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Important Information Regarding Respironics Sleep Apnea Machines

Dear Valued Patient,

We would like to inform you about recent developments regarding Respironics sleep apnea machines (CPAP, BPAP, ASV, etc.):

Respironics to stop selling sleep apnea machines

Philips Respironics will discontinue the sale of new sleep apnea machines in the United States under a settlement with the FDA. As part of this arrangement, the company will maintain ongoing service for existing sleep and respiratory care devices with healthcare providers and patients. Additionally, they will supply accessories, consumables, and replacement parts. Users currently utilizing Respironics machines are advised to continue usage until alternative guidance is provided by the FDA.

Issues with overheating (Dreamstation 2)

The FDA has warned users of Philips DreamStation 2 CPAP machines to monitor for signs of overheating, following reports of issues like fire and burns. Recommendations include placing the machine on a flat surface, away from flammable materials including carpet or fabric, and regular cleaning of CPAP machine and the water reservoir. Users should inspect for unusual smells or changes, unplug in case of any new smells or sounds from the machine, report concerns to the FDA and Philips and consult their DME company. The FDA is collaborating with Philips to understand and address the safety issue. Report device problems through the MedWatch Voluntary Reporting Form. For questions, contact DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.

Further details can be found on the FDA website.

Formaldehyde release from the CPAP machines

Patients using Respironics CPAP machines may have concerns about a ProPublica investigative report on the release of formaldehyde from the machines. The FDA has indicated that more tests are required to determine if there is a genuine concern. Respironics claims the machines are safe, emphasizing that the silicone foam was tested within recognized safety limits. FDA is actively monitoring the issue and we will provide updates as more information becomes available. Patients should be reassured that, for the time being, they can continue using their Respironics CPAP devices. In the meantime, please follow all safety instructions provided by Philips.

Can I get a new CPAP machine by a different manufacturer?

If it's been more than 5 years since your insurance paid for your last CPAP machine, they may reimburse a new device (Please note that any replacement machine you may have obtained from Respironics is not considered within this timeframe). However, if it has been less than 5 years, getting a new CPAP device may require out-of-pocket payment. To ascertain the specifics of your coverage, we recommend contacting your insurance provider for confirmation.

If you would like to discuss any of the above in further detail, please contact your healthcare provider.

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