THE UNIVERSITY OF MICHIGAN HOSPITAL AND HEALTH CENTERS

EQUIPMENT MANAGEMENT PLAN

PURPOSE

The purpose of this plan is to outline an Equipment Management Program that provides for the safe and
reliable operation of medical equipment used in the treatment of patients throughout the University of
Michigan Hospitals and Health Centers (UMHHC). The Equipment Management Program will ensure that
the equipment provides accurate, reliable information to the clinicians, that the equipment is safe for the
patients and operators, and that the equipment is utilized to its fullest capacity in order to optimize patient
care.

ORGANIZATION ROLES AND RESPONSIBILITIES

The Equipment Management Committee oversees the Equipment Management Program as part of the
UMHHC Environment of Care Program. The committee is responsible for designing, implementing, and
monitoring an Equipment Management Program that is based upon manufacturer recommended practice,
organizational experience, as well as policies, standards, regulations and applicable laws that govern the
UMHHC. The committee reports to the Environment of Care Committee, however, the committee has the
authority to expand the program as necessary to ensure the highest level of safety and participation by all
UMHHC staff. The committee is comprised of representatives from Biomedical Engineering, Capital
Equipment, Maintenance, Medical Center Risk Management, Pathology, Patient Equipment, Purchasing,
Radiation Oncology, and Radiology Engineering Services.

The Equipment Management Committee monitors six branches of the Equipment Management Program.
Each branch is responsible for the technical and engineering support of certain medical equipment at the
UMHHC. Technical support of medical equipment includes, but is not limited to, incoming inspection,
installation, monitoring, preventive maintenance, troubleshooting, repairs, modification for improvement,
reliability, and safety. Engineering support of medical equipment includes, but is not limited to, modification
for improvement, reliability, safety, hazard alert/recall monitoring and notification, incident investigation, and
research development.
1) Biomedical Engineering - The Biomedical Engineering department is responsible for the technical and
engineering support of the majority of the medical equipment at the UMHHC, with the exception of that
which is covered by the other five branches. The Biomedical Engineering department is comprised of
medical engineers, biomedical engineering technicians, industrial electricians, and maintenance
mechanics who together directly support the medical equipment, or coordinate the support of the medical
equipment by an outside source.
2) Maintenance - The Maintenance department is responsible for the technical and engineering support for
the sterilizers, instrument washers, and reverse osmosis systems at the UMHHC. The Maintenance
department is comprised of an electrical service group, an HVAC service group, a plumbing service group,
and maintenance mechanics. These service groups and maintenance mechanics together directly support
the equipment or coordinate the support of the equipment by an outside source.
3) Pathology - The Pathology department is responsible for the technical and engineering support for the
laboratory equipment at the UMHHC. The Pathology department staff coordinate the support of the
laboratory equipment by an outside source, either via US Counseling or directly with the
vendor/manufacturer.
4) Patient Equipment - The Patient Equipment department is responsible for the technical and engineering
support for the rental patient equipment (e.g. infusion pumps, syringe pumps, etc.) at the UMHHC. The
Patient Equipment department staff coordinate the support of the rental patient equipment by the company
from whom the equipment was rented from.
5) Radiation Oncology - The Radiation Oncology department is responsible for the technical and
engineering support for the radiation therapy equipment at the UMHHC. The Radiation Oncology
department staff coordinate the support of the radiation therapy equipment by an outside source, either via
US Counseling or directly with the vendor/manufacturer.
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6) Radiology Engineering Services - The Radiology Engineering Services department is responsible for the
technical and engineering support for the diagnostic radiology equipment at the UMHHC. The Radiology
Engineering Services department is comprised of medical engineers and biomedical engineering
technicians who together directly support the diagnostic radiology equipment, or coordinate the support of
the diagnostic radiology equipment by an outside source.

All UMHHC staff are responsible for adhering to the policies and procedures developed in support of the
Equipment Management Program. Responsibilities include, but are not limited to, ensuring all equipment
used within the patient care vicinity has been inspected prior to use, immediately reporting problems with
medical equipment, and requesting education on the operation of unfamiliar medical equipment.

EQUIPMENT MANAGEMENT PLAN ACTIVITIES

Selection and acquisition of equipment: Each of the six branches of the Equipment Management Program
actively participates in the selection and acquisition of equipment. Activities revolving around the
identification of the need for equipment replacement include, but are not limited to, submitting planned capital
equipment requests based on depreciation schedules, monitoring approved capital equipment and construction
projects, monitoring hazard alerts/product recalls, and reactively replacing equipment based on inability to
further maintain. Assistance provided during the selection process includes, but is not limited to, identifying
technical specifications, writing Requests For Proposals, reviewing bids, verifying performance specifications,
coordinating clinical trials, benchmarking with similar institutions, consulting external agencies that focus on
equipment safety (e.g. AAMI, ECRI, FDA, etc.), performing site visits, and negotiating with vendors.
Assistance provided during the acquisition process includes, but is not limited to, coordinating construction
activities to prepare the site for the equipment, coordinating installation efforts, performing acceptance testing,
and coordinating training of clinical staff/service personnel.

