Clinical engineering spend (i.e. in house vs. original equipment manufacturer vs. 3rd party)

Harborview Medical Center Page 1 of 18
Section: ENVIRONMENT OF CARE MANAGEMENT PLANS Effective Date: August 1994
Subject: Medical Equipment Management Plan Revised Date: February 2, 2004
I. PURPOSE OF THE PLAN
1. Mission
The mission of Harborview Medical Center (HMC) is to provide and teach
exemplary patient care and to provide health care for those patients of King
County it is obligated to serve. Consistent with this mission, the Board of
Trustees, medical staff, and administration have established and provided ongoing
support for the Medical Equipment Management Program described in this plan.
2. Purpose
The Medical Equipment Management Plan (MEMP) is written to assure that
Harborview Medical Center has an effective plan in place to manage all technology
(powered, non-powered, disposable, etc.) used in the treatment of patients. This
plan is designed to assure effective utilization, safe and cost effective use, timely
repairs and preventive maintenance of patient related technology. The Clinical
Engineering Department administers the MEMP.
3. Policy
To comply with federal, state, and local government regulations, and JCAHO
standards.
II. OBJECTIVES OF THE PLAN
A. Selection and purchase of patient related medical technology at HMC that is
appropriate to the scope of services, the needs of patients and clinicians.
B. Assure operational reliability and functionality of patient related medical
technology through appropriate management.
C. Reduce incidents, which result in unplanned failures.
D. Manage process for monitoring equipment recalls and hazard alerts.
E. Identify opportunities to improve patient related medical technology performance.
III. ORGANIZATIONAL RESPONSIBILITY
A. The Clinical Engineering Department was created by administrative direction in
August of 1994. The Board of Trustees administrates the Clinical Engineering
Department through the division of Clinical Support Services. The Clinical
Engineering Director works under the general direction of the Associate
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Administrator for Clinical Support Services.
B. The Clinical Engineering Department is responsible to provide meaningful input
to the Associate Administrator for Clinical Support Services on patient care
technology related issues. Based on this input, which includes budget planning,
staffing levels and business operations, the Associate Administrator for Clinical
Support Services approves the Clinical Engineering Department yearly
operational goals, resources and strategic plans.
C. The Director of Clinical Engineering, a degreed engineer, defines departmental
goals, basic operational performance levels and procedures, daily management
and quality assurance principles consistent with the direction provided by the
Associate Administrator for Clinical Support Services and the Board of Trustees.
The Director of Clinical Engineering is responsible for implementation and
performance of the Medical Equipment Management Plan. The MEMP includes
all clinical equipment repairs, maintenance and service, independent of
ownership or service methodology.
D. Technology Management is performed by the Clinical Engineering Department via
the principles of strategic technology planning, technology assessment,
equipment planning, equipment procurement and assets management. This plan
follows the HMC QA and value compass models. The Clinical Engineering
Department applies strategic technology planning principles system wide. These
include, but are not limited to, technology audits, assessment of new and
emerging technologies, budget strategy and analysis, and prioritizing technology
acquisition and/or replacement. The Clinical Engineering Department interfaces
and functions in a professional alliance with education departments, Risk
Management, Facilities, Engineering, Materials Management, Finance,
Administration, Medical Directors, physicians, nurses and allied healthcare
personnel to implement, prevent and resolve patient technology related issues.
E. The Clinical Engineering Department is a standing member of the Code 199,
EOC, Emergency Preparedness, Single Use Device, Laser Safety, Critical Care
Advisory, Imaging Council and Products Standards Committees. The Clinical
Engineering Department Director serves as co-chair of the Single Use Device Re-
use Committee and as Laser Safety Officer (LSO) to support the Laser Safety
Committee. The department also participates in long range bond planning, IT
security, IT Technology User Groups (TUG) and other meetings appropriate to its
mission.
F. The Clinical Engineering Department has been approved to provide this service
with the director, technicians and clerical support. The department is responsible
for all clinical services. The Clinical Laboratory is primarily supported by the
University of Washington Scientific Instruments Department with oversight from
the HMC Clinical Engineering Department.
