Philips updates providers on FDA report

AMSTERDAM, the Netherlands – Philips does not anticipate a delay to its recall or replacement program as a result of a recent report from the U.S. Food and Drug Administration, the company told its provider customers in a Nov. 23 letter. 

The FDA recently published the results of its inspection of Philips’ manufacturing facility, noting the silicone-based foam used in a singular, similar CPAP/BiPAP device marketed outside of the U.S. failed one safety test for the release of volatile organic compounds. 

“In its observation from the inspection, the FDA has maintained its recommendations related to the continued use of devices for patients and health care providers,” the letter states. “Philips does not anticipate delay to the recall or replacement program as a result of the FDA report.” 

Philips says it continues to collaborate with the FDA on additional testing on the silicone-based foam in its DreamStation 2 and repaired DreamStation CPAP/BiPAP devices, noting the material passed applicable testing, with the exception of the one test. 

The company also noted in the letter that it has updated the language included in the recall to align it with the current FDA recommendations. For CPAP and BiPAP users, the update includes a recommendation that patients speak with their clinicians to determine the risks and benefits of continued therapy on recalled devices. 

“The previous version of the Urgent Medical Device Recall directed patients to stop use, prior to consulting with their clinician,” the letter states. “This update was made to align to the FDA’s recommendations, and to provide clinicians with a wider range of options to consider for each individual patient.”