Explained: Philips Respironics consent decree

In June 2021, Philips initiated a voluntary recall notification* for certain CPAP and BiPAP sleep therapy devices and ventilators related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices.

Following an inspection by the U.S. Food and Drug Administration (FDA) of Philips Respironics’ facility in Murrysville, where these 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 final agreement on the consent decree with the DOJ and FDA, that primarily focuses on Philips Respironics’ business operations in the US.

Acute patient management from Philips provides continuous clinical surveillance, advanced interoperability and predictive insights across care settings. With access to critical data at all points of care, caregivers can easily stratify high-risk patients, make decisions together and fine-tune care with precision for every patient.

*This is a voluntary recall notification in the US and a voluntary field safety notice in other countries.

Understanding the consent decree

The consent decree provides Philips Respironics with 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 consent decree. 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 CPAP and BiPAP sleep therapy 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 final agreement on the consent decree 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 consent decree 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 consent decree 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:

In the US, millions of patients are currently using Philips Respironics sleep and respiratory care devices. Philips Respironics will be permitted to continue servicing these sleep and respiratory care devices that are already with healthcare providers and patients, and to sell accessories (including masks), consumables (including patient circuits), and replacement parts (including repair kits). Until the relevant requirements of the consent decree are met, Philips Respironics will not resume selling new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the US.
It is common for consent decrees to include provisions to allow for exports. 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.
Philips Respironics will continue to prioritize completing the remediation of the sleep and respiratory devices under Respironics’ voluntary June 2021 recall. More than 99% of the actionable registered CPAP and BiPAP sleep therapy devices have been remediated globally, while the remediation of the ventilators is ongoing in coordination with the relevant competent authorities.
Philips’ press release can be found here and the final consent decree can be found here.

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.