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).

Resolving the recall for patients remains our highest priority

2023

Finalize recall of sleep therapy devices

Agree details of further testing with FDA¹

Manage litigation, DoJ investigation

483 remediation and clarity on proposed Consent Decree

YTD 2023

Remediation of >99% of sleep therapy devices complete²; ventilators ongoing

FDA feedback received on testing and analysis for sleep therapy devices¹

Reached agreement to resolve economic loss class action in the US

483 remediation in progress

Started serving new patients with sleep therapy devices outside the US

2023-2025

Finalize recall and testing

Manage litigation, DoJ investigation

Manage impact of proposed Consent Decree

Gradually restore position

Taking the learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips

1. Following ongoing communications with the FDA, Philips Respironics has agreed to implement additional testing to supplement current test data on PE-PUR foam. The FDA stated that current testing is extensive and conducted with independent parties and expressed no concerns with its validity or objectivity. Philips Respironics is in discussions with the FDA on the details of further testing

2. Over 99% of the sleep therapy device registrations that are complete and actionable have been remediated

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

Positive and reassuring test results

Positive and reassuring test results

Positive and reassuring complete test results for DreamStation1 devices¹

Devices exposed to Ozone

Exposure to VOC emissions unlikely to result in appreciable harm to health

Based on assessment of ozone-induced degradation from up to 500 cleaning cycles

Bioassay evaluation, chemical characterization and toxicological risk assessment (ISO 10993)

Exposure to particulates is unlikely to result in an appreciable harm to health in patients, even based on a worst-case assumption that the patient is exposed to 100% of the foam volume

Particulate Matter testing (ISO 18562-2)

Foam degradation does not contribute to appreciable elevated levels of respirable particles

Exposure to particulate from degraded foam with self-reported ozone use is unlikely to result in an appreciable harm to health in patients

Visual inspection

Foam degradation does not contribute to appreciable elevated levels of respirable particles

Low prevalence of significant visible foam degradation

Ozone cleaning exacerbates foam degradation

July '23: Additional visual inspection confirms low prevalence of significant visible foam degradation/volume reduction

VOC testing (ISO 18562-3)

Emissions within ISO limits based on ISO 18562-3 (devices not exposed to ozone)

Positive and reassuring for SystemOne and DreamStation Go¹

Exposure to foam particulates and VOCs is unlikely to result in an appreciable harm to health in patients, including in devices exposed to Ozone cleaning

Based on complete, third party:

Risk assessment of foam particulates - Particulate Matter testing (ISO 18562-2)

VOC testing (ISO 18562-3)

Bioassay evaluation, chemical characterization, toxicological risk assessment (ISO 10993)

1. Following ongoing communications with the FDA, Philips Respironics has agreed to implement additional testing to supplement current test data on PE-PUR foam. The FDA stated that current testing is extensive and conducted with independent parties and expressed no concerns with its validity or objectivity. Philips Respironics is in discussions with the FDA on the details of further testing

Next steps

Next steps

Additional testing for sleep therapy devices to supplement current test dataas agreed with the FDA¹

VOC and Particulate Matter testing, as well as chemical evaluation andtoxicological assessments for Trilogy 100/200 (~3% of registered devices),and OmniLab (~2% of registered devices)

New Trilogy 100/200 devices passed VOC and PM testing to date, as well as several biocompatibility tests including ISO 10993 cytotoxicity, irritation and sensitization testing

New and lab-aged Trilogy 100/200 foam failed ISO 10993 genotoxicity testing under laboratory conditions, and therefore a weight of evidence assessment is ongoing to confirm or exclude potential risks for patients

These devices contain a different type of PE-PUR foam than the DreamStation1 devices²

1. FDA has requested, and Philips Respironics has agreed to implement additional testing to supplement current test data. The FDA has not expressed concern with the validity or objectivity of the testing done to date. Philips Respironics is in discussions with the FDA on the details of further testing

2. The known differences between the DreamStation foam and the foam for the Trilogy 100/200, are that the latter can be used with an acrylic pressure sensitive adhesive, has a lower density, has a different thickness, and also contains an additive to reduce potential flammability

Summary of third-party epidemiological studies

Summary of third-party epidemiological studies

There were thirteen identified epidemiological studies, all of which found no consistent statistical association between use of PAP devices - including Philips Respironics’ - and the risk of cancer in patients with obstructive sleep apnea (OSA) - click here for more details

Two of the studies¹ showed no statistical difference in cancer risk between users of Philips Respironics PAPdevices and users of other brands of PAP devices

Eleven studies provided limited additional insights, but their results also suggested no excess risk of cancer associated with use of PAP devices

The 2022 study by Palm and others reported more frequent prescription of respiratory relief medication among patients with both OSA and obstructive lung disease, but no statistical difference in hospitalization, i.e., health outcomes, was observed for OLD among OSA patients between the users or polyurethane PAP and non-foamPAP - click here for more details

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; Cancer risk in adherent users of polyurethane foam-containing CPAP devices for sleep apnea, European Respiratory Journal 2022.

