What You Should Know:
– Philips Respironics, a subsidiary of Royal Philips, has finalized a consent decree with the US Department of Justice (DOJ) and Food and Drug Administration (FDA) to address issues raised during a 2021 inspection of a Philips facility in Pennsylvania.
– The agreement focuses on Philips Respironics’ operations in the US, particularly regarding the recall of certain sleep and respiratory care devices.
– The company’s focus will now be on completing remediation efforts, ensuring patient safety, and regaining regulatory approval to resume sales of new devices in the US.
Focus on Remediation and Compliance
The consent decree outlines a roadmap for Philips Respironics to:
- Prioritize Recall Remediation: Philips will continue efforts to remediate millions of sleep apnea and respiratory care devices recalled in June 2021 due to potential health risks associated with degraded sound abatement foam.
- Independent Oversight: Independent experts will be brought in to review recall remediation efforts and ensure Philips Respironics’ business operations comply with FDA regulations.
- Continued Patient Support: Philips Respironics can continue servicing existing devices in the hands of patients and healthcare providers. Additionally, they can sell accessories, consumables, and replacement parts for these devices.
Sales Restrictions Remain in US
The FDA has not yet authorized Philips Respironics to resume sales of new CPAP, BiPAP, or other respiratory care devices in the US. This restriction will remain in place until Philips meets the requirements outlined in the consent decree.
Global Sales Continue with Restrictions
Philips Respironics can continue to sell new devices, accessories, consumables, and replacement parts outside the US, subject to specific requirements.
Safety of Devices with New Foam Confirmed
Philips Respironics has conducted tests on devices using a new silicone sound abatement foam and found no safety issues. Patients can continue to use these devices following the instructions for use.
Financial Impact
Philips anticipates incurring costs associated with remediation activities and profit disgorgement related to US sales. These costs are estimated at 100 basis points in 2024. The company’s previously announced 2023-2025 financial outlook remains unchanged, already factoring in the consent decree.
“Strengthening patient safety and quality remains Philips’ highest priority and the increased scrutiny will help us to improve even more. With the agreement on a consent decree for Philips Respironics in place, we now have a clear path forward to gradually restore the business, serving patients around the world,” said Roy Jakobs, CEO at Philips.