Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 1 of 7
Medical Equipment Management Plan
I
EXECUTIVE SUMMARY
System/Hospital Name strives to create a safe, secure and positive healing
environment to support the delivery of exemplary healthcare to all patients,
staff and visitors. Each environment of care poses unique risks to the
patients served, the employees and medical staff who use and manage it,
and to others who enter the environment. The medical equipment
management program (MEMP) is designed to identify and manage the risks
of the medical equipment at System/Hospital Name. The specific risks of
each environment are identified by conducting and maintaining a proactive
risk assessment. The identified risks are tracked and mitigated through the
Environment of Care (EOC) committee. The MEMP is based on applicable
laws, regulations, and accreditation standards and is designed to manage the
specific risks identified for medical equipment at System/Hospital Name.
The MEMP describes the risk, safety, and management activities that
System/Hospital Name has put in place to reduce the potential for adverse
impact on the safety and health of patients, staff, and other people, coming to
the organization’s facilities. The MEMP is evaluated annually to determine if it
accurately describes the program and that the scope, objectives,
performance, and effectiveness of the program are appropriate.
This plan includes equipment used for the diagnosis, treatment, monitoring,
and/or care of patients, which meets the criteria for inventory, within
System/Hospital Name and its clinics.
II
PRINCIPLES
A. Selection of appropriate equipment to support the services of
System/Hospital Name is an essential part of assuring that safe
effective care and treatment are rendered to persons receiving
services.
B. Orientation, education, and training of operators of medical equipment
are essential parts of assuring that safe effective care and treatment
are rendered to persons receiving services.
C. Assessment of needs for continuing technical support of medical
equipment and design of appropriate calibration, inspection,
maintenance, and repair services is an essential part of assuring that
medical equipment is safe and reliable.
III
OBJECTIVES
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 2 of 7
The purpose of the Medical Equipment Management Plan is to promote quality patient
care services performed within the hospital and its clinics. The director of Biomedical
Engineering will manage and facilitate the program to accomplish the following:
A. Promote safe and effective use of System/Hospital Name’s medical
equipment by staff and physicians.
B. Ensure that medical equipment used to care for patients, at the
hospital and its clinics, performs within accepted medical equipment
standards.
C. Ensure medical equipment used within the hospital and its clinics is
maintained within specifications to ensure its safe operation and
readiness for use when needed.
D. Protect patients, visitors, employees and physicians in the use of
medical equipment.
E. To meet standards of accreditation as defined by the Joint Commission
and other regulatory agencies.
IV
PROGRAM MANAGEMENT STRUCTURE
A. The Board of System/Hospital Name receives regular reports of the
activities of the MEMP from the Environment of Care Committee. The
Board reviews the reports and, as appropriate, communicates
concerns about identified issues back to the Environment of Care
Committee.
B. Biomedical Engineering assures that an appropriate medical
equipment maintenance program is implemented. Biomedical
Engineering also collaborates with the Safety Officer to develop reports
of MEMP performance for presentation to the Environment of Care
Committee on a routine basis.
C. Biomedical Engineering schedules and/or completes all calibration,
inspection, and maintenance activities required to assure safe reliable
performance of medical equipment in a timely manner.
D. Individual staff members are responsible for being familiar with the
risks inherent in their work and present in their work environment. They
are also responsible for implementing the appropriate organizational,
departmental, and job related procedures and controls required to
minimize the potential of adverse outcomes of care and workplace
accidents.
V
ELEMENTS OF THE MEDICAL EQUIPMENT PROGRAM
ME.EC.01.01.01.7 – Medical Equipment Management Plan
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 3 of 7
The Medical Equipment Management Program is described in this
management plan. The MEMP describes the procedures and controls in
place to minimize the potential harm that any patients, staff, and other
people coming to the facilities of System/Hospital Name might experience.
ME.EC.02.04.01.1 - Selection and Acquisition of Equipment
Biomedical Engineering assists, advises, and/or coordinates ad-hoc
advisory group activities for product selection and standardization. This
includes the pre-purchase evaluation of medical equipment involving
nursing, technical and administrative personnel that helps in choosing
safe, effective and serviceable medical equipment. Training requirements
are identified at this time. The department manager is responsible for the
coordination of all training of their staff .
ME.EC.02.04.01.2 - Criteria and Inventory
The Director of the Biomedical Engineering department is responsible for
the development of criteria used to identify risks associated with medical
equipment.
The criteria are used to evaluate risks related to the function of medical
equipment, physical risks related to the use of equipment, and any history
of patient safety issues related to the use of the equipment.
The Director of the Biomedical Engineering Department is responsible for
assuring that all medical equipment is screened at the time of
commissioning. The screening procedure is applied, as appropriate, to
loaner equipment, demonstration equipment, and equipment owned by
physicians or other qualified individuals that is used as part of the care or
treatment of a patient in any service of System/Hospital Name.
ME.EC.02.04.01.3 - Maintenance Strategies
The Director of the Biomedical Technology Services uses manufacturer
recommendations, applicable codes and standards, accreditation
requirements, and local or hospital experience to determine the
appropriate maintenance strategy for assuring safety and maximizing
equipment availability and service life. The strategies may include
predictive maintenance, reliability-centered maintenance, interval-based
inspections, corrective maintenance, or metered maintenance to ensure
reliable performance.
