Devices

FDA Hits Philips with 29-page 483 Over Recalled Device

FDA recently inspected Philips Respironics and issued a 29-page Form FDA-483 based on a Class 1 recall follow-up involving its continuous and non-continuous ventilators. The inspection was initiated to assess compliance with regulatory requirements and to investigate concerns about the devices’ polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration.

A recall notice says the foam may break down and enter the device’s air pathway. “If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device,” the notice says, adding that exposure to debris or chemicals could cause serious adverse events in patients. There have been more than 1,200 complaints and more than 100 injuries reported on the issue. The ventilators are used to provide respiratory support or treatment for sleep disorders.

Following the initial recall, Philips Respironics developed a plan to repair the foam in the recalled devices with a different, silicone-based foam. The agency initially approved this plan based on testing the company provided.

“However, during the manufacturing facility inspection, the FDA obtained additional information, not previously available to the agency, regarding the silicone-based foam used in a singular, similar device marketed outside the U.S., which failed one safety test for the release of certain chemicals of concern, called volatile organic compounds (VOCs),” an FDA notice says. “Similar testing provided by Philips Respironics to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips Respironics retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam.”

Currently, while the independent testing is conducted, FDA says it does not recommend that patients who have participated in a repair and replace program discontinue use of the product. “The FDA has reached this determination based on an overall benefit-risk assessment,” the notice says. “At this time, the agency has determined that discontinuing use of one of these devices may be more harmful to a patient’s health and quality of life.”

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