FDA Reminds people that CPAP machines with an ultraviolet light or ozone gas have not been FDA approved for disinfecting, washing, or sanitizing. In the United States presently, the FDA released a Wellbeing communication to warn patients and healthcare providers that ozone gas or ultraviolet (UV) light devices or supplies (such as tubing, masks, headgear) claim to disinfect, sanitize or clean continuous positive airway pressure (CPAP) are not legally sold for this reason in the USA by the Food and Drug Administration. At BestCPAP we ensure that we provide equipment that is approved by FDA.
CPAP devices are also used in patients with obstructive sleep apnea at home, a condition where the airway of a person gets blocked during sleep causing breathing to stop and resume intermittently. CPAP air pressure systems preserve open airways while sleeping.
The FDA recommends that health workers and customers obey cleaning instructions from the CPAP manufacturer, which typically involves routine cleaning using water and soap, in order to ensure the safe and efficient cleaning of CPAP devices and accessories.
The FDA issued 11 reports in 2017-2019 from patients suffering from the use of ozone gas related to product cleaning, sanitizing, or disinfection of CPAP devices and accessories. FDA has identified cough, trouble breathing, nasal inflammation, headaches, asthma attacks, and others. The FDA received no records of adverse events for the washing, disinfecting, or sanitizing of the CPAP devices and accessories of UV light products.
Does SoClean have an Ozone smell?
“A number of manufacturers have been identified by the FDA to market ozone gas or UV light products for cleaning, disinfecting and sanitizing in the home, CPAP devices, and supplies,” said William H. Maisel, M.D., M.P.H, director of the FDA Center for Devices and Radiological Health Product assessment and quality office. “High levels of ozone gas exposure can exacerbate existing chronic diseases in a patient or increase the risk of a respiratory infection. UV-light-based products can cause burning, damage to the eye, or increase the risk of overexposure to skin cancer. The FDA contacted producers of products which made these claims to submit data showing their safety and efficacy.”
Whilst the FDA has not cleared or endorsed CPAP machines and accessories for the sale in the U.S., its own experimental laboratory studies have been carried out on some of these products that have been illegally sold. The test showed that ozone-using disinfectants created environmental ozone levels above limits which are considered acceptable for human exposure. Even after the waiting period recommended by the ozone-based system manufacturer, ozone levels were also high in CPAP machines and piping. The experiments in the FDA showed also how much UV light and time CPAP masks and accessories and UV cleaners were exposed to these lights. CPAP components may be inadequately disinfected which may result in safety and performance problems if the components in the CPAP are exposed to insufficient UV light or processed for insufficient time.
Ozone is a gas that can destroy bacteria that are toxic. However, ozone must be present at a concentration much greater than that considered healthy for people in order to be effective in destroying harmful bacteria. Even if products that claim to clean, disinfect or clean CPAP devices using ozone gas claim to be built to retain ozone gas inside the system and its supplies, it can leak in the form of connections to tubes, filters, or containers used to house CPAP accessories. Once the leaks happen, ozone gas where it is put in the room and where the devices are made use of could momentarily increase to dangerous levels particularly when the room is not well aerated or when the room is small.
The FDA contacted the ozone and UV product manufacturers who say that the CPAP devices and accessories are safe, sanitized, or disinfected. Every manufacturer has been told that FDA reviews and clearances or approvals are required on the basis of the expected use of their product and technical characteristics and data should be given to show protection and efficacy.
In the case of additional details, the FDA will continue to track the reports of adverse events linked to the use of ozone gas or CPAP UV-based instruments that claim the washing, sanitizing or disinfection of CPAP devices and components, and update them to the public. The FDA requires individuals to disclose the use of these devices in accordance with the FDA.
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At BestCPAP, we ensure that we get the approved equipment for your health. We care about your health and that is why you should order our CPAP machines. Call us today for the best deal!