For Immediate Release
Contact: Brian Stallard, firstname.lastname@example.org, (703) 647-2771
AAMI is exploring two exciting new directions for AAMI guidance and standardization. One is a joint effort with the American Dental Association (ADA) aimed at developing a steam sterilization standard for dental facilities. The other represents AAMI’s commitment to defining safe and effective practices for the use of artificial intelligence (AI) for medical care.
AAMI/ADA Joint Effort
Amanda Benedict, vice president of standards at AAMI, is working with leadership from the ADA to create a new AAMI Sterilization working group focused on creating a steam sterilization and sterility assurance standard specifically for dental practices.
“There are more than 80,000 dental facilities across the country, and many of them are relatively small,” she explained. “These facilities’ sterile processing operations are on a much different scale than those of sterile processing departments within a hospital, for example, and there is a need to provide these facilities with comprehensive recommendations for steam sterilization and sterility assurance that are applicable to the dental facility sterile processing environment.”
The anticipated sterilization standard will draw from the recommendations in ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, the preeminent American National Standard for steam sterilization in a healthcare facility.
The aim, said Benedict, is to “work with a committee of subject-matter experts, including representatives from dentistry, industry, and regulatory agencies such as the U.S. Food and Drug Administration (FDA), to distill the content to what is relevant to dental facilities and include additional specific applicable guidance.”
Standardization in AI and Machine Learning
The AI space it is a completely new focus for AAMI standards.
Taking an important first step in AI and machine learning standards for much of the healthcare industry, clinicians, and regulators, AAMI is standing up a new AI standards committee. Consisting of representatives from BSI, the FDA, and developers of machine learning technology, the AAMI AI committee will be responsible for developing the guidance documents and other work identified in the white paper.
What’s more, the AAMI AI committee and a mirroring BSI AI committee are pooling experts to draft risk management guidance for AI and machine learning in medical devices. Like the AAMI/ADA effort, this new document will repurpose key lessons from an internationally known standard, ANSI/AAMI/ISO 14971, Medical devices—Application of risk management to medical devices, while leveraging the joint drafting committees’ international AI expertise.
“When we talk about AI in healthcare, we’re talking about machine learning, data-driven systems that reach conclusions that we can’t necessarily predict,” explained Joe Lewelling, senior advisor on content and strategy at AAMI. “These are disruptive technologies in that they will change the way healthcare is designed, delivered, maintained, and even regulated.”
In May 2020, AAMI joined forces with BSI to publish the position paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and Performance, which examines how machine learning is different from traditional medical devices and software. It outlines a need for new standards and regulator initiatives to promote the safety, effectiveness, and availability of AI and machine learning in healthcare.
Call for Participation
AAMI AI is currently accepting applications to participate in future discussions. The AAMI Sterilization working group for the joint AAMI/ADA standard will be starting soon.
“The best time for stakeholders to join these efforts and add their perspectives and expertise to shaping the standards is at the beginning of the work,” said Benedict.
There is no deadline for committee applications, and they accepted on a rolling basis. Interested parties, including representatives of clinical practices, academia, regulatory authorities, and industry can find out how you can get involved at AAMI.org.
AAMI (www.aami.org) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 healthcare technology professionals united by one important mission—supporting the healthcare community in the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for health technology and sterilization professionals.