Medical Equipment Management Policy

BIOMEDICAL DEPARTMENT
Document Title: Medical Equipment Management - Policy And Procedure

Document Ref. Number: ULEC/001 Version Number : 1.0
Approval Date: March 2022 Effective Date: March 2022
Page No.: Page 1 of 8 Next review: March 2025
Revision History Nil
Document owner: Department of Biomedical: ULEC
Applies to: Biomedical Department : ULEC
POLICY AND PROCEDURES
Name Designation Signature Date

Prepared Biomedical
Mansour Awad March 2022
by: Engineer
Reviewed/
Approved Lina Abushalbak QM March2022
by:
CHANGES / MODIFICATIONS LIST
Sr. No. Subject Page No. Date
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PAGE OF CONTENTS
S. ORDER PARTICULARS
1. Purpose
2. Scope
3. Goals
4. Responsibility
5. Procedures

1. PURPOSE:
1.1 The objective of ULEC Equipment Management Plan is designed to assess and control the
physical and clinical risks of all equipment used in the diagnosis, treatment, monitoring and
care of our patients.
2. SCOPE:
2.1 The scope of Medical Equipment Management Plan defines the processes which ULEC
provides for the safe and proper use of medical equipment used in the patient care setting.
3. GOALS:
3.1 To minimize the clinical and physical risks of equipment through inspection, testing and
regular maintenance
3.2 To establish criteria for identifying, evaluating and inventorying equipment included in the
program
3.3 To provide education to personnel on the capabilities, limitations and special applications of
equipment; operating, safety and emergency procedures of equipment; the procedures to
follow when reporting equipment management problems, failures and user errors; and the
skills and/or information to perform maintenance activities
4. RESPONSIBILITY:
4.1 Head of the Biomedical Engineering Department is responsible for maintaining the Medical
Equipment Management Program.
4.2 Each department head is responsible for orienting new staff members to the capabilities,
limitations, special applications of equipment, basic operating and safety procedures,
emergency procedures if failure occurs, maintenance responsibilities, if applicable, and the
reporting procedures for equipment problems, failures and user errors.
5. PROCEDURES:
5.1 SELECTION AND ACQUISITION OF MEDICAL EQUIPMENT:

5.1.1 A needs assessment will be completed by each department for replacement or new
equipment.
5.1.2 The needs assessment will be reviewed by the purchasing committee and the
biomedical engineer
5.1.3 The biomedical Engineer will determine if the equipment meets appropriate space
requirements, load and phase requirements, minimum safety standards of 3 wire AC
line cord with Clinic grade plug, appropriate warranties and manufacturer's reliability
prior to purchase. If the equipment does not meet the above specifications and other as
required it may not be ordered and an alternate choice may be submitted for approval.
5.2 ESTABLISHING RISK CRITERIA FOR IDENTIFYING, EVALUATING AND

TAKING INVENTORY OF MEDICAL EQUIPMENT TO BE INCLUDED IN THE
EQUIPMENT MANAGEMENT PROGRAM:
5.2.1 All mechanical and electrical patient care equipment will be evaluated prior to use, based
on function including diagnosis, care, treatment and monitoring; physical risks
associated with use to patients and operators, maintenance requirements and history of
equipment incidents.
5.2.2 All new and existing equipment meeting the evaluation criteria are included in the
equipment management program.
5.2.3 All new equipment shall be inventoried and inspected prior to use for patient care or any
other use.
5.2.4 Equipment that fails electrical safety tests shall not be approved for use until the
deficiencies have been corrected.
5.2.5 There is a current inventory of all equipment included in the equipment management
program.

5.3 HAZARD NOTICES AND RECALLS:
5.3.1 All product safety alerts, hazard notices and recalls will be directed to the biomedical
engineer.
5.3.2 The Biomedical Engineer will check the clinical equipment inventory to screen for
equipment matches and will evaluate the severity of the risk.
5.3.3 In most cases, the notices may be addressed without removing equipment from service.
5.3.4 In the event equipment must be removed from service, the equipment is replaced with a
safe effective substitute if required.
5.3.5 The Biomedical Engineering Department will impound equipment removed from use
due to recall notices until it can be rendered safe.
5.3.6 The Biomedical Engineer will report to the Medical Director on any hazard notices and
recalls affecting the hospital and all follow up activities undertaken.
5.4 MONITORING AND REPORTING OF MEDICAL DEVICE INCIDENTS

RESULTING IN DEATH, SERIOUS INJURY OR SERIOUS ILLNESS OF ANY
INDIVIDUAL:
5.4.1 Report incidents to the device manufacturer/supplier when the facility determines a
device has or may have caused or contributed to the death or serious injury of an
individual.
5.4.2 ULEC established methods for reporting these events:
5.4.2.1 The appropriate personnel will be notified immediately.
5.4.2.2 All packaging and disposable materials will be returned.
5.4.2.3 The device will be inspected and control settings and any damage will be recorded.
The equipment will be packed, tagged and seized.
5.4.2.4 An investigation shall be conducted.
5.4.2.5 The Biomedical Engineer is responsible for managing reporting process.
5.4.2.6 OVR Form to be completed

5.5 INVESTIGATION AND REPORTING OF EQUIPMENT MANAGEMENT
PROBLEMS, FAILURES AND USER ERRORS:
5.5.1 All equipment failures and user errors will be investigated and reported. Included in the
report will be the error/failure date, location of the equipment, cause or affected area,
resolution and follow-up.
5.5.2 In the event the equipment problem was caused by user error, the user(s) will be in
serviced on the operation and use of the equipment.
5.6 EQUIPMENT MAINTENANCE STRATEGIES:

