Philips Respironics Finalizes Consent Decree Regarding Business Operations in the US with Department of Justice, FDA

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Philips Respironics announced that it has finalized a consent decree with the US Department of Justice (DOJ) and the FDA, mainly focused on its operations in the United States, which includes manufacturing facilities in Pennsylvania, including its headquarters in Pittsburgh. The decree comes as a result of FDA inspections and discussions initiated in July 2022, stemming from a 2021 facility inspection.

As part of the decree, Phillips Respironics aims to finish remediation of all recalled sleep and respiratory care devices, as 99% of all CPAP and BiPAP devices have been taken care of, with remediation efforts for ventilators in progress. Additionally, the company is required to comply with the FDA’s Quality System Regulation, including retaining independent experts for overseeing its compliance improvement program.

This decree will also enable Philips to export its products, subject to meeting certain requirements and continue servicing products already in use in the United States.¹

“Patient safety and quality is our number one priority. We know what we must do to meet the consent decree requirements,” said Steve C de Baca, chief patient safety and quality officer, Phillips, in a press release. “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 devices every day.”

In January, Philips announced that it would stop selling sleep and respiratory devices in the United States. At the same time, the company agreed to terms on the consent decree, which will allow for continued sales in the country once requirements of the decree are met. Despite ending sales in the United States, Philips stated that it planned to continue offering new sleep and respiratory care devices, accessories, consumables, replacement parts, and services.²

“Patient safety and quality remain Philips’ highest priority across the company. Resolving the consequences of the Respironics recall for our patients and customers is a key focus area and I acknowledge and apologize for the distress and concern caused,” said Roy Jakobs, CEO, Royal Philips, in a press release. “We are fully committed to complying with the consent decree, which is an important step and provides a clear path forward.”

Philips has introduced new devices that include silicone sound abatement foam, which have reported no safety issues during testing and have been cleared for continued use.¹

“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 Jakobs, in the release.

References

1. Philips Respironics reaches agreement with US government on a consent decree creating a clear path forward. Philips. April 10, 2024. Accessed April 10, 2024. https://www.philips.com/a-w/about/news/archive/standard/news/press/2024/philips-respironics-reaches-agreement-with-us-government-on-a-consent-decree-creating-a-clear-path-forward.html

2. Philips delivers strong full-year results; agrees with FDA on terms of consent decree focused on Philips Respironics in the US. Philips. January 29, 2024. Accessed April 10, 2024. https://www.philips.com/a-w/about/news/archive/corpcomms/news/press/2024/philips-fourth-quarter-results-2023.html