Sleep Treatments | Sleep Review
Connecticut Attorney General William Tong called on the U.S. Food and Drug Administration (FDA) to step up its oversight of the Philips Respironics recall to ensure that millions of affected patients get their CPAP, biPAP and ventilators as quickly as possible safe to use again as possible. He sent a letter to FDA commissioner Janet Woodcock detailing his concerns.
Philips Respironics issued a voluntary recall 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 on June 14, 2021. issued 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, which indicates potentially life-threatening problems related to the degradation of polyester-based polyurethane (PE-PUR) foam. Particles that are released from degrading PE-PUR foam into the airways of the devices and the outgassing of chemicals are toxic and potentially carcinogenic.
According to a press release issued by Tong, affected patients have reported that calls to the toll-free number provided do not connect callers with anyone who is aware of the callback, and callback requests are not being met.
Tong has asked the company to provide replacement machines, refunds, and repair guides. While Philips can and must take stronger action immediately to help patients, the recall is being regulated by the FDA. Philips has stated that the FDA has approved a corrective action plan, but neither the FDA nor the company have publicly released the plan, causing confusion and concern. More transparency is needed to ensure public confidence in the plan.
“I realize that the millions of people who rely on these devices are scared, upset, and deplorably not knowing what to do. The corrective action plan approved by your agency to be followed by Philips has not been disclosed by either the FDA or Philips. This lack of transparency puts patients at risk, ”Tong says in his letter.
Patients using a Philips ventilator are recommended to register their product with Philips for updates and recall instructions.
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