Connecticut Attorney General William Tong urged the U.S. Food and Drug Administration (FDA) to step up its oversight of the Philips Respironics recall to ensure that millions of impacted patients can resume safe use of their CPAP, biPAP, and ventilator devices as soon as possible. He sent a letter to Janet Woodcock, commissioner of the FDA, detailing his concerns.
Philips Respironics issued a voluntary recall on June 14, 2021 of its E-30, Dream Station ASV, Dreams Station ST, AVAPS, System One ASV4, C-Series ASV, C-Series S/T, AVAPS, Omnilab Advanced +, System One (Q Series), Dream Station, Dream Station Go, Dorma 400, Dorma 500, REMStar SE Auto, Trilogy 100, Trilogy 200, A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40, and A-Series BiPAP A30, noting potentially life-threatening issues related to degradation of polyester-based polyurethane (PE-PUR) sound abatement foam. Particulates released from degrading PE-PUR foam into devices’ air pathways and off-gassing of chemicals are toxic and potentially carcinogenic.
According to a press release issued by Tong, impacted patients have reported that calls to the toll-free phone number provided do not connect callers with people knowledgeable about the recall, and requests for return phone calls are not fulfilled.
Tong has called on the company to provide replacement machines, reimbursement, and repair guidance. While Philips can and must take stronger action immediately to assist patients, the recall is regulated by the FDA. Philips has indicated that the FDA has approved a corrective action plan, but neither the FDA nor the company have publicly released the plan, leading to confusion and concern. Greater transparency is necessary to ensure public confidence in the plan.
“It is abundantly clear to me that millions of people who rely on these devices are scared, upset, and woefully lacking understanding of what to do. The corrective action plan approved by your agency, to be followed by Philips, has not been disclosed either by the FDA or by Philips. This lack of transparency leaves patients at risk,” Tong states in his letter.
Patients who use a Philips ventilator device are encouraged to register their product with Philips to receive updates and guidance on the recall.