Comments on Revisions to Medical Equipment (EC6)
Note: ASHE comments are highlighted in yellow.
General note
The chapter numbering should stay the same as it is now to provide continuity with existing plans. Leave Medical equipment as EC 6.
Current Standard: EC.6.10 Current EP: 3
The organization establishes and uses risk criteria* for identifying, evaluating, and creating an inventory of equipment to be included in the medical/laboratory equipment management plan before the equipment is used. These criteria address the following:
Equipment function (diagnosis, care, treatment, life support and monitoring)
Physical risks associated with use
Equipment incident history* Note: The organization may choose not to use risk criteria to limit the types of equipment to be included in the medical equipment management plan, rather include all medical equipment.
Revised Standard: EC.5.01.0 Revised EP: 2
The [organization] maintains an inventory of all medical equipment or an inventory of selected equipment categorized by risk associated with its function (diagnosis, care, treatment, life support, and monitoring), physical risks associated with use, and equipment incident history. (see also EC.1.01.0 EP 6)
Eliminate the parenthetical statement” (diagnosis, care, treatment, life support, and monitoring)”
Revised Standard: EC.5.01.0 Revised EP: 4
The [organization] defines intervals for inspecting, testing, and maintaining equipment on the inventory based upon criteria such as manufacturers’ recommendations, risk levels, and current [organization] experience.
Revise to read: “…risk levels, or current [organization] experience.
Current Standard: EC.6.10 Current EP: 6
The organization identifies and implements processes for monitoring and acting on equipment hazard notices and recalls.
Revised Standard: EC.5.01.0 Revised EP: 5
The [organization] monitors and acts on equipment hazard notices and recalls. (see also EC.2.01.0 EP 11)
This is Redundant with 2.01.0 EP 11. Eliminate EP 5.
Current Standard: EC.6.20 Current EP: 2
2. The organization documents performance and safety testing of all equipment identified in The medical/laboratory{/3} equipment management program before initial use.
Revised Standard: EC.5.02.0 Revised EP: 1
Before initial use of medical equipment, the [organization] performs safety, operational, and functional checks according to manufacturer guidelines.
Revise as follows. "Before initial use of medical equipment identified in the medical/laboratory equipment management program, the [organization] performs safety, operational, and functional checks."
Current Standard: EC.6.20 Current EP: 4
The organization documents inspection and maintenance of non-life support equipment on the inventory that is consistent with maintenance strategies to minimize clinical and physical risks identified in the equipment management plan (see standard EC.6.10).
Revised Standard: EC.5.02.0 Revised EP: 3
The [organization] inspects, tests, and maintains non-life support equipment identified in the medical equipment inventory, as evidenced by documentation.
This seems to broaden the scope of this EP There may be items on the medical equipment inventory for which the best maintenance strategy is run to fail. This EP as written might lead organizations to believe they need to perform some type of inspection, maintenance and/or testing on devices for which there is no benefit.
Revise as follows:
“The [organization] inspects, tests, and maintains non-life support equipment included in the medical equipment inventory, consistent with risk criteria and strategies identified in EC 5.01.0 EP 3 and EP 4, as evidenced by documentation