In June of 2021, Philips Respironics Sleep and Respiratory Care recalled over five million CPAP and BiPAP machines – one of the largest medical device recalls in recent history. The recall was in response to discovering that the sound abatement foam used in these products may break down and enter the user’s air pathway, leading to a number of health risks. Indeed, the recall has been associated with more than 100 deaths at this point.
The FDA started investigating and now, the Department of Justice (DOJ) is getting involved.
Here’s a rough timeline of what’s happened recently:
On April 8th, the DOJ subpoenaed Philips Respironics to gain information about the company’s recall. Reports from the New York Times indicate the DOJ is currently negotiating terms of a consent decree, a settlement agreement approved by the court. Basically, the DOJ is trying to understand the timeline of what the company knew and when they knew it.
Currently no other details about the DOJ investigation are available.
A year and half ago Philips put out a voluntary recall; however, the FDA found its recall notice insufficient. On March 10th, the FDA stepped in and issued a notification order to Philips. The notification order outlined the numerous complaints they received from patients and consumers, including expressions of fear about an extensive delay in receiving their replacement device.
In a press release the FDA’s director Jeff Shuren stated, “The FDA has heard the frustration expressed by patients and durable medical equipment suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process.”
CPAP User Still Wait for Replacement Machines
While users wait for a replacement device, some are choosing to continue using their recalled device despite the health implications.
Joyce Baldassarre, 64, who was diagnosed with sleep apnea six years ago is one of those people. She told the New York Times, “We don’t wear this for funsies. It’s certainly not attractive. We wear it so we don’t die in our sleep.”
According to the Philips website, replacement devices will continue to ship throughout the end of 2022. Philips states the replacement devices use a new silicone compared to the recalled polyester-based polyurethane sound abatement foam component.