In late July, the U.S. Food and Drug Administration issued a safety alert advising consumers of safety risks associated with specific brands of portable ultraviolet devices claimed to disinfect objects and surfaces. According to the agency’s alert, “The FDA is aware that some manufacturers are marketing unsafe UV wands to consumers to disinfect surfaces and kill germs in the home or similar spaces outside most health care settings. The FDA recommends that consumers do not use these products and consider using safer alternative methods.”
LED industry insiders have cautioned about such safety risks in the past several years, as UVGI products flooded the consumer market in the early stages of the coronavirus pandemic. As time and research into the effectiveness of UV radiation against SARS-CoV-2 have marched on, public health advisors and scientists have decreased the focus on surface contamination as a vehicle for that particular pathogen. That is not to say that other microbes pose no concern with regard to contact with contaminated surfaces. Indeed, infections in clinical settings can often be spread in this manner, leading market consultants and product developers to recommend multimodal approaches involving proper manual (“terminal”) cleaning, continuous visible-light disinfection to reduce bioburden, and UV application at proper doses and schedules to minimize exposure of occupants.
Products found too potent
Regardless, on the direct-to-consumer side, correct safety information and operational guidance is critical as some manufacturers have placed unsafe designs into the hands of users without appropriate protections or warnings in place.
UV wand manufacturers with products on the FDA’s warning list include:
- In My Bathroom LLC, “dba” IMB
- Magic UV Light Sanitizer
- Max‐lux Corporation
- MerchSource LLC
- OttLite Technologies Inc.
- PhonoSoap LLC
- Vanelc
In its advisory, FDA noted, “When a product is advertised to disinfect in seconds, it likely means that it gives off an unsafe level of UV-C radiation. The FDA testing determined that some UV wand products give off at a distance of about two inches, as much as 3,000 times more UV-C radiation than the exposure limit recommended by the International Commission on Non-Ionizing Radiation Protection.”
FDA has linked a letter of notification to each of the manufacturers in question on its safety communication page. In one such letter to Max-Lux Corporation, the agency wrote:
“STL is an electronic product whose primary purpose objectively is as a handheld product intended to emit UV radiation for sanitizing purposes. […] instructions for use, which were provided by the destination agent but not included with the shipping package or with the multiple boxes containing an STL […] inside the shipping package, instruct the user to “[h]old the UV-C lamp toward the items, leave 1 inch above surface and go back and forth slowly over the entire surface for 30 to 60 seconds to be sterilized.’ Following these directions would cause the user to hold the STL in the hand for the duration of the sterilization process, causing the hand to be in close proximity to the source of the radiation for the entirety of the sterilization process.”
FDA further noted that the STL product’s spectral irradiance at the 200- to 400-nm range was effectively measured at 4.02 W/m2 at a distance of 5 cm from the wand, “present[ing] a risk of injury to the user and nearby persons.” The agency advised that the ICNRP recommended exposure limit is “3.0 mJ/cm2 effective spectrally weighted in the UV range, within an 8-hour period.”
The “risk of injury” by an unshielded user includes photokeratitis and erythema — damage to the eyes and skin.
Check out the UV wand alert updates on the FDA website, where you can also find additional resources to report on problems with products.
CARRIE MEADOWS is managing editor of LEDs Magazine, with 20 years’ experience in business-to-business publishing across technology markets including solid-state technology manufacturing, fiberoptic communications, machine vision, lasers and photonics, and LEDs and lighting.
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