Medical Equipment Management Plan

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NYU HOSPITALS CENTER MEDICAL EQUIPMENT MANAGEMENT PLAN
Eric Rackow, M.D. President 4/27/06

Max Cohen, M.D. Chief Medical officer

4/26/06

John P. Harney Executive Vice President & Chief Operating Officer

4/27/06

Sandra Iberger Vice President & Chair Environment of Care Committee

5/21/06

Amy Horrocks Vice President

4/19/06

Azhar Siddiqui Director, Clinical Engineering

4/18/06

Revised: December, 2005

NYU Hospitals Center Medical Equipment Management Plan (MEMP)

Table of Contents
Subject Purpose Scope Fundamentals Objectives Responsibilities 1. The Board of Trustees 2. The President of NYU Hospitals Center 3. The Executive Vice President, Senior Vice President and Vice Presidents 4. The Chair of the Environment of Care Committee (EOC) 5. Environment of Care Committee (EOC) 6. The Director of Clinical Engineering 7. The Senior Administrative Director of Clinical Laboratories and Manager of Anatomic Pathology 8. The Director of Radiology 9. The Director of Nuclear Medicine (or designee) 10. The Director of Radiation Safety 11. The Directors of Quality Assessment and Improvement and Risk Management 12. Department Heads 13. Staff who rent, lease or borrow medical equipment 14. Staff JCAHO Standard EC 6.10 Processes 1. Written Plan 2. Selecting and Acquiring Medical Equipment 3. Risk Criteria for Inventory of Medical Equipment 4. Strategies for Maintaining Medical Equipment 5. Scheduled Maintenance 6. Medical Equipment Hazard Notices and Recalls 7. Safe Medical Device Act Reporting 8. Emergency Procedures 1. Inventory of Medical Equipment 2. Testing Before Initial Use 3. Maintenance of Life Support Equipment 4. Maintenance of Non-life Support Equipment 5. Sterilizer Performance Testing 6. Testing of Dialysis Water Performance Monitoring Annual Evaluation Orientation and Training of Staff Orientation and Education of Medical Equipment Users Page 1 2 2 3 4 4 4 4 4 6 7 8 9 9 10 11 11 11 11 12

EC 6.20

EC 9.10

12 12 13 15 16 21 22 24 24 25 25 25 26 26 26 28 28 30

Revised: December, 2005

NYU Hospitals Center Medical Equipment Management Plan (MEMP)

PURPOSE The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has specific requirements for medical equipment management planning. However, before JCAHO promulgated these requirements, NYU Hospitals Center (NYUHC) had established a comprehensive program for managing medical equipment. The purpose of the Medical Equipment Management Plan (MEMP) is to describe how NYUHC’s programs meet JCAHO requirements. The MEMP supports a safe patient care and treatment environment by managing risks associated with the use of clinical equipment technology. The MEMP includes processes for selection, maintenance and training, which are designed to promote the safe and effective use of medical equipment while minimizing risks to patients and staff. Medical equipment used for diagnostic, monitoring and therapeutic purposes is a key component of medical treatment. The mission of the MEMP is to enhance patient care by promoting the safe and effective use of medical equipment through the application of sound Clinical Engineering practices. This is accomplished by providing professional and technical consultation and support, periodic equipment inspections, corrective and preventive maintenance, quality assurance activities, incident investigations and analysis of support effectiveness. Consistent with this mission, the Board of Trustees, Medical Staff, and Administration have established and provide ongoing support for this MEMP, which focuses on patient safety. The MEMP is designed to assure selection of appropriate medical equipment; to support the medical care processes of NYUHC; to assure effective preparation of staff responsible for the use or maintenance and repair of equipment; and to assure continual availability of safe, effective equipment through a program of planned maintenance, timely repair, and evaluation of all events that could have an adverse impact on the safety of patients or staff.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

SCOPE This plan covers all in-patient and ambulatory care facilities operated by NYUHC as listed below: • Tisch Hospital – 560 First Avenue • Schwartz Healthcare Center – 530 First Avenue, Floors 1, 2, 9 through 14 • Rusk Institute of Rehabilitative Medicine – 400 East 34th Street • NYU Clinical Cancer Center – 160 East 34th Street • Hassenfeld Children’s Center – 317 East 34th Street, 8th Floor • Rivergate Epilepsy and Transplant Centers – 403 East 34th Street, Floors 3 and 4 • The Vestibular Rehabilitation Center – 660 First Avenue The Hospital for Joint Diseases maintains a separate Medical Equipment Management Plan, which is consistent with this plan. The MEMP is designed to assure selection of appropriate medical equipment to support the medical care processes of NYUHC and its ambulatory care facilities. The program is also designed to assure effective preparation of staff responsible for the use or maintenance and repair of the equipment. Finally, the program is designed to assure continuous availability of safe, effective equipment through a program of planed maintenance, timely repair, and evaluation of all events that could have an adverse impact on the safety of patients or staff. The Clinical Engineering Department staff has primary responsibility for the maintenance and repair of all medical equipment, including equipment under maintenance agreement (contract) with outside vendors. All staff who use medical equipment are required to learn and implement various general and specific procedures to assure safe and reliable use of medical equipment. In addition, all patient care staff and support staff are responsible for learning and implementing the reporting mechanisms for problems, failures and user errors associated with the use of medical equipment.

FUNDAMENTALS Medical equipment is subject to damage and wear. Regular maintenance and evaluation are necessary to assure that equipment delivers the expected performance within specified parameters.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

Taken into consideration are regulatory requirements, manufacturers’ recommendations, and professional experience and judgment. Inspection intervals are established based upon regulatory and/or manufacturer’s recommendations, known risks and hazards. Intervals can also be changed by statistical data showing that a longer interval would not adversely affect the functionality. A preventive maintenance (PM) format, including data and documentation of quantitative and qualitative tests performed, is followed and completed for each piece of equipment inspected. These inspections are formalized and follow automated and semi-automated procedures. A label indicating the date of the inspection, the due date of the next inspection, and initials of the person performing the test is affixed on the equipment. Detailed test data are recorded in the equipment electronic and/or paper history files. The sophistication and complexity of clinical equipment continues to expand. Therefore, the MEMP establishes procedures for researching and selecting new medical equipment technology. The MEMP establishes training programs in conjunction with manufacturers to ensure patient care providers develop an understanding of clinical equipment limitations, safe operating conditions, and safe work practices, and emergency clinical interventions during failures. The MEMP establishes processes for managing those aspects of clinical equipment that have a potential to harm patients and staff.

