Philips Respironics says it plans to conduct extra testing on sure CPAP and respiratory care gadgets concerned in its June 2021 recall on the request of the US Meals and Drug Administration (FDA).
The FDA requested extra testing after concluding that Philips’ testing to this point was insufficient to completely consider the dangers posed to customers by the gadgets’ potential polyester-based polyurethane sound abatement foam degradation.
“Following ongoing communications with the FDA, Philips Respironics has agreed with the FDA’s suggestions to implement extra testing on sure sleep and respiratory care gadgets to complement present take a look at information,” says an announcement from Philips.
Philips notes within the assertion that it has been working with the FDA over the previous two years on its take a look at and analysis program and revealed common take a look at updates as agreed with the FDA.
In its newest replace in July, Philips concluded that dangers associated to foam degradation in its recalled gadgets had been throughout the relevant security limits and had been “unlikely to end in considerable hurt to well being in sufferers.”
The FDA, nonetheless, remained “unhappy” with the standing of the recall.
Philips continues in its assertion, “Philips’ first precedence is the well being and well-being of sufferers, each when it comes to offering substitute gadgets and testing to hunt extra readability on the protection of the sleep and respiratory care gadgets beneath the recall. We perceive how vital these sleep and respiratory care gadgets are to sufferers that use them.
“Philips shares the identical goal because the US Meals and Drug Administration (FDA) and different regulators to make sure the best requirements of affected person security and high quality within the supply of healthcare. Philips stays dedicated to working carefully with regulators the world over, as we proceed to dedicate all crucial assets to make sure that sufferers obtain remediated gadgets, and the take a look at and analysis program is accomplished.”