FDA issues safety communication on CPAP cleaning devices

Wednesday, March 11, 2020

WASHINGTON – The U.S. Food and Drug Administration has issued a safety communication informing patients and health care providers that devices to clean, disinfect or sanitize CPAP devices or accessories using ozone gas or ultraviolet light are not legally marketed for this use by the FDA, so their safety and effectiveness is unknown. The FDA has identified several manufacturers that are marketing ozone gas or UV light-based products and asked them to submit data demonstrating their safety and effectiveness. “Exposure to high levels of ozone gas may worsen a patient’s existing chronic respiratory diseases or increase the change of a respiratory infection,” said William H. Masel, M.D., M.P.H., director of the office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “UV light-based products could cause burns, eye damage or increase the risk of skin cancer due to over exposure.” The FDA has received 11 reports from 2017-19 from patients experiencing cough, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when they’ve used ozone-gas based products. It has not received any adverse event reports for UV light products. The FDA recommends consumers and health care providers follow the cleaning instructions provided by CPAP manufacturers, which normally include regular cleaning with soap and water.