Philips Respironics Product Recall: Important Information for AvantSleep Clients
December 2, 2021 (latest update)
On Tuesday, Nov. 16, Philips Respironics provided an update to the language included in the recall notifications that have been provided to customers in the U.S. This update aligns the language in the recall notifications to that of the current FDA recommendations. That update can be found at www.philips.com/src-update. For CPAP and BiPAP users, it includes an important update, recommending that they speak with their clinician to determine the risks and benefits of continued therapy on recalled devices. The updated recall notification can be found here.
Philips Respironics has assured us that it continues to focus its resources on the completion of the repair and replacement program. They have indicated that the repair/replacement process has begun and is accelerating. AvantSleep remains committed to repairing/replacing the affected devices as soon as this is made available to us by Philips Respironics.
August 10, 2021
In addition to the medical device recall issued by Health Canada on June 23, 2021 Health Canada Recall, an Advisory was issued on July 30, 2021: Health Canada Advisory
The guidance from Health Canada in the Advisory is as follows:
Issue: Philips Respironics is recalling several models because of reports of the sound-reducing foam breaking down, which could pose potential health risks. There is no definitive link to adverse health effects based on the company’s preliminary assessments.
What to do:
- Talk to your physician or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
- Register your device on the Philips recall website or call 1-877-907-7508.
- Clean your device only according to the manufacturer’s Instructions for Use, as the use of non-validated cleaning methods could contribute to potential issues.
RECALL ACTION: PHILIPS HAS RELEASED A STEP 2 TO THE PROCESS
What has been done?
Step 1: Device Registration: This step has been completed by AvantSleep on your behalf.
What are the next steps?
Step 2: Patient Registration: Register now
Respironics now requires all patients to register their devices, this is in addition to the device registration we completed on your behalf. They have indicated this will expedite the reconciliation process and allow them to verify whether or not your device is active. Please indicate the device is “active” when you submit. You will need your device serial number to complete this process, it can be found on the bottom of your device. If you have 2 devices (DreamStations and SystemOne), please ensure to register both of them.
If you would like AvantSleep to complete the Patient Registration on your behalf, please contact [email protected].
Respironics regrets that it may take some time to replace affected devices. The repair process requires regulatory agency approval, which they are working toward obtaining as quickly as possible. They will begin the repair/replacement process immediately upon that approval. They have indicated it is their absolute number one priority to replace affected devices as quickly as possible.
Please continue to check our website for the most up to date information regarding the product recall.
Thank you for your continued understanding,
July 7, 2021
On June 14, 2021 Philips Respironics announced a voluntary recall for Continuous and Non-Continuous Ventilators (certain CPAP, BiLevel PAP and Ventilator Devices) due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices. For information on the Recall Notice, a complete list of impacted products, and potential health risks, visit philips.com/src-update.
Health Canada issued a medical device recall June 23, 2021: Health Canada Recall.
Health Canada has categorized this as a Hazard Type II. Type II hazard is defined by Health Canada as a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote. Please see this link for details: Health Canada Hazard Classification.
The device I use is on the list of impacted products. What action do I need to take?
As per Philips Respironics recall notification (U.S. and Canada) / field safety notice (International Markets) the following actions should be taken:
- For patients using BiLevel PAP and CPAP devices: Discontinue use of your device and consult with your physician to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in this recall.
- For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy, without consulting physicians to determine appropriate next steps.
Philips is recommending that customers and patients halt use of ozone-related cleaning products, and adhere to their device Instructions for Use for approved cleaning methods.
For further advice from Philips Respironics, click here to read their press release.
What action is AvantSleep taking?
Patient safety is of utmost importance to us at AvantSleep and we are doing everything we can to address this issue. For existing patients who purchased an impacted Philips Respironics product from AvantSleep, we have already registered your device for corrective action and will communicate with you as we receive more information from Philips Respironics.
For additional information, please read the following recommendations from the American Thoracic Society: Recommendations for Sleep and Critical Care Medicine Professionals Re: Philips Recall Notice. You may wish to bring this letter with you to your physician to help determine whether the benefits of continuing therapy outweighs the risks.
Consider contacting your insurance provider to determine if you are eligible for a new device. Typically, insurance will cover a new device after 5 years of use, but you may be eligible sooner.