Manual:
Critical Access Hospital
Chapter:
Environment of Care EC
Topic:
Medical Equipment - Inventory/High Risk Equipment/Maintenance Strategies
What equipment is required to be included in a medical equipment inventory and how is high-risk equipment and maintenance strategies determined?
Any examples are for illustrative purposes only.
If your organization is using The Joint Commission accreditation process for deemed status purposes, then all medical equipment is required to be included in the written inventory.
The written inventory identifies high-risk devices. High-risk medical equipment includes all life support equipment and any other device for which there is a risk of serious injury or death to a patient or staff member should it fail. The term high-risk equipment is equivalent in scope and nature to the CMS term critical equipment.
Maintenance activities and frequencies follow manufacturers' instructions and recommendations for maintaining, inspecting, and testing all medical equipment in the inventory. These maintenance activities and frequencies, including an alternative equipment maintenance (AEM) strategy, are documented in writing.
The alternative equipment maintenance (AEM) strategy program must not reduce safety and is based on accepted standards of practice such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of maintenance and run-to-fail strategies.
AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers' recommendations:
If your organization is using The Joint Commission accreditation process for deemed status purposes, then all medical equipment is required to be included in the written inventory.
The written inventory identifies high-risk devices. High-risk medical equipment includes all life support equipment and any other device for which there is a risk of serious injury or death to a patient or staff member should it fail. The term high-risk equipment is equivalent in scope and nature to the CMS term critical equipment.
Maintenance activities and frequencies follow manufacturers' instructions and recommendations for maintaining, inspecting, and testing all medical equipment in the inventory. These maintenance activities and frequencies, including an alternative equipment maintenance (AEM) strategy, are documented in writing.
The alternative equipment maintenance (AEM) strategy program must not reduce safety and is based on accepted standards of practice such as the American National Standards Institute/Association for the Advancement of Medical Instrumentation handbook ANSI/AAMI EQ56: 2013, Recommended Practice for a Medical Equipment Management Program. An AEM strategy may include reduced or altered maintenance tasks, relaxed frequencies of maintenance and run-to-fail strategies.
AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers' recommendations:
- Equipment subject to federal or state law or Medicare Conditions of Participation
- Imaging and radiologic equipment (diagnostic or therapeutic)
- Medical LASER devices
- New medical equipment with insufficient maintenance history to support the use of an AEM strategy
Last updated on May 11, 2023
with update notes of: Review only, FAQ is current
First Published Date: April 11, 2016
Last Reviewed Date: October 21, 2021