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 reports of deaths reportedly associated with the products.
The Food and Drug Administration 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. But the troubled response, experts said, underscores a critical compromise that’s been made in medical device oversight: The FDA, without enough manpower to fully police the countless medical devices on the market, must rely on companies to self-report any problems that call into question the safety of their own devices. But as the Philips recall makes clear, that collaborative approach to oversight falls apart when companies don’t do their part. And ultimately, experts said, it’s patients who pay the price.
“You’d hope that if there’s a problem, it wouldn’t take you a decade and 90,000 [adverse event] reports and 200-plus deaths to figure it out,” said Vinay Rathi, chief resident in otolaryngology at Mass Eye and Ear, Brigham and Women’s, Massachusetts General Hospital and co-author of an editorial about the recall in JAMA Internal Medicine.
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