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Letter to the Editor| Volume 135, P199-200, May 2023

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Misinterpretation of medical device cleaning standards

Published:March 06, 2023DOI:https://doi.org/10.1016/j.jhin.2023.02.009
      We read with concern a recent manuscript by Deasy et al. [
      • Deasy E.C.
      • Scott T.A.
      • Swan J.S.
      • O'Donnell M.J.
      • Coleman D.C.
      Effective cleaning and decontamination of the internal air and water channels, heads and head-gears of multiple contra-angle dental handpieces using an enzymatic detergent and automated washer-disinfection in a dental hospital setting.
      ] claiming “effective cleaning and decontamination” of the internal components of dental handpieces (DHPs). We feel it is important to note that the test methods and claims in the report are inconsistent with current international standards for cleaning and disinfection of reusable medical devices in washer-disinfectors (WDs) [

      International Organization for Standardization. BS EN ISO 15883-1: 2006. Washer-disinfectors Part 1: General requirements, terms and definitions and tests 2006. London: British Standards Institute.

      ,

      International Organization for standardization. BS EN ISO 15883-2:2009. Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 2006. London: British Standards Institute.

      ,

      International Organization for Standardization. BS EN ISO 15883-5: 2021. (Incorporating corrigendum January 2022). Washer-disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy. London: British Standards Institute.

      ]. The aim of the manuscript was to “investigate the effectiveness of washer-disinfection at reducing microbial bioburden of internal components … of dental handpieces …”. The authors state that there are no specific standards for DHPs; however, DHPs, as medical devices, are given as examples of the types of devices in the WD standard series (ISO 15883-2 [

      International Organization for standardization. BS EN ISO 15883-2:2009. Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 2006. London: British Standards Institute.

      ]) and specifically as powered devices. Cleaning and disinfection requirements in these standards therefore apply. For example, cleaning validation using defined test soils and disinfection efficacy requirements described in the standards [
      International Organization for Standardization
      BS EN ISO 17664-1: 2021. Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Critical and semi-critical medical devices.
      ] are applicable to these reusable medical devices.
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      References

        • Deasy E.C.
        • Scott T.A.
        • Swan J.S.
        • O'Donnell M.J.
        • Coleman D.C.
        Effective cleaning and decontamination of the internal air and water channels, heads and head-gears of multiple contra-angle dental handpieces using an enzymatic detergent and automated washer-disinfection in a dental hospital setting.
        J Hosp Infect. 2022; 128: 80-88
      1. International Organization for Standardization. BS EN ISO 15883-1: 2006. Washer-disinfectors Part 1: General requirements, terms and definitions and tests 2006. London: British Standards Institute.

      2. International Organization for standardization. BS EN ISO 15883-2:2009. Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. 2006. London: British Standards Institute.

      3. International Organization for Standardization. BS EN ISO 15883-5: 2021. (Incorporating corrigendum January 2022). Washer-disinfectors Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy. London: British Standards Institute.

        • International Organization for Standardization
        BS EN ISO 17664-1: 2021. Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Critical and semi-critical medical devices.
        British Standards Institute, London2021