Machines that help people breathe were recalled a year ago, but many still use them
In Rochester, N.Y., Diane Coleman has relied on a machine to help her stay alive, but she worries that it might be slowly undermining her health.
Her ventilator was among millions of breathing devices that Philips Respironics recalled last summer over safety concerns about numerous models of its ventilators, BiPAP and CPAP machines.
The reason: Polyester-based polyurethane foam used to muffle noise in those machines could degrade, giving off chemical gases and bits of black debris that could be swallowed or inhaled.
The possible risks: headaches, dizziness, nausea, irritated eyes and airways, and “toxic or cancer-causing effects,” according to federal regulators. The Food and Drug Administration put the recall in its most serious category, involving “a reasonable probability” that a product “will cause serious adverse health consequences or death.”
Yet a year later, many patients are still awaiting replacements — and some are using the recalled machines despite those possible risks.
Coleman said her machine underwent some initial repairs, but she is seeking a new one after federal regulators sought more safety testing of the replacement foam used for such fixes. The 68year-old, who is president and chief executive of the disability rights group Not Dead Yet, has a form of muscular dystrophy and uses her ventilator roughly 22 hours each day.
She is nervous about how it could affect her, but “it’s not like I can stop using it.”
Home ventilators are typically provided through an equipment vendor rather than being owned by the patient, complicating the process of changing machines. And even used ones cost thousands of dollars, online listings show. The CPAPs and BiPAPs that help people breathe while they sleep can cost more than $1,000, and insurance companies limit how often they will pay for replacements.
The vast scope of the Philips recall — which covers numerous models manufactured for more than a decade — has sent a flood of people to seek new machines at a time when supply chains are already strained.
As of this spring, Philips said that repairing and replacing devices would take until “approximately the end of 2022” for the majority of users. Philips spokesperson Steve Klink said in a statement that the recall was “a complex undertaking because of the sheer volume of devices to be remediated, and the outreach to every individual patient.” The company said it expects to replace or repair roughly 5.5 million devices globally, the bulk of which are CPAP or BiPAP machines.
“In an average year, we produce and distribute around 1 million sleep devices,” Klink said. Despite challenges with the supply chain, “we have scaled up by more than a factor of three, but inevitably it still takes time to remediate over 5 million devices. While we are working as fast as we can, we acknowledge that this has been worrying for patients.”
The danger of stopping a ventilator that sustains someone’s oxygen flow is obvious. Even switching to a different model can be precarious. Halting recalled CPAP or BiPAP machines can also be “unacceptably risky” for certain patients, physicians warned in the American Journal of Respiratory and Critical Care Medicine.
The devices are commonly used to treat sleep apnea, a disorder in which breathing is repeatedly interrupted during sleep, which can increase the risk of heart problems and leave people dangerously drowsy during the day. The FDA has advised patients who use the recalled CPAP or BiPAP machines to talk to their doctors about whether to stop.
Tom Wilson, who administers a Facebook support group for CPAP users affected by the recall, said he has read comments from group members who say they haven’t had any communication with Philips despite registering their devices with the company as much as a year ago. Some have paid out of pocket to get other devices.
“It becomes a choice between continuing to use a potentially cancer causing device or spending $1,000 or more, especially for those with severe obstructive sleep apnea,” Wilson said in an email.
In New Jersey, Chloe Berger said she stopped using her CPAP machine and suffered debilitating migraines and exhaustion. “I couldn’t maintain a job. I was just too tired,” said Berger, 30, a therapist who said she had to give up one job, then another, because she was struggling to stay awake.
Berger said she paid out of pocket for a different machine in April, roughly two months before Philips sent her a replacement. Waiting had taken an emotional and mental toll on her, she said. “You feel like you’re swimming upstream, and nothing is happening.”
The massive recall has already spurred class-action lawsuits from users across the country.
“They’ve botched the whole thing,” said Dena Young, senior counsel at Berger Montague, who said that most of the people represented by her firm had not gotten a replacement or repair. As they wait, “some of them are still using the Philips because they don’t have a choice.”
Federal investigators have also taken interest: In April, Philips said the U.S. Department of Justice had subpoenaed the company in regards to events leading to the recall.
Consumer safety advocates argue that the halting process underscores the shortcomings of the recall system, which relies heavily on private companies to inform consumers and take action.
“It isn’t actually easy for the FDA to take products off the market,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit research center that has raised concerns about the safety of medical products. “It should be a lot easier than it is.”
But the actions that the FDA has taken so far in the Philips recall also show that the agency “has more power in recalls than they usually use,” Zuckerman said.