Max-Lux—Safe-T-Lite UV WAND: May Expose Users and Nearby People to Unsafe Levels of Ultraviolet-C Radiation, Potentially Causing Injury
October 6, 2021 | Strategic Insights for Health System
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Problem:In a September 29, 2021, Safety Communication, FDA states that use of the above products may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-C) radiation, potentially causing injury to the skin (erythema), eyes (photokeratitis), or both after a few seconds of use. The instructions for use (IFU) for affected product instruct users to hold the product in hand for the duration of the 30- to 60-second disinfection process. The affected product emits a level of radiation that is more than 3,000 times stronger than the ultraviolet exposure limit at a distance of about two inches that is recommended by an international group of experts. FDA has issued a Notification of Defect Letter to Max-Lux, notifying the firm that the FDA had concluded according to its regulations that affected product has a defect. The manufacturer has not confirmed the...