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G. The Board of Trustees and CEO receive regular reports of the activities of the
MEMP from the EOC Committee. The Board of Trustees reviews the reports and,
as appropriate, communicates concerns about identified issues and regulatory
compliance.
H. Department Managers and educational departments and programs are
responsible for orienting new staff to their department and, as appropriate, to job
and task specific uses of clinical equipment. When requested, the Clinical
Engineering Department provides assistance.
I. Individual staff members are responsible for learning and following job and task-
specific procedures for safe clinical equipment operation.
IV. SCOPE
The MEMP applies to all hospital owned, leased, rented, evaluation and clinical
research technology used for the diagnosis, treatment and monitoring of patients.
The program establishes the role of the Clinical Engineering Department in the
selection, acquisition and maintenance of patient related medical technology used in
the hospital and clinics. The Clinical Engineering Department assists with clinical
training as requested. The development and measurement of the competency of the
staff responsible for the maintenance of medical equipment is included in the scope
of this program.
The Plan addresses processes surrounding these general areas:
1. Selection and Acquisition of Equipment;
2. Criteria for systems and components included;
C) Hazard notices and recalls;
D) Safe Medical Devices Act;
E) Reporting and investigating equipment management problems, failures, and user errors;
F) Maintenance strategies;
G) Inspection, testing and maintaining;
H) An annual evaluation of the equipment-management plan’s objectives, scope, performance and
effectiveness reported to the EOC committee;
I) An equipment orientation and education program for maintainers of equipment;
J) Emergency procedures;
K) An equipment orientation and education program for users of equipment;
L) Ongoing monitoring of performance;
M) Sterilizers;
N) Dialysis;
O) Surgical instrument repair;
P) Bed Shop;
Q) Specific program guidelines; and
R) Other activities
I. PROCESSES OF Medical Equipment Management Plan:
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A) Selection and Acquisition of Equipment
1. The Director of Resource Management has overall responsibility for
coordinating the clinical equipment selection and acquisition process.
Managers of departments where clinical equipment is used collaborate with
Resource Management, Purchasing, Clinical Engineering and other individual
department managers, as appropriate, select and acquire medical equipment.
2. Clinical Engineering recommends technology for purchase during the capital
budgeting process. This includes replacement equipment for technology that is
obsolete, has risk management concerns, standardization issues or provides
new services.
3. Clinical Engineering reviews and works with departments on acquisition of new
technology that has been approved in the capital budget. This includes
evaluations, assuring manuals, training (clinical and service), warranties,
service contracts, etc.
4. The Manager of Purchasing is responsible for coordination of vendor
negotiations, maintaining a record of negotiation activities and ensuring
clinical equipment considered for purchase meets minimum standard
specifications.
5. The Clinical Engineering Department inspects all medical equipment prior to
initial patient use, to assure it meets the unique needs of HMC. All patient
related powered equipment is required to be initially inspected by the Clinical
Engineering Department. All new or evaluated equipment is inspected to UL (or
equivalent) labeling, preferably hospital/medical label (UL 544). Equipment is
inspected for good workmanship, ease of use, human factors, ease of repair,
service and operator documentation. Specific tests may be performed on non-
medical UL labeled equipment to assure patient and operator safety.
6. All new medical equipment has Clinical Engineering inventory identifications
attached, and is appropriately and accurately included in the computerized
maintenance management system inventory. Additional labels showing
warranty expiration and battery replacement are also attached. A hard copy file
including original purchase order is initiated. Operator and service manuals
are maintained on file in the Clinical Engineering Department.
2. Criteria for Systems and Components Included in Plan
1. All powered (electrical, air, nitrogen, etc.) technology that is directly involved or
supports patient care is included in the Medical Equipment Management
program. Clinical Engineering oversees all patient related medical technology
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repairs, maintenance and service independent of ownership or service
methodology.
