Ventilator

Millions of ventilators, BiPAP and CPAP machines from Philips Respironics were recalled last summer over safety concerns.

Cancer has been a stated concern: Since 2020, more than 1,100 such reports about Philips CPAP or BiPAP machines have included the words “cancer,” “tumor” or “tumour,” said Madris Kinard, chief executive of Device Events, which gathers data to track problems with medical devices. The Center for Devices and Radiological Health said in May that it was not convinced that such testing was enough to downgrade the estimated harm from the tested machines. He urged patients to talk to their doctors to weigh the risks and benefits of continuing to use a recalled device. The company said that when its executive committee became aware of the issue and its possible significance early last year, it took “adequate actions” that led to the voluntary recall. Another study from Sweden found signs of an increased incidence of lung cancer, but said the findings were inconclusive and might be related to regional differences in cancer risks. Miles has a rare form of dwarfism that causes a “floppy airway” that needs to be reopened with mechanical ventilation. This year, the FDA found that Philips’ efforts to alert patients were insufficient, concluding that many patients were probably still unaware of the health risks nine months after the recall had begun. As they wait, “some of them are still using the Philips because they don’t have a choice.” As of this spring, Philips said that repairing and replacing devices would take until “approximately the end of 2022” for the majority of users. Emails showed that the company was aware of “foam degradation issues” as early as October 2015, the FDA investigator found. 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. 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.