equipment supplier about what steps to take. He read about the recall on Twitter and then called a Philips hotline to register his device. He said a representative placed him on a waiting list for a replacement, with no estimate for how long that might take.
“I will continue to use my machine until I get a replacement,” said Mr. Camp, 72, a retired foreign service officer who lives in Falls Church, Va. “I believe any risk of cancer is less than the risk of the serious consequences of sleep apnea.”
A recall slip that a patient shared with a reporter said Philips would prioritize patients with “more advanced clinical needs.”
Mr. Fante provided no timeline other than to say the company was working “expeditiously” and “we are not able to provide an immediate solution.” The company, he said, was “already producing repair kits and replacement devices in large quantities” of about 55,000 units a week that had not yet been cleared for shipping. He added that the company was not taking orders for sleep therapy devices for new patients.
The F.D.A. is the sole regulator of these machines, but does not conduct hands-on inspections of the repair and replacement devices, said Shirley Simson, an agency spokeswoman. Beyond providing the agency with a plan, Philips must conduct extensive testing and the F.D.A. will then review the data before any machines can be sent to patients.
“We will authorize such a plan as soon as the company provides the agency with sufficient evidence to support the safe and effective mitigation of the product defect, including fixing or replacing the devices patients are currently using,” she said.
As the Delta coronavirus variant surges, doctors remain concerned about the supply of these machines.
“Because the number of people coming into the hospital with severe respiratory symptoms has increased as a result of Covid-19, the demand for these devices has also increased, which is problematic since available supply has decreased as a result of the Philips recall,” said Dr. David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare.
The American Hospital Association, an industry group, said it had reactivated a program to help distribute ventilators and supplies to regions where the Delta variant had hit hardest, according to Thomas Jordan, a spokesman.
The F.D.A. is not aware of any effect on the care of Covid patients from the shortage of BiPAP and CPAP machines, Ms. Simson said.
A BiPAP machine (also known as BPAP) stands for bi-level positive airway pressure, and the device pumps air in two ways. Inhalations are assisted with a higher pressure and exhalations have a lower one. These typically work best for patients with neuromuscular diseases who take smaller breaths. Machines that use continuous positive airway pressure, or CPAP, keep the airway open with a single, continuous stream of air.
As a result of the Philips recall, “both doctors and patients are extremely uncertain,” Dr. Schulman said. “How do we advise our patients when we know that the potential risks are serious, but haven’t any idea whether they are extremely rare or just uncommon?”
Dr. Schulman said the problem was the lack of clear answers: “The imperfect information is affecting hundreds of each doctor’s patients all at once.”
Dr. Timothy I. Morgenthaler, a sleep medicine specialist at the Mayo Clinic in Rochester, Minn., said that new patients and those affected by the recall had told him they were placed on waiting lists by medical suppliers. Several weeks later, they still did not know when to expect their devices.
“Philips’ recall notification for all types of machines sends this message: Your machine is dangerous,” Dr. Morgenthaler said. “If you are dependent upon it for life, keep using it now, and if you aren’t sure that is the case, stop using it. And discuss with your physician what you ought to do.”
He said it would be helpful to know the time needed for replacements and how to quantify the risks.
“Unfortunately, neither of those important pieces of information are supplied,” Dr. Morgenthaler said. “The risk of good or bad decisions is passed to the patient and provider. I hope we are doing it right.”
Mayo Clinic contacted more than 4,500 patients who might have been affected by the recall, and removed the devices from its hospitals and sleep clinics. Dr. Morgenthaler, who previously served as Mayo Clinic’s chief patient-safety officer, said that with an increasing number of medical devices being pushed into service, there was a “marked increase” in recalls.
“The question is could Philips have known ahead of time that would occur?” Dr. Morgenthaler said. “Manufacturers — and perhaps regulators like the F.D.A. — should learn from this particular mistake and ensure that this does not happen again.”
Aside from the Philips machines already under recall, the F.D.A. said it had no evidence that additional BiPAP, CPAP or ventilation machines from the company or other manufacturers were affected. ResMed, Fisher & Paykel and 3B Medical are among the companies manufacturing similar devices. ResMed, one of the largest, said that its devices were “safe to use.”
In an August earnings call, Mick Farrell, the chief executive of ResMed, said the company had experienced a “demand spike” and would “not be able to fill the entire supply gap” created by the Philips recall. He said he expected ResMed to earn more than $300 million in additional revenue in the 2022 fiscal year as a result of increased demand.
Jayme Rubenstein, a ResMed spokesman, said the company was prioritizing manufacturing devices for patients with immediate ventilator needs, including Covid patients, followed by machines for those with central and obstructive sleep apnea.
In an April 2020 survey of home medical-equipment suppliers, more than half reported supply-chain interruptions for CPAP machines, and 62 percent reported up to a 60-day delay. The Philips recall has “certainly exacerbated” the situation, said Thomas Ryan, the chief executive of the American Association for Homecare, which commissioned the study and represents the suppliers. (Philips is on its board.)
“Given the shortages of materials to make these devices, such as resins and computer chip modules, and transportation bottlenecks, I expect that supply will continue to lag behind demand into 2022,” he said. “It is becoming a crisis.”
Amy Sloane, who learned she had sleep apnea in 2017, started using a DreamStation BiPAP Auto SV machine the following year. Overall, she said, her sleep improved. But in reading about the recall, she grew concerned when she learned that the sonic cleaning device she used could break down the foam barrier.
“Even more upsetting,” she said, “when I manually wiped out my DreamStation water reservoir, there were black particles on the wipe.”
Ms. Sloane, 57, a lawyer who lives in Baltimore, registered her device with Philips for the recall early. But she said the company’s only response was to tell her to consult her physician, who advised her to stop using it immediately. Within a few days, her doctor was able to prescribe an auto-adjusting CPAP machine by another manufacturer.
Since June, about 40 lawsuits against Philips have been filed on behalf of patients in more than 20 states. Steven Bloch, a lawyer for Silver Golub & Teitell in Stamford, Conn., said his firm filed four actions in Massachusetts, home to Philips’s U.S. headquarters.
A multidistrict litigation petition has already been filed, and legal experts ultimately expect all the cases to be consolidated in one state, akin to what occurred with lawsuits against opioid manufacturers.
Royal Philips first disclosed the device problem in April. Mr. Fante, the spokesman, said the company had set aside about $591 million to cover the repair-and-replacement orders and other related costs.