2. The Medical Equipment Management program scope of work includes support
for the following functions: critical care, surgery (surgical hand instruments
discussed separately), anesthesia, general medical/surgical nursing units,
Emergency Department (ED), psychiatric inpatient and outpatient, endoscopy,
rehabilitative medicine, physical therapy, pulmonary function, respiratory
therapy, central service, cardiology, radiology, ultrasound, nuclear medicine,
EEG, epilepsy center, peripheral vascular lab, cerebral vascular lab, urgent
care, sleep lab, pathology, the twenty (20) outpatient clinics located at
Harborview Medical Center, Pioneer Square Clinic, Outpatient Physical
Therapy, patient-related CCTV, Medic One and adult technologies used by
Airlift Northwest. The University of Washington Scientific Instruments
Department supports Laboratory Medicine with oversight from Clinical
Engineering and under the auspices of this plan.
3. Clinical Engineering is responsible for establishing written criteria for
determining preventive maintenance needs of medical equipment, performing
an evaluation of medical equipment against these criteria and maintaining an
inventory of medical equipment. This criteria is reviewed and implemented by
the EOC committee.
4. Controls are in place to ensure evaluation of medical equipment by Clinical
Engineering prior to initial use on a patient. The Purchasing Department is
responsible for notifying Clinical Engineering when new medical equipment is
delivered to the hospital. New equipment is inspected and evaluated by
Clinical Engineering prior to its release to the user department. The Clinical
Engineering Department maintains documentation of the incoming inspection
and evaluation. Equipment found to meet the criteria during the incoming
inspection is classified as medical equipment and entered into the medical
equipment inventory.
5. Clinical Engineering is responsible for managing the medical equipment
inventory process. A computer system is used to maintain the inventory in an
electronic database format. Additions, deletions and other changes are entered
into the computer system by Clinical Engineering staff. The medical
equipment inventory database is audited for accuracy.
3. Hazard Notices and Recalls
1. Clinical Engineering is responsible for managing the medical equipment
Hazard Notices and Recall Process.
2. Product Safety Alerts, Product Recall Notices, Hazard notices, etc. are received
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from a variety of external sources. The external sources direct correspondence
to different managers and staff based on known points of contact or general
titles.
3. When a piece or type of equipment subject to a Hazard Notice or Product Recall
is identified, appropriate action is taken to address the hazard.
4. Clinical Engineering supports the process by using the medical equipment
inventory to screen known equipment for matches and by evaluating the
relative severity of the risk. In most cases, the issues are addressed without
removing equipment from service. When conditions warrant, equipment is
removed from service and replaced with a safe effective substitute. In unusual
cases when no substitute is available, a member of Clinical Engineering
provides support of users to ensure the identified hazard is minimized until it
can be corrected. Equipment removed from service is impounded by Clinical
Engineering until it can be rendered safe.
5. Clinical Engineering also participates with Risk Management in reviewing
technology related incident reports. These reviews include a feed back
mechanism to assure appropriate action.
6. The Clinical Engineering Department also reviews recalls and other device
related notifications and forwards such information to appropriate clinical
managers. This "alert" material also includes a tracking and feedback
mechanism to assure all reports are appropriately managed
7. The Clinical Engineer reports quarterly to the EOC Committee on any
Equipment Hazard Notices or Product Recall affecting HMC and on follow-up
activities.
4. Safe Medical Devices Act (SMDA)
1. Risk Management is responsible for managing the Safe Medical Devices Act
Reporting process.
2. Clinical Engineering collects information about potentially reportable events
through the Medical Equipment Management Program, incident reporting and
investigation process. Risk Management and Clinical Engineering participate
in the investigation and documentation of clinical equipment incidents to
determine if the incident is reportable under criteria established by the Food
and Drug Administration (FDA).
3. The Sentinel Event Committee investigates and documents reportable
incidents.
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5. Reporting and investigating equipment management problems,
failures, and user errors
The medical equipment management program is designed to assure selection of
appropriate equipment, assist in the development of competent operators, and
reliable equipment performance. An important part of meeting these objectives is
monitoring each area to determine if unusual numbers or patterns of undesirable
events occur.
The Clinical Engineering Department, when entering work codes in computerized
maintenance management system (CMMS), uses the following definitions:
1. Failure - Any event requiring repair of a piece of medical equipment
inventoried in the CMMS system and managed by the Clinical
Engineering Department. Failures are identified by closing codes in the
CMMS for Calibration, Corrective Maintenance, PM and Repair, and
Physical Damage.
