The Philips Respironics consent decree provides a clear path forward.
Feb 27, 2024 | 3 minute read
About the author About the author
Roy Jakobs is the Chief Executive Officer of Royal Philips. As CEO, he is also Chairman of the Board of Management and the Executive Committee. With his extensive global executive leadership experience, Roy drives Philips’ strategy to help deliver people-centered, high-quality care.
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About the author About the author
Steve C de Baca is Chief Patient Safety & Quality Officer of Royal Philips. He has more than 30 years of quality and regulatory affairs experience in the medical technology industry.
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Continue Strengthening patient safety and quality is Philips’ highest priority. An important step in our ongoing safety and quality efforts was the update in January 2024 that Philips reached agreement on the terms of a consent decree with the US Department of Justice (DOJ) and the US Food and Drug Administration (FDA).
Philips Respironics recall
Firstly, we’d once again like to deeply apologize for the distress and concern the Respironics recall has caused to patients and customers. Please be assured that the team is continuing to work hard to resolve this. We are committed to completing the Respironics recall and complying with the consent decree, while servicing healthcare providers and their patients with high-quality products.
Understanding the consent decree
A consent decree is an agreement negotiated between the US government and a company to resolve a civil enforcement action. In our case, the consent decree follows an FDA inspection of a Philips Respironics manufacturing facility in the US. This consent decree, which primarily focuses on Philips Respironics’ business operations in the US, provides a clear path forward with defined actions, milestones, and deliverables to address process compliance requirements.
Ensuring patient safety and quality
We want to reiterate again that we share the same objective as the FDA to ensure patient safety and quality in the delivery of our products and services. Across the company, we have already intensified efforts to strengthen both of these priorities. The actions we have taken and will continue to take, are focused on ensuring patient safety and quality remains our number one priority.
While we acknowledge that more work needs to be done, Philips Respironics has been working with the FDA, already making significant changes in its organization, quality management system and operations. This includes strengthening quality management process compliance and the governance and capabilities of the relevant teams.
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