AAMI Standards Monitor Online 22 July 2022
Standards Monitor Online (SMO) is a free subscription service that is delivered to your email every three weeks. This AAMI resource keeps you up to date with standards-related activities:
NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
NEWSWORTHY!! AAMI/FDA/BSI International Conference on Medical Device Standards and Regulation will return “in-person” on 18-19 October 2022. Click here for more information.
NEWSWORTHY!! Publication of the New Editions of the Standards for Medical Device Interoperability, AAMI/UL 2800 Series | More information is available here.
PUBLISHED! AAMI TIR104:2022, Guidance on transferring health care products between radiation sterilization source is available here.
REAFFIRMED! AAMI TIR65:2015/(R)2022, Sustainability of medical devices – Elements of a responsible life cycle is available here.
The AAMI Standards Insider webinar series was last held on Thursday, May 19th from 1:00-2:00 PM ET. This one-hour FREE webinar provided news and updates about AAMI’s standards program and portfolio. The next webinar will be held on Thursday, August 18th from 1:00-2:00 PM ET. Registration for upcoming webinars and recordings of past webinars are available here.
ANSI/AAMI ST79:2017 & A1:2020, A2:2020, A3:2020, & A4:2020, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (reaffirmation of an American National Standard and amendments). This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of reusable medical devices, quality process improvement and new product evaluation. Contact: Amanda Benedict
AAMI EQ, Medical Equipment Management Committee. The committee is working on the development of AAMI EQ110/Ed.1, Guidance for health care technology management education programs. This standard seeks to provide a recommended framework for new or established education programs in health care technology management (HTM). Contact: Jody Allen
AAMI SM-WG10, Cloud Computing. The AAMI Standards Board has approved the formation of a new working group under AAMI SM, Software and Information Technology, and authorized the group to begin work on a Technical Information Report based on the approved AAMI CR510:2021, Appropriate Use of Public Cloud Computing for Quality Systems and Medical Devices. This new WG is seeking members from the General interest, Industry, Regulatory and User categories to join.
Contact: Ovidiu Munteanu
AAMI TIB, Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use Committee. The committee has recently approved development of a new AAMI Technical Information Report (TIR) on Guidance for Closed System Transfer Device Testing with Hazardous Drugs. This TIR seeks to provide guidelines for physical and chemical compatibility of the drug with the Closed System Transfer Device (CSTD), which may include but not limited to holdup volume, coring/fragmentation of the vial rubber stopper, microbial ingress, stability/shelf-life, and usability. TIB-WG04 is seeking cochairs, user, regulatory and general interest members to participate in the development of AAMI TIR112. We are currently scheduled for a meeting on 20 July, 10:30 – 11:30 am (CST), if interested in attending email. Contact: Sam Alameda
The committees listed below are seeking new members in the indicated stakeholder interest category to participate in the development of their documents. Definitions of the various stakeholder groups are:
An individual or organizational representative, who purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare; individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc
An individual or organizational representative involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents developed by AAMI; this interest category includes manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc.
An individual or organizational representative involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI; this interest category includes those representing federal, state, local, foreign, or other government entities
An individual or organizational representative with a general material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories; this interest category can include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc.
Please contact the staff person indicated for more information on how to join
AAMI Committees and U.S. TAGs
Open meetings of AAMI committees and U.S. Technical Advisory Groups (TAGs) are listed here and at the AAMI website (www.aami.org). Note: If you plan to attend a meeting, please send a brief note to the
AAMI Standards Department (standards@aami.org) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
July 2022
AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen
AAMI TIB, Transfusion, Infusion and Injection, and Blood Processing Equipment for Medical and Pharmaceutical Use. AAMI TIB WG04 will meet on 20 July 2022, 10:30h to 11:30h (CST), to discuss AAMI TIR112, Guidance for closed system transfer device (CSTD) testing with hazardous drugs, next steps in its development. Contact: Sam Alameda
AAMI PC-WG03, Pacemaker & ICD MRI Compatibility Working Group (open meeting). 26 July 2022, 13:00h to 15:00h EST, web meeting. Contact: Ladan Bulookbashi
AAMI ID, Infusion Device Committee (open meeting). 29 July 2022, 13:00h to 15:00h EST, web meeting. Contact: Ladan Bulookbashi
August 2022
AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen
AAMI SP, Sphygmomanometer Committee (open meeting). 8 August 2022, 11:00h to 12:30h EST, web meeting. Contact: Ladan Bulookbashi
September 2022
AAMI EQ, Medical Equipment Management Committee (open meeting – advanced registration REQUIRED). Every Friday, 15:00h to 16:30h EST, web meetings. Contact: Jody Allen
AAMI Fall 2022 Sterilization Standards Week (open meetings – advanced registration REQUIRED; registration to open in July). 12-15 September 2022, 08:00h to 17:00h EST, Arlington, VA and web meetings. Contact: sterilization@aami.org
US TAG to ISO/TC 198 (open meeting – advanced registration REQUIRED; registration to open in July). 15 September 2022, 13:00h to 15:00h EST, Arlington, VA and web meetings. Contact: sterilization@aami.org
November 2022
AAMI RD, Renal Disease and Detoxification Committee Infusion Device Committee (open meeting).
6 -7 November 2022, Details to follow, Orlando FL, hybrid meeting. Contact: Jill Zajac
Information on draft international standards under ballot can be found in ANSI Standards Action.
International Committee and Working Group MeetingsCall or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
September 2022
ISO/TC 84, Devices for Administration of Medicinal Products and Catheters (closed meeting). 22 September 2022, 9:00h to 11:30h EST, Plenary web meeting. Contact: Jill Zajac
December 2022
ISO/TC 198, Sterilization of health care products (closed meeting). 5-9 December 2022, 9:00h to 17:30h EST, Plenary meeting and meetings of affiliated working groups. Contact: Amanda Benedict
AAMI, in collaboration with the British Standards Institution, is launching an effort to develop standards for artificial intelligence (AI) and machine learning (ML) in medical technologies. In May of this year, AAMI published a whitepaper discussing the need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and ML in healthcare. (https://www.aami.org/detail-pages/press-release/aami-bsi-position-paper-sets-machine-learning-agenda)
There were seven recommendations made in the whitepaper. One of the most urgent was for guidance on applying ISO 14971, Medical Devices—Application of Risk Management to Medical Devices, when evaluating medical technology utilizing AI and, in particular, ML. AAMI and BSI have established a partnership to jointly develop a document which provides this guidance, as well as other needed AI standards identified in the whitepaper.
As a result of this initial work, AAMI is creating a new consensus body, tentatively call the AAMI Artificial Intelligence Committee (AAMI AI) to develop this work. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry should contact standards@aami.org for more information about the project or participation on the committee.
