The U.S. FDA has updated a safety communication regarding medical device reports associated with the breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilator, BiPAP machine, and CPAP machine recalls.
The new data come nearly one year into Philips’ recall, which has grown to include over 5 million ventilator and sleep apnea devices. The company first publicly acknowledged product safety issues during an April 2021 earnings call and announced the recall in June.
The recall is due to foam in the machines breaking down and possibly being inhaled or ingested by users, risking exposure to toxic chemicals.
In March, the FDA ordered Philips to notify all of its distributors, healthcare providers and patients after finding that the company hadn’t adequately communicated the recall. The agency’s Center for Devices and Radiological Health also proposed earlier this month a separate order that would require Philips to submit a plan to repair and replace affected devices.
Read the full article at Med Tech Dive.