2. Problem - Any event requiring evaluation of the performance of equipment
resulting in assignment of a CMMS closing code of Software Failure or No
Trouble Found.
3. User Error - An equipment performance related event determined to be
caused by confirmed inappropriate action by an operator. All user errors
are identified by the CMMS closing code of Staff.
6. Inspection, Testing, and Maintenance Strategies
1. Clinical Engineering has overall responsibility for managing the inspection, testing,
and maintenance process of patient related medical technologies.
2. The Clinical Engineering Department performs or manages scheduled preventive
maintenance, testing, inspection and calibration of patient related medical
equipment included in this plan. Equipment that through experience, significant
mechanical components, or is considered required for life support (i.e., anesthesia
machines, ventilators) is inspected more frequently. Life support equipment is
typically inspected quarterly.
3. Equipment is presently inspected to industry standards and manufacturers'
specifications. The Clinical Engineering Department is constantly updating the list
of procedures for specific equipment types by reviewing data from peer university
medical centers, ASHE, AAMI and ECRI. These documents, in addition to specific
information from manufacturers and industry standards, provide the written
procedures for equipment inspection. The goal is for computerized maintenance
management program to incorporate these procedures.
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4. Electrical safety testing is performed on initial equipment inspection and after
invasive repair. Electrical leakage current criteria per international standards are
not to exceed 300 microamps. Any equipment not meeting this specification is
reviewed with the Clinical Engineering Department Director to determine
appropriate alternatives. Electrical ground integrity is always verified to meet
international standards of less than 0.5 ohms.
5. A significant amount of the department's effort and time is devoted to repair of
equipment. All repairs are prioritized and performed in a timely manner. To assure
consistent patient care, specific technologies have Ioaners in specific departments,
Central Service or Clinical Engineering to assure that technology is available to
clinicians during repairs or other maintenance activities.
6. Repair and maintenance work is prioritized by life support/life saving (ventilators,
anesthesia machines, defibrillators), diagnostic (laboratory, radiographic,
imaging), and finally "routine" (otoscopes, exam lights) technologies.
7. Clinical Engineering functions in a dynamic clinical environment. All patients are
to be treated as one would want their own family members treated. The rule is to
repair or provide technical support in clinical environment as if one of our own
loved ones was presently connected to, or would be the next patient interfaced
with the medical device.
8. Clinical Engineering is available on an on-call basis 24 hours a day, seven days a
week. On-call coverage includes technician responsible for “biomedical” coverage
as well as technician responsible for “imaging” coverage. Both technicians
support each other. An emergency call back and other programs are in place to
assure this 24 hour coverage.
9. Each vendor is to provide the hospital with copies of two operator and one service
manual as part of the purchasing process. This information plus hospital
experience and general industry experience with the type of equipment is used to
determine inspection, testing and maintenance needs of the equipment.
10. The Clinical Engineer reports quarterly to the EOC Committee on inspection,
testing and maintenance activities related to medical equipment.
11. All new medical equipment is inspected by Clinical Engineering prior to use on a
patient. Medical equipment not owned by HMC is also inspected prior to initial
use on a patient. Examples of equipment not owned by the hospital include:
• Physician owned equipment
• Rented or leased equipment
• Equipment loaned by a vendor or other health care organization
• Demonstration or evaluation equipment
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• Research Equipment
• Patient owned technology
Rental
• The Clinical Engineering Department in conjunction with Materials
Management has certified UHS, Mediq/PRN and KCI as acceptable
and preferred vendors for supplying rental equipment. The vendor
provides scheduled or as needed written reports to Clinical
Engineering on testing and devices delivered to HMC. Clinical
Engineering audits and validates these reports on a yearly basis to
assure they meet HMC and industry standards.
• Rental equipment provided by other vendors is to be inspected
prior to use in patient care areas.
• For rental equipment from vendors other than the three preferred,
a unique identification umber and label is attached by Clinical
Engineering to track the equipment and the time in clinical use.
