AAMI Standards Monitor Online 29 November 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:
NEWSWORTHY!ISO/TC 121, Renewed attention on ventilators is just the beginning, click here for more information.
NEW! We have completed transitioning our standards groups to the NEW AAMI Committee Central platform! Information is available here.
REAFFIRMED! The following consensus reports have been reaffirmed as of 6 October 2022 under the AAMI COVID-19 Response Team and are available here.
- AAMI CR501:2020/(R)2022, Emergency Use Ventilator (EUV) Design Guidance
- AAMI CR502:2020/(R)2022, End User Disclosures for Emergency Use Ventilators (EUVs)
- AAMI CR503:2020/(R)2022, Emergency Use Resuscitator Systems Design Guidance
- AAMI CR504:2020/(R)2022, End User Disclosures for Emergency Use Resuscitator Systems
- AAMI CR505:2020/(R)2022, Emergency Use CPAP/BiPAP Design Guidance
- AAMI CR506:2020/(R)2022, End User Disclosure for CPAP/BiPAP
- AAMI CR507:2020/(R)2022, Basic Safety of Emergency Use Medical Devices
- AAMI CR508:2020/(R)2022, Emergency Use Ventilatory Assistance Helmet (VAH) Design Guidance
- AAMI CR509:2020/(R)2022, End User Disclosures for Emergency Use Ventilatory Assistance Helmet (VAH)
- AAMI CR511:2020/(R)2022, Emergency use Guidance for Remote Control of Medical Devices
The next AAMI Standards Insider webinar will be held on Thursday, February 16th from 1:00-2:00 PM ET. The one-hour FREE webinar provides news and updates about AAMI’s standards program and portfolio. Registration for the upcoming webinars and recordings of past webinars in the series – including the November 17th session - will be available on the webpage. Check back soon!
AAMI ST90, Processing of Health Care Products—Quality Management Systems for Processing in Health Care Facilities (reaffirmation of an American National Standard). This document specifies minimum requirements for quality management systems (QMSs) to effectively, efficiently, and consistently process (transport, clean, decontaminate, disinfect, inspect, package, sterilize, and store) medical devices to prevent adverse patient events and nonmanufacturer-related device failures. Contact: Jody Allen
AAMI HE75, Human factors engineering—Design of medical devices (revision of an American National Standard). This standard addresses a broad range of human factors engineering topics as they relate to the design and evaluation of medical devices. This document is expected to be useful to human factors and usability engineering specialists, software developers, industrial, biomedical, mechanical, and electrical engineers and other development personnel. There are significant updates being proposed in this revision of the 2009 document. Contact: Hae Choe
AAMI HIT1000-2, Health IT software and systems—Part 2: Application of quality systems principles and practices Specifies a process to build on the principles in existing quality systems principles and practices, as well as identify the specific roles and responsibilities needed to ensure health IT safety and quality as well as patient safety hazards associated with health IT software and systems, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Contact: Chenai Maguwah
AAMI HIT1000-3, Safety and effectiveness of health IT software and systems—Part 3: Application of risk management Identifies the core concepts and principles needed to maintain safe and effective health IT software and systems to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. Contact: Chenai MaguwahAAMI HIT1000-4, Safety and effectiveness of health IT software and systems—Part 4: Application of human factors engineering Describes an approach to developing and validating a health IT system’s user interface so that such systems are safe and effective. The intent is to promote good development practices without being overly prescriptive. As such, this standard covers the development, acquisition, integration, implementation, and operational use lifecycle stages. Additionally, this standard includes a section describing usability considerations for health IT system replacement and decommissioning. Contact: Chenai Maguwah
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. The group will begin having monthly meetings beginning in 2023. 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 (email@example.com) indicating the name and date of the meeting so that staff can contact you in the event of a last-minute cancellation.
AAMI ST, Industrial moist heat sterilization Working Group (open meeting). 1 December 2022, 13:00h to 17:00h EST. Contact: Tommy Kim
AAMI CN, Small-bore Connectors Committee (open meeting). 6 December 2022, 13:00h to 16:00h EST. Contact: Colleen Elliott
AAMI COVID-19 Response Team (open meeting). 7 December 2022, 15:00h to 16:00h EST, web meeting. Contact: Colleen Elliott
AAMI AR, Anaesthetic and respiratory equipment Committee and AR/Working Groups (open meeting). 7 December 2022, 16:00h to 17:00h EST, web meeting. Contact: Colleen Elliott
AAMI Spring 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in January 2023). 20-24 March 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
September 2023AAMI Fall 2023 Sterilization Standards Week (open meetings; hybrid – advanced registration REQUIRED; registration to open in July 2023). 18-22 September 2023, 08:00h to 17:00h EST, Arlington, VA, and web meetings. Contact: Sterilization Standards
Information on draft international standards under ballot can be found in ANSI Standards Action.International Committee and Working Group Meetings
Call or email the indicated staff person at AAMI for more information about upcoming international standards meetings.
ISO/TC 198, Sterilization of health care products and meetings of affiliated groups (closed meetings). 5-9 December 2022, 09:00h to 17:30h EDT, Plenary meeting, and meetings of affiliated working groups. Contact: Amanda Benedict
ISO/TC 121/SC1, Breathing attachments and anaesthetic machines (closed meeting).
9 December 2022, 02:00h to 06:00h EDT. Contact: Colleen Elliott
ISO/TC 210, Quality management and corresponding general aspects for medical devices (closed meetings). 12-16 December 2022, 09:00h to 17:30h EST, Plenary meeting, and meetings of affiliated working groups. Contact: Amanda Benedict
ISO/TC 150 Implants for surgery (closed meetings). 6-7 December 2022, 08:00h to 10:00h EST, Plenary meeting. Contact: Jill Zajac
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting). 29 January 2023, 17:00h to 20:00h EDT, Plenary meeting. Contact: Colleen Elliott
ISO/TC 215 – IEC/SC 62A/JWG 7 in conjunction with ISO/TC 215, Health Informatics (closed meetings). 9-13 January 2023, 8:30h to 17:00h, Sapporo, Japan. Contact: Hae Choe
ISO/TC 121/SC3, Respiratory devices and related equipment used for patient care (closed meeting).
2 February 2023, 17:00h to 20:00h EDT, Plenary meeting. Contact: Colleen Elliott
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 firstname.lastname@example.org for more information about the project or participation on the committee.