Evaluation of equipment for inclusion into the Equipment Management Program: All equipment that
directly supports patient care, or that is located within the patient care setting, regardless of ownership, is
assessed for inclusion into the Equipment Management Program. Two different methods are utilized by the
six branches of the Equipment Management Program. The first method, which is utilized by all branches
except Maintenance, incorporates a modified American Hospital Association method that factors in equipment
function, clinical application, manufacturer recommended preventive maintenance, impact of preventive
maintenance, and customer impact if failure were to occur. Based on the scoring outcome, equipment is
assigned a risk category of 1LS (high risk/life support), 1 (high risk), 2 (less risk) or 3 (no risk). All category
1LS, 1 and 2 equipment is included in the Equipment Management Program. The second method, which is
utilized solely by Maintenance, is the same scoring methodology that is utilized for the Utilities Management
Program that factors in area of utility/equipment support, physical risk if the utility/equipment were to fail,
maintenance requirements of the utility/equipment, and incident history of the utility/equipment. Based on the
scoring outcome, the utility/equipment is assigned an APMI number. Any utility/equipment with an APMI
score of 12 and above are included in the Utilities Management Program, and subsequently the Equipment
Management Program.

Incoming inspections (Hospital owned equipment): All hospital owned equipment that directly supports
patient care, or that is located within the patient care setting, regardless of acquisition method, is inspected
prior to initial use. Equipment is inspected to assure physical condition, functionality, accuracy,
patient/operator safety, electrical safety, and proper documentation. If appropriate, as is the case for
radiographic and nuclear imaging systems, equipment is also inspected by certified physicists and State of
Michigan inspectors. All equipment has a universal asset tag identification label attached, and is included in
the computerized maintenance management system inventory. An appropriate inspection label is also
attached, based on the risk category of the device. Operator and service manuals are maintained on file in the
department that will be responsible for the technical and engineering support of the equipment.

Incoming inspections (Rental equipment): Material Services and Purchasing Services have certified certain
vendors as preferred vendors for supplying rental patient equipment. These vendors conduct electrical safety
inspections on their devices before delivering them to the hospital and are responsible for all maintenance and
repair of their devices. These vendors will provide written service history reports to UMHHC upon request.
Rental equipment provided by non-preferred vendors is inspected by Biomedical Engineering prior to initial
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use. Rental equipment in the patient care setting has (a) a brown label that indicates that the equipment is
non-hospital owned, (b) an appropriate risk category label that indicates that Biomedical Engineering has
accepted the equipment prior to patient use, and (c) an asset tag identification label if the equipment is
anticipated to remain in the facility for three months or longer.

Incoming inspections (Other non-hospital owned equipment): Equipment that is used in the patient care
setting which has been brought into the hospital for evaluation, trial use, etc. is inspected by Biomedical
Engineering prior to initial use. Non-hospital owned equipment in the patient care setting has (a) a brown
label that indicates that the equipment is non-hospital owned, (b) an appropriate risk category label that
indicates that Biomedical Engineering has accepted the equipment prior to patient use, and (c) an asset tag
identification label if the equipment is anticipated to remain in the facility for three months or longer. The
manufacturer/vendor who brought the device into the hospital for evaluation, trial use, etc. is responsible for
all maintenance and repair of their devices.

Incoming inspections (Research equipment): Equipment that is used in the patient care setting which has
been brought into the hospital for research purposes is inspected by Biomedical Engineering prior to initial
use. Research equipment in the patient care setting has (a) a brown label that indicates that the equipment is
non-hospital owned, (b) an appropriate risk category label that indicates that Biomedical Engineering has
accepted the equipment prior to patient use, and (c) an asset tag identification label if the equipment is
anticipated to remain in the facility for three months or longer. The research department who brought the
device into the hospital for research purposes is responsible for coordinating all maintenance and repair of
their devices.