Loaner
• All powered equipment being evaluated at HMC in clinical areas on
patients is required to be inspected by Clinical Engineering.
• The vendor is provided with a purchase order number initiated by
the requesting department for tracking and legal purposes.
• All loaner equipment is provided a unique identification number
and label which is used to track and inventory this equipment.
• Equipment loaned from the VA or UWMC are accepted as
equivalent to HMC testing due to cooperation and knowledge
between these Academic Medical Centers and their respective
Clinical Engineering Departments.
Evaluation
• The vendor is provided with a purchase order number initiated by
the requesting department for tracking and legal purposes.
• All evaluated equipment is inspected for the required UL label,
preferably hospital/medical label UL 544. or equivalent labeling.
Equipment is inspected for good workmanship, ease of use, human
factors, ease of repair, service and operator documentation.
Evaluation equipment undergoes EMI testing and/or vendor is
requested to provide EC 601 certification. Specific tests may be
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performed on non-medical UL labeled equipment to assure patient
and operator safety.
• All evaluation equipment is provided a unique identification
number, which is used to track and inventory this equipment.
• Unless other arrangements are provided in writing, loaner
equipment is maintained by the vendor to HMC specifications.
Research
• Clinical Engineering works with vendors and clinicians in
partnership arrangements to improve patient care technology. All
products are to be FDA approved or approved by the University of
Washington's Human Subjects Board.
• Clinical Engineering performs safety testing and other regulatory
requirements on Beta Testing and research technology used in
patient care setting.
• Beta testing equipment is provided a unique identification number
and tag which is used to track and inventory this equipment as
well as making clinicians aware of the beta testing or research
aspect of the equipment.
• It is beyond the present scope of work for the Clinical Engineering
Department to support pure non-patient related research.
Requests for such services are directed to UW Scientific
Instruments Department.
• Clinical Engineering does not repair or support research-related
technology.
Patient Owned Technology
• Use of non-hospital furnished electrical/powered equipment or
appliances, especially in critical care areas is highly discouraged.
• The nursing staff is responsible for conducting a visual inspection
of devices for obvious mechanical defects (intact cases and covers)
and determining whether these devices should be used by a
patient, taking any special environmental circumstances into
consideration. The nursing staff also monitors the circumstances
under which the device is being used. Clinical Engineering is
available to support these nursing staff reviews.
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7. Inspection, testing and maintaining equipment;
Outlined in F (see above).
8. Annual Evaluation
The scope, objectives, performance and effectiveness of the Medical Equipment
Management Plan is evaluated annually. Revisions are made as required and
approved by the Environment of Care Committee.
1. The EOC Committee is responsible for coordinating the annual evaluation
process with each of the seven functions associated with management of the
Environment of Care. Clinical Engineering is responsible for performing the
annual evaluation of the Medical Equipment Management Program.
2. The annual evaluation uses a variety of information sources including the
computer system, incident report summaries, meeting minutes, EOC
Committee reports and other summaries of activities. In addition, findings by
outside agencies such as accrediting or licensing bodies, insurance companies,
or qualified consultants are used.
3. The annual review examines the objectives, scope, performance, and
effectiveness of the Medical Equipment Management Program. The findings of
the annual review are presented in a narrative report supported by relevant
data. The report provides a balanced summary of the Medical Equipment
Management Program performance over the preceding 12 months. Strengths
are noted and deficiencies are evaluated to set goals for the next year or longer-
term future.
4. The annual review is presented to the EOC Committee. The Committee reviews
and approves the report. The deliberations and actions and recommendations
of the Committee are documented in the minutes. The managers of the plans
are responsible for implementing the recommendations in the report as part of
the performance improvement process.
5. The annual evaluation is also distributed via Quality Improvement Council to
the Board of Trustees, the CEO, the Chief Operating Officer and other
department managers as appropriate. The Board of Trustees reviews the report
and records its actions in the Board minutes. This finalizes the review.
Clinical Engineering is responsible for implementing the recommendations in
the report as part of the performance improvement process.
