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:
  • 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

For organizations that do not use The Joint Commission accreditation process for deemed status purposes, then you may maintain a written inventory of either, all medical equipment, or an inventory of selected equipment categorized by physical risk that includes all life-support equipment.  New equipment is evaluated prior to initial use to determine if it will be included in the inventory.

Reference EC.02.04.01
Last updated on June 01, 2020
Manual: Critical Access Hospital
Chapter: Environment of Care EC

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