Industry activities aimed at IFU improvements


Ralph J. Basile, Vice President of Healthmark Industries, provides the following updates on additional standards activities aligned with the Association for the Advancement of Medical Instrumentation (AAMI) Sterilization Standards Committee Workgroup 12 (AAMI ST/WG12).

  • AAMI ST98, Cleaning validation of health care products: This is an “upgrade” of AAMI TIR30 to a cleaning validation standard. AAMI ST98 includes requirements for development and validation of a cleaning process for medical devices. Currently in early draft stages, this is an ambitious effort to better define and extend the requirements for validating the cleaning procedures developed by medical device manufacturers for their devices.
  • Standard ISO 15883-5, Washer disinfectors — Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy: Similar to AAMI ST98, but in later draft stages, the update of this document will set more clear requirements for validating the performance of automated washer-disinfectors.
  • ANSI/AAMI/ISO 17664, Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices: One of the most significant additions to this updated document is a much greater focus on the provision of cleaning instructions.
  • ASTM F3208-17 and F3293-18: These two new ASTM International standards are related to test soils used to validate the cleaning IFUs for medical devices. The purpose of these standards (and related ones in development) are the use of test soils that better represent the challenges of clinical soiling. By employing methods that better reflect the real world conditions of contamination in clinical-use, the cleaning procedures developed by medical device companies will, hopefully, be more effective.
  • ASTM D8179-18: Detergents, needless to say, play a critical role in the success of any cleaning procedure. The recently published ASTM D8179-18 is the first standard related to detergents intended to clean medical devices. It identifies test methods to be used by manufacturers of detergents to better characterize the performance of their formulations for cleaning medical devices.
  • ASTM F3275-19: The just published ASTM F3275-19 is the first in a series of standards related to brushes intended to clean medical devices. By employing these test methods, manufacturers of brushes will be able to design more effective brushes and medical device manufacturers will be facilitated in making their recommendations for the proper brush(es) to use.
  • Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff: Released on June 9, 2017, this update put much greater emphasis and focus on effective cleaning of medical devices and this is sure to influence heavily the development of IFUs.


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