FDA says Philips’ testing of recalled devices is inadequate

Dive Brief:

The Food and Drug Administration called for further testing by Philips to evaluate the risks of soundproofing foam used in its recalled sleep apnea machines and ventilators.
“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,” Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a Thursday statement that included more details on the recall and the agency’s actions.
Philips has claimed use of the devices is "not expected to result in appreciable harm to health in patients,” but agreed with the FDA’s recommendations to run additional testing.

Dive Insight:

Philips’ recall of sleep apnea devices and ventilators has continued since June 2021, when the company began an effort to repair or replace millions of devices that used polyester-based polyurethane (PE-PUR) foam for soundproofing.

The company first disclosed the foam problems in April 2021, flagging possible risks to users of some CPAP machines in an earnings call.

It found that the sound abatement foam could break down into particles that can be inhaled by patients who use the machines. Exposure to these compounds could cause nausea, headaches, inflammation and “toxic carcinogenic effects,” according to an FDA recall notice.

More than 15 million devices could be affected, according to the FDA’s recall database, including about 10 million in the U.S. alone.

Since then, Philips has walked back some of its statements about the foam risk. Based on the results of a test and research program the company ran with five independent laboratories, it claimed the devices were unlikely to harm patients’ health.

After reviewing the available data, the FDA said that it does not believe the testing and analysis is adequate to evaluate the risks to users, and called for additional testing. Philips spokesperson Steve Klink wrote in an emailed statement that Philips has agreed with the FDA’s recommendations to implement additional testing. The company is still in discussions with the FDA on the details of that further testing.

Philips is in the process of sending patients repaired or replacement devices. According to the company's website, it has sent 2.49 million remediated devices to patients or durable medical equipment providers.

Recently, the company settled a class action lawsuit by patients who purchased the recalled devices, agreeing to pay out a minimum of $479 million. The company still faces personal injury claims, and is in talks with the U.S. Department of Justice about a proposed consent decree.

Sen. Richard Blumenthal has also called for action from the DOJ after ProPublica and the Pittsburgh Post Gazette found that Philips withheld thousands of complaints from the FDA in the 11 years leading up to the recall.