Respironics field action

On June 14, 2021, Royal Philips’ subsidiary, Philips Respironics, initiated a voluntary recall notification* for certain sleep and respiratory care products to address identified potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam in these devices. Following the substantial ramp-up of its production, service, and repair capacity, the repair and replacement program in the U.S. and several other markets is under way. Philips Respironics has also been conducting a comprehensive test and research program on the PE-PUR foam to better assess and scope potential patient health risks related to possible emission of particulates from degraded foam and certain Volatile Organic Compounds (VOCs).

Repair and Replacement, Testing and Program Management
Repair and Replacement, Testing and Program Management
Extensive patient, clinician and regulator engagement

Driving patient engagement and registrations with new dedicated registration system and infrastructure

Patient outreach through mailing, call center, websites and direct contact with interest groups

6.6M direct-to-patient mail notifications, 29.2M digital impressions, 10.6M patients reached via traditional media, 3.8M clinical impressions; comprehensive DME outreach

Met the requirements in FDA's 518(a) order and continue to report progress

Expect to remediate around 5.5M devices; registrations trending in line with our modelling

Engagement with regulators to optimize the recall efforts, and agree priority replacement

Sharing progress on testing program to ensure patients and physicians fully informed

Around 90% of the recall program units produced and shipped by end 2022

Production capacity – DreamStation (compared to pre-recall)

The task at hand

Around 5.5M devices expected to be repaired or replaced

Equivalent to over 5x previous annual production volume

>1K new product configurations released globally

Partnering with DME’s for patient delivery

Progress to date

Tripled production capacity compared to pre-recall

>1,000 people cross functional team engaged

3M repair and replace units produced to date

Dependency on supply of materials and global logistics capacity

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Please click here for the latest testing results and updates

Independent analysis of health risks

Independent of Philips Respironics, in December 2021, an analysis was published in the American Journal of Respiratory and Critical Care Medicine [1] that did not find a higher risk of incident cancer among obstructive sleep apnea (OSA) patients who used a Philips Respironics PAP device as compared to OSA patients who used a PAP device from other manufacturers, or OSA patients without treatment. The analysis and conclusion were based on data from a large multicenter cohort study involving 6,903 OSA patients on PAP devices between 2012 and 2020, including 1,220 Philips Respironics PAP users.

In May 2022, an analysis was published online in the European Respiratory Journal [2] that concluded that sustained and adherent CPAP therapy of OSA using Philips Respironics devices, compared with other manufacturers’ devices, was not associated with an increased risk of cancer after a median follow-up time of 7.2 years. The analysis and conclusion were based on data from a large multicenter cohort study involving 4,447 OSA patients on CPAP devices between 2007 and 2018, including 1,648 Philips Respironics CPAP users. Philips Respironics was not involved in the study or the analysis.

[1] An Association between Positive Airway Pressure Device Manufacturer and Incident Cancer? A Secondary Data Analysis; American Journal of Respiratory and Critical Care Medicine, 2021, Volume 204, Issue 12 pp. 1484–1488; Tetyana Kendzerska, Richard S. Leung, Mark I. Boulos, Daniel I. McIsaac, Brian J. Murray, Gregory L. Bryson, Robert Talarico, Atul Malhotra, Andrea S. Gershon, Constance Mackenzie, and Marcus Povitz.

[2] Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnoea, European Respiratory Journal 2022, in press (https://doi.org/10.1183/13993003.00551-2022), Grégoire Justeau, Chloé Gervès-Pinquié, Marie Jouvenot, Thierry Pigeanne, Sandrine Launois, Laurene Leclair-Visonneau, Philippe Masson, Acya Bizieux-Thaminy, Sébastien Bailly, Nicole Meslier, Abdelkebir Sabil, Jean-Louis Racineux, Wojciech Trzepizur, and Frédéric Gagnadoux.
Cooperation and Engagement with Regulators
Cooperation and Engagement with Regulators
Philips Respironics continues to work closely with the U.S. Food and Drug Administration (FDA) and other regulators and competent authorities globally

FDA Form 483 issued on November 12, 2021, following an inspection of a Philips Respironics site in the U.S.

Philips Respironics has submitted a comprehensive response and detailed action plan with ongoing engagement with the FDA; Philips Respironics will first work through the process with the FDA and other regulators before commenting in detail

Importantly, the Form 483 did not change the FDA’s recommendation to patients or care providers related to the use of the devices, nor the authorization to execute the repair and replacement program

The FDA issued an order under Section 518(a) of the Federal Food, Drug and Cosmetic (FD&C) Act on March 10, 2022, regarding recall outreach

Philips Respironics is complying with the FDA’s order

Philips Respironics and the FDA are fully aligned on the need to increase awareness of the recall and give healthcare providers, consumers and patients access to timely information

On May 2, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) proposed that an order under Section 518(b) of the FD&C Act be issued to require Philips Respironics to submit a plan for the repair, replacement or refund of the purchase price of the affected recalled devices

Philips Respironics is working closely with the FDA to continue to optimize the recall efforts
Litigation Update
Litigation Update
Civil complaints filed in several jurisdictions alleging economic loss, personal injury and the need for medical monitoring related to certain CPAP, BiPAP and mechanical ventilator devices subject to the recall

As of June 2022, approximately 190 personal injury lawsuits and approximately 100 class actions have been consolidated into U.S. multidistrict litigation in Pennsylvania; plaintiffs have filed their consolidated economic loss complaint, and the proceedings remain in preliminary stages

Outside the U.S., Philips or its affiliates are also defendants in litigation in Australia, Austria, Canada, Chile, Germany and Israel, as well as in smaller or individual actions in other countries

Philips is also defending a securities class action and a lawsuit brought by SoClean in the U.S.; Philips has moved to dismiss both cases

All litigation is in preliminary stages – the outcome and potential cost of the lawsuits cannot currently be determined; the company has not taken any provision related to litigation to date

Philips has a strong and experienced legal defense team in place

Frequently Asked Questions and key materials

Summary of a systematic literature review of PAP device use and cancer risk - July 25, 2022 (182.0KB)

Respironics field action - FAQ - July 25, 2022 (246.0KB)

Third party epidemiological studies - FAQ related to the Swedish Study by Palm et al. - July 8, 2022 (201.0KB)

More information

For more information on the recall notification for customers, users and physicians, please click here.

News

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Disclaimers

* This is a recall notification for the US only, and a field safety notice for the rest of the world

Respironics field action

Extensive patient, clinician and regulator engagement

Around 90% of the recall program units produced and shipped by end 2022

Testing

Philips Respironics is conducting a comprehensive test and research program to better assess and scope potential patient health risks:

Independent analysis of health risks

Frequently Asked Questions and key materials

More information

News

You may also find the following articles interesting

Philips provides update on Philips Respironics’ PE-PUR sound abatement foam test and research program

Philips Respironics provides update on filed MDRs in connection with the voluntary recall notification/field safety notice* for specific CPAP, BiPAP and mechanical ventilator devices

Philips Respironics issues voluntary recall notification/field safety notice* for the V60 ventilator product family

Philips Respironics provides update for the US on ongoing CPAP, BiPAP and Mechanical Ventilator field action

Philips provides update on the test and research program in connection with the CPAP, BiPAP and Mechanical Ventilator recall notification*

Philips provides update on earlier announced voluntary CPAP, BiPAP and Mechanical Ventilator recall notification

Philips starts repair and replacement program of first-generation DreamStation devices in the US in relation to earlier announced recall notification

Philips issues recall notification* to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices

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