Devices

CPAP Cleaning Safety Communication

FDA has posted a safety communication to alert consumers and healthcare providers to the fact that the agency has not authorized for market any products using ozone gas or ultraviolet light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories. The notice says that most often CPAP manufacturers recommend regular cleaning of device accessories such as hoses, masks, tubing, and headgear with mild soap and water.

The agency has received reports from patients experiencing cough, difficulty 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 notice says.

And it says that although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns, or an increased risk of skin cancer.

FDA says it is working with manufacturers of products that claim to clean, sanitize, or disinfect CPAP machines and accessories with either ozone gas or UV light to submit the recommended testing to support the use of the devices as claimed.

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