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Advancing the Sustainable Use of Ethylene Oxide through Process Validation.

Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts...

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Published in:Biomedical Instrumentation & Technology Vol. 55; no. S3; pp. 35 - 45
Main Authors: McEvoy, Brian, Wiehle, Stacy Bohl, Gordon, Ken, Kearns, Gerry, Laranjeira, Paulo, McLees, Nicole
Format: Journal Article
Published: Association for the Advancement of Medical Instrumentation (AAMI) 2021Supplement
Online Access:View this record in EBSCOhost
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      dt: 2021Supplement
      vid: 55
      iid: S3
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      pub: Association for the Advancement of Medical Instrumentation (AAMI)
      place: Arlington, Virginia
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        10.2345/0899-8205-55.s3.35
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        atl: Advancing the Sustainable Use of Ethylene Oxide through Process Validation.
      aug:
        au:
          McEvoy, Brian
          Wiehle, Stacy Bohl
          Gordon, Ken
          Kearns, Gerry
          Laranjeira, Paulo
          McLees, Nicole
      sug:
        subj:
          Ethylene Oxide
          Sterilization and Disinfection
          Industry
      ab: Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10-6 is typically achieved, with multiple layers of conservativeness delivered, using "overkill" approaches to validation. Various optimization strategies are being used throughout the medical device industry to deliver the required SAL while utilizing only necessary amounts of sterilant. This article presents relevant experiences and describes challenges and considerations encountered in delivering EO process optimization. Thus far, the results observed by the authors are encouraging in demonstrating how EO processing can be optimized in the delivery of critical single-use medical devices for patient care.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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