By AAMI
Medical device management is essential for hospitals and medical device servicing organizations alike. Now, a new AAMI standard establishes clear guidance for the stakeholders involved with medical equipment management programs.
ANSI/AAMI EQ56:2024: Standard for a Medical Equipment Management Program is a new standard from the Association for the Advancement of Medical Instrumentation (AAMI) that establishes minimum requirements for a medical equipment management program seeking to ensure safety and operational efficiency. EQ56 was previously classified as an AAMI recommended practice.
The voluntary, consensus-based document applies to healthcare delivery organizations (HDOs) including hospitals, clinics, and long-term care facilities. It also applies to device manufacturers and independent service providers. EQ56 addresses how each stakeholder should manage medical equipment and support optimal patient outcomes.
EQ56 establishes requirements related to staffing, stakeholder management, and institutional policies, including:
- Hospital Leadership: Leadership shall set policies, allocate resources, and communicate as needed with service providers.
- Relationship Management: Service providers shall identify stakeholders like HDO executives and suppliers and meet established expectations.
- Resources: Service providers must maintain a staff that meets expectations for inspections, repair, and support.
- The standard also addresses operational policies and sets clear requirements for:
- Inventory Management: Shall include evaluation, inspection, and record-keeping processes.
- Medical Equipment Safety: HDOs shall consider training, recall management, inspections, and planned maintenance.
- Repair Programs: Shall include written procedures to define service provider activities and necessary documentation.
- Service Continuity and Availability: Service providers shall create a service continuity plan to deal with disruptions.
- Change Management: Service providers shall have plans for recalls, software changes, and other events.
- Quality Management: Service providers shall define their methods for maintaining quality of service.
AAMI EQ56 also includes information on computerized maintenance management systems, benchmarking, capacity management, program budgeting, and more in its annexes.
Ultimately, the standard will ensure that medical facilities, third-party service organizations, and original equipment managers (OEMs) can improve their existing technology management program or start one from scratch.
The document was produced by AAMI’s HTM Program Management Working Group, composed of regulatory experts, HTM professionals, and medical device manufacturers. During the production of EQ56, the group was co-chaired by Britt Berek, Quality and Compliance Program Development at JLL Healthcare, and Dennis Carr, Senior Program Manager at STERIS.
According to Carr, the committee was focused on providing “the guidance to an HTM [professional] for developing their maintenance program within their facility and giving them the foundation.” AAMI EQ56 “really touches on most of the content you would need” for a robust maintenance program.
Berek believes the revision process for EQ56 was a success. The document now includes “more concise language and careful consideration of what requirements to include and how to frame them. The intent was to identify the fundamental minimum attributes any service provider would need to address.”
EQ56 is available on AAMI ARRAY for AAMI members and can be purchased a la carte by non-members.
For more information, visit aami.org.
