The document discusses medical equipment management standards and programs. It outlines requirements for hospitals to establish a medical equipment program that includes inventorying all equipment, inspecting and testing equipment on acquisition and according to manufacturers' recommendations, and including preventive maintenance. Staff must be qualified and trained. The program must also monitor for hazard notices, recalls, and incidents, and report any deaths or injuries resulting from equipment. Medical equipment is classified into various risk categories.

1. MEDICAL EQUIPMENT
Measurable Elements of FMS.8
1. The hospital establishes and implements a medical equipment program throughout the hospital.
2. There is an inventory of all medical equipment.
3. Medical equipment is inspected and tested when new and according to age, use, and
manufacturers’ recommendations thereafter.
4. The medical equipment program includes preventive maintenance.
5. Staff providing these services are qualified and trained for the services being provided.
Measurable Elements of FMS.8.1
1. The hospital has a system in place for monitoring and acting on medical technology
hazard notices, recalls, reportable incidents, problems, and failures.
2. When laws and regulations require, the hospital reports any deaths, serious injuries, or
illness that are a result of medical technology.
3. The medical technology management program addresses the use of any medical
technology with a reported problem or failure, or that is the subject of a hazard notice or is
under recall.
Supply Chain Management of Medical Equipment
JOINT COMMISSION INTERNATIONAL (JCI) STANDARD
Complied with JCI standard in Facility Management and Safety (FMS) 8, 8.1 are the medical
equipment plan. The hospital should manage medical equipment as required in the standard.

2. Diagnosis
Therapeutic
Life Support or
Resuscitation
Critical Monitoring
Energy-Emitting
Miscellaneous
Special Medical Equipment
•Hi-Technology
Classification of Medical Equipment
put information Ready in a cloud
entory
5. Calibration Result on Mobile (Fast Audit)
Receive and Input Data Automatically Calculate View result Anytime, Anywhere
Web-Based & Application
o Repair / CM Management
o PM Management
o Calibration Management
o Assets Inventory and Data Management
o Report and Data Analytic
BMEXXXXX
KTY00123
Calibration report Calibration & Preventive Maintenance Schedule
Preventive Maintenance & Calibration
According medical equipment safety, should be
preventive maintenance and calibration to the medical
equipment. Should make plan according to age, use,
and manufacturers’ recommendations thereafter. So
as the inventory lists are all of the medical equipment
can set the PM-Cal plan and action as the plan
Inventory
All of medical equipment should be in inventory lists and separate risk level – classification of
medical equipment also
Preventive Maintenance & Calibration

3. FDA, ECRI, Manufacture
Hazard Recalls and Alert Report on
website, Homepage and E-mail
BME Check and Monitoring
Checking
Result
BME Report to Department
Corrective, Upgrade or Disposal
and Replacement
Record Report
Yes
No
Hazard Alert Monitoring and Recall
Hazard alert and monitoring
Prepare the hazard alert and monitoring policy. For monitoring hazard notices, recalls,
reportable incidents, problems, and failures. Resource from ECRI, US FDA, manufacturer
and suppliers