The year 2023 is expected to be extremely action packed and productive for the AAMI Standards Program. As of January 2023, AAMI Standards leaders Amanda Benedict and Hae Choe have assumed key roles in advising international guidance. Additionally, the Standards staff is working towards five major highlights the health technology community should look forward to:
1. Improved “regulatory readiness” of standards: Efforts are underway to develop guidance on writing standards content that lends itself better to uniform interpretation and conformity assessment. This is expected to make standards easier to use for both industry and regulatory stakeholders.
2. New AAMI Committee Central platform: We know that this one is at the top of the wish list for many (OK, pretty much all) of our standards group members. We’re thrilled to announce that work is underway to identify a new, more user-friendly technology solution for AAMI’s Standards development platform. We expect to be able to launch the new tool before the end of 2023.
3. New editions of AAMI EQ56, AAMI PB70 and AAMI HE75: These critically important standards for medical equipment management programs, protective barriers and human factors engineering, respectively, have completed or are nearing completion.
4. Combination products going international: Although it’s too soon to speculate on specifics, there is significant interest in developing international standards and technical documents for combination products. Potential pathways have been identified to elevate AAMI technical documents within the international standards arena.
5. More standards for healthcare technology management (HTM): The AAMI Medical Equipment Management (EQ) Committee and its affiliated working groups will be starting work on several new projects for standardization in important areas of HTM, including health technology acquisition and HTM education programs.
Hae Choe Leads in ANSI and IEC International Standards Roles
AAMI Principal Director of Standards Hae Choe has begun her role as vice president of technical at the United States National Committee (USNC) of the American National Standards Institute (ANSI).
USNC serves as the U.S. body for the International Electrotechnical Commission (IEC). In her role as the vice president of technical, Choe will be the Chair of USNC’s Technical Management Committee (TMC), which manages all of the U.S. mirror committee activities in standards for IEC. Reportedly, this is the first time in history that someone from the U.S. medical/health sector has been elected as the chair of the USNC TMC.
As part of being elected as the chair of the TMC at USNC, Choe was also elected into the IEC Standardization Management Board (SMB) as the U.S. primary voting member.
“Not only a governing body, the SMB is intrinsically linked to all phases of standards development at IEC,” Choe said, explaining the responsibilities of the board’s members. “SMB has been delegated to manage the standards work of the commission and as such, takes the leadership role in ensuring that the standards development at the IEC is not only on schedule and managing expectations, but is also forward thinking.”
“Taking on both the USNC and IEC roles is overwhelming but also very exciting,” she added. “I am honored to have been elected into these roles. What is most fascinating is that there are so many converging areas for standards development and collaborative work. By taking on the IEC SMB member role, for instance, I was approached by several other Technical Committee leads at IEC wanting to understand IEC 60601-1 and how we can work together. This year, I plan to soak everything in.”
Amanda Benedict Represents U.S. Engagement in ISO Global Standards Development
Additionally, AAMI Vice President of Standards Amanda Benedict has assumed her role as chair for the ANSI ISO Council.
Representing the interests of more than 270,000 companies and organizations and 30 million professionals, ANSI is the official U.S. representative to the International Organization for Standardization (ISO). The ANSI ISO Council helps guide the organization in recommending policy and process-related positions for ISO bodies, including the ISO General Assembly, ISO Council, ISO Technical Management Board, ISO Committee on Consumer Policy, ISO Committee on Developing Countries, ISO Conformity Assessment Committee, and subgroups of these committees.
“The AIC advises on U.S. interests to inform ANSI policy and process-related positions on ISO standardization issues, as well as reactions to proposed areas of new standards activity and allocation of secretariat roles,” said Benedict. “I’m thrilled to be chairing this group and working alongside ANSI members and staff to ensure the U.S. continues to participate effectively in international standardization and conformity assessment through ISO.”
“We’re immensely proud of Amanda’s work on the international stage,” added AAMI President and CEO Pamela Arora. “This appointment is a credit to Amanda’s commitment to the global harmonization of high-quality standards, which wonderfully aligns with AAMI’s mission to advance the development, management and use of safe and effective health technology around the world.”
