NYU Hospitals Center Of the NYU Langone Medical Center

MEDICAL EQUIPMENT MANAGEMENT PLAN

Approved by:

Signature:

Robert I, Grossman M.D.

Dean and Chief Executive Officer Aubrey Galloway, M.D.

Chairman, Medical Board Bernard A. Bimbaum, M.D.

Senior Vice President and Vice Dean Chief of Hospital Operations Kevin Hamfifan Senior Vice President for TisclVÿusk Hospital Operations David A. Dibner Senior Vice President for HJD Hospital Operations Paul Schwabacher, P.E. Sr. VP, Facilities Management Chair, Environment of Care Committee Tom Fascianella Director of HJD Loss Prevention Chaiÿ. Environment of Care Subcommittee, HJD

Rupert Kishun Director of Clinical Engineering

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Revised: August 8, 2012

NYU Hospitals Center Of the NYU Langone Medical Center MEDICAL EQUIPMENT MANAGEMENT PLAN

Approved by: Robert I, Grossman M.D. Dean and Chief Executive Officer Aubrey Galloway, M.D. Chairman, Medical Board Bernard A. Birnbaum, M.D. Senior Vice President and Vice Dean Chief of Hospital Operations Kevin Hannifan Senior Vice President for Tisch/Rusk Hospital Operations David A. Dibner Senior Vice President for HJD Hospital Operations Paul Schwabacher, P.E. Sr. VP, Facilities Management Chair, Environment of Care Committee Tom Fascianella Director of HJD Loss Prevention Chair, Environment of Care Subcommittee, HJD Rupert Kishun Director of Clinical Engineering

Revised: August 8, 2012

Signature:

NYU Hospitals Center Medical Equipment Management Plan Table of Contents Standard

EC.01.01.01 EC.02.04.01 EC.02.04.01 EC.02.04.01 EC.02.04.01 EC.02.04.01 EC.02.04.01 EC.02.04.03 EC.02.04.03 EC.02.04.03 EC.02.04.03 EC.02.04.03 EC.04.01.01 EC.04.01.01 EC.04.01.01

Subject Purpose Scope Objectives Responsibilities 1 The Board of Trustees 2 The Chief of Hospital Operations 3 The Senior Vice Presidents for Hospital Operations 4 All Senior Vice Presidents and Vice Presidents 5 The Chair of the Environment of Care Committee 6 The Chair of the NYUHJD Environment of Care Subcommittee 7 The Environment of Care Committee The NYUHJD Environment of Care Subcommittee 8 The Director of Clinical Engineering 9 The Senior Administrative Director of Clinical Laboratories and Director of Anatomic Pathology 10 The Director of Radiology 11 The Director of Nuclear Medicine (or designee) 12 The Director of Radiation Safety 13 The Directors of Quality Assessment and Improvement and Risk Management 14 Department heads 15 Staff who rent, lease or borrow medical equipment 16 All personnel who work at NYUHC Medical equipment management policies and procedures Managing medical equipment risks 1. Written medical equipment management plan (EP7) 2. Selecting and acquiring medical equipment (EP1) 3. Written inventory of medical equipment (EP2) 4. Written procedures for inspection, testing, and maintenance (EP3) 5. Criteria for inspection, testing, and maintenance (EP4) 6. Safe Medical Device Act Reporting (EP5) 7. Emergency procedures (EP6) Inspection, testing, and maintenance of medical equipment 1. Testing before initial use (EP1) 2. Maintenance of life support equipment (EP2) 3. Maintenance of non-life support equipment (EP3) 4. Performance testing of sterilizers (EP4) 5. Testing of hemodialysis water (EP5) Monitoring environmental conditions 1. Equipment problems, failures, and user errors (EP1, EP10) 2. Medical equipment damage (EP5) 3. Other performance monitoring 4. Annual evaluation (EP15)

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NYU Hospitals Center Medical Equipment Management Plan

PURPOSE

The Joint Commission (TJC) has specific requirements for medical equipment management planning. However, before TJC promulgated its requirements, NYU Hospitals Center (NYUHC) had established a comprehensive program for managing medical equipment. The purpose of this Medical Equipment Management Plan (MEMP) is to describe how NYUHC’s programs meet TJC’s requirements. This plan covers all hospitals and ambulatory care facilities operated by NYUHC. Where the location-specific details differ significantly, the MEMP summarizes the differences.