OBJECTIVES The main objectives of this written MEMP are to comply with each JCAHO standard and element of performance for medical equipment management planning, which includes all of the following: • • • • • To purchase clinical equipment that is appropriate to the scope of services and that meets the needs and preserves the safety of patients and patient care providers. To increase operational reliability and functionality of medical equipment through preventive maintenance (PM). To reduce incidents which result in unplanned failures. To identify opportunities to improve the performance of medical equipment. To identify all medical equipment used for treatment, diagnosis and monitoring of patients, based on the risks of the equipment in use, the maintenance requirements, and the history of the hospital and of the types of equipment. Page 3

NYU Hospitals Center Medical Equipment Management Plan (MEMP) • • • • •

To manage medical equipment by use of PM, calibration, testing and inspection of the equipment; and by maintaining documentation of the status of the equipment. To collect information about problems, failures, malfunctions and user errors, to allow identification of areas where improvement is necessary, or possible. To prioritize repairs to equipment and provide quick turn around time for repairs. To evaluate reports of problems and failures for the need to report, through the Safe Medical Device Act reporting mechanism, any equipment or devices which have or may have caused death, or significant medical harm. To report to the EOC, on a regular basis, the data and information about equipment management, staff competence, and regulatory issues that have been collected, aggregated and analyzed; and the results of issues that have been selected for the program.

RESPONSIBILITIES 1. The Board of Trustees Responsible for: • Reviewing information and reports from the EOC Committee, Hospital Administration and other hospital personnel about medical equipment and acting on them as needed. • Communicating concerns about medical equipment to Hospital Administration and other appropriate personnel as needed. 2. The President of NYUHC Responsible for: • Allocating the resources needed to comply with the MEMP. • Planning for the space, equipment and resources needed to safely and effectively support the services NYUHC provides. • Appointing the Chair of the EOC Committee. • Reviewing information and reports about EOC issues, and acting on them as needed. • Ensuring appropriate information on EOC issues is presented to the Executive Committee of the Medical Board (ECMB), and forwarded from that committee through the hospital’s committee structure to the Patient Care and Quality Assessment Oversight Committee (PCQAOC) and the Board of Trustees. 3. The Executive Vice President, Senior Vice President and Vice Presidents Responsible for:

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NYU Hospitals Center Medical Equipment Management Plan (MEMP) • •

Reviewing information and reports about EOC issues, and acting on them as needed. Ensuring Department Heads meet their responsibilities for implementing the MEMP.

4. The Chair of the Environment of Care (EOC) Committee Responsible for: • Leading the EOC committee in its efforts to ensure that NYUHC has an effective medical equipment management program. • Championing EOC committee recommendations about medical equipment to the Executive VP for Hospital Administration and senior leadership. 5. Environment of Care Committee Responsible for: a. Reviewing, discussing and approving key documents and criteria developed by Plan Owners for their plans, including: ƒ Written plans ƒ Goals and objectives ƒ Performance measures ƒ Annual evaluations of plan objectives, scope, performance and effectiveness ƒ Safety policies, and other key policies and procedures b. Examining information, data and reports submitted by the Plan Owners, including the following: ƒ Information on pertinent regulations, standards, guidelines and codes ƒ Risk assessments and hazard vulnerability analyses ƒ Reports from sub-committees, task forces and other committees ƒ Performance monitoring reports ƒ Hazard surveillance reports ƒ Incident reports ƒ Reports of inspections by outside agencies; citations, summons and/or violations ƒ Statistical and anecdotal data on environment of care issues ƒ Drill critiques ƒ Reports on training programs c. Providing a forum for discussion of other significant environment of care issues. d. Convening sub-committees and/or task forces, incorporating non-committee members, as needed; reviewing and approving their reports.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

e. Analyzing identified environment of care issues and developing recommendations for resolving them. f. Referring issues/recommendations to appropriate personnel/departments/committees for follow-up and resolution. g. Recommending at least one Performance Improvement activity annually. h. Communicating issues, problems, findings and recommendations to Hospital Administration, the Executive Committee of the Medical Board, the Patient Care and Quality Assessment Operations Committee, and the Board of Trustees. i. Maintaining written minutes, which record attendance and reflect the issues discussed, recommendations, actions taken and any follow-up. 6. The Director of Clinical Engineering Responsible for: • Serving as the plan owner for the MEMP. • Establishing and maintaining an inventory of all Patient Care Devices that are available for use. Incorporating all new medical Patient Care Devices into the inventory. Conducting a bi-annual review of the appropriateness of such status in accordance with the policy on medical equipment maintenance. • Establishing and maintaining a Clinical Equipment Management System for all the Patient Care Devices, which: − assigns a unique identifier number to each device, − documents all inspections (initial and PM) and all repair service performed on patient care devices, − communicates inspection dates to staff by indicating inspection date and expiration of PM on equipment, − records all Safe Medical Devices Act (SMDA) 1990 and all recall actions on Patient Care Devices, and − identifies equipment failures that are due to improper maintenance, operator error, abusive actions, and EMI activity or recall activity. • Establishing and maintaining a PM program for Patient Care Devices as designated by this program. • Assigning each Patient Care Device, or class of devices, a PM schedule (annual, semi-annual, or quarterly) based on evaluation of the following criteria: − equipment function (life support, monitoring, diagnostic, etc), − physical risk associated with its use, − maintenance requirements as defined by the manufacturer, − device maintenance / service history,

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

• • • •





• • •

equipment incident history, including known SMDA 1990 activity and recall history, − energy delivery to the patient, and − other manufacturer or regulatory agency recommendations. The EOC Committee shall approve such schedule. Reviewing on a bi-annual basis the PM schedule, classifications and inventory status of Patient Care Devices, and making recommendations on updates to the EOC Committee. Controlling, coordinating and documenting all repairs of Patient Care Devices. Coordinating, implementing, and documenting the initial inspection of Patient Care Devices, regardless of ownership, prior to use. Reviewing reports of equipment failures, identified above, and − identifying trends, − monitoring and evaluating the effectiveness of maintenance activities, − providing monthly service summaries to customer departments, identifying specific concerns, and − providing quarterly reports to the EOC Committee on the program activities. Participating in the equipment selection and acquisition process. Screening proposed purchases for maintenance concerns, applicable ECRI evaluation and hazard reports, recall history, and applicable institution equipment standardization initiatives. At the request of the Director of Quality Assessment and Improvement and/or Risk Management, assisting in the investigation, evaluation and documentation of medical equipment involved in patient incidents, in accordance with the SMDA 1990 requirements. Maintaining appropriate references, standards, specifications and other documents in support of the MEMP. Establishing, implementing and maintaining a training program for patient care equipment maintainers that meet the requirements of JCAHO and the SMDA of l990. Removing any equipment from service if it is deemed to be unsafe for use.


