Philips Respironics says it plans to conduct additional testing on certain CPAP and respiratory care devices involved in its June 2021 recall at the request of the US Food and Drug Administration (FDA).
The FDA requested additional testing after concluding that Philips’ testing to date was inadequate to fully evaluate the risks posed to users by the devices’ potential polyester-based polyurethane sound abatement foam degradation.
“Following ongoing communications with the FDA, Philips Respironics has agreed with the FDA’s recommendations to implement additional testing on certain sleep and respiratory care devices to supplement current test data,” says a statement from Philips.
Philips notes in the statement that it has been working with the FDA over the past two years on its test and research program and published regular test updates as agreed with the FDA.
In its latest update in July, Philips concluded that risks related to foam degradation in its recalled devices were within the applicable safety limits and were “unlikely to result in appreciable harm to health in patients.”
The FDA, however, remained “unsatisfied” with the status of the recall.
Philips continues in its statement, “Philips’ first priority is the health and well-being of patients, both in terms of providing replacement devices and testing to seek more clarity on the safety of the sleep and respiratory care devices under the recall. We understand how important these sleep and respiratory care devices are to patients that use them.
“Philips shares the same objective as the US Food and Drug Administration (FDA) and other regulators to ensure the highest standards of patient safety and quality in the delivery of healthcare. Philips remains committed to working closely with regulators across the world, as we continue to dedicate all necessary resources to ensure that patients receive remediated devices, and the test and research program is completed.”