The Association for the Advancement of Medical Instrumentation (AAMI) has signed a memorandum of understanding with the Global Clinical Engineering Alliance (GCEA). The agreement establishes a joint effort from AAMI and GCEA to strengthen the healthcare technology management (HTM) field, known globally as clinical engineering (CE).
AAMI’s core mission is to promote the safe and effective use of healthcare technology. To that end, AAMI produces industry standards related to medical devices and their use, and strives to elevate, standardize, and promote the HTM field. GCEA was founded to support and empower the clinical engineering profession across the world and to contribute to international harmonization efforts.
This MOU is a natural fit for the missions of both organizations and is expected to yield multiple new initiatives that will support the HTM/CE community around the globe. This will include:
- Co-marketing of events like AAMI eXchange and the International Clinical Engineering and Health Technology Management Congress (ICEHTMC).
- Creation, translation, and distribution of educational materials, guides, and other resources for HTM/CE professionals.
- Expanding the network of HTM professionals internationally.
After the signing of the MOU, AAMI’s Vice President of HTM Danielle McGeary stated, “The signing of this MOU with the Global Clinical Engineering Alliance is a key opportunity to bring AAMI’s HTM work to an international audience with the goal of creating international HTM standards and guidance that will further harmonize the field globally.”
According to GCEA President Yadin David, “This collaboration creates a powerful framework for advancing healthcare technology innovation, safety, and management on a global scale. Through this agreement, both organizations can strategically align their expertise and resources, enabling the development of global guidelines, best practices, and educational programs in clinical engineering across the world. Ultimately, this partnership will ensure that the global health care community benefits from improved medical technologies, elevated standards, and enhanced health care delivery systems. Our shared commitment to safety, innovation, and education will play a pivotal role in improving patient outcomes and enhancing health equity worldwide.”
A statement of work from AAMI and GCEA related to forthcoming collaborations between AAMI and GCEA is expected later this year.
AAMI, CTA TO COLLABORATE ON AI STANDARDS
As artificial intelligence (AI) becomes more integrated into the health care sector, there is a pressing need for industry standards that will protect patients and promote best practices.
The Association for the Advancement of Medical Instrumentation (AAMI) has signed a memorandum of understanding with the Consumer Technology Association (CTA) that will enable the production of new industry standards related to the use of AI and machine learning (ML) in health care products.
The new MOU establishes a framework for AAMI and CTA to collaborate on efforts like the production of new standards documents. Any forthcoming projects will promote the safe, effective use of AI and ML-enabled tools and are expected to impact medical device manufacturers and end users, and the health IT field.
Pat Baird, senior regulatory specialist at Philips, and longtime member of both associations said, “Standards are a great way to share good practices and warn about common pitfalls for a particular topic; I’m happy that AAMI and CTA are starting down a path where even more people can share their perspectives, experiences, and ideas of what good looks like.”
The MOU states that AAMI and CTA intend to coordinate standardization activities related to digital health products and solutions that have AI or ML capabilities. This may include:
- Post-market surveillance methodology for over the counter (OTC) health devices.
- Evaluation and assessment criteria for AI and ML-enabled products.
- Other activities such as mutual recognition of standards, information sharing, and workshops.
- The potential for additional collaborative projects.
Collaboration with CTA and its members is an opportunity for AAMI to advance its core mission of producing regulatory ready standards. Since 1967, AAMI has used its voluntary industry standards to ensure medical devices and products promote optimal patient outcomes. This new relationship with CTA is a continuation of that mission.
According to Matt Williams, Vice President of Standards at AAMI, “This MOU with CTA is a major milestone in AAMI’s ongoing work related to artificial intelligence. I look forward to the opportunities that this joint endeavor will bring to both our organizations in the future.”
“As health technologies develop at an unprecedented rate, industry-driven standards will be crucial to ensuring the efficacy, safety, and innovation of these products and services,” said Kerri Haresign, Sr. Director of Technology and Standards at CTA. “For CTA, collaborating with AAMI marks an important step in creating the standards needed to guide the responsible development of AI in health care.”
AAMI members interested in the specifics of the new relationship can learn more by reaching out at standards@aami.org.