7. The Senior Administrative Director of Clinical Laboratories and Manager of Anatomic Pathology Responsible for: • Establishing and maintaining an inventory of all clinical laboratory devices that are available for use. • Establishing and maintaining an equipment management system for all the appropriate clinical laboratory devices (or using the Clinical Engineering system) which: − assigns a unique identifier number to each device, serial number or control numbers

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)



• • •





• •

documents all inspections (initial and PM) and all repair service performed on clinical laboratory devices. Clinical Laboratories maintain all the diagnostic analyzers records through the life of the instruments. − records all SMDA1990 and all recall actions on clinical laboratory devices, − identifies equipment failures that are due to: improper maintenance, operator error, abusive actions, EMI activity, or recall activity. Establishing and maintaining a PM program for all clinical laboratory devices; − Assigning each clinical laboratory device, or class of devices, a PM schedule (annual, semi-annual, or quarterly) based on maintenance requirements as defined by the manufacturer and/or regulatory agency recommendations. Controlling, coordinating and documenting all repairs of clinical laboratory devices. Coordinating, implementing, and documenting the initial inspection of all clinical laboratory devices, regardless of ownership, prior to use. Reviewing reports of equipment failures, identified above, and − identifying trends, − monitoring and evaluating the effectiveness of maintenance activities, − maintaining maintenance logs for all analyzers Participating in the equipment selection and acquisition process. Screening proposed purchases for maintenance concerns, applicable ECRI evaluation and hazard reports, recall history, and applicable institution equipment standardization initiatives. At the request of the Director of Quality Assessment and Improvement and/or Risk Management, assisting in the investigation, evaluation and documentation of clinical laboratory devices involved in patient incidents, in accordance with the SMDA 1990 requirements. Maintaining appropriate references, standards, specifications and other documents in support of the MEMP. Establishing, implementing and maintaining a training program for clinical laboratory device maintainers that meet the requirements of JCAHO and the SMDA of 1990.


8. The Director of Radiology Responsible for: • Establishing and maintaining an inventory of all Radiological Imaging Devices that are available for use. • Responsible for providing regular PM and service reports to the Director of Clinical Engineering. • Establishing and maintaining an equipment management system for Radiological Imaging Devices (or using the Clinical Engineering system), which: − assigns a unique identifier number to each device,

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

• •

• • •





• •

documents all inspections (initial and PM) and all repair service performed on Radiological Imaging Devices, − records all SMDA 1990 and all recall actions Radiological Imaging Devices, − identifies equipment failures that are due to: improper maintenance, operator error, abusive actions, EMI activity, or recall activity. Establishing and maintaining a PM program for all Radiological Imaging Devices. Assigning each Radiological Imaging Device, or class of devices, a PM schedule (annual, semi-annual, or quarterly) based on manufacturer’s recommendations and other manufacturer or regulatory agency recommendations. The EOC Committee shall approve such schedule. Controlling, coordinating and documenting all repairs of Radiological Imaging Devices. Coordinating, implementing, and documenting the initial inspection of the Radiological Imaging Devices prior to use; Reviewing reports of equipment failures, identified in above, and − identifying trends, − monitoring and evaluating the effectiveness of maintenance activities, − providing monthly service summaries to the Director of Clinical Engineering for inclusion in the institution maintenance of Medical Instrumentation program and reporting activities. Participating in the equipment selection and acquisition process. Screening proposed purchases for maintenance concerns, applicable ECRI evaluation and hazard reports, recall history, and applicable institution equipment standardization initiatives. At the request of the Director of Quality Assessment and Improvement and/or Risk Management assisting in the investigation, evaluation and documentation of radiological imaging devices involved in patient incidents, in accordance with the SMDA 1990 requirements. Maintaining appropriate references, standards, specifications and other documents in support of the MEMP. Establishing, implementing and maintaining a training program for radiological imaging device maintainers that meet the requirements of JCAHO and the SMDA of 1990.


9. The Director of Nuclear Medicine (or designee) Responsible for: • Establishing and maintaining an inventory of all Nuclear Medicine Patient Care Devices that are available for use. • Responsible for providing regular PM and service reports to the Director of Clinical Engineering.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP) •

Establishing and maintaining an equipment management system for all the Nuclear Medicine Patient Care Devices, which: − assigns a unique identifier number to each device, − documents all inspections (initial and PM) and all repair service performed on Nuclear Medicine Patient Care Devices, − records all SMDA 1990 and all recall actions on Nuclear Medicine Patient Care Devices, − identifies equipment failures that are due to improper maintenance, operator error, abusive actions, EMI activity, or recall activity. • Establishing and maintaining a PM program for all Nuclear Medicine Patient Care Devices. • Assigning each Nuclear Medicine Patient Care Device, or class of devices, a PM schedule (annual, semi-annual, or quarterly) based on evaluation of the following criteria: − The manufacturer’s recommendations and/or other manufacturer or regulatory agency recommendations. The EOC Committee shall approve such schedule. • Controlling, coordinating and documenting all repairs of Nuclear Medicine Patient Care Devices. • Coordinating, implementing, and documenting the initial inspection of all Nuclear Medicine Patient Care Devices, regardless of ownership, prior to use. • Reviewing reports of equipment failures, identified above, and − Identifying trends, − Monitoring and evaluating the effectiveness of maintenance activities, − Providing monthly service summaries to the Director of Clinical Engineering for inclusion in the institutional maintenance of medical equipment program and reporting activities; • Participating in the equipment selection and acquisition process. Screening proposed purchases for maintenance concerns, applicable ECRI evaluation and hazard reports, recall history, and applicable institutional equipment standardization initiatives; • At the request of the Directors of Quality Assessment and Improvement and/or Risk Management, assisting in the investigation, evaluation and documentation of Nuclear Medicine Patient Care Devices involved in patient incidents, in accordance with the SMDA 1990 requirements. • Maintaining appropriate references, standards, specifications and other documents in support of the MEMP. • Establishing, implementing and maintaining a training program for Nuclear Medicine Patient Care Device maintainers that meet the requirements of JCAHO and the SMDA of 1990. 10. Director of Radiation Safety Responsible for:

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NYU Hospitals Center Medical Equipment Management Plan (MEMP) •

Ensuring all X-ray imaging equipment used by Radiology and any other clinical service is subject to acceptance and subsequent scheduled functional testing by licensed Medical Physicists in the Radiation Safety group as required by the NY State and City Health Code. Such testing addresses the issue of whether it is safe, effective, accurate and applicable.

