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2017 Fall AAMI Sterilization Standards Meetings Update

By: Emily Mitzel, MS

The AAMI Sterilization Standards Meetings were held on 16-18 October 2017.  There were almost 300 medical device manufacturers, FDA personnel, heath care facility personnel, testing laboratory personnel, consultants, and others in attendance.

One item of interest from USFDA/CDRH is that the Office of Device Evaluation (ODE), Office of Compliance (OC), and Office of Surveillance and Biometrics (OSB) are merging into a single structure specified as the Center for Devices and Radiological Health (CDRH) Total Product Life Cycle (TPLC).

A second item of interest is the Accreditation Scheme for Conformity Assessment (ASCA) in which FDA is ensuring testing laboratories are consistent and are complying with current standards.

Medical Device Reprocessing Update:

  • AAMI TIR30:2011 Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices is in the process of review and is being rewritten.
  • ISO/FDIS 17664 – Sterilization of Medical Devices Information to be provided by the device manufacturer for the processing of reusable medical devices last published in 2004 will be publishing a new version (hopefully by the end of 2017).
  • A new document currently titled ISO/NP 22913, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Medical devices not intended for direct patient contact, was approved and will be written.
  • The current draft of ISO 15883-5 – Test soils and methods for demonstrating cleaning efficacy is undergoing a major revision.

The dates of the next AAMI Sterilization Standards meetings are:
19-22 March, 2018
22-25 October, 2018