Incoming inspections (Patient owned equipment): Use of patient owned electrically powered equipment or
appliances, especially in critical care areas, is highly discouraged but is not prohibited. The clinical staff
providing direct patient care to the patient in question is responsible for determining whether a device should
be used by the patient, taking patient condition and any special environmental circumstances into
consideration. If the patient is not electrically susceptible (e.g. no penetrations through the skin), the clinical
staff conducts a visual inspection of the device for obvious defects (e.g. intact cases and covers, power cord
integrity, etc.) prior to patient use. Biomedical Engineering is available to train clinical staff in conducting
these device inspections. If the patient is electrically susceptible, and the clinical staff recommends use of the
device, Biomedical Engineering conducts an electrical safety inspection of the device prior to patient use.
Patient owned equipment in the patient care setting has (a) a brown label that indicates that the equipment is
non-hospital owned and (b) an appropriate risk category label that indicates that Biomedical Engineering has
accepted the equipment prior to patient use.

Preventive maintenance inspections: In conjunction with the evaluation of equipment for inclusion in the
Equipment Management Program, each classification of device is assigned a preventive maintenance
inspection strategy and schedule. The preventive maintenance inspections for most equipment included in the
Equipment Management Program are interval-based, however some are meter-based (note, interval-based
preventive maintenance inspections are still assigned to meter-based devices to ensure that the device’s meter
is checked). The frequency for interval-based preventive maintenance inspections is determined based upon
manufacturer recommendations, risk levels, and past organizational experience. Preventive maintenance work
orders are generated on a monthly basis, with expectations that the work orders be completed in a timely
manner. Additional preventive maintenance work orders may be generated for those devices that have missed
their previous preventive maintenance inspections (e.g. device could not be located, device was in use, etc.), or
that came due for preventive maintenance off-cycle (e.g. meter-based inspections).

Repairs: All repairs are prioritized and performed in a timely manner. To assure the continuation of patient
care in the event of equipment failure, backup devices are available for most critical devices (e.g. anesthesia
units, physiologic monitors, defibrillators, ventilators, infusion pumps, etc.). Backup devices may be located
either within the using department, in Biomedical Engineering, or in Patient Equipment, depending on the
criticality of reduction in downtime. These backup devices are also available for use in expanding the facility’s
capacity to provide patient care in the event of internal/external disasters. In addition, departments maintain
individualized emergency procedure plans for critical equipment and/or systems (e.g. physiologic monitoring,
nurse call system, etc.) to ensure continuity of patient care in the event of equipment and/or system failures.

Review of hazard alerts and product recalls: Notification of hazard alerts and product recalls come from a
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variety of sources (e.g. manufacturers, vendors, ECRI, FDA, etc.). In conjunction with hospital policy 05-02-
007 “Product Recall / Hazard Warning Control Program,” all hazard alerts and product recalls are promptly
reviewed, acted upon, and documented, regardless of their origination. To aid this process, an e-mail group
has been established to promote the rapid dissemination of hazard alerts and product recalls throughout the
facility. Members of this e-mail group have been identified as representatives for their department to receive
hazard alerts, review the alerts, identify any hazards that may impact their department, disseminate the notice
and it’s corrective action to all appropriate department personnel, and submit a Product Recall Summary form
to Safety Management Services for any alerts that impacted their department. Ultimately, Safety Management
Services is the central point within UMHHC to maintain records of hazard alerts and product recalls that
impact the facility, however further detailed records (e.g. specific work orders for every effected device) may be
maintained at the individual department level.

Incident investigations: In conjunction with hospital policy 05-02-006 “Safe Medical Device Act (SMDA)
Policy,” all incidents involving medical devices are reported via the hospital incident reporting system. In
addition, all explanted devices suspected of possible failure are reported via the hospital explant reporting
system. Biomedical Engineering and Hospital and Health Centers Risk Management perform a thorough
investigation in a timely manner, sequestering equipment as appropriate, documenting findings, identifying
deficiencies that could result in future incidents, and recommending corrective action to eliminate any
identified deficiencies. All reported incidents are reviewed by the SMDA Committee for evaluation of
effectiveness. In the event that the incident reasonably suggests that a medical device has or may have caused
or contributed to a serious injury, illness or death, the SMDA Committee reports the incident as required by the
Safe Medical Device Act of 1990 to the manufacturer and/or the Food and Drug Administration. The SMDA
Committee in turn reports directly to the Environment of Care Committee.

Data collection/management: The primary tool and resource for data collection/management is a
computerized maintenance management system. This system incorporates the equipment inventory, all service
history records for equipment in the inventory, a work order system, and the preventive maintenance
schedules/procedures. This system is used as an administrative tool to track equipment, to initiate work
orders, to measure performance indicators, to determine equipment failure trends, to identify training needs,
and to produce management reports.