11. The Directors of Quality Assessment and Improvement and Risk Management Responsible for: • Ensuring that NYUHC’s reporting policies and procedures address the steps to be followed for reporting and resolving equipment related incidents. • Complying with hospital procedure for to investigate, document and repors as necessary all patient-related incidents in compliance with the SMDA of 1990 and New York State requirements. • Notifying the Director of Clinical Engineering whenever such reports are made. • Ensuring that equipment related incidents are reviewed by appropriate technology experts. • Ensuring that the proper safeguards are taken to preserve the confidentiality of equipment related incident reporting and investigations. 12. Department Heads Responsible for: • Implementing methods and procedures to assist department personnel in complying with the MEMP. • Provide training for all department personnel in equipment operation, safety, hazard recognition and prevention, and problem reporting. • Ensuring compliance concerning the inspection of all rented, loaner, privately owned, or other equipment prior to being put into use. • Ensuring that staff education and training on the operation of equipment is performed and documented in compliance with JCAHO standards. • Complying with relevant inspection, calibration, preventive maintenance, training, service, safety, operation and documentation procedures required by all appropriate agencies and authorities. • Providing on a monthly basis copies of all maintenance reports on Patient Care Devices performed by non-Clinical Engineering Department (e.g., vendor reps.) for inclusion in the institutional medical equipment maintenance program. 13. Staff who rent, lease or borrow medical equipment Responsible for: • Ensuring that all equipment is brought to Clinical Engineering for incoming inspection, • Ensuring that all accessories and manuals needed for the functional testing of the equipment are available to Clinical Engineering. Page 11

NYU Hospitals Center Medical Equipment Management Plan (MEMP) • •

Ensuring that equipment is brought back to Clinical Engineering for periodic PMs if it stays at NYUHC longer than the next PM due date. Promptly notifying Clinical Engineering when equipment is returned or removed from NYUHC.

14. Staff Responsible for: • Completing training required by the MEMP. • Obtaining and using medical equipment in accordance with NYUHC and departmental policies and procedures. • Notifying their supervisors of incidents, unsafe conditions, or other pertinent problems. PROCESSES The MEMP promotes the safe and effective use of medical equipment at NYUHC. The plan includes the following elements: 1. Written plan (EC.6.10.1) This written management plan describes key processes NYUHC has developed and implemented in order to manage the effective, safe and reliable operation of medical equipment. 2. Selecting and acquiring medical equipment (EC.6.10.2) Department Heads collaborate with Purchasing, Hospital Administration and Clinical Engineering in the selection and acquisition of medical equipment. Department Heads are responsible for identifying equipment needs, evaluating financial responsibility, and justifying equipment purchases. The Purchasing Director is responsible for coordinating vendor negotiations. Hospital Administration coordinates and processes capital equipment requests and purchases. The Capital Equipment Committee has ultimate responsibility for the approval of capital equipment requests. The capital equipment acquisition policy is maintained in the hospital’s Administration Policy Manual. Department Heads normally initiate the selection and acquisition process by identifying and documenting their needs and submitting a Purchase Requisition with an accompanying justification letter. This justification documents a variety of issues such as

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

a financial analysis and a determination of installation requirements. Computerized equipment receives a separate evaluation by the Information Technology Department. Final recommendations related to medical equipment selection are developed after negotiations conducted by the Purchasing Department have been completed. The Capital Equipment Committee has final approval over all new medical equipment purchases. Documentation related to the selection and acquisition process is maintained by the Purchasing Department. At the earliest possible stage prior to purchase, Clinical Engineering participates in prepurchase assessments, and determinations are made based on both clinical and technical criteria. The process is intended to assure that the equipment selected meets the following requirements: • It is appropriate for its intended use. • It is compatible with existing equipment interfaces and/or shared use of accessories. • It will not cause undue user education difficulties. • It is FDA approved, and meets the design requirements of IEC 601 and the safety requirements of UL, CSA, etc. • It is not under recall and doesn’t have documented safety and use concerns. • Any special installation planning requirements can be accommodated. • Space requirements can be accommodated. • Load and phase requirements can be accommodated. • It meets the minimum safety standard of 3 wire AC line cord or equivalent. • It has appropriate warranties and the manufacturer is reliable. • The manufacturer provides adequate equipment support. • It conforms with standardization efforts when possible If the equipment does not meet the above specifications, it may not be ordered or an alternate choice may be submitted for approval. 3. Risk criteria for inventory of medical equipment (EC.6.10.3) NYUHC has established and uses risk criteria for identifying, evaluating, and creating an inventory of equipment to be included in the medical equipment management plan before the equipment is used. Clinical Engineering establishes written risk criteria for determining preventive maintenance needs of clinical equipment, performs an evaluation of clinical equipment against these criteria, and maintains an inventory of clinical equipment.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

Heads of departments where such specialized equipment is located are responsible for coordinating their departmental efforts with the Clinical Engineering department. An inventory of active medical equipment is maintained on a computerized system in the Clinical Engineering Department. The active inventory includes the equipment handled under contracts, with adequate documentation. The inventory includes device type, manufacturer, model, serial number, location and risk level category. New equipment is added to the inventory upon acceptance inspection per Clinical Engineering (CE) Policy 06. Equipment is removed from the inventory when it is removed from service, although a record of its history is maintained. Clinical Engineering uses the inventory to monitor and control the quality of services provided and assure adequate safety performance and cost effectiveness of medical equipment. Equipment used for the diagnosis, treatment, monitoring and care of patients within the hospital is evaluated for inclusion in the medical equipment inventory. The evaluation consists of an analysis of the equipment function, clinical application or physical risk and the equipment incident history as stated in CE Policy 05. The written criteria for medical equipment include: • Equipment function (diagnostic, therapeutic, analytical, and life support). • Physical risks associated with use of the equipment (clinical application, inappropriate therapy or misdiagnosis, potential patient injury or patient death). • Equipment incident history (likelihood of failure). • Preventive maintenance requirements by manufacturer (annually, semi-annually, quarterly, monthly, or none) • Environmental use classification. (Non–patient areas, general care areas, labs, critical care areas, anesthetizing location). Based on the above criteria, the Clinical Engineering Department will ensure that the new equipment is inspected for: 1. 2. 3. 4. 5. 6. Presence of all accessories required for proper operation. Presence of Operators Manuals and Technical Service Manuals, and Schematics. Proper operation of the equipment as specified in the performance specifications in the manufacturer’s service literature. Passage of electrical safety requirements as specified by NFPA, and other applicable agencies. Inclusion into, or exclusion from, the Medical Equipment Management Program. Compliance on labeling of equipment, to ensure that the equipment has been “evaluated for safety and suitability for intended use” by a nationally recognized

