Explained: Philips Respironics consent decree
In June 2021, Philips initiated a voluntary recall notification* for certain continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) sleep therapy devices and ventilators related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. CPAP and BiPAP machines are medical devices used for the treatment of obstructive sleep apnea.
Following an inspection by the U.S. Food and Drug Administration (FDA) of Philips Respironics’ facility in Murrysville, where the recalled devices are manufactured and serviced, and the FDA’s subsequent inspectional observations, Philips began discussions with the US Department of Justice (DOJ) and FDA in July 2022 regarding the terms of a proposed consent decree. On January 29, 2024, Philips announced that it agreed with the DOJ and FDA on the terms of the proposed consent decree. Philips’ subsidiaries Philips Holding USA and Philips Respironics have now reached a final agreement with the DOJ and FDA, that primarily focuses on Philips Respironics’ business operations in the US.
Following an inspection by the U.S. Food and Drug Administration (FDA) of Philips Respironics’ facility in Murrysville, where the recalled devices are manufactured and serviced, and the FDA’s subsequent inspectional observations, Philips began discussions with the US Department of Justice (DOJ) and FDA in July 2022 regarding the terms of a proposed consent decree. On January 29, 2024, Philips announced that it agreed with the DOJ and FDA on the terms of the proposed consent decree.
*This is a voluntary recall notification in the US and a voluntary field safety notice in other countries.
Understanding the consent decree
The final agreement with the DOJ and FDA provides Philips Respironics with a clear path forward and a roadmap of defined actions, milestones, and deliverables to meet relevant regulatory requirements.
Strengthening patient safety and quality remains Philips’ highest priority and the company has intensified these efforts to achieve greater benefits for patients, clinicians and customers who rely on Philips’ products and services every day.
Philips is fully committed to complying with the final agreement. Philips CEO Roy Jakobs, as well as Chief Patient Safety and Quality Officer Steve C de Baca and Chief Region Leader Philips North America Jeff DiLullo are responsible for ensuring the remediation actions are delivered by the various teams.
Commenting on the consent decree, Steve C de Baca said:
“Patient safety and quality is our number one priority. We know what we must do to meet the consent decree requirements. Philips Respironics has been working with the FDA, and is already making significant changes in its organization, quality management systems and operations. This includes strengthening the quality management processes and deepening the competencies of the relevant teams. We are fully committed to meeting the terms of the consent decree and continuing to serve the millions of patients who rely on our products and services every day.”
To hear more from Steve C de Baca please click on the video below.
FAQs
What is a consent decree?
A consent decree is an agreement negotiated between the US government and a company to resolve a dispute between them as an alternative to litigating. In this case, the consent decree is with the FDA and meant to address FDA’s concerns around certain quality-related matters, in part following from an FDA inspection of a Respironics’ manufacturing facility in the US.
Why did the U.S. government seek a consent decree from Philips Respironics?
Following Philips Respironics’ voluntary recall of certain continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) devices and ventilators in June 2021, an inspection by FDA of Philips Respironics’ facility in Murrysville in the second half of 2021 and the subsequent inspectional observations, Philips began discussions in July 2022 regarding the terms of a proposed consent decree. Philips’ subsidiaries Philips Holding USA and Philips Respironics have now reached a final agreement with the DOJ and FDA which primarily focuses on Philips Respironics’ business operations in the US. The decree provides Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business.
Why did Philips Respironics agree to enter a consent decree?
Philips’ aim is to serve healthcare providers and their patients with innovative sleep and respiratory products and services. The agreement provides Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business.
What are the main terms of the consent decree?
The agreement will provide Philips Respironics with a roadmap of defined actions, milestones, and deliverables to demonstrate compliance with regulatory requirements and to restore the business. The main terms include:
Does the consent decree only affect customers and patients in the US, or will it have an affect outside of the US?
Outside the US, Philips Respironics will continue to provide new sleep and respiratory care devices, accessories (including masks), consumables (including patient circuits), replacement parts (including repair kits) and services, subject to certain requirements that Philips Respironics will meet.
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