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Reprocessing of reusable medical devices

P S Malchesky1, V C Chamberlain, C Scott-Conner

  • 1STERIS Corporation, Mentor, Ohio, USA.

ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|April 1, 1995
PubMed
Summary

Designing reusable medical devices requires collaboration between users and manufacturers to ensure cost-effective, safe reprocessing and infection control. This approach balances device functionality with reprocessing needs for better healthcare.

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Area of Science:

  • Biomedical Engineering
  • Material Science
  • Infection Prevention and Control

Background:

  • Medical device advancements, especially in minimally invasive procedures, drive the need for innovative engineering and materials.
  • Reusable medical device design is crucial for cost-effective healthcare, necessitating focus on reprocessing, safety, and environmental impact.

Purpose of the Study:

  • To highlight the importance of collaborative design in developing reusable medical devices.
  • To address the challenges and requirements for safe and effective reprocessing of medical devices.
  • To emphasize the shift in customer definition for reusable devices, including all stakeholders in the reprocessing chain.

Main Methods:

  • Review of current requirements for medical device reprocessing based on intended use (critical vs. semi-critical).

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  • Analysis of design considerations for cleaning, disinfection, and sterilization.
  • Examination of regulatory requirements for manufacturers' reprocessing instructions.

    • Main Results:

    • Critical devices necessitate sterilization, while semi-critical devices require high-level disinfection; sterilization is preferred when feasible.
    • Adequate cleaning is a prerequisite for sterilization or disinfection.
    • Device design must facilitate easy cleaning and sterilization, moving beyond solely clinical functionality.

    Conclusions:

    • Effective reprocessing requires devices amenable to cleaning and sterilization, with manufacturers providing clear instructions.
    • User and manufacturer collaboration is essential for designing cost-effective, reusable medical devices.
    • Current trends favor reusing devices, including those initially intended as disposable, to manage costs and resources.