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

testing laboratory, and /or acceptable Listings as to the Safety of Goods. (e.g. UL, CSA, etc.) If equipment passes all required inspections the technician will affix an Inventory Control Number and Clinical Equipment Maintenance inspection stickers based on the PM schedules currently outlined in Section 5. The Technicians will fill in the appropriate information on these stickers, and place it in a visible location on the device. The Clinical Engineering Technician who performs the inspection is responsible for ensuring the completion of the initial inspection documentation. The Receiving Department is responsible for delivering new equipment to the Clinical Engineering Department when it is received onsite. Medical equipment remains assigned to the program until a minimum of three (3) years of maintenance data has been accumulated. At that time, a review of the reliability of the equipment is performed. Devices that show consistently low repair/re-calibration need are placed either on a reduced PM schedule or removed from the equipment management program. All such actions are based on the approval of the EOC. Medical equipment not being monitored by Clinical Engineering (e.g. equipment in Radiology, Nuclear Medicine, and laboratories) is monitored by the appropriate individuals in those areas. 4. Strategies for maintaining medical equipment (EC.6.10.4) The Director of Clinical Engineering has overall responsibility of identifying appropriate strategies for all equipment on the inventory for achieving effective, safe, and reliable operation of all equipment in the inventory, and managing the medical equipment inspection, testing and maintenance process. Clinical Engineering ensures the correct operation and integrity of all medical equipment through in-coming inspections, testing, corrective maintenance and repairs. Clinical Engineering accomplishes this through interval-based inspection. • Incoming Inspection – Clinical Engineering inspects all medical equipment (new, used, loaner and rental) for electrical safety, physical condition and performance verification upon arrival, per EC 6.10 (2). User department managers notify the Clinical Engineering Department upon delivery of equipment to arrange for its incoming inspection prior to use.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP) •

Preventive Maintenance (PM) – Medical equipment is subject to effective periodic maintenance, performed by Clinical Engineering, the manufacturer, or a third party. Current standards of practice or the specific criteria are set in CE Policy 15 and this MEMP. Service Contracts/Warranty – Manufacturers or a third party may cover specific medical equipment under contract. This equipment is repaired and maintained by the outside source. Upon receipt of their documentation, Clinical Engineering reviews it and, if acceptable, enters it into the equipment management program history. Repairs - Clinical Engineering staff perform in-house repairs as per CE Policy 15. Manufacturers and other outside vendors conduct repairs of specific contracted devices.





Each vendor provides the hospital with copies of operator and service manuals 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. A preventive maintenance (PM) schedule is established to address the unique maintenance needs of each type of medical equipment. Work Orders are prepared following requests for service by user departments and during routine preventive maintenance checks. The Director or designee assigns technicians to perform assigned Work Orders. The computer system tracks all work performed on medical equipment maintained by Clinical Engineering. All contractors perform assigned work and return completed Work Orders to Clinical Engineering. The computer database is used to retain long-term historic documentation. 5. Scheduled Maintenance (EC.6.10.5) NYUHC defines intervals for inspecting, testing, and maintaining appropriate equipment on the inventory (that is, those pieces of equipment on the inventory benefiting from scheduled activities to minimize the clinical and physical risks) that are based upon criteria such as manufacturers’ recommendations, risk levels, and current hospital experience. All equipment included in the program is inspected and tested prior to its initial use and at set intervals, commonly referred to as preventive maintenance (PM).

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

A systematic approach to scheduled maintenance of medical equipment is a means of making certain that the equipment is safe for use and can obtain maximum utilization at a reasonable cost. Equipment in the inventory benefits from scheduled activities to minimize the clinical and physical risks. Clinical Engineering has established and operates a continual PM program based on risk criteria and organizational experience. This is documented and categorized according to priority of testing in CE Policy 15. Each device is assigned a risk classification based on five distinct categories: • equipment function: energy delivering, patient monitoring, or patient convenience devices • physical risk • maintenance (PM) • incident history, and • environment use Each item of equipment will be assigned numerical scores for equipment function, physical risk, and maintenance requirements, according to the following: A. EQUIPMENT FUNCTION Equipment function will be evaluated on a scale from 1 to 10 as follows: Score Type 10 Life Support; Radiation Therapy 9 Surgical and Intensive Care 8 Physical Therapy and Treatment 7 Surgical & critical care monitoring; radiology systems Additional physiologica Definition Devices used to support life; devices used for radiation therapy Examples Defibrillator, ventilator, pacemaker, infant incubator Electrosurgical unit, laser

Category THERAPEUTIC (Devices that apply some form of energy)

DIAGNOSTIC (Devices used to diagnose patient ailments)

Devices therapeutic in nature, but alone don’t support life Devices intended to treat a Dialysis machine, patient’s ailment infusion pump, traction unit, diathermy Monitors & modules used EEG machine, nonin the surgical or critical invasive blood care environment; pressure monitor, radiology systems x-ray generator

6

Devices not routinely used adult scale, tympanic in critical care thermometer,

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

ANALYTICAL (Devices primarily used outside the patient care area that provide information to assist in the diagnosis of patient.) MISCELLANEOU S

5

l monitoring and diagnostics Analytical laboratory

environment

ultrasound unit

4

Laboratory accessories Computer and related Patient related Non-patient related; test equipment

Devices used in the clinical laboratory to perform diagnostic testing of specimens Devices used to prepare specimens for analysis Devices used to record, print, gather, or distribute data Devices related to patient care, but not directly used Devices unrelated to patient care

blood gas analyzer, clinical chemistry analyzer, cell counter shaker, centrifuge, incubator, microtome computer, ticket printer, QC system X-ray view box, sterilizer, chair lift ECG simulator, office equipment, kitchen equipment, UPS

3

2

1

B.

