Validation of the Device Feature Approach for Reusable Medical Device Cleaning Evaluations.

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  • Author(s): Kremer TA; Felgar J; Rowen N; McDonnell G
  • Source:
    Biomedical instrumentation & technology [Biomed Instrum Technol] 2023; Vol. 57 (4), pp. 143-152. Date of Electronic Publication: 2024 Jan 03.
  • Publication Type:
    Journal Article
  • Language:
    English
  • Additional Information
    • Source:
      Publisher: Published by Hanley & Belfus for the Association Country of Publication: United States NLM ID: 8905560 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0899-8205 (Print) Linking ISSN: 08998205 NLM ISO Abbreviation: Biomed Instrum Technol Subsets: MEDLINE
    • Publication Information:
      Original Publication: [Philadelphia, PA : Published by Hanley & Belfus for the Association, c1989-
    • Subject Terms:
      Equipment Reuse* ; Sterilization*; Humans ; Automation ; Patient Safety ; Health Facilities
    • Abstract:
      The identification of worst-case device (or device set) features has been a well-established validation approach in many areas (e.g., terminal sterilization) for determining process effectiveness and requirements, including for reusable medical devices. A device feature approach for cleaning validations has many advantages, representing a more conservative approach compared with the alternative compendial method of testing the entirety of the device. By focusing on the device feature(s), the most challenging validation variables can be isolated to and studied at the most difficult-to-clean feature(s). The device feature approach can be used to develop a design feature database that can be used to design and validate device cleanliness. It can also be used to commensurately develop a quantitative cleaning classification system that will augment and innovate the effectiveness of the Spaulding classification for microbial risk reduction. The current study investigated this validation approach to verify the efficacy of device cleaning procedures and mitigate patient risk. This feature categorization approach will help to close the existing patient safety gap at the important interface between device manufacturers and healthcare facilities for the effective and reliable processing of reusable medical devices. A total of 56,000 flushes of the device features were conducted, highlighting the rigor associated with the validation. Generating information from design features as a critical control point for cleaning and microbiological quality will inform future digital transformation of the medical device industry and healthcare delivery, including automation.
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    • Publication Date:
      Date Created: 20240103 Date Completed: 20240105 Latest Revision: 20240106
    • Publication Date:
      20240106
    • Accession Number:
      PMC10764062
    • Accession Number:
      10.2345/0899-8205-57.4.143
    • Accession Number:
      38170936