Safe and effective sterilization of medical devices plays a critical role in preventing the incidence of surgical site infections and ensuring patient safety.1 Sterility assurance is the shared responsibility of three main parties:

  • Medical device manufacturers (MDMs) should determine the approved methods of sterilization for the medical devices they produce1
  • Medical Sterilizer manufacturers should provide a reliable sterilization method and evaluate sterility efficacy for specific devices and sterilization systems1
  • Healthcare professionals and staff in the central sterile services department perform the sterilization process and are responsible for carrying this out in line with devices’ instructions for use1

MDMs and sterilizer manufacturers must work together to test an instruments performance, provide sterility assurance and ensure material compatibility and functionality.1 Due to the distinct combination of parameters used by each sterilizer for each device, sterility assurance must never be assumed and each medical device must be thoroughly tested in line with exacting safety and quality standards.1, 2

ASP has developed The STERRAD™ Sterility Guide, an extensive database of devices that have undergone vigorous validation to meet STERRAD™ system sterility claims.1, 3 Containing over 23,000 device listings from over 100 different MDMs, it is the first of its kind online tool, designed to provide STERRAD system customers with a trusted resource for up-to-date sterilization information.1, 3


  1. Advanced Sterilization Products. STERRAD™ Superiority Factsheet Volume 4 - The Importance of Instrument Validation. AD-200105-01-CT_B-MDR.

  2. International Organization for Standardization. ISO 14937:2009

    Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

  3. Advanced Sterilization Products.



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