5.6.1 All Medical equipment in ULEC will undergo preventive maintenance as outlined in the
Preventive maintenance program
5.7 EQUIPMENT TESTING, INSPECTING AND MAINTAINING INTERVALS:

5.7.1 The equipment that is included in the inventory that would benefit from scheduled
maintenance activities to minimize clinical and physical risk is based on the following
criteria:
5.7.1.1 Manufacturer’s recommendations
5.7.1.2 A maintenance strategy will be developed for all medical devices in the hospital.
Maintenance procedures will be developed and maintained by the manager of
Biomedical Engineer, using the manufacturer’s maintenance recommendations
5.8 ORIENTATION AND EDUCATION PROGRAM FOR EQUIPMENT

MAINTAINERS:
5.8.1 Thorough training will be provided to equipment maintainers upon hire and as needed
thereafter regarding the maintenance and care of medical equipment.
5.8.2 All equipment maintainers will be tested for their knowledge and skills necessary to
perform equipment repair and maintenance according to their job specifications.
5.8.3 Staff will be oriented and educated on the reporting process for equipment management
problems, failures and user errors.

5.9 EMERGENCY PROCEDURES:
5.9.1 Equipment, which meets ULEC criteria for critical to patient safety, shall have
emergency procedures in the event a malfunction or failure occurs. Equipment
considered critical to patient safety includes life support, life sustaining or other critical
equipment whose malfunction or failure may result in an adverse patient outcome.
5.9.2 Biomedical engineer with each department will develop and follow specific clinical
response procedures in the event of an equipment failure:
5.9.3 Equipment will be removed from service and tagged immediately.
5.9.4 Institute clinical emergency procedures required ensuring patient care is not
compromised.
5.9.5 If replacement of equipment is necessary, Quality Manager (depending on the kind of
equipment) will be notified to obtain a replacement.
5.9.6 The Biomedical Engineering Department will be notified of the failure.
5.9.7 An incident report will be completed describing the failure.
5.10 ANNUAL EVALUATION OF THE MEDICAL EQUIPMENT MANAGEMENT
PLAN:
5.10.1 The annual evaluation of the Medical Equipment Management Program will include a
review of the scope according to the current JCI standards to evaluate the degree in
which the program meets accreditation standards and the current risk assessment of the
hospital. A comparison of the expectations and actual results of the program will be
evaluated to determine if the goals and objectives of the program were met. The overall
performance of the program will be reviewed by evaluating the results of performance
improvement outcomes. The overall effectiveness of the program will be evaluated by
determining the degree that expectations were met.
5.10.2 The performance and effectiveness of the Medical Equipment Management Program
shall be reviewed by the bio Medical engineer.
5.10.3 It is the responsibility of the Biomedical Engineering Department to keep the Preventive
Maintenance Program up-to-date, accurate and ongoing. It is the responsibility of
Biomedical Engineering Department to determine the interval of such maintenance, if
the manufacturer does not specify it or if the equipment or device is thought to be more
problematic than usual.
5.10.4 Documentation for the Preventive Maintenance Program will be kept in the Biomedical
Engineering Department and will be made available at any time.

5.11 PREVENTIVE MAINTENANCE PROGRAM:

5.11.1 Equipment included in this program will meet one or more of the following criteria:
5.11.1.1 The equipment is essential for life support or is used in the diagnosis or monitoring
of any physiologic condition of a patient.
5.11.1.2 The equipment manufacturer has specified that the equipment receives a preventive
maintenance inspection/calibration.
5.11.1.3 The equipment has a higher than normal incident rate of failure during routine
operation due to clinical application.
5.11.1.4 The equipment requires a more intensive maintenance schedule, by reason of its
complexity or extended use schedule.
5.11.1.5 The incident of failure history indicates that the equipment is in need of an
intensified schedule of preventive maintenance.
5.11.1.6 The equipment is supplied by or maintained by an outside vendor.
5.11.1.7 The equipment is under a lease and the preventive maintenance schedule is part of
the lease.
5.11.1.8 The equipment is under warranty covering service parts only and the preventive
maintenance is to be accomplished by the vendor
REFERANCIES:
University of California.

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BIOMEDICAL DEPARTMENT

Document Title: Medical Equipment Management - Policy And Procedure

Name Designation Signature Date

CHANGES / MODIFICATIONS LIST

Sr. No. Subject Page No. Date

Document Title: Medical Equipment Management - Policy And Procedure

Document Title: Medical Equipment Management - Policy And Procedure

Document Title: Medical Equipment Management - Policy And Procedure

5.2 ESTABLISHING RISK CRITERIA FOR IDENTIFYING, EVALUATING AND

Document Title: Medical Equipment Management - Policy And Procedure

5.4 MONITORING AND REPORTING OF MEDICAL DEVICE INCIDENTS

Document Title: Medical Equipment Management - Policy And Procedure

5.6 EQUIPMENT MAINTENANCE STRATEGIES:

5.7 EQUIPMENT TESTING, INSPECTING AND MAINTAINING INTERVALS:

5.8 ORIENTATION AND EDUCATION PROGRAM FOR EQUIPMENT

Document Title: Medical Equipment Management - Policy And Procedure

Document Title: Medical Equipment Management - Policy And Procedure

5.11 PREVENTIVE MAINTENANCE PROGRAM:

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