Summary: The new ANSI/AAMI EQ103:2024 standard establishes clear requirements for alternate equipment management (AEM) programs, helping healthcare organizations align with CMS regulations and ensure safety, reliability, and compliance in medical device maintenance.
Key Takeaways
- Clear Compliance Requirements: ANSI/AAMI EQ103:2024 establishes minimum requirements for AEM programs, providing clarity and resolving compliance debates between healthcare organizations and regulatory bodies.
- Comprehensive Guidance: The standard includes detailed guidance on preventive, predictive, and reactive maintenance, performance metrics, and CMS Conditions of Participation to enhance safety and reliability in medical device management.
- Ease of Adoption: EQ103 was designed for consistency with existing requirements from CMS, The Joint Commission, and other AAMI standards, making it user-friendly and straightforward for healthcare organizations to implement.
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Alternate equipment management (AEM) plans for medical devices often create tension between original equipment manufacturers (OEMs) and the organizations responsible for purchasing and maintaining these devices.
To address this, the Association for the Advancement of Medical Instrumentation (AAMI) has released a new industry standard: ANSI/AAMI EQ103:2024; Alternate equipment management (AEM) program in healthcare delivery organizations (HDOs). This standard resolves long-standing debates over compliance by clearly defining the minimum requirements for an AEM program.
Clear AEM Compliance Standards
Since the 2014 CMS Survey & Certification Group letter permitting certain AEM activities, accrediting bodies and healthcare technology management (HTM) professionals have grappled with how to align their practices. With EQ103, HTM service providers and healthcare delivery organizations can confidently ensure their programs meet safety and regulatory standards.
The standard offers comprehensive guidance for healthcare delivery organizations aiming to meet CMS Conditions of Participation. Key components include:
- Minimum requirements for an AEM program.
- Development and implementation of preventive, predictive, and reactive maintenance.
- Program performance metrics, including quality, safety, reliability, and care availability.
- Reference materials, such as CMS’s State Operations Manual.
Inside EQ103
AAMI’s AEM Working Group, led by co-chairs Maggie Berkey, biomedical equipment specialist at Bio-Electronics, and Colleen Haugen-Ortiz, HTM quality specialist at GE HealthCare, developed EQ103. Berkey emphasized that the standard equips HTM professionals to fully meet accrediting body requirements.
Haugen-Ortiz highlights that EQ103 was designed for consistency and ease of use, explaining that the working group ensured alignment with existing requirements from CMS, The Joint Commission, and other AAMI standards like EQ56 and EQ89.
The new standard is expected to be an invaluable resource for HTM professionals and their organizations in delivering safe, high-quality patient care. Additionally, AAMI plans to release a technical information report on AEM implementation to provide further practical guidance.