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Dive Brief:

  • The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is proposing that the agency issue an order to require Philips to submit a plan for the repair or replacement of its recalled sleep-apnea devices or refund the purchase price. It would apply to devices manufactured after November 2015.
  • The Philips Respironics recall currently totals more than 5 million devices. Philips would have an opportunity for an informal hearing before the FDA determines whether or not to issue an order.
  • Philips said in an emailed statement it’s studying the information and intends to share its views with the FDA. “We have been and continue to cooperate with the FDA,” a company spokesperson wrote, adding that the company had produced 1.1 million replacement devices and repair kits for its U.S. customers and aims to finish “the vast majority” of its repair and replacement program in 2022.

    Dive Insight:

    The agency’s proposal wouldn’t be the first time the FDA has gotten involved in the recall. In March, the agency ordered Philips to notify customers, including both patients and suppliers, of the recall and the health risks of using the devices. In a letter, the FDA said that it kept hearing from patients and customers who were unaware of the recall.

    Philips recently indicated that it expects more devices will need to be repaired or replaced as a result of more patient registrations in mid-February, “when there was extensive communication around the recall,” CEO Frans van Houten told investors in an April 25 earnings call.

    Now, the company estimates 300,000 more units will need to be repaired or replaced in addition to the 5 million units in the recall.

    So far, Philips said it had produced more than 2.2 million repair kits and replacement devices. The company no longer expects to complete the recall this year, but it estimates it will have completed 90% of the production and shipment by the end of 2022.

    Recently, Philips also disclosed that the U.S. Department of Justice is subpoenaing the company for “information related to events leading to the Respironics recall.”

    The recall, which affects Philips Respironics’ ventilators, bi-level positive airway pressure (BiPAP) and continuous positive airway pressure (CPAP) machines, has been ongoing since June of 2021. It started after Philips found the polyurethane foam used to dampen sound from the machines could break down, possibly exposing patients to toxic chemicals if particles are inhaled or ingested by users.

    ResMed, another manufacturer of respiratory care devices, initially saw an opportunity to capture market share during its competitor’s recall. However, an ongoing shortage of semiconductors and other electronic components has slowed ResMed’s efforts.

    Currently, patients face an estimated 12- to 18-month backlog, ResMed CEO Mick Farrell said in a recent earnings call. This means a wait as many as eight weeks for a device.

    In some cases, patients may continue using the affected devices if stopping would pose a greater risk than continuing to use it, the FDA noted in an FAQ about the recall.