GESTIÓN EN SALUD PÚBLICA: FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized

domingo, 1 de marzo de 2020

FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized

https://www.fda.gov/news-events/press-announcements/fda-reminds-patients-devices-claiming-clean-disinfect-or-sanitize-cpap-machines-using-ozone-gas-or?utm_campaign=022720_PR_Devices%20Claiming%20to%20Clean%20CPAPs%20with%20Ozone%20Gas%2C%20UV%20Light%20Not%20FDA%20Authorized&utm_medium=email&utm_source=Eloqua

FDA Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized

Today, the U.S. Food and Drug Administration is issuing a Safety Communication to inform patients and health care providers that devices claiming to clean, disinfect or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light are not legally marketed for this use by the FDA in the U.S., and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown. CPAP devices are often prescribed for home use to patients with obstructive sleep apnea, a condition where an individual’s airway becomes blocked during sleep causing breathing to intermittently stop and start. CPAP devices use air pressure to keep airways open during sleep.

To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA is recommending that consumers and health care providers follow the cleaning instructions provided by the CPAP’s manufacturer, which normally include regular cleaning with soap and water.

“The FDA has identified several manufacturers that are marketing ozone gas or UV light-based products claiming to clean, disinfect or sanitize CPAP devices and accessories in the home,” said William H. Maisel, M.D., M.P.H, director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “Exposure to high levels of ozone gas may worsen a patients’ existing chronic respiratory diseases or increase the chance of a respiratory infection. UV light-based products could cause burns, eye damage or increase the risk of skin cancer due to over exposure. The FDA has contacted manufacturers of products making these claims and asked them to submit data demonstrating their safety and effectiveness.”

The FDA has received 11 reports from 2017-2019 from patients experiencing cough, difficult breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories. The FDA has not...