Download EC.02.04.01EP2-a-Pol..

Page 1 of 3
Title: Policy on Medical Equipment Inventory
Effective
Date:
Reviewed :
Revised:
Function: Environment of Care
POLICY
The Facility Name maintains either a written inventory of all medical equipment or
an inventory of selected medical equipment for conducting maintenance, testing,
and inspection activities. All new medical equipment will be evaluated before initial
use to determine whether to include this equipment in the inventory.
RISK CRITERIA
Written criteria are used to identify risks associated with medical equipment.
Medical Equipment is defined as all electrical and non-electrical equipment used for
the treatment, diagnosis, monitoring and care of patients. The risks include,
physical risks associated with use and equipment incident history.
The risks identified are used to assist in determining the strategies for
maintenance, testing, and inspection of medical equipment. In addition, the
identified risks are used to guide the development of training and education
programs for staff that use or maintain equipment.
INVENTORY
Equipment requiring planned maintenance is listed as part of an inventory. The list
includes equipment maintained by the <<Biomedical Engineering Department>> as
well as equipment maintained by vendors. Medical equipment in clinics of the
Facility Name will be evaluated to for the inventory as well.
The clinical manager and << Biomedical Engineering Director>> will evaluate
orientation and training requirements at the time the equipment is purchased.
Detailed orientation for operators and <<Biomedical Engineering Staff>> will be
provided as necessary. The <<Engineering Department>> evaluates new types of
equipment before initial use to determine whether to include this equipment in the
inventory
PROCEDURE
1. The <<Identify Department (e.g. Biomedical Engineering Department)>>
maintains either a written inventory of all medical equipment or an inventory
of selected medical equipment.
2. Based on the Risk Factor Threshold, the <<Biomedical Engineering Director>>
will determine to include or exclude the equipment from the inventory. The
Risk Factor, along with information from manufacturers and resources, will
also be used to determine the frequency of these activities.
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Page 2 of 3
Title: Policy on Medical Equipment Inventory
Effective
Date:
Reviewed :
Revised:
Function: Environment of Care
3. All new and existing equipment that is part of the medical equipment
inventory program is assigned a permanent equipment identification control
number. This identification number will remain with the equipment for the
duration of the equipment use in the facilities. This number will be retired
and removed from the Maintenance Management System (MMS) when the
equipment has been replaced. Equipment rented or borrowed will be
assigned a temporary unique identifier, which is used while that equipment is
used by the organization.
4. The identification number will also be the preventive maintenance file
number for the hard copy records. All new and existing equipment are
assigned relevant preventive maintenance task code or codes.
5. Criteria for determining inclusion on the medical equipment inventory will be
developed by the <<Biomedical Engineering Director>>. Information from
manufactures recommendations, ECRI, FDA, and other authorities on medical
equipment will be used. The criteria will be:
Equipment Function (E)
Therapeutic – Life Support
Therapeutic – Surgical or Intensive Care
Therapeutic – Physical Therapy or Treat
Diagnostic – Surgical or ICU Monitoring
Risk Value
10
9
8
7
Diagnostic – Other Physiological Mont
Analytical – Laboratory
Analytical – Laboratory Accessories
Analytical – Computer and Related Equipment
Miscellaneous – Patient Related
Miscellaneous – Non-Patient Related
6
5
4
3
2
1
–
Physical Risk (P)
Potential Patient Death
Potential Patient Injury
Inappropriate Therapy or Misdiagnosis
Equipment Damage
No Significant Identified Risks
History of Medical Equipment (H)
Poor
Moderate
Adequate
Good
Excellent
Risk Value
5
4
3
2
1
Risk Value
5
4
3
2
1
6. Each piece of medical equipment will be evaluate by the above criteria and
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Page 3 of 3
Title: Policy on Medical Equipment Inventory
Effective
Date:
Reviewed :
Revised:
Function: Environment of Care
added to the inventory. The risk values for the criteria will be added to
determine the risk factor for each piece of equipment:
(Risk Factor or Maintenance Value = E + P + H)
7. The Risk Factor will be used to determine the inspection, testing, and
maintenance activities. The Risk Factor, along with information from
manufacturers and resources, will also be used to determine the frequency of
these activities. Based on the Risk Factor Threshold, <<Biomedical
Engineering Director>> will determine to include or exclude the equipment
from the inventory (Attachment I).
8. Equipment included in the medical equipment management inventory
program is assigned an individual control number in which all work orders
and preventive maintenance forms are referenced.
9. Equipment determined not to be in the medical equipment management
inventory program will require an initial safety inspection and be released for
use. Repairs will be performed as necessary.
10.Leased equipment will be evaluated utilizing the medical equipment inventory
system and included into the medical equipment management inventory
program as appropriate.
11. If the lease includes preventive maintenance and service, the leasing
department will inform the clinical engineering director when any
maintenance has been performed or the equipment is returned. The leasing
department will be responsible for administering the manufacturer or leasing
agent’s maintenance documentation on site through the term of the lease.
12.Medical equipment will randomly evaluated during periodic Environmental
Tours and adverse findings (e. g., outdated stickers, broken equipment,
missing stickers) will be reported to biomedical engineering and the
Environment of Care® (EC) Committee.
ATTACHMENT:
Attachment I- Medical Equipment Inclusion Assessment Form (ME-EC.02.04.01EP2 c)
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