Philips Museum in the Netherlands - Photo by Alf van Beem via Wikimedia Commons
This June, Philips Respironics issued a recall for some of their CPAP, BiPAP, ASV, and ventilator devices due to safety concerns over a sound-proofing foam made from polyester-based polyurethane (PE-PUR). The concern, according to a recall notification published on the Philips website, is that a series of complaints (.03 percent total complaint rate in 2020) have been made about the presence of particles or debris within the air pathway of some devices. In the case of degradation due to age and/or wear, Philips has determined that there may be risks associated with inhalation of the foam particles or related off-gassing of chemicals, potentially causing headaches, upper airway irritation, coughs, chest pressure, or sinus infections, as well as possible exacerbation of existing conditions such as asthma. There is also a concern that the foam may degrade due to unrecommended cleaning methods, such as ozone, or using devices in high heat and high humidity environments. Particles such as those released by degraded PE-PUR materials under high heat may be a possible carcinogen when inhaled for prolonged periods, making the risk potentially greater the longer a patient is exposed.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Philips since 2011. Houten went on to say that the company is "working hard towards a resolution, which includes the deployment of the updated instructions for use and a comprehensive repair and replacement program for the affected devices." Patient safety, Houten insists, is a core value and a primary objective of the company.
The recall affects specific models listed below, and any device being used for life-sustaining purposes should not be stopped or removed without the direct support and assistance of a physician. While the recall is unfortunate, Philips is taking proactive steps to ensure that patients are safe and can continue with a new or existing model that does not contain the PE-PUR product under investigation. The recall is considered a voluntary recall, and the Food and Drug Administration (FDA) recommends following the Philips guidelines for replacing a recalled device or having the company remove the PE-PUR foam with a new material that is compliant with FDA regulations.
Instructions and Recommendations
Philips published the following recall recommendations for patients and customers:
In summary:
If you are using one of the affected life-sustaining mechanical ventilator devices:
Do not stop or disrupt your prescribed therapy until you have talked to your physician. Philips recommends immediate consultation with a healthcare professional to determine the best options for your specific health needs.
Ventilator options for life-sustaining therapy may be limited in cases where therapy disruption can have immediate harmful consequences. In these situations, the company explains, the benefit of continued therapy may outweigh the risks of PE-PUR foam degradation. If recommended by a physician, Philips suggests an alternative inline bacterial filter.
If you are using one of the affected CPAP or BiPAP therapy devices:
Do discontinue using your device and work with your physician and/or a Durable Medical Equipment (DME) provider to determine how to proceed with a replacement or repair process.
To ensure that your product is one of the recalled models, use the Philips registration process to look up the serial number, check for updates, and begin a claim if your device is one of the recalled models.
For further information, visit the Philips recall webpage or call them directly at: 877-907-7508
Keep in mind that Philips advises customers to contact their medical provider as soon as possible. A medical provider can help determine how to proceed if you are using an affected device, and whether it is recommended to stop or pause treatment during the process. A healthcare provider can also prescribe a new PAP device as needed.
Repair and Replacement Program
Philips has created a repair and replacement program to streamline the recall process and better serve those patients at risk of using the potentially compromised products. Working with the U.S. health and medical-device regulatory agencies, the company is ensuring an effective recall and a swift replacement process for the PE-PUR foam components of their devices. The PE-PUR foam will be replaced with a new, safe material to reduce sound, and if necessary, the devices themselves may be replaced to minimize risk
As part of the repair and replacement program, the new sound reduction materials will be thoroughly tested to ensure the safest possible replacement product. And to facilitate the shift to safer products, Philips is increasing the production of its DreamStation 2 CPAP devices, which do not contain PE-PUR foam.
List of Affected Devices
The following list was obtained from the Philips Respironics Recall Notification and Field Safety Notice, published on June 14 of this year.
Note: Affected Devices All Manufactured Before 26 April 2021.
1. CPAP and BiPAP Devices
Continuous Ventilators, Minimum Ventilatory Support, Facility Use:
E30 (Emergency Use Authorization only)
Continuous Ventilators, Non-life Supporting:
DreamStation: ASV
DreamStation: ST, AVAPS
SystemOne: ASV4
C Series : ASV, S/T, AVAPS
OmniLab Advanced Plus: In-Lab Titration Device
Non-continuous Ventilators:
SystemOne: (Q series)
DreamStation: CPAP, APAP, BiPAP
DreamStation GO: CPAP, APAP
Dorma 400, 500: CPAP
REMStar SE Auto: CPAP
2. Mechanical Ventilators
Continuous Ventilators:
Trilogy 100 and 200 Ventilators
Garbin Plus, Aeris, LifeVent: Ventilator
Continuous Ventilators, Minimum Ventilatory Support, Facility Use:
A-Series BiPAP Hybrid A30
A-Series BiPAP V30 Auto: Ventilator
Continuous Ventilator, Non-life Supporting:
A-Series BiPAP A30 and A40
List of Products Not Affected by the Recall
DreamStation 2
Trilogy Evo, Evo OBM, EV300, and 202
BiPAP A40 EFL and A40 Pro
M-Series
Omnilab (original based on Harmony 2)
Dorma 100 and 200, and REMStar SE
Other products such as oxygen concentrators and airway clearance devices.
Future Implications
Philips removed the PE-PUR sound-proofing foam from all of their devices beginning in April 26 of this year, following preliminary testing on the potential risks. Based on recommendations made by the company as well as the FDA, there are no existing health risks for these devices beyond those associated with the PE-PUR foam, which is currently under investigation and is not conclusively determined as a health risk. Given that the percentage of complaints is lower than one percent, in some cases there may be more risks associated with stopping therapy than with continued use of a recalled product. According to the FDA, there have been no reports of death as a result of these issues, and further testing will be required to determine the extent of any potential risk.
Additional information
For continued updates on the Philips product recall, as well as instructions for customers, physicians, and other healthcare professionals, contact a Philips representative or visit the company website at: www.philips.com/SRC-update.
Sources
Philips Respironics Recall Notification - https://www.usa.philips.com/a-w/about/news/archive/standard/news/press/2021/20210614-philips-issues-recall-notification-to-mitigate-potential-health-risks-related-to-the-sound-abatement-foam-component-in-certain-sleep-and-respiratory-care-devices.html?src=search
Philips Respironics Recall Notification and Field Safety Notice - https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
U.S. Food and Drug Administration - Company Announcement - https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/philips-issues-recall-notification-mitigate-potential-health-risks-related-sound-abatement-foam