WASHINGTON – The U.S. Food and Drug Administration has published an important Safety Communication concerning the recent Philips respiratory device recalls. According to a press release from AAHomecare, the publication summarizes significant issues and concerns linked to the recalls. It encourages patients who are using CPAP or BiPAP machines to discuss treatment options and alternatives with their medical providers. According to hmenews.com, the letter recommends that patients using the recalled breathing machines to discuss with their doctor if the “benefits outweigh the risks identified in the recall notification.”
The U.S. Food and Drug Administration also stated that the agency is working with Philips to assess the issue, the scope of the recall, and help determine the mitigation strategies. The FDA is also investigating the medical device incident reports related to the affected devices during the period of 2009-21 for reports that could be associated with this problem. The communication also includes a hyperlink to the Medwatch Reporting Form for patients to report problems directly to the FDA.
Additionally, this updated communication urges customers to register their breathing devices on Philips’ website.
AAHomecare stated that it would continue to work with clinical groups, respiratory stakeholders, major payers, government entities, and contractors to help hasten replacement devices and continue providing high-quality medical care for patients who continue to use their breathing machines near term. Earlier this week, the medical association issued a letter to the DME medical director outlining the challenges providers will likely face during the recall.
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