9. An equipment orientation and education program for maintainers of equipment
1. As part of the technology management program, local technical training classes
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are included in all significant purchases. Biomedical equipment technicians are
encouraged to attend any and all relevant classes. All staff is encouraged to attend
other classes and seminars provided by University of Washington and others on
other non-technical topics that will improve self and customer satisfaction.
2. Yearly interns from Biomedical Technician Associate of Arts programs are an
active part of in-house training program. The ability of our staff to assist and
educate and be challenged by students is a key part of educational program.
3. The department director is active with American College of Clinical Engineering
(ACCE), AAMI, and University Hospital Consortium as peer organizations. The
Clinical Engineering Department holds membership in the Washington State
Biomedical Association (WSBA), ASHE, AAMI and NFPA.
10. Emergency Procedures
1. The common hospital wide emergency action guide includes a section on Medical
Equipment. The procedures provide information about notifying appropriate
administrative staff of the emergency, action to take to protect patient safety,
contacts for spare equipment or repair services, and contacts to obtain additional
staff to manage the emergency.
2. To assure continuation of patient care, several key technologies (i.e., physiological
monitoring, and anesthesia machines) have in-department spares that are
immediately available. In addition, housewide spares for select technologies are
maintained in Central Service.
3. Clinical Engineering maintains a select inventory of critical items (defibrillators,
ICP monitors) that are used as spares when equipment is being repaired. This
select equipment is purchased by HMC and maintained for this application based
on experience and criticality of technology to HMC mission.
4. Clinical Engineering actively supports the planning for internal and external
disasters as requested. This includes amateur radio operator liaisons, radios
communications support and maintenance. The Clinical Engineering Department
maintains a "disaster cart" of spare equipment that is used should a major
internal system fail or external pressures require additional resources.
11. An equipment orientation and education program for users
of equipment
1. Each new staff member of HMC participates in a general orientation program,
which includes an overview of the Medical Equipment Management Program. The
overview introduces new staff members to the general concept of the plan. Basics
of department functions and safeguards (electrical safety, electromagnetic
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compatibility) in addition to resource contacts are included. The Organization
Development and Training Department conducts the general orientation. Each
staff member must complete the general orientation during the first thirty days of
employment. Organization Development and Training tracks attendance to insure
compliance. The Organization Development and Training Department maintains
permanent records of participation and performance during orientation.
2. Each new staff member also participates in a department and job specific
orientation. Department managers provide new personnel with department
specific orientation to the Medical Equipment Management Program. The goal of
the department specific orientation is to provide new personnel with current
information including departmental equipment, job specific requirements for
equipment operation and emergency procedures.
3. All staff members of HMC are required to participate in an annual mandatory
training program. The annual training includes material addressing Medical
Equipment. As necessary the requirement for annual education can be met by
completing a self-study packet or attending a regularly scheduled continuing
education program. The Organization Development and Training Department
tracks participation.
4. The department works with nursing education and other departments to ensure
training on new technologies.
5. The director and technicians provide routine training-during any troubleshooting
for clinicians. This is typically one-on-one and informal, and effective to minimize,
correct and determine trends in technology misunderstanding. All such activities
are included in work order process and used for all tending of device failures.
12. Ongoing Monitoring of Performance
1. Clinical Engineering is responsible for establishing performance improvement
standards to objectively measure the effectiveness of the Medical Equipment
Management Program. Clinical Engineering determines appropriate data sources,
data collection methods, data collection intervals, analysis techniques and report
formats for the performance improvement standards. Human, equipment, and
management performance are evaluated by Clinical Engineering to identify
opportunities to improve the Medical Equipment Management Program. The
performance improvement standards are communicated to EOC Committee.
2. The EOC committee report summarizes performance compared to the performance
improvement standard. If deficiencies are identified a plan of action is developed
to address the deficiency. The EOC Committee is responsible for evaluating the
relevance of performance improvement standards.
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3. The performance improvement measurement process in one part of the evaluation
of the effectiveness of the Medical Equipment Management Program. A
performance improvement standard has been established to measure important
aspects of the Medical Equipment management Program. Compliance with this
standard is considered essential to meeting the overall objective of providing
quality support of patient care. The Clinical Engineering Department uses
performance improvement criteria's established by professional standards or
various other university medical centers. These include, but are not limited to:
documentation (establishment of folders) of all new incoming technologies;
completion of scheduled inspections, review of significant numbers of failures and
inspection frequency; assuring inservicing of all technologies; validation of
computerized inventory; client satisfaction surveys.