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 4 of 7
ME.EC.02.04.01.4 - Inspection, Testing, and Maintenance Intervals
The Director of the Biomedical Technology Services uses manufacturer
recommendations, risk levels, and hospital experience to determine the
appropriate maintenance intervals for assuring safety and maximizing
equipment availability and service life.
A computerized maintenance management system is used to schedule
and track timely completion of scheduled maintenance and service
activities.
The Director of the Biomedical Technology Services is responsible for
assuring that the rate of timely completion of scheduled maintenance and
other service activities meets regulatory and accreditation requirements.
ME.EC.02.04.01.5 – Management of Medical Equipment Hazard Notices
and Recalls
The Director of Biomedical Technology Services (or his designee)
coordinates the management of medical equipment hazard notices and
recalls. The steps in the management process include:
1. Routing of all medical equipment hazard and recall notices to the
responsible Biomedical Technology Services staff.
2. Logging of all hazard and recall notices determined to apply to equipment
in use or storage in any location operated by Baylor University Medical
Center Facilities.
3. Generation and circulation of an internal hazard and recall notice tracking
sheet to all appropriate Biomedical Technology Services staff with
instructions addressing how to respond to the hazard or recall notice.
4. Tracking of circulated notices to assure timely completion of activities
required to eliminate or manage the issues addressed by the hazard or
recall notice.
5. As appropriate, routine reports of any actions taken to address published
hazard and recall notices related to medical equipment.
The Risk Management Coordinator and the Director of Biomedical
Technology Services are responsible for the Safe Medical Devices Act
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 5 of 7
(SMDA) Reporting process. Information about reportable events is
processed through the incident reporting process.
Internally, the Risk Manager applies the Root Cause Analysis (RCA)
process to all SMDA events. The findings of the RCA are used to update
or develop procedures and controls, make changes in the environment, or
provide additional education and training to eliminate or reduce the risks
that led to the reportable event.
ME.EC.02.04.01.6 - Emergency Procedures
The Biomedical Technology Services staff and appropriate clinical care
givers collaborate to identify the appropriate amount of back-up
equipment during the evaluation/selection process of choosing the
medical equipment. In the event of a medical equipment failure:
A. The clinical department personnel will take appropriate clinical
intervention until replacement equipment is available or the
medical equipment is repaired.
B. The clinical department will contact Biomedical Technology
Services to see if back-up equipment is available. If equipment is
not available, contact Supply Chain Management for help.
C. The clinical department will contact Biomedical Technology
Services at 214-820-4646 for repair of medical equipment.
ME.EC.02.04.03 – Medical equipment is maintained, tested, and
inspected
ME.EC.02.04.03.1 - Equipment Inventory and Initial Testing
Biomedical Technology Services maintains a current, accurate, and
separate inventory of all equipment included in a program of planned
inspection or maintenance. The inventory includes equipment owned by
Baylor University Medical Center, leased and rented equipment, and
personally owned equipment used for the diagnosis, treatment, and
monitoring of patient care needs.
The Director of Biomedical Technology Services assures effective
implementation of the program of planned inspection and maintenance.
All equipment in the program is tested for safety, operation and function
prior to use on patients.
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 6 of 7
ME.EC.04.02.03.2 - Testing of Life Support Equipment
The Director of Biomedical Technology Services assures that scheduled
testing of all life support equipment is performed in a timely manner.
Reports of the completion rate of scheduled inspection and maintenance
are presented to the Environment of Care Committee each quarter. If the
quarterly rate of completion falls below 100%, the manager of the MEMP
will also present an analysis to determine what the cause of the problem
is and make recommendations for addressing it.
ME.EC.04.02.03.3 - Testing of Non-Life Support Equipment
The Director of Biomedical Technology Services assures that scheduled
testing of all non-life support equipment is performed in a timely manner.
Reports of the completion rate of scheduled inspection and maintenance
are presented to the Environment of Care Committee each quarter. If the
quarterly rate of completion falls below 90%, the manager of the MEMP
will also present an analysis to determine what the cause of the problem
is and make recommendations for addressing it.
ME.EC.04.04.03.4 - Testing of Sterilizers
The Sterile Processing staff is responsible for daily load testing and
Biomedical Technology Services is responsible for maintenance of all
types of sterilizers used at Baylor University Medical Center. Records of
load testing are maintained by Sterile Processing and regular
maintenance records are maintained by Biomedical Technology
Services. Load testing results are reported to the Environment of Care
Committee for evaluation and action.
ME.EC.02.04.03.5 - Testing of Dialysis Water Systems
Biomedical Technology Services is responsible for maintenance of
dialysis equipment used in Baylor University Medical Center. The
program of maintenance includes regular cleaning and disinfection of all
dialysis equipment and testing for compliance with biological and
chemical standards for the dialysis water supply. Water and Power
Technologies performs regular maintenance and testing of the dialysis
water supply. Dialysis department staff performs daily tests for purity of
the water used for dialysis and out of range results are documented as
patient safety incidents and reported to the Risk Manager for evaluation
and action. Any event resulting in a patient injury or death will be treated
as a Sentinel Event.
Subject Category:
Policy Manual:
Effective date:
Approved by:
POLICY:
Medical Equipment Management Plan
Department:
EOC
The Joint Commission - Environment of Care
Revised date:
Policy #
Review date:
Page 7 of 7