AAMI Sterilization Standards

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. https://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm558632.htm

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