Important Information for PAP Patients – June 21, 2021 (latest update)
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.
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. only) / 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 MedSleep taking?
Patient safety is of utmost importance to us. We have asked all of the CPAP Vendors who provide services to our patients to register their devices for replacement, in addition to contacting patients on Philips equipment.
Additional Information:
For additional information, we strongly encourage you to read the following recommendations from the American Thoracic Society: Recommendations for Sleep and Critical Care Medicine Professionals Re: Philips Recall Notice.
In the event that you wish to make an appointment to discuss this matter with your prescribing physician, please contact our office and an appointment will be made for you on a best effort basis. There is a significant demand for these appointments and we will schedule yours as quickly as we can.
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.
Thank you.
Kostas Tsambourlianos
President
MedSleep Inc.
