An anonymous reader cites a ProPublica report. Reeling from one of the most disastrous recalls in decades, Philips Respironics says it will stop selling sleep apnea machines and other breathing equipment in the U.S. under a settlement with the federal government. Announcement, this will almost end the company's reign as one of the top manufacturers of respiratory equipment in Japan. The agreement, announced by Philips early Monday morning, comes as the company acknowledges that industrial foam installed in machines to reduce noise can break down and release potentially toxic particles and fumes. The move comes more than two years after millions of popular respirators were removed from shelves after the company removed them. For masks worn by patients.
It could be years before Philips can resume selling devices made at its two factories outside Pittsburgh. The company said it must first meet all conditions of a multiyear consent order negotiated with the Justice Department on behalf of the Food and Drug Administration in response to the recall. The company's move to aggressively promote its machines in advertising campaigns and health conferences has been met with relentless criticism of the machines' safety — in one case, with the help of an Elvis impersonator. Ta. An investigation by ProPublica and the Pittsburgh Post-Gazette found that the company withheld thousands of complaints about crumbling foam for more than a decade until it warned customers of the dangers. The people using the machines included some of the country's most frail populations, including young children, the elderly, veterans, and people with chronic illnesses.
“It's about time,” said Richard Callender, a former Pennsylvania mayor who used one of the recalled machines for years. “How many people will have to suffer, get sick and die?” Philips said the deal includes a continuous positive airway pressure device that Philips announced in 2021 for use in sleep therapy. The company said it includes other requirements that it must meet before it can resume selling its devices, including its flagship Dream Station 2 (CPAP). Apnea. The settlement is still being finalized, requires court approval, and has not yet been announced by the government. It remains unclear how the suspension will affect patients and doctors. The company's U.S. market share for sleep apnea devices in 2020 was about 37%, lower than its only competitor, medical device maker ResMed, according to an analysis by iData Research. Data shows that Philips dominates the market in ventilator sales.