The FDA has updated its communications on the major recall of ventilators from Philips (NYSE: PHG) with new data on device reports and patient deaths.
In June 2021, Philips Respironics recalled millions of certain Ventilators, Bi-Level Positive Airway Pressure (BiPAP) and Continuous Positive Airway Pressure (CPAP) devices due to potential health risks caused by ruptured polyurethane sound-absorbing foam polyester-based (PE-PUR). down. Foam particles could enter a device’s vent, causing a range of potential health problems and toxic and carcinogenic effects for the user.
According to the FDA notice, the agency has received more than 21,000 medical device reports (MDRs), including 124 death reports, associated with PE-PUR foam failure or suspected foam failure in Philips Respironics ventilators between April 2021 and April 30. 2022.
In the MDRs received by the FDA – both mandatory reports from Philips and voluntary reports from healthcare professionals, consumers and patients – a range of injuries have been reported, including cancer, pneumonia, asthma , other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, lumps and chest pain.
Philips submitted 30 MDRs between 2011 and April 2021 that they identified as being associated with the PE-PUR foam failure. Eight of the reports were from the United States and there were no reported cases of patient injury or death.
Philips submitted 30 MDRs between 2011 and April 2021 that they identified as being associated with the PE-PUR foam failure. Eight of these reports were from the United States. There were no reports of patient injury or death among these 30 MDRs. The FDA has acknowledged the shortcomings of its MDR monitoring system, saying they only include one of its major sources of postmarketing surveillance data.
The FDA has stated that the effectiveness of the MDR system is limited because the incidence, prevalence, or cause of an event generally cannot be determined from the reporting system alone due to under-reporting of events, inaccuracies in reporting, lack of verification that the device caused the reported event, and lack of information on how often the device is used.
Amsterdam-based Philips said last year it was no longer taking orders for sleep therapy systems as it dealt with the Class I recall, which saw it disappear from the sleep therapy market for at least less than a year. In March, the FDA issued a notification order alerting Philips that its notification efforts regarding the recall of its ventilators have been insufficient to date.
Last month, the company revealed a subpoena from the Department of Justice seeking information related to the recall of its respirators. The subpoena sought “information related to the events leading to Respironics’ recall.” Phillips said its affiliates are cooperating with investigators.
In an update released May 2, the FDA’s Center for Devices and Radiological Health (CDRH) offered Philips to submit a plan to repair, replace, or refund the purchase price of recalled devices manufactured after November. 2015.
When the FDA offered its order to Philips earlier this month, a Philips spokesperson issued the following statement:
“We have been notified by the FDA that it is proposing to issue an order under Section 518(b) of the Federal Food, Drug, and Cosmetic Act, in connection with the recall of Philips Respironics for some CPAPs, BiPAPs and mechanical ventilators. Philips is reviewing the information and intends to share its views with the FDA. We have been and continue to cooperate with the FDA.
“To date, Philips Respironics has produced a total of 1.1 million replacement devices and repair kits for customers and patients in the United States, and aims to complete the vast majority of the repair and replacement in 2022.