A recent Medtech Dive article highlighted the medtech safety issues facing hospitals in the year ahead. Concerns included managing devices approved via the EUA process, substandard PPE, and the lack of regulation/safety concerns around UV light products.
According to MEdtech, “Ultraviolet light technologies can have a germicidal effect but may not deliver a high enough dose to inactivate microorganisms”, ECRI said. The devices typically are not regulated by the FDA, nor are they required to perform EPA Hospital Disinfectant testing. Microbiology test results are self-reported. Improper use can also expose the operator or others to unsafe levels of UV light.
Concerns other than those raised in the article are also important to consider. In addition to a lack of any regulatory oversight UV light is highly susceptible to shadowing – dirt, dust, fluids, or other objects may interfere with light transmission. Irregularly shaped items will be difficult to cover with a uniform, effective UV dose. UV light significantly loses power as distance increases, this is known as the Inverse Square Law. So, if you double the distance from a UV light source you only have 25% of the power remaining. Angle of incidence, the angle between the light source and the item to be disinfected also leads to a pronounced reduction in UV power/efficacy.
ECRI’s report on these risks comes shortly after an FDA report which raised similar concerns about UV light disinfection.