PHYSICAL RISK ASSOCIATED WITH CLINICAL APPLICATION Physical risk will be evaluated on a scale from 1 to 5 as follows: Score Definition 5 Failure of the device could result in the death of a patient 4 Failure not likely to cause death but may result in injuries Failure could result in misdiagnosis or improper therapy Failure not likely to cause any adverse outcome with the patient or affect safety of patients or staff Failure will not cause an adverse outcome with the patient or affect patient or staff safety Examples Defibrillator, ventilator, anesthesia machine Hypo/hyperthermia unit, laser, electrosurgical unit ECG machine, blood gas analyzer, centrifuge Gel warmer, heat sealer, suction pump Exam light, computer terminal, video printer

Category PATIENT DEATH

PATIENT OR OPERATOR INJURY INAPPROPRIATE THERAPY OR MISDIAGNOSIS MINIMAL RISK

3

2

NO SIGNIFICANT RISK

1

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

C.

MAINTENANCE REQUIREMENTS Maintenance requirements will be evaluated on a scale from 1 to 5 as follows: Score 5 Definition Devices that are predominantly mechanical, pneumatic, or fluidic in nature Devices that have mechanical, pneumatic, or fluidic components, but are primarily electronic in nature Devices that need only performance verification and safety testing, primarily electronic in nature Devices that require less extensive testing of performance Devices that may require only visual inspection Examples Dialysis machine, ventilator, anesthesia machine, x-ray table Infant incubator, blood warmer, laser, portable x-ray system Defibrillator, infusion pump, electrosurgical unit, traction unit Lab microscope, scales, general medical device Exam light, computer terminal, video camera

Category EXTENSIVE

ABOVE AVERAGE

4

AVERAGE

3

BELOW AVERAGE

2

MINIMAL

1

4.

The inclusion of equipment into the preventive maintenance program is based on the severity index. The severity index is calculated by adding the above assessed scores. SEVERITY INDEX = FUNCTION + RISK + MAINTENANCE. A. All equipment that scores a severity index of 10 or more shall be included in the preventive maintenance program. All equipment that receives a maintenance requirement score of 4 or 5 shall be included in the preventive maintenance program, regardless of the severity index.

B.

5.

Equipment that is multi-functional will be assigned a severity index that corresponds to the highest values of function, risk and maintenance of any of the component functions.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

6.

The Director of Clinical Engineering shall obtain written approval from the hospital’s EOC Committee acknowledging the list of equipment types that are excluded from the preventive maintenance program, and thus will receive no periodic maintenance. The inspection interval is based on the severity index, maintenance requirements, equipment incident history, and specific hospital experience. A. The following shall be the minimum acceptable inspection interval standards: Severity Index required Severity Index required B. = = 10 to 15 16 to 20 = = annual periodic maintenance semiannual periodic maintenance

7.

All equipment that receives a maintenance requirement score of 4 or 5 shall receive at least semiannual periodic maintenance.

8.

Under certain circumstances the Director of Clinical Engineering may establish more frequent inspection intervals for specific types of equipment, regardless of the severity index or maintenance requirement score. These circumstances might include: Equipment Incident History Medical Device Recalls or Hazard Alerts Demonstrated Problems with Similar Equipment Equipment PM History Regulatory Requirements Safety Committee Directives

Clinical Engineering conducts periodic evaluations to determine the PM frequency or the necessity and effectiveness of performing scheduled PM on specific types of devices. Devices that have exceedingly low failure rates (less than 5% of all PM’s performed per device type for the last 3 years), no PM replacement parts, or do not require calibration may have their PM frequency reduced or removed from the PM schedule upon approval by the EOC. Devices used specifically by the Blood Bank are scheduled according to CAP and/or the manufacturer’s recommendations. This policy may be extended to other highly specialized devices where practical experience is limited.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

Clinical Engineering assigns different colors of PM stickers to equipment based on the PM interval for that equipment. Based on these PM intervals, annual PM cycles are established for each location. Environmental rounds are conducted by Clinical Engineering Department as per CE Policy 01. The purpose of the rounds is to: • Detect conditions that are a source of potential future problems. • Identify situations that must be corrected to avoid potential malfunction or misuse of medical equipment. • Identify situations of misapplication of medical equipment to potentially reduce user error. Each piece of equipment listed in the inventory has written equipment testing procedures and checklists. A label, indicating the date and initials of the person who performed the inspection, is affixed to the equipment. Medical equipment not owned by NYUHC is also inspected before use on a patient. Examples of equipment not owned by NYUHC include physician owned equipment, rented or leased equipment, and equipment loaned by a vendor. If a piece of equipment cannot be located or is not readily available for maintenance, the users are notified and asked to assist. The users exert reasonable efforts to make the equipment available for inspection and to identify equipment no longer in use. Equipment not found for three PM cycles or for 2 years is removed from the PM schedule and the status changed to inactive. Inspections are scheduled monthly and completion is reported quarterly to the EOC on inspection, testing, and maintenance activities related to medical equipment.

6.

Medical Equipment Hazard Notices and Recalls (EC.6.10.6)

NYUHC identifies and implements processes for monitoring and acting on equipment hazard notices and recalls, and Clinical Engineering actively participates in the handling of the Medical Device Recalls. The Purchasing Department receives and distributes the alerts and recalls to staff. When notice of an equipment hazard or recall is received by Clinical Engineering, the Director or designee will ensure that the equipment inventory database is reviewed to determine if any NYUHC equipment is affected.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

If there are no devices of the type identified in the alert or recall, the Director or designee will: ƒ ƒ ƒ Initial the alert or recall and return to Purchasing. Notify Purchasing that no equipment of that type exists in the hospital. Make an appropriate entry in the Alerts records database.

If there is equipment in the inventory which has been identified in the alert or recall, the Director or designee will: ƒ ƒ ƒ ƒ ƒ ƒ ƒ ƒ Notify the Purchasing Department of the alert or recall. Notify the Department Manager of the alert or recall. Locate the equipment. Take the recommended steps described in the alert. Make an appropriate entry in the Alerts database. Document the actions on a work order in the equipment database for the particular medical equipment. Notify the department manager of the action taken. Notify the Purchasing department of the action taken.

The Director of Clinical Engineering will provide the Environment of Care Committee with a summary of the findings on a regular basis and actions taken to comply with the product alert or recall.

7.

