Philips has come under increased scrutiny from federal regulators as investigations into the sound-deadening foam it used on various models of its CPAP machines are revealing much deeper problems within the company.
The foam first came to regulators’ attention this past summer after the discovery that it could degrade and enter the breathing circuits of some of the company’s CPAP machines. Initial reports indicated that the foam particles could cause irritation and certain asthmatic responses, however, the news became much more dire for Philips when the FDA added the risk of “toxic and carcinogenic effects” to the list. Carcinogens are products or compounds known to cause cancer in humans.
Regulators are now expanding their investigation into Philips and asking how much the company knew about this problem and how long they knew about it.
Form 483 filings, which indicate possible sources of FDA rule violations within a regulated company, show that foam issues came to Philips’ attention no less than 14 times between April 2016 and January 2021. Plans were put in place to change the design of the devices to account for the risks, but the FDA found that procedures to implement those changes were inadequate. At the same time, Philips failed to ensure that its breathing machines were properly serving customer and patient needs.
Most recently, FDA regulators discovered that the foam in question was being used for a similar device the company markets and sells outside of the United States and it had failed tests related to off-gassing of various volatile organic compounds. Investigators – and the legal community – are sure to be curious why a material that had previously failed international safety checks was being used in a device marketed to American customers.
