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

Harborview Medical Center of 19

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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004Engineering Director works under the general direction of the Associate 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004supported by the University of Washington Scientific Instruments Department with oversight from the HMC Clinical Engineering Department.

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:

A) Selection and Acquisition of Equipment;B) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004V. PROCESSES OF Medical Equipment Management Plan:

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.

B) Criteria for Systems and Components Included in Plan

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Subject: Medical Equipment Management Plan Revised Date: February 2, 20041. 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 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.

C) Hazard Notices and Recalls

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Subject: Medical Equipment Management Plan Revised Date: February 2, 20041. 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 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.

D) 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).

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3. The Sentinel Event Committee investigates and documents reportable incidents.

E) 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.

F) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004to 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.

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:

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004 Physician owned equipment Rented or leased equipment Equipment loaned by a vendor or other health care organization Demonstration or evaluation equipment 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,

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004preferably 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 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004by 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.

G) Inspection, testing and maintaining equipment;

Outlined in F (see above).

H) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004and 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.

I) An equipment orientation and education program for maintainers of equipment

1. As part of the technology management program, local technical training classes 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.

J) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004internal system fail or external pressures require additional resources.

K) 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 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.

L) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004and 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.

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.

M) Sterilizers

Sterilizers are maintained by the Facilities Engineering Department and included in the scope of the Utility Management Plan.

N) 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

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004regulatory 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.

O) 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 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 15



Subject: Medical Equipment Management Plan Revised Date: February 2, 2004plan.

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.

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/FacilitiesClinical 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 EngineeringFacilities 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-

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Subject: Medical Equipment Management Plan Revised Date: February 2, 2004patient 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 InterferenceThe 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 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 CommunicationsClinical 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.

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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 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, 1994May/September, 1995April/July/August, 1996September, 1997July, 1999January/September, 2001February, 2003February, 2004

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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)

Health & Medicine