The regulator made this revelation in a Jan. 31 notice, saying that there have been more than 116,000 medical device reports – including 561 deaths – over the now-recalled devices. The reports stemmed from foam breaking down in certain Philips Respironics ventilators, bi-level positive airway pressure (BiPAP) sleep therapy devices, and continuous positive airway pressure (CPAP) machines that were included in a major recall announced in June 2021. (Related: A majority of Americans with sleep apnea are unaware they have it.)
Following the June 2021 recall, the health agency required the company, in part, to "provide a link for healthcare providers and registrants to access all available testing results and third-party confirmed conclusions on findings from testing polyester-based polyurethane (PE-PUR) foam used in devices manufactured by Philips for particulates and VOCs, regardless of the Philips devices that the foam may have been tested in."
According to the regulator, black pieces of PE-PUR foam or certain chemicals – including invisible volatile organic compounds (VOCs) – could be breathed in or swallowed by persons using affected devices. Inhalation of degraded foam and VOCs could result in serious injury and may require medical intervention to prevent permanent injury.
Philips' response to FDA appears to be lacking
The breakdown of the PE-PUR foam in these devices, which is used to reduce sound and vibration, may have resulted from exposure to hot and humid conditions. The FDA added that this issue, reportedly impacting about 15 million machines worldwide, may be worsened by using ozone cleaners or other cleaning methods not recommended by the manufacturer.
"Philips investigates all received complaints and allegations of malfunction, serious injury or death… and has found no conclusive data linking these devices and the deaths reported," wrote the company in response to the FDA's missives. Philips, which is based in Pennsylvania, issued updates on the matter last July 24, 2023.
Despite this, the FDA said: "We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices. Although Philips concluded that the exposure to foam particles and VOCs from these devices is ‘unlikely to result in an appreciable harm to health in patients,’ [we] believe additional testing is necessary."
Between July and September 2023, the health regulator received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these Philips devices, Reuters reported.
To address device shortages, the FDA indicated working with other manufacturers and government partners to help make more machines available throughout the recall. Along with these actions, the regulatory agency issued two recommendations for the company.
It urged Philips to provide monthly updates to patients and consumers who have registered their devices on the Philips website – including information on the expected time for a replacement device and the current rate of replacement of recalled devices. It also called on the company to provide detailed information for device users, durable medical equipment (DME) suppliers, distributors, retailers and healthcare providers on the replacement process.
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Watch this video of mouth and throat exercises to help stop snoring and sleep apnea.
This video is from the Smarty90 channel on Brighteon.com.
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