Please click here for the full testing results and updates
Regulatory and legal update
Regulatory and legal update
Civil litigation

Civil litigation

Collective and individual civil complaints have been filed in various jurisdictions globally, including but not limited to the United States, Australia, Canada, Israel and Chile. The complaints variously allege economic loss, personal injury and, in some cases, the need for medical monitoring

In the United States, putative economic loss and medical monitoring class actions and personal injury lawsuits have been consolidated into a multidistrict litigation (MDL) in Pennsylvania

reached an agreement to resolve all economic loss claims in the class action, which received preliminary Court approval on October 10, 2023; provision of EUR 575 million has been recorded in Q1 2023

As of October 16, 2023, around 670 personal injury claims have been filed and are currently pending and approximately 54,000 individuals had joined the voluntary, court-approved census registry for potential personal injury claimants who have not filed claims but may do so in the future

Visibility on potential outcomes on medical monitoring class action and personal injury claims is not expected before late 2024

SoClean, a manufacturer of ozone-based CPAP cleaning devices, filed an amended complaint against Philips and certain of its US affiliates, including Philips Respironics, in October 2022 for alleged unfair competition, tortious interference with business relationships, defamation and commercial disparagement

Philips believes SoClean’s claims have no basis in fact or law and is seeking dismissal of the case in its entirety, including on the basis that the FDA has stated that CPAP ozone cleaners, like SoClean’s products, “are not legally marketed for this use”

Securities class action suit was filed against the company in August 2021 in the US, alleging Philips’ statements in connection with the recall triggered a fall in stock price. Plaintiffs filed a Second Amended Complaint in November 2022, which Philips has since moved to dismiss

Given the uncertain nature of the relevant events, and of their potential impact and associated obligations, if any, the company has not provided for these matters other than the settlement of the economic loss claims in the US MDL

FDA/DOJ

FDA/DOJ

Philips Respironics continues to engage with the US Food and Drug Administration (FDA) on the steps it has taken in response to the FDA’s Form 483 observations

Since July 2022, Philips Respironics has been in discussions with the US Department of Justice (DOJ), acting on behalf of the FDA, regarding the terms of a proposed consent decree to address the identified issues on a forward-going basis

On April 8, 2022, Philips Respironics and certain of Philips’ subsidiaries in the US received a subpoena from the DOJ to provide information related to events leading to the Philips Respironics recall

Medical Device Reporting

Medical Device Reporting

Medical device manufacturers are required to submit medical device reports (MDRs) to the FDA when they receive complaints for certain types of device malfunctions and safety issues

These complaints may be submitted to the manufacturer by health care professionals, patients, caregivers and consumers

The FDA acknowledges that “the submission of an MDR itself is not evidence that the device caused or contributed to the adverse outcome or event” and that the “cause of an event cannot typically be determined from this reporting system alone.”

Following Philips’ public statements on possible risks to users in April 2021 and the June 2021 recall notification/field safety notice, Philips Respironics received a steep increase in complaints allegedly associated with possible foam degradation

This led to approximately 116,000 MDRs filed by Philips Respironics to the FDA from April 2021 through September 30, 2023, of which 7,200 in the three months July 2023 – September 2023

The vast majority 93% of the MDRs filed since April 2021 up to and including September 2023 are alleged technical malfunctions that do not involve serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in the MDRs
Frequently Asked Questions and key materials

Frequently Asked Questions and key materials

Respironics field action - Progress update - October 23, 2023 (316.0KB)

Respironics field action - FAQ - October 23, 2023 (242.0KB)

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

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.

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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

Resolving the recall for patients remains our highest priority

2023

YTD 2023

2023-2025

Taking the learnings of Respironics recall to raise Patient Safety and Quality to the highest standards across Philips

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

More information

News

You may also find the following articles interesting

Philips provides update on Respironics recall

Philips response to recent media articles related to Philips Respironics’ voluntary recall notification/field safety notice

Philips Respironics - PE-PUR testing results and conclusions available to date

Philips provides update on completed set of test results for CPAP/BiPAP sleep therapy devices

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 provides update on completed set of test results for first-generation DreamStation sleep therapy devices

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 update related to Trilogy 100/200 repairs

Summary of a systematic literature review of Positive Airway Pressure device use and cancer risk

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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