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HIT ConsultantPhilips Respironics Reaches Final Agreement with US Regulators on Sleep Apnea Device Recall

Finalized Consent Decree Provides Pathway for Philips Respironics to Enhance Device Safety and Compliance

Philips Respironics, a subsidiary of Royal Philips, has concluded an agreement with US regulators, finalizing a consent decree that addresses safety concerns and operational compliance following a 2021 facility inspection. This agreement is crucial for the company as it strives to complete remediation efforts for recalled devices and aims to resume the sale of new sleep and respiratory care devices in the US while continuing to support current users and manage financial implications effectively.

Key Points:

  • Final Agreement Reached: Philips Respironics has finalized a consent decree with the US Department of Justice and the FDA, focusing on addressing issues from a 2021 inspection.
  • Recall Remediation Priority: The company is committed to remediating millions of devices recalled in June 2021 due to potential health risks from degraded sound abatement foam.
  • Independent Oversight: External experts will oversee the recall remediation process to ensure compliance with FDA regulations.
  • Continued Support for Patients: Philips Respironics will continue to service existing devices and sell necessary accessories, consumables, and replacement parts.
  • Sales Restrictions in the US: The sale of new CPAP, BiPAP, and other respiratory care devices remains restricted in the US until further compliance is demonstrated.
  • Global Operations: Sales outside the US will continue, adhering to specific regulatory requirements.
  • Safety Verification of New Foam: Tests confirm that devices using new silicone sound abatement foam are safe for use following provided instructions.
  • Financial Considerations: Expected costs from remediation and profit disgorgement related to US sales are factored into Philips’ 2023-2025 financial outlook, with an estimated impact of 100 basis points in 2024.
  • Commitment to Safety and Quality: Philips emphasizes strengthening patient safety and quality as its highest priority, acknowledging that the increased scrutiny from this agreement will foster improvements.

The sleep apnea product market, valued at USD 4.21 billion in 2022, is projected to climb to USD 6.97 billion by 2030, depicting a Compound Annual Growth Rate (CAGR) of 6.51% throughout the forecasting timeline.

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