Philips Respironics Consent Decree Approved
A federal court has approved an FDA-brokered consent decree against Philips Respironics over its defective continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines, and other devices. CDRH director Jeff Shuren calls the action a significant milestone, as it “marks the first time a device company is providing a remediation payment option for a recalled device under a consent decree.”
The decree, which was preliminarily announced by the company in late January (see story), personally names Roy Jakobs, CEO of Royal Philips, along with several other executives as individual defendants. “The consent decree, with limited exceptions, restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met,” an agency release says. “The decree also requires implementation of a Recall Remediation Plan, agreed to by the FDA and Philips Respironics, to help ensure relief is provided to patients impacted by Philips Respironics’ June 2021 recall of certain ventilators, CPAP and BiPAP machines, by way of receiving a new or reworked/remediated device or, for certain devices, providing the option for a partial refund.”
The decree follows numerous recalls by the company in 2021 because of potential health risks totaling over 15 million devices worldwide, FDA says. “The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. If the foam breaks down, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. Immediately following Philips’ recall, the FDA issued an alert notifying device users that problems reportedly associated with the PE-PUR foam breakdown could potentially result in serious injury and may require medical intervention to prevent permanent injury.”
The complaint, which was filed by the Department of Justice on behalf of the agency, alleges that Philips Respironics introduced devices into interstate commerce that were adulterated because the devices were not manufactured following GMPs. In addition, it alleged that the company introduced devices into interstate commerce that were misbranded because it failed to submit to FDA required information about specific corrections (or removals) the company made to devices.
FDA says the consent decree restricts the company from manufacturing and distributing devices at or from Philips Respironics facilities in Pennsylvania and California until the company completes the repair/rework, replacement and refund activities set forth in the Recall Remediation Plan, and are in compliance with GMP requirements. “The company can continue to manufacture and distribute certain devices that the FDA has determined to be ‘medically necessary,’ which are specified in the decree, as well as replacement parts and accessories to support the use of devices in customers’ possession,” the agency says. Philips Respironics is also required to retain an independent expert to inspect other facilities to evaluate whether they are operating in compliance with FDA regulations.
Additionally, the decree requires the company to contract with an independent testing expert to review and evaluate its testing, including biocompatibility data, on the new, silicone-based foam the company is using to replace and rework some machines impacted by the 6/2021 recall. “This independent expert will assess, among other things, Philips’ plan for testing the silicone-based foam, including testing that has been completed, is ongoing, or is planned, to ascertain whether that testing will enable a determination that the silicone-based foam does not degrade during the labeled service life of the device and does not introduce any new or similar potential health concerns to the PE-PUR sound abatement foam,” FDA says. The expert is required to submit findings of the evaluation to FDA for review. The company will also be required to submit a plan to address any gaps in testing, analysis or other information that may be identified by the expert.