4. The Clinical Engineering Department utilizes a computerized maintenance
management system which can track significant numbers of failures and other
trends that are used in improving management techniques.
5. The Clinical Engineering Department has several active Quality Assurance
programs. They include but are not limited to: customer surveys, review of rental
companies, review of contract companies (i.e. dialysis), review of service vendors,
review and acceptance of final QA documentation (ISO 9000 and FDA GMP) for
new technologies purchased by HMC, and departmental cost effectiveness.
13. Sterilizers
Sterilizers are maintained by the Facilities Engineering Department and included in
the scope of the Utility Management Plan.
14. Dialysis
1. HMC presently uses a third party vendor for dialysis support. This vendor
supplies all equipment and performs water testing to assure industry and
regulatory compliance.
2. Clinical Engineering annually reviews their documentation to assure compliance
with industry and regulatory standards for the equipment maintenance and water
testing.
3. The relationship is treated as a preferred rental vendor as the equipment is not
permanently located at HMC.
15. Surgical Instrument Repair
1. In February of 2001 HMC through a Process Improvement initiative created the
position for an instrument maker. This position is included in the Clinical
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Engineering Department. The primary responsibility of this position is
refurbishing external fixation devices used to support orthopedic surgery. The
skill set present results in savings from repair of hand instruments as well as
improved QA of all hand instrument technology.
2. This program has been a significant financial and maintenance success. In
addition to refurbishing external fixation devices, a complete surgical hand
instrument set maintenance program has been implemented. Additionally, hand
instruments are routinely repaired in-house. This program also provides
oversight to third party and OEM repairs of surgical instruments.
3. In calendar year 2003, over three hundred and fifty surgical sets were inventoried
and had preventive maintenance performed at least twice per set. This is over
three (3) tons of surgical hand instruments that received preventive maintance.
The instrument shop includes two Instrument Makers. The instrument shop
follows HMC Clinical Engineering guidelines as presented in this plan.
P) Bed Shop
1. In November, 2001 Facilities Engineering Bed Shop was transferred to the
Clinical Engineering Department. This transition was a component of a larger
patient safety initiative to upgrade all HMC medical/surgical beds.
2. The Clinical Engineering Bed Shop is responsible for the repair and maintenance
of all Medical/Surgical patient beds, Intensive Care patient beds, Operating Room
tables, stretchers, and wheelchairs.
This program has developed an inventory of all responsible technologies, received
factory training on technologies, developing replacement strategies, implementing
a PM program, and repairs.
4. The Bed Shop follows HMC Clinical Engineering guidelines as presented in this
plan.
Q] Specific Program Guidelines
Service Contracts
• To reduce service contract costs, Clinical Engineering is typically primary
first line service. Clinical Engineering accepts this role and works with
clinicians and vendors to provide one-stop technological service for all
patient related technology whether on contract or not. All requests for
service should begin by contacting Clinical Engineering (including items
serviced by outside vendors). This process also allows for accurate record
keeping on all service contracts, review of cost effectiveness of contract,
and quality audits of work performed.
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• Effective with Fiscal 97-98 Budget Year all medical equipment contracts
(N/C 620) dollars are contained in Clinical Engineering Budget.
• The Clinical Engineering Department routinely performs audits of service
vendors to assure quality service.
Obsolete Equipment
• The Clinical Engineering Department works with department managers,
vendors and Resource Management to identify equipment that is
technologically obsolete or no longer in clinical use. It is to HMC's and
Clinical Engineering's cost effective and productivity benefit not to
attempt to maintain equipment that is no longer supportable or used.
• All equipment relocated or removed from service is identified and Finance
is made aware of the relocation or removal from service via asset
numbers. All equipment relocated or removed from service is reviewed by
the Materials Management Surplus Coordinator, according to HMC
policy.
