By Damien Berg, BA, BS, CRCST, AAMIF
The Healthcare Sterile Processing Association (HSPA) is actively involved in developing U.S. and international standards that affect the sterile processing discipline. HSPA also collaborates with allied healthcare organizations, accreditation organizations and federal agencies to represent the profession and provide essential guidance as needed.
The following summarizes HSPA’s recent and ongoing activities with the Association for the Advancement of Medical Instrumentation (AAMI) working groups and the International Organization for Standardization (ISO), as well as its collaboration with surveying organizations and the U.S. Food and Drug Administration (FDA). This participation aligns with HSPA’s strategic plan to elevate education, engagement and visibility for our members and the profession.
ANSI/AAMI working groups updates
Revision of ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities: The working group has formed a core task group to lead and streamline the revision process. As of June 2026, we are at the beginning stages of engagement with committee member volunteers who will help draft the sections, along with designated reviewers, to pull it all together so we can send it to the larger working group for comments and discussion; this will occur in September during the AAMI Fall Sterilization Standards Week. This is an aggressive timeline; however, the AAMI staff, co-chairs, task group leaders and members are all engaged and committed to the project. We are excited about the terrific progress that will continue.
New document on ultraviolet (UV) disinfection for ANSI/AAMI ST58, Chemical sterilization and high-level disinfection in health care facilities: This document will set the foundation for future development and approvals of UV disinfection technologies in the U.S. We are rounding the corner on this document’s completion, with the hope of completing the final draft and reviewing all comments so it can go for vote and be released in 2027.
IFU survey results shared with the FDA
During the 2026 HSPA conference in April, we conducted a survey with four questions to present to the FDA regarding end users’ perspectives on instructions for use (IFU) and the challenges sterile processing professionals face. The survey garnered an incredible response, and the results have been forwarded to the FDA for comment and review. HSPA will provide more details about those results soon.
Collaboration with accreditation agencies
HSPA continues to meet with representatives from the Joint Commission and DNV, with all parties benefiting from knowledge sharing and focused discussions on critical sterile processing-related topics. The organizations have been engaged and eager to work with us. The knowledge gained from these collaborative meetings will enable us to share important survey- and accreditation-related updates with our members and other sterile processing professionals.
International (ISO)
Finally, HSPA is proud to be a part of ISO, where we represent the U.S. on various important topics for the profession. In May, we participated in a meeting in California with fellow ISO members from around the world to discuss the latest standard on medical device cleaning; we are also actively working on packaging, transportation and healthcare management topics. HSPA’s participation gives U.S.-based sterile processing professionals a voice and view into the global practices and how we can align as needed.
HSPA staff’s eagerness to learn, contribute and provide valuable perspectives on issues impacting our members and the profession is reflected in our ongoing participation at the local, national, international and federal levels. Further updates will be shared as these activities advance and more details become available.
Damien Berg, BA, BS, CRCST, AAMIF, is the vice president of strategic initiatives for HSPA.
