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Tag: Food and Drug Administration


Vendors

FDA releases alert on Philips BiPAP machines

August 30, 2022HME News Staff

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material.  “If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine...

Food and Drug Administration, Philips, Recall


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Specialty Providers

FDA report underscores need for qualified providers

March 3, 2010Theresa Flaherty, Managing Editor

WASHINGTON - A December Food and Drug Administration (FDA) advisory about the potential risks of negative pressure wound therapy (NPWT) underscores the importance of ensuring that the therapy is offered by qualified providers, say industry stakeholders. "The FDA's real objective is to be sure that providers and patients are aware that there are serious risks associated with NPWT," said Patricia Burns, senior director of clinical affairs for Smith & Nephew. "We are very committed to the appropriate...

Food and Drug Administration, Negative pressure wound therapy


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