On Thursday the Food and Drug Administration (FDA) released an order to recall certain breathing assistance machines. The machines were manufactured by Philips Respironics and include ventilators, continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. The machines were sold nationwide, but the notice does not indicate a specific date range, nor a specific serial number lot of machines.
The machines were designed to provide pressure based respiration assistance for patients with medical conditions. Included in the machines were sound abatement foam that muffled some of the noise associated with the strong motors powering the devices. However, this foam was made out of polyester-based polyurethane (PE-Pur) which per the order provides an unreasonable risk of substantial harm to public health when it degrades. This risk is elevated if an ozone cleaner is used on the device.
Philips originally initiated a recall of these ventilators in June 2021, however the FDA found that the original recall was ineffective in its communications with the public regarding the risks presented by the product. The FDA noted that it had concern that it is likely a significant portion of patients and consumers using the recalled products are unaware of the health risks presented by those products.
The new order is issued under section 518(a) of the Federal Food, Drug, and Cosmetic Act. The order includes a requirement that Philips actively notify all devices users, durable medical equipment supplies, distributors, retailers and healthcare providers. The FDA also recommends that the manufacturer maintain the recall information visible on its website with monthly updates including expected timeframe and rate of replacement of the devices. The order requires Phillips to provide the notification within 45 days.