Safe Medical Devices Act Reporting (EC.6.10.7)

NYUHC identifies and implements processes for monitoring and reporting incidents in which a medical device is suspected or attributed to the death, serious injury, or serious illness of any individual, as required by the Safe Medical Devices Act of 1990. All incidents related to medical devices where there is patient injury are evaluated for reporting under the requirements of the Safe Medical Device Act. Clinical Engineering follows the NYUHC Medical Staff Rules and Regulations for incident reporting. When contacted by a user department regarding service on a device that may have been involved in a patient injury, Clinical Engineering shall: (a) Ensure that the caller has notified their supervisor.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

(b)

(c)

(d) (e) (f) (g)

(h) (i)

Remind the caller that an incident report must be filled out and forwarded to either the Nursing Department Quality Assurance Manager or the Risk Management Department. Remind the caller that ALL ACCESSORIES, ATTACHMENTS, and DISPOSABLES such as tubing sets, infusion sets, leads, catheters, etc. are kept with the equipment (including packaging). Maintain the chain of custody on Part B of the Defective Equipment Tag. Sequester the device and accessories in the Clinical Engineering Director’s office. Inform Risk Management that the device has been delivered to Clinical Engineering and has been sequestered. Upon approval of the Director of Risk Management, Clinical Engineering shall perform a performance verification inspection, special note shall be made to control settings and operating mode of the device, as delivered to Clinical Engineering, (AT NO TIME WILL THE DEVICE BE DISASSEMBLED WITHOUT PRIOR APPROVAL OF THE DIRECTOR OF RISK MANAGEMENT) A report of the inspection findings shall be filed in the appropriate device history file, and a copy of the report forwarded to Risk Management. Upon approval of the Director of Risk Management, the device shall be released for either further inspection/testing, long term sequestering, or returned to service.

Clinical Risk Management manages the medical equipment incident reporting process. Reports of patient incidents come to the Clinical Risk Manager. Reports of staff member incidents, including user errors, are directed to appropriate department heads and Clinical Risk Management. Reports of equipment damage are received from the Clinical Engineering Management Program. When a staff member is involved in any type of incident, the appropriate department manager immediately investigates the incident. Cases involving patients and property are reviewed by the Clinical Risk Manager to determine if further investigation is required. Serious cases are considered as potential Sentinel Events and processed accordingly. The Clinical Risk Manager analyzes reported incidents and reports the results to the QA&I Committee. The analysis looks for patterns of behavior or circumstances that need to be addressed to reduce the risk of occurrence in the future. The incident reporting and investigation process is not used to measure the performance due to the extremely low volume of incidents. Each incident is evaluated as an event and appropriate follow up action is taken.

8.

Emergency Procedures (EC.6.10.8)

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

NYUHC identifies and implements processes for emergency procedures that address the following: • What to do in the event of equipment disruption or failure • When and how to perform emergency clinical interventions when medical equipment fails • Availability of backup equipment • How to obtain repair services Medical equipment, which meets NYUHC's criteria as critical to patient safety, has emergency procedures established for implementation in the event of the occurrence of an equipment malfunction or failure. Equipment considered critical to patient safety includes life support, life sustaining or other critical equipment whose malfunction or failure may result in an adverse patient outcome. NYUHC has developed specific policies and procedures for the response of all employees during disruption and failure of medical equipment. Our emergency procedures explain the type of failure, what to expect during the failure, who to contact for repair and how to reach them, what their clinical response should be, and we have also addressed possible alternate sources. Appropriate staff response, implemented in a timely manner is critical for the safety, of patients, visitors and staff.

EC.6.20 1. Inventory of Medical Equipment (EC.6.20.1) NYUHC documents a current, accurate, and separate inventory of all equipment identified in the medical equipment management plan, regardless of ownership. The Clinical Engineering department maintains record of all equipment identified in the plan regardless if it is owned or rented/leased equipment. It also ensures preventative maintenance records are maintained for equipment whether it is serviced by our own biomedical engineers or by outside vendors. Clinical Engineering maintains all this data via the computerized medical equipment tracking system, or manually with repair documentation completed by outside vendors in binders. The Director of Clinical Engineering ensures that all equipment included in the PM inventory is maintained as required by the set PM schedule. 2. Testing Before Initial Use (EC.6.20.2)

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

NYUHC documents performance and safety testing of all equipment identified in the medical management program before initial use. Clinical Engineering has developed a policy and procedures for the performance testing of any medical equipment to be complete either by clinical engineering staff, or by the manufacturer’s representatives with a member of the clinical engineering department witnessing the completion of all necessary acceptance and electrical safety checks before any equipment is use for patient care or treatment. Records of these tests are documented and maintained on file in the Clinical engineering department. 3. Maintenance of Life support Equipment (EC.6.20.3) NYUHC documents maintenance of equipment used for life support that is consistent with maintenance strategies to minimize clinical and physical risks identified in the equipment management plan Clinical Engineering has developed preventive maintenance procedures for all critical medical devices in the hospital. The preventive maintenance procedures are developed using the manufacturer's preventive maintenance recommendations, NFPA standards and ANSI standards. Our facility is continually reviewing equipment’s preventative maintenance records to ensure that inspection frequency match the equipment criticality or history of incidents. We also review the recommended life expectance for equipment use and look to schedule multi-year capital planning programs to replace older equipment over several years. This equipment replacement program and PM inspection ensures that we provide equipment which minimizes clinical and physical risk to patients. 4. Maintenance of Non-life Support Equipment (EC.6.20.4) NYUHC documents maintenance of non-life support equipment on the inventory that is consistent with maintenance strategies to minimize clinical and physical risks identified in the equipment management plan. Both medical equipment use for life support and non-life support are maintained on the same computerized medical equipment tracking system. This system is located in the Clinical Engineering office. The preventative maintenance procedures for these types of equipment are developed based on manufacturer’s recommendations and any incident history data.

5. Sterilizer Performance Testing (EC.6.20.5)

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

NYUHC uses various steam sterilizers, and documents performance testing of all sterilizers used. Performance testing is completed with each sterilization batch using a test strip and/or other procedures. These test’s results are reviewed by central processing and other user departments’ staff which log all this data in record books for each sterilizer. The Facilities Management Department also conducts a quarterly inspection of sterilizers to ensure they are operating properly and the results of the annual inspections are reported quarterly to the EOC by Clinical Engineering. 6. Renal Dialysis Water Testing (EC.6.20.6) NYUHC documents chemical and biological testing of water used in renal dialysis and other applicable tests based upon regulations, manufacturers’ recommendations, and hospital experience. NYUHC follows the AAMI standards. The testing is conducted regularly and results reported monthly to the Hemodialysis QA&I Committee. The number of tests done in a quarter is reported quarterly to the EOC Committee by Clinical Engineering.

