News
New AAMI Standard Clarifies Rules for Alternate Equipment Management in Medtech
- By John K. Waters
- 01/13/2025
A newly released industry standard is set to resolve long-standing debates surrounding alternate equipment management (AEM) plans for medical devices. The Association for the Advancement of Medical Instrumentation (AAMI) has unveiled ANSI/AAMI EQ103:2024, which establishes minimum requirements for AEM programs in healthcare delivery organizations (HDOs).
The release of EQ103 follows years of discussion since the U.S. Centers for Medicare & Medicaid Services (CMS) issued a 2014 letter permitting specific AEM activities. Healthcare technology management (HTM) professionals and accrediting bodies have since grappled with how to interpret and implement compliance measures.
A Roadmap for Compliance and Safety
The new standard aims to provide clarity and uniformity for HTM service providers and HDOs, such as hospitals, ensuring safety and compliance while maintaining flexibility.
"HTM professionals can use the standard to make sure that at a minimum you have every single 'T' crossed and 'I' dotted when you go and talk to your accrediting body," said Maggie Berkey, Biomedical Equipment Specialist at Bio-Electronics and co-chair of AAMI’s AEM Working Group, in a statement
The document outlines the critical elements of an AEM program, including preventive, predictive, and reactive maintenance requirements. It also provides benchmarks for program performance, including safety, reliability, and care availability. Additionally, EQ103 aligns with CMS Conditions of Participation and incorporates guidance from the State Operations Manual.
Collaboration and Expertise Behind the Standard
AAMI’s Alternate Equipment Management Working Group, led by Berkey and co-chair Colleen Haugen-Ortiz, Healthcare Technology Management Quality Specialist at GE HealthCare, developed EQ103. Haugen-Ortiz points to the group’s focus on ensuring ease of adoption by aligning the standard with existing CMS and Joint Commission requirements, as well as related AAMI standards like EQ56 and EQ89.
"We made sure to compare what we [AAMI] were doing with what’s currently out there," Haugen-Ortiz said in a statement.
The standard not only sets a baseline for AEM programs but also serves as a tool for HTM professionals to demonstrate compliance and commitment to quality patient care.
Looking Ahead: Additional Guidance on the Horizon
AAMI plans to release a technical information report (TIR) on AEM implementation later this year, providing further detailed guidance for organizations adopting EQ103.
HTM professionals and healthcare organizations can access EQ103 through AAMI’s ARRAY platform. The standard is expected to become a cornerstone resource in the ongoing effort to balance regulatory compliance with the operational demands of medical device management.
About the Author
John K. Waters is the editor in chief of a number of Converge360.com sites, with a focus on high-end development, AI and future tech. He's been writing about cutting-edge technologies and culture of Silicon Valley for more than two decades, and he's written more than a dozen books. He also co-scripted the documentary film Silicon Valley: A 100 Year Renaissance, which aired on PBS. He can be reached at [email protected].