sterile processing
sterile processing
By Damien Berg, BA, BS, CRCST, AAMIF
HSPA’ s Role in Global Standards Development and Guidance for SPDs
The Healthcare Sterile Processing
Association( HSPA) has significant representation in the development of U. S. and international standards, contributing to the guidance, education, science-based support and best practices for sterile processing( SP) professionals around the globe. The association’ s role with the International Organization for Standardization( ISO) is far-reaching, serving among the U. S. experts on several committees that bridge U. S. and international standards on critical subject matter, including instructions for use( IFU), packaging, transport, and healthcare management.
Like U. S.-based standards, international standards directly and indirectly impact our membership. So far in 2025, HSPA has participated in global in-person and virtual meetings. These meetings will help the U. S. learn from and align with our international partners to ensure safe, high-quality, best practice-based processing of medical instruments. Some excellent documents are in draft stages, and more details will be shared once completed.
HSPA also represents the U. S. with the World Federation of Hospital Sterilization Science( WFHSS). HSPA’ s President attends the WFHSS’ s World Sterilization Congress and participates and votes as a member of the General Assembly, whose mission is the promotion of the worldwide harmonization of sterilization departments and decontamination practices.
Additionally, HSPA receives invitations and participates in several international organizations and events that promote best practices and scientific research. This year, we spoke at the Pan-American Conference in Lima, Peru. Further, we attended the Endoscope Hygiene Experts Forum, where global experts, including HSPA, reviewed and presented the latest science and gave recommendations to be presented and shared with the profession.
The Need for Current Standards in SPD
Having ready access to the latest standards is essential for promoting quality, safety and best-practice adherence in all areas where device processing occurs. Sterile Processing Week, which begins the second Sunday of October each year, provides an excellent opportunity for SP leaders to assess their standards library and meet with the organization’ s C-Suite executives to explain why current standards are so vital( if guidance documents are missing from the SPD’ s library, request their support for acquiring them).
The following lists some essential ANSI / AAMI standards and technical information reports( TIRs) for SP professionals. It is important to note that HSPA bases its education and certification content on these consensus documents.
ANSI / AAMI ST58:2013 /( R) 2018 Chemical sterilization and high-level disinfection in health care facilities
Provides guidance for selecting and using liquid chemical sterilants( LCSs)/ high-level disinfectants( HLDs) and gaseous chemical sterilizers.
ST79:2017 /( R) 2022 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Guides on steam sterilization, sterility assurance and the proper use of processing equipment. Included within the scope of its recommended practices are functional and physical design criteria for sterilization processing areas( decontamination, preparation, sterilization, and sterile storage areas); staff qualifications, education and other personnel considerations; processing procedures; installation, care and maintenance of steam sterilizers; and quality control.
ANSI / AAMI ST91:2021 Flexible and semi-rigid endoscope processing in health care facilities
Provides guidelines for point of use treatment, transporting, leak testing( where indicated), cleaning, packaging( where indicated), high-level disinfecting and / or sterilizing, storage, and quality control procedures of flexible gastrointestinal( GI) endoscopes, flexible bronchoscopes, flexible ear, nose, and throat endoscopes, flexible urology endoscopes, and other types of reusable flexible endoscopes used in procedural and surgical settings, and semi-rigid operative endoscopes( e. g., choledochoscopes) used in health care facilities.
ANSI / AAMI ST108:2023 Water for the processing of medical devices
Guides on selecting the water quality necessary for processing categories of medical devices. It addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.
AAMI TIR99:2024 Processing of dilators, transesophageal and ultrasound probes in health care facilities
Guides the appropriate processing of dilators and ultrasound probes in healthcare facilities to make them safe for patient care. It includes information on the selection and use of cleaning, disinfection and sterilization systems that have been cleared for marketing by the FDA for use in hospitals and other health care facilities.
AAMI TIR109 External transport of reusable medical devices for processing
Guides maintaining the integrity of sterilized items when transported between facilities( e. g., from one healthcare facility to another or between an off-site reprocessing center and a healthcare facility).
Damien Berg, BA, BS, CRCST, AAMIF, is the vice president of strategic initiatives for the Healthcare Sterile Processing Association( HSPA).
26 • www. healthcarehygienemagazine. com • sept-oct 2025