The US Food and Drug Administration (FDA) has reiterated its commitment to oversee the recall of specific Philips-made respiratory devices as it remains “unsatisfied” with the present process.
In a statement released on the FDA website, Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH) has said that the organisation is dedicated to monitoring the recall status and process for Philips’ bilevel positive airway pressure (BiPAP) machines, and continuous positive airway pressure (CPAP) machines.
The statement comes after it was found that Philips knew for over a decade about the defects in its respiratory devices before issuing a recall in 2021. Now that recall is being overseen directly by the FDA.
Shuren said: “The FDA remains unsatisfied with the status of this recall, and we continue to take steps to protect the health and safety of individuals using these devices.”
According to a ProPublica and Pittsburgh Post-Gazette joint investigation, the company’s respirator subsidiary, Respironics, had been found to have altered the design of its ventilators and sleep apnoea machines in 2010, utilising polyester-based polyurethanesame in its packaging. This was despite evidence that the packaging in question was liable to break down under heat and humidity.
After initiating the recall in 2021, Philips began running additional tests on the packaging foam, known as PE-PUR, at the FDA’s request. Additionally, the FDA ordered the company to provide a link for healthcare providers and registrants to access all available testing results and third-party confirmed conclusions.
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Shuren added: “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 appreciable harm to health in patients, the FDA believes additional testing is necessary.
“Philips has agreed to conduct the requested additional testing. 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.”
As part of its efforts to provide rolling information on the recall, the FDA has published a new resource section on its website, including a timeline of FDA activities related to the June 2021 recall.