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FDA issues Safety Communications on ozone and UV cleaners
#1
FDA issues Safety Communications on ozone and UV cleaners
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 received any adverse event reports for UV light products claiming to clean, disinfect or sanitize CPAP devices and accessories.
Ozone is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in killing harmful bacteria, it must be present at a concentration far greater than what is considered safe for humans. Although products claiming to clean, disinfect or sanitize CPAP devices that use ozone gas claim that they are designed to keep ozone gas inside the machine and its accessories, leaks can occur at tubing connections, filters or through containers used to house CPAP accessories. When leaks occur, ozone gas in the room where the devices are used may temporarily rise to unsafe levels especially if the room is small or not well ventilated.
Additionally, if the CPAP machine or accessories are used without first allowing fresh air to circulate through the entire CPAP system to remove any remaining ozone gas, this could lead to someone inhaling ozone gas, which could cause breathing problems.
Direct exposure to UV light may cause injury depending on its wavelength, intensity and exposure time. Additionally, the UV light may not be able to penetrate all components of CPAP devices and accessories, like the plastic tubing, masks and connectors, which could lead to inadequately disinfected components that may be unsafe for people to reuse.
While these devices claiming to clean, sanitize or disinfect CPAP machines and accessories have not been FDA cleared or approved for marketing in the U.S., the FDA conducted its own preliminary lab testing on several of those illegally marketed products. The testing demonstrated ozone-using disinfection devices generated ambient levels of ozone above limits considered safe for human exposure. Ozone levels were also high in CPAP machines and tubing even after waiting the amount of time recommended by the ozone-based device manufacturer after a cleaning cycle. The FDA’s studies also showed the power of the UV light and time during which CPAP masks and accessories were exposed to this light varied considerably among UV cleaners. If CPAP components are exposed to insufficiently strong UV light or processed for an insufficient amount of time, the CPAP components could be inadequately disinfected leading to safety and performance issues.
The FDA has contacted manufacturers of the ozone gas and UV light products that claim to clean, sanitize or disinfect CPAP devices and accessories. Each manufacturer was informed that based on their product’s intended use and technological characteristics, FDA review and clearance or approval is needed and that data would need to be provided to demonstrate safety and effectiveness.
The FDA will continue to monitor reports of adverse events associated with the use of ozone gas or UV-based CPAP devices that claim to clean, sanitize or disinfect CPAP devices and accessories and update the public should new information become available.
The FDA encourages individuals to report adverse events related to the use these devices to the FDA.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

https://www.fda.gov/news-events/press-an...Dl29lgxRPQ
Fred Bonjour - Project Manager and Lead Tester for OSCAR - Open Source CPAP Analysis Reporter 
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#2
RE: FDA issues Safety Communications on ozone and UV cleaners
Fascinating
Dave

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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEBSITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#3
RE: FDA issues Safety Communications on ozone and UV cleaners
Talk about burying the lead into the Corona Virus panic.
Sleeprider
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.
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#4
RE: FDA issues Safety Communications on ozone and UV cleaners
ResMed note possible damage to CPAP devices ... I had previously posted this in another thread ...

To Our Valued Patient,

ResMed announced an update to its limited warranty that may affect whether you choose to use an ozone device with your ResMed machine and mask. Please review the detail of this update below.*

ResMed user guides advise patients to periodically clean ResMed machines, components and masks with mild detergent and warm water only. Some patients choose to use other means to clean and/or disinfect their machines.

With the increased use of ozone devices, ResMed has observed that prolonged and repeated use of an ozone device may eventually cause internal damage to a ResMed machine, leading to an increase in motor noise.

Warranty update: Effective for sales of ResMed machines on or after February 1, 2020, ResMed’s limited warranty will exclude damage to ResMed machines caused by use of ozone devices.

The limited warranty on ResMed masks, with the exception of ResMed AirTouch™ products, will not be affected.

ResMed is not taking a position on whether you should use an ozone device. That decision is up to you, as the patient, to balance the convenience of using an ozone device versus the likelihood of potential damage to your ResMed machine.

ResMed is reinforcing the cleaning instructions in its machine user guide: periodic cleaning with mild detergent and warm water is all that is required with a ResMed machine, component or mask. This letter requires no action on your part.

If you have any further questions, please feel free to contact the manufacturer of the ozone device you are currently using or, for medical advice, your physician.

https://www.resmed.com/us/dam/documents/...letter.pdf

BTW: THIS ALSO APPLIES TO THE ROOM-SIZE OZONE PURIFIERS THAT ARE NOW POPPING UP TO FIGHT THE CORONAVIRUS!
"The object in life is not to be on the side of the majority, but to escape finding oneself in the ranks of the insane." -- Marcus Aurelius
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#5
RE: FDA issues Safety Communications on ozone and UV cleaners
I've read the lab reports supporting the efficacy of SoClean and Lumin. I have written many reports on sterilization and sanitization for review by the agency and will be shocked if the studies reported will come close to meeting FDA requirements.
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INFORMATION ON APNEA BOARD FORUMS OR ON APNEABOARD.COM SHOULD NOT BE CONSIDERED AS MEDICAL ADVICE. ALWAYS SEEK THE ADVICE OF A PHYSICIAN BEFORE SEEKING TREATMENT FOR MEDICAL CONDITIONS, INCLUDING SLEEP APNEA. INFORMATION POSTED ON THE APNEA BOARD WEB SITE AND FORUMS ARE PERSONAL OPINION ONLY AND NOT NECESSARILY A STATEMENT OF FACT.

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