Sam Brusco, Associate Editor10.06.23
The U.S. Food and Drug Administration (FDA) reaffirmed its commitment to oversee the ongoing recall of Philips Respironics respiratory devices, and that the agency “…remains unsatisfied with the status of this recall.”
“The FDA continues to take steps, including regular monitoring of Philips' reported progress on the remediation and replacement of these critical devices,” FDA’s Center for Devices and Radiological Health director Jeff Shuren, MD, J.D. said in an agency press release yesterday.
This FDA statement follows the recent publication of a joint ProPublica and Pittsburgh Post-Gazette investigation alleging that Philips was aware since 2010 of the potential health risks concerning the breakdown of the PE-PUR (polyester-based polyurethane) foam used to muffle the sound of its ventilators, CPAP, and BiPAP devices.
Philips began the recall in 2021 and began to run further tests on its sound abatement foam at the request of the FDA. The agency also ordered the company to offer a link for healthcare providers and registrants to all testing results and third-party confirmed conclusions from testing.
The FDA also published a new resource section with agency activities related to the 2021 recall. They remain unconvinced of the data Philips has thus far provided.
“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,” Shuren commented. “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,’ the FDA believes additional testing is necessary.”
“Philips has agreed to conduct the requested additional testing,” he went on. “Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”
Today the company issued a statement claiming continued cooperation with the FDA and that it indeed agreed to conduct more extensive testing on its respiratory devices. However, the company reaffirmed that based on results to date, “…use of its sleep therapy devices are not expected to result in appreciable harm to health in patients.”
“The FDA continues to take steps, including regular monitoring of Philips' reported progress on the remediation and replacement of these critical devices,” FDA’s Center for Devices and Radiological Health director Jeff Shuren, MD, J.D. said in an agency press release yesterday.
This FDA statement follows the recent publication of a joint ProPublica and Pittsburgh Post-Gazette investigation alleging that Philips was aware since 2010 of the potential health risks concerning the breakdown of the PE-PUR (polyester-based polyurethane) foam used to muffle the sound of its ventilators, CPAP, and BiPAP devices.
Philips began the recall in 2021 and began to run further tests on its sound abatement foam at the request of the FDA. The agency also ordered the company to offer a link for healthcare providers and registrants to all testing results and third-party confirmed conclusions from testing.
The FDA also published a new resource section with agency activities related to the 2021 recall. They remain unconvinced of the data Philips has thus far provided.
“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,” Shuren commented. “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,’ the FDA believes additional testing is necessary.”
“Philips has agreed to conduct the requested additional testing,” he went on. “Based on the currently available information, the FDA maintains its recommendations regarding the potential health risks associated with the PE-PUR foam breakdown in these recalled devices.”
Today the company issued a statement claiming continued cooperation with the FDA and that it indeed agreed to conduct more extensive testing on its respiratory devices. However, the company reaffirmed that based on results to date, “…use of its sleep therapy devices are not expected to result in appreciable harm to health in patients.”