AAMI News December 2019

Standards Spotlight: New Projects for Sterilization and HTM Education

Standards Spotlight
AAMI’s new projects cover transportation of medical devices, water quality for sterilization processes, and guidance for healthcare technology degree programs.

The AAMI Standards Board approved three new work item proposals in November—two projects in the sterilization area and one in the medical equipment management area.

AAMI ST108, Water for the processing of reusable medical devices, is a new standard that is intended to replace the technical information report (TIR) AAMI TIR34:2014/(R)2017, Water for the reprocessing of medical devices. ST108 will establish the minimum requirements for the appropriate grades of water used at different points in the reusable medical device processing sequence. These minimum requirements will help ensure successful cleaning, disinfection, and sterilization of devices and minimize the chance of device damage during processing.

ANSI/AAMI ST79:2017 and ANSI/AAMI ST91:2015 have established that water quality is a critical variable for processing reusable medical devices. The U.S. does not currently have consensus standards for water quality for reusable medical device processing, therefore, members of the consensus standards group responsible for AAMI TIR34 decided to advance the current TIR, which offers information about water for reprocessing medical devices, to a standard that establishes minimum requirements for water quality.

Through the establishment of this standard for water quality, sterile processing professionals in healthcare facilities will have more leverage in obtaining water of the quality necessary to effectively process reusable medical devices with decreased staining or corrosion, thus advancing patient care. This new standard also will provide information about how water-borne contaminants affect medical devices and processing efficacy and methods for measuring these contaminants.

AAMI TIR109, External transport of medical devices processed by health care facilities, is a new AAMI TIR that will provide comprehensive guidance on externally transporting medical devices between one healthcare facility and another healthcare facility or centralized processing facility, either for patient use, sterilization, disinfection, or decontamination.

Centralized processing facilities that service multiple healthcare facilities are becoming more commonplace, as is the sharing of instrumentation among surgery centers in multi-hospital systems. With more sterile packages on the road, there is a growing risk of compromised patient safety from medical device contamination during transportation. External transport is discussed in ANSI/AAMI ST79:2017, but there is a need for more extensive guidance on the external transport of medical devices to address increasing shifts to centralized processing. AAMI TIR109 will aim to fill that need.

AAMI EQ110, Guidance for health care technology management education programs, is a new standard that will provide a baseline for healthcare technology management (HTM)
education programs that offer associate or bachelor’s degrees.

EQ110 will offer a recommended framework for new or established degree programs in HTM. It will define the basic requirements for starting such a program and provide guidance on resolving gaps in existing HTM educational programs.

Employers have complained for years about a shortage of high-quality HTM educational programs, and thus a shortage of new, qualified HTM graduates to hire. Disparities also exist in terms of the alignment of these programs with the needs of today’s healthcare environment. Additionally, there is uncertainty among HTM education administrators, who often have limited resources, on defining minimum requirements and minimum expectations for students. AAMI’s Medical Equipment Management Committee seeks to address the issue through the development of this standard.

For more information about activities within the AAMI standards development committees and how you can get involved, visit www.aami.org/standards.


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