Orientation and continuing education (users of equipment): Users of equipment require orientation to
equipment either upon initial hire, upon reassignment to new job responsibilities, upon introduction of new
equipment, or upon individualized recognition of need. Upon initial hire or reassignment to new job
responsibilities, each department is responsible for providing orientation to employees to provide them with
the skills needed to safely utilize the equipment in their work environment. Some departments have developed
specific classroom training programs, while other departments rely on supervisor or mentor review with the
employee at the direct worksite. Upon introduction of new equipment, in conjunction with hospital policy 05-
02-005 “Medical Device Training and Education,” it is each individual department’s responsibility for
assessing new equipment and developing appropriate educational plans for all departments who may interface
with the equipment. Educational plans shall address initial orientation needs as well as ongoing continuing
education, if appropriate. Ongoing continuing education needs are typically specified in departmental annual
competency programs. Training conducted upon individualized recognition of need can be provided either by
an employee’s supervisor/mentor who recognizes need through daily activity or by service maintenance
department personnel who recognize operator error problems through repair calls.

Orientation and continuing education (maintainers of equipment): Maintainers of equipment require

orientation to equipment either upon initial hire, upon reassignment to new job responsibilities, or upon
introduction of new equipment. Upon initial hire or reassignment to new job responsibilities, the service
maintenance department managers provide orientation to employees to provide them with the skills needed to
maintain and/or repair equipment in their work environment. Orientation may be provided through a
combination of supervisor review with the employee at the direct worksite, staff cross-training, and service
school attendance. Upon introduction of new equipment, service maintenance department managers assess
what is the most appropriate methodology for obtaining the skills needed to maintain and/or repair the new
equipment and pursue training as appropriate. Typically, significant capital equipment purchases include
negotiations for training service personnel.

Service contract reviews: A contracted equipment service management group, US Counseling, works in
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conjunction with the clinical departments, the service maintenance department managers, and Capital
Equipment to review all proposed service contracts on equipment. Service contracts are reviewed for practical
application and cost effectiveness. If a service contract is implemented, requests for service on contracted
equipment are coordinated through US Counseling.

New product development (IRB reviews): Biomedical Engineering works with clinicians and vendors in
partnership arrangements to improve patient care technology. All devices used in investigations are either
FDA approved or are approved by Biomedical Engineering. Biomedical Engineering performs safety and
functional testing on prototype technology used in patient care settings and a written document is prepared for
each equipment related IRB application. The document, denoting either approval for use or recommendations
for change, is sent to the IRB chair and the principal investigator.

MONITORING OVERALL EQUIPMENT MANAGEMENT PROGRAM PERFORMANCE

The Equipment Management Committee monitors the overall Equipment Management Program in several
ways.

First, each branch of the Equipment Management Program is expected to report to the committee on a
quarterly basis preventive maintenance completion, product problems/hazard alerts that impact the facility,
current quality improvement indicators, and any other equipment management issues. The committee reviews
the reports to ensure the facility is maintaining compliance with policies, standards, regulations and applicable
laws that govern the UMHHC, as well as identify program deficiencies and implement corrective action to
eliminate any identified deficiencies.

Second, a member of the SMDA Committee is expected to report to the committee on a quarterly basis a
summary of incident investigation activity. The committee reviews the summary to ensure the facility is
maintaining compliance with policies, standards, regulations and applicable laws that govern the UMHHC, as
well as identify program deficiencies and implement corrective action to eliminate any identified deficiencies.

Finally, the committee conducts an annual review and evaluation of the Equipment Management Plan,
including plan objectives, scope, performance, and effectiveness. Effectiveness will be determined by
evaluating the program’s ability to have:
(a) met all core objectives, scopes, and performance denoted in the prior year plan, and
(b) made progress on areas for improvement denoted in the prior years annual evaluation.

Quarterly and annual reports are presented to the Environment of Care Committee for consideration, approval,
and incorporation into the overall UMHHC Environment of Care Program.

CURRENT PERFORMANCE IMPROVEMENT INDICATORS

Operator Errors: Hospital staff knowledge of proper equipment operation and maintenance will be assessed
by monitoring the number of work orders associated with operator errors compared to the total number of
repair work orders for a given month. The performance indicator is 4%.

Inventorying Incoming Equipment: The accuracy of capturing incoming equipment will be assessed by
monitoring the number of work orders associated with a maintenance/repair call for an item not previously
inventoried. The performance indicator is zero instances.

SUPPORTING POLICIES AND PROCEDURES

This plan adheres to all policies, standards, regulations and applicable laws that govern these facilities.
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This Equipment Management Plan has been reviewed by the Equipment Management Committee.

Jennifer Nolan Date

Chair, Equipment Management Committee

This Equipment Management Plan has been approved by the Environment of Care Committee.

Bruce Cadwallender Date

Chair, Environment of Care Committee