New Standard for Medtech Alternate Equipment Management (AEM)

AAMI Document Clarifies Repair Requirements

Arlington, VA, Jan. 13, 2025 (GLOBE NEWSWIRE) — Alternate equipment management (AEM) plans for medical devices can create friction between original equipment manufacturers (OEMs) and organizations that purchase and maintain those devices.

Today, the Association for the Advancement of Medical Instrumentation (AAMI) announces the release of an industry standard that clarifies the issue. Since the 2014 CMS Survey & Certification Group letter allowing certain AEM activities, accrediting bodies and healthcare technology management (HTM) professionals have debated over compliance.

ANSI/AAMI EQ103:2024; Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs) settles these questions by clearly establishing the minimum requirements for an AEM program. HTM service providers and healthcare delivery organizations like hospitals that adhere to the standard can be confident in the safety and conformance of their program.

EQ103 also provides concrete guidance for healthcare delivery organizations seeking to meet the Conditions of Participation set by CMS. It addresses:

• The minimum required components of an AEM program.

• The development and implementation of preventive, predictive, and reactive maintenance.
• Program performance, such as quality, safety, reliability, and care availability.
• Additional resources from CMS and its State Operations Manual.

EQ103 was produced by AAMI’s Alternate Equipment Management (AEM) Working Group, led by co-chairs Maggie Berkey, Biomedical Equipment Specialist at Bio-Electronics, and Colleen Haugen-Ortiz, Healthcare Technology Management Quality Specialist at GE HealthCare. According to Berkey, 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.”

Haugen-Ortiz noted that EQ103 was written to facilitate uniformity and easy adoption. AAMI’s experts made sure to “compare what we [AAMI] were doing with what’s currently out there,” including “requirements from CMS and The Joint Commission, and other AAMI standards such as EQ56 and EQ89.”

ANSI/AAMI EQ103 is expected to be a profoundly helpful resource for HTM professionals and their employers as they seek to deliver quality patient care. Further, AAMI intends to release a forthcoming technical information report (TIR) on AEM implementation to provide further guidance.

Individuals and organizations interested in EQ103 are encouraged to purchase the standard on AAMI ARRAY. Journalists with questions about the standard and its implications for the medical profession can contact the AAMI media team at dvisnovsky@aami.org.