Performance Monitoring The Director of Clinical Engineering manages performance monitoring for the MEMP. • At least once per calendar year, Clinical Engineering recommends goals to the EOC and one or more indicators that can be used to objectively measure the performance of the MEMP. Clinical Engineering also recommends appropriate data sources, data collection methods, data collection intervals, analysis techniques, and report formats for the indicators. These recommendations are based on information and data that have been collected and discussed by the EOC committee during the preceding year. As a rule, the indicators are recommended with a view towards monitoring important elements of the MEMP and providing a general sense of whether it is functioning effectively. The indicators are not intended to monitor all aspects of the plan. • Clinical Engineering incorporates the goals and indicators into the Annual Evaluations of the MEMP. The EOC committee discusses the goals and indicators and modifies them as needed before approving them. • Once indicators have been approved, Clinical Engineering collects and analyzes data and periodically reports to the EOC committee. The frequency of reporting varies depending on the indicators selected. However, data is reported at least once a year as part of the Annual Evaluation of the MEMP. • If warranted (e.g., when conditions change), Clinical Engineering may change indicators during the calendar year, as long as the EOC committee approves the changes.

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

At the time this plan was written, the Clinical Engineering Department was implementing the following Performance Indicators and Standards: 1. Preventive maintenance of life support equipment. Target 100% - A measure of compliance. Clinical Engineering completes scheduled preventive maintenance of life support equipment (defibrillators, ventilators, heart-lung bypass machines, and pacemakers). Preventive maintenance by of all equipment. Target >95% - A measure of compliance. Clinical Engineering completes scheduled preventive maintenance of all medical equipment (including life support equipment). Preventive maintenance by Radiology of all Radiology equipment. Target >95% - A measure of compliance. SIEMENS completes scheduled preventive maintenance of all radiological medical equipment. Operator / User Errors. Target <2% - A measure of training program effectiveness. Medical equipment users don’t request repairs / service because they don’t know how to use equipment. Patient Incidents. Target 0 - A measure of plan effectiveness. Medical equipment does not malfunction when it is being used on patients. Safe Medical Devices Act reporting. Target 100% - A measure of compliance. Risk Management reports patient incidents involving medical equipment in compliance with the Safe Medical Devices Act. Renal dialysis water. Target 100% - A measure of compliance. The hospital maintains proper documentation of chemical and biological testing of water used in renal dialysis. Preventive maintenance of sterilizers – Target >95%. A measure of compliance. Facilities Management completes scheduled preventive maintenance of sterilizers per hospital policy.

2.

3.

4.

5. 6.

7.

8.

The Clinical Engineering Department shall monitor Performance Improvement Indicators/Standards, Equipment Management Effectiveness Indicators/Standards, Corrective Maintenance Indicators/Standards, and performance regarding actual or potential risks through the following activities: • • Participating in hospital-wide environmental rounds, including Clinical Engineering Department environmental rounds, which are conducted monthly in patient care areas. Collecting and analyzing data on all services provided by Clinical Engineering Department on a monthly basis.

Annual Evaluation

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

Once each calendar year, the Director of Clinical Engineering drafts an Evaluation of the MEMP. The draft addresses the scope, objectives, performance and effectiveness of the plan. The draft includes the information on the following: • • • • • • Equipment inventory Management of the PM program Equipment repairs (turn-around time, call back within one month) Equipment failure, incidents reports, user errors Current level of performance Performance improvement plan of Clinical Engineering Department

The annual evaluation uses a variety of information sources including incident report summaries, meeting minutes, the EOC committee reports, and other summaries of activities. The draft evaluation provides a balanced summary of the MEMP performance over the preceding 12 months. Strengths are noted and deficiencies are evaluated to set goals for the next year or longer-term future. The draft Evaluation is distributed to the EOC Committee Distribution List for review and comment, and comments are incorporated. The final Evaluation is then presented to the EOC Committee for approval. The Chair of the EOC committee presents a summary of the evaluation to the Executive VP for Hospital Operations. The Executive VP communicates this information to the President of NYUHC, the PCQAOC and the Board of Trustees. Orientation and Training of Clinical Engineering Staff The Human Resources department conducts a general orientation twice a month. All staff members must complete the general orientation during the first thirty days of employment. Clinical Engineering staff is hired with at least an associate degree in clinical or electrical engineering and basic equipment repair skills either from previous work experience or from formal education programs. All staff get a department specific training session with regards the Medical Equipment management plan. In addition, Clinical Engineering staff members also receive a department-specific orientation, which includes activities related to inspection, testing and maintenance, repair of equipment and patient and staff equipment safety issues. The goal of the department orientation program is to provide new staff members with current

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

information regarding area-specific issues and departmental responsibilities. The medical equipment-training program addresses the following: • • • • • • The capabilities, limitations and special applications of equipment. Basic operating and safety procedures for equipment use. Emergency procedures in the event of equipment failure. Information and skills necessary to perform assigned maintenance responsibilities. Processes for reporting medical equipment management problems, such as failures and user errors. Personal safety including use of protective equipment and other OSHA recommendations as specific to the job.

Clinical equipment technicians are trained on the maintenance of new equipment either by the manufacturer or by other, more experienced technicians within the department. Equipment with low probability of failure and/or low risk level may not necessarily require formal training. New equipment to be repaired or maintained by Clinical Engineering is not placed in service until the vendor trains the Clinical Engineering staff on how to perform basic repairs. Moreover, repair manuals are required for new equipment and appropriate manufacturers technical support information is provided to the Clinical Engineering and user departments, as appropriate. The competency of staff is evaluated by the Supervisor as part of the annual appraisal process. If the Supervisor believes that a technician is not able to repair a specific type of equipment, he is immediately taken off that assignment until he is sufficiently retrained and demonstrates competency in repairing that equipment. This is done as per CE Policy 12. All staff members of the Clinical Engineering Department are required to participate in a mandatory continuing education and training program, and in-service training conducted regularly. Nursing In-service in collaboration with the manufacturer and with significant input from Clinical Engineering, trains nursing staff to use patient care equipment. Orientation and Education of Medical Equipment Users All staff that use medical equipment are trained in the use of such equipment prior to actual use on patients. The Nursing In-service Department is responsible for the training,

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NYU Hospitals Center Medical Equipment Management Plan (MEMP)

evaluating competency, and retraining of nursing personnel utilizing equipment. Other non-nursing personnel are trained on equipment use when and if necessary.

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