New Programs/Facilities
Clinical Engineering works with Facilities Management, Facilities
Engineering and Administration to assist with clinical architectural and
equipment planning for new facilities and programs. Clinical Engineering
also assists with acquisition and performs new equipment inspections,
and primary maintenance on technology in new facilities
Coordination with Facilities Engineering
Facilities Engineering and Clinical Engineering have a mutual and
productive work relationship at both the management and technician
peers. Facilities Engineering is primarily responsible for fixed and non-
patient care related technologies. Facilities Engineering performs several
tasks related to patient care equipment including repairs, maintenance
and testing of Line Isolation Monitors, electrical receptacles, sterilizers,
and medical gas system. Clinical Engineering functions in a consultative
role with Facilities Engineering as requested.
Electro Magnetic Compatibility/Electromagnetic Interference
The current hospital policy on EMI has been approved by the Critical
Care Advisory Committee. Clinical Engineering is the lead department
managing this issue. Due to circumstances unique to HMC, portable
transmitting devices are not banned in any hospital location. All new and
evaluation equipment is inspected with a strong radio frequency signal of
multiple frequency bands at close proximity to determine EMI
susceptibility. Vendors are also questioned regarding policy of radio
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transmitting devices in proximity to equipment under test. Vendors are
requested to comply and document compliance with IEC 601. Failure of
EMI testing results in corrective action to minimize EMI abnormalities.
Walk through of clinical areas is also performed with transmitting
devices to observe any equipment abnormalities.
Wireless Communications
Clinical Engineering is responsible for all wireless communications on
the HMC campus. This includes system design, approval of all external
antenna installations as well as tracking and service of radio
communications devices and systems. This is done to assure that users
of radios have effective tools to meet their needs, while assuring a safe
patient environment. All radio equipment used at HMC is cataloged by
Clinical Engineering to assure frequencies, power, etc are acceptable in
the healthcare environment.
In fiscal 97-98 the Director proposed and implemented a campus wide
radio system. This system included internal antenna system design,
installation and improvements to assure paging and other
communication system functioned in the new LRCIP facility.
Maintenance of portable two way radios and systems including site
management of all radio equipment on the roofs of HMC is coordinated
and managed by Clinical Engineering Department.
R) Other Activities
The department also supports and provides consultative assistance to security
on CCTV and other electronic technology issues.
Clinical Engineering (CLE) is a team of engineering professionals working in a
clinical environment to resolve technology issues related to patient care. The
Clinical Engineering Department functions and provides engineering services to
a clinical environment supporting technology, clinicians and the patient
technology interface. To reduce risks, improve patient outcomes and enhance
patient care in a cost effective manner. This is accomplished via cost effective
maintenance, repair and acquisition of all clinical technology, and proper
management of clinical technology resources. It is the goal of the Clinical
Engineering Department to be the technical liaison, reference and resource for
all clinical equipment. The mission of the Clinical Engineering Department is to
provide knowledgeable, timely and cost effective quality service to clinicians in
a professional and responsible manner to improve and enhance patient care by
supporting all aspects of patient care related technology.
During the course of daily activities, sensitive and confidential patient and risk
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management information is shared, provided and overheard by the Clinical
Engineering staff. All such information is to remain strictly confidential.
Discussions of such information should not occur in public areas.
Trauma is the leading cause of death among healthy young adults. As
HMC's role as a Level I Adult & Pediatric Trauma Center, the hospital
frequently admits and treats this patient population. Clinical Engineering
strives to provide appropriate technological options to meet all potential patient
populations. Specific options are to be clearly presented to clinicians and
included in Strategic Technology Planning initiatives. Additionally, Clinical
Engineering staff is to be cognizant of specific patient and family conditions
when functioning in a clinical environment.
Prepared By:
Duane A. Mariotti, Director of Clinical Engineering August/October, 1994
May/September, 1995
April/July/August, 1996
September, 1997
July, 1999
January/September, 2001
February, 2003
February, 2004
Management Plan Sponsor: Date:
Chair of Environment of Care Committee: Date:
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Clinical engineering spend (i.e. in house vs. original equipment manufacturer vs. 3rd party)

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