RESEARCH REVIEW ARTICLE: Independent Validation Demonstrates UV-C LED Disinfection Efficacy Equivalent to Hydrogen Peroxide Mist-Based Systems: Addressing Methodological Flaws in Recent Evaluations.

OverviewA recent study assessing the sporicidal efficacy of UV-C LED high-level disinfection (HLD) system for ultrasound probe reprocessing concluded that UV-C LED disinfection underperforms compared to hydrogen peroxide (H2O2) mist-based devices (Nanosonics: TrophonEPR and Trophon2). However, our independent secondary testing of a UV-C LED disinfection system (Lumicare ONE(R)) under clinically relevant conditions yielded contrasting results, demonstrating equivalent efficacy to H2O2 mist-based devices.1-7 Using the same biological indicators (BIs) (106 Geobacillus stearothermophilus spores, Bionova(R) BT93/6) on stainless steel coupons, we conducted three validation conditionsO_LIBI in glassine packaging/Tyvek(R) (non-clinical scenario) C_LIO_LIBI with packaging removed (bare metal coupon) C_LIO_LIBI with packaging removed and flame-sterilized metal coupon (This validation process has a potential to simulate heat-induced surface changes to the metal coupon) C_LI The Lumicare ONE(R) UV-C LED HLD system achieved a 100% pass rate under both clinically relevant conditions (bare metal and flame-sterilized BIs), while under the non-clinical scenario BI in glassine packaging/Tyvek(R) test type was removed since UV-C is unable to penetrate packaging materials. This paper also identifies methodological concerns in the referenced study, includingO_LIThe use of an inappropriate BI (Bionova(R) BT93), explicitly validated for hydrogen peroxide (H2O2) based sterilization to demonstrate penetration of Tyvek(R) peel packaging but not UV-C applications, as per the manufacturers guidelines. C_LIO_LIA misrepresentation of Therapeutic Goods Administration (TGA) sporicidal efficacy requirements. C_LI The Lumicare ONE(R) system goes beyond TGA mandatory requirements in completing a Carrier Test using Geobacillus stearothermophilus spores. The Lumicare ONE(R) system reduced the numbers of Geobacillus stearothermophilus ATC 7953 by greater than a > 6 log10, thus meeting the pass criteria of the Association of Official Analytical Chemists (AOAC 966.04). The Lumicare ONE(R) system has independently demonstrated a greater than > 6-log10 reduction of TGA-mandated test organisms, including Clostridium sporogenes and Bacillus subtilis, and is registered on the Australian Register of Therapeutic Goods (ARTG) as a hospital-grade disinfectant. Our findings highlight the importance of proper study design, appropriate BI selection, and regulatory alignment when evaluating emerging disinfection technologies. UV-C LED systems represent a validated, effective alternative to hydrogen peroxide (H2O2) mist-based devices in clinical ultrasound probe reprocessing.