The U.S. Food and Drug Administration (FDA) issued a warning on Sept. 29, 2021, about the potential risk of injury associated with the Safe-T-Lite UV WAND. The Safe-T-Lite UV WAND is manufactured by Max-Lux Corporation Limited. Using it may expose the user and people nearby to unsafe levels of ultraviolet radiation after a few seconds of use and may cause injury to the eyes, the skin.
Consumers use the Max-Lux Safe-T-Lite UV WAND to disinfect surfaces and kill germs in the home or similar spaces but have an unsafe level of radiation and do not have the safety features against injury, so the FDA recommends using safer general-purpose disinfectant as an alternative.
Product Description and Background
- The Max-Lux Safe-T-Lite UV WAND is a portable UV-C germicidal wand that emits UV-C radiation to disinfect surfaces.
- The use of Max-Lux Safe-T-Lite UV WAND is by holding it for about 30 to 60 seconds during the disinfection process. The product emits over 3,000 times the ultraviolet radiation exposure limit than the recommended level by an international group of experts.
- The FDA concluded that according to their regulations, the Safe-T-Lite UV WAND has a defect. They issued a Notification of Defect Letter to Max-Lux Corporation Limited and will continue to monitor this issue and update the public of any information as it becomes available.
Limits of UVC Radiation Effectiveness according to FDA
- Direct exposure: The virus is inactivated by UVC radiation during direct exposure to the radiation. The inactivation of viruses may not be effective on surfaces when soil, dust, or body fluids block the UV radiation.
- Dose and duration: Many of the UVC lamps for home use have low doses and need longer exposure to provide effective inactivation of the bacteria or virus.
UVC Radiation
UVC radiation has effectively been used for decades to disinfect the air, water, and nonporous surfaces to reduce the spread of bacteria. UVC radiation is effective in destroying the outer protein coating of SARS-Coronavirus and inactivating it. And, it may also be effective in inactivating the Coronavirus Disease 2019 (COVID-19) however, the wavelength dose and duration of the UVC required to inactivate the virus have limited data.
Some UV lamps generate ozone, so inhaling it can irritate the airway. Some UVC can degrade certain materials such as polymers, plastic and dyed textile. Because UVC lamps contain mercury toxic even in small amounts, be cautious when cleaning and disposing of broken lamps.
The FDA website (fda.gov) provides forms for consumers to report problems. If injured by a UV light, search for the Accidental Radiation Occurrence Report form on the FBI website. When the new page opens, the link for this form is midway down the page.
Written by Janet Grace Ortigas
Edited by Cathy Milne-Ware
Sources:
U.S. FDA: Risk of Exposure to Unsafe Levels of Radiation with Safe-T-Lite UV WAND: FDA Safety
Communication
U.S. FDA: How to Determine if Your Product is a Medical Device
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