SCOPE

This MEMP covers the following facilities: Hospitals Address 301 E 17 St 550 1st Ave

Health Care Facility Hospital for Joint Diseases (HJD) Rusk Institute of Rehabilitative Medicine Tisch Hospital Health Care Center (HCC)

Note: The Tisch/Rusk campus is commonly referred to as the Superblock. Ambulatory Care Facilities Address 63 Downing St 305 2nd Ave 359 2nd Ave 614 2nd Ave 324 E 23 St

160 E 32 St 160 E 34 St 317 E 34 St 403 E 34 St

NYS DOH Article 28 Ambulatory Care Program Occupational and Industrial Orthopedic Center HJD Ambulatory Center Initiative for Women with Disabilities Harkness Center for Dance Injuries HJD Ambulatory Care Services Diabetes Foot and Ankle Center Wound Healing Center Hassenfeld Children’s Center (includes Fink program) Clinical Cancer Center Adult Infusion Center Rivergate Transplant and Epilepsy Centers -1-

NYU Hospitals Center Medical Equipment Management Plan Address 240 E 38 St

NYS DOH Article 28 Ambulatory Care Program Center for Multiple Sclerosis Center for Rusk Ambulatory Care (Rusk Home) Charles C. Harris Skin and Cancer Unit Outpatient Brain Injury and Vestibular Rehabilitation Pre-Admission Testing 333 E 38 St Center for Musculoskeletal Care 339 E 38 St Outpatient Surgery Center 221 Lexington Ave Center for Women’s Imaging 207 E 84 St Center for Women's Health 97-77 Queens Blvd Columbus Imaging and Infusion Center

OBJECTIVES

The main objectives of this MEMP are: 1) to properly manage medical equipment risks and to ensure patient safety through the appropriate acquisition, evaluation, and maintenance of medical equipment; and 2) to maintain the hospital’s compliance with federal and state regulations and relevant agencies' accreditation standards.

RESPONSIBILITIES

The administration and oversight of medical equipment management is primarily the responsibility of Clinical Engineering with some management and oversight of imaging equipment performed by the original equipment manufacturers under hospital contracts. The Electrical Shop is responsible for maintaining beds. Management of medical device incidents is primarily the responsibility of Risk Management. Management of equipment hazard notices and recalls is primarily the responsibility of the Purchasing Department. Other specific responsibilities are listed below: 1. The Board of Trustees Responsible for: Reviewing information and reports from the Environment of Care (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.

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NYU Hospitals Center Medical Equipment Management Plan 2. The Chief of Hospital Operations Responsible for: Reviewing information and reports about medical equipment and acting on them as needed. Reviewing and approving plans from the Senior Vice Presidents for Tisch/Rusk and NYUHJD for the space, equipment, and resources needed to manage medical equipment properly. Reviewing and approving recommendations for the resources needed to comply with the MEMP throughout NYUHC. 3. The Senior Vice Presidents for Hospital Operations Responsible for: Planning for the space, equipment, and resources needed to manage medical equipment at their facilities. Allocating the resources needed to comply with the MEMP at their facilities. 4. All Senior Vice Presidents and Vice Presidents Responsible for: Reviewing information and reports about hazardous medical equipment. Following up on medical equipment management deficiencies and trends identified during the Safety Officer’s semi-annual environmental rounds. Ensuring department heads and other personnel who report to them meet their responsibilities for implementing the MEMP. 5. 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 senior leadership and the Medical Board. 6. The Chair of the NYUHJD EOC Subcommittee Responsible for: Leading the NYUHJD EOC subcommittee in its efforts to ensure the NYUHJD campus has an effective medical equipment management program. Championing EOC committee recommendations about medical equipment to the Senior VP for NYUHJD and the EOC committee. 7. The EOC Committee The NYUHJD EOC Subcommittee (NYUHJD campus) These responsibilities are described in the Safety Management Plan.

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NYU Hospitals Center Medical Equipment Management Plan 8. The Director of Clinical Engineering Responsible for: Serving as the plan owner for the MEMP. Establishing and maintaining an inventory of selected equipment (including all life support equipment) categorized by physical risk associated with use and equipment incident history. 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 under the MEMP, which: assigns a unique identifier (Control Number) to each device; documents all inspections (initial and preventive maintenance) and all repair service performed on Patient Care Devices; communicates inspection dates to staff by indicating inspection date and expiration of preventive maintenance 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 preventive maintenance program for Patient Care Devices as designated by this program. Assigning each Patient Care Device, or class of devices, a preventive maintenance 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, 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 preventive maintenance 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, on departmental request or on as needed basis, 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. -4-

NYU Hospitals Center Medical Equipment Management Plan 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 the Joint Commission and the SMDA of l990. Removing any equipment from service if it is deemed to be unsafe for use. 9. The Senior Administrative Director of Clinical Laboratories and Director 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 documents all inspections (initial and preventive maintenance) 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 preventive maintenance program for all 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, 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 the Joint Commission and the SMDA of 1990. -5-

NYU Hospitals Center Medical Equipment Management Plan 10. 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 preventive maintenance 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, documents all inspections (initial and preventive maintenance) 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 preventive maintenance program for all Radiological Imaging Devices. Assigning each Radiological Imaging Device, or class of devices, a preventive maintenance 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 the Joint Commission and the SMDA of 1990.

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NYU Hospitals Center Medical Equipment Management Plan 11. 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 preventive maintenance and service reports to the Director of Clinical Engineering. 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 preventive maintenance) 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 preventive maintenance program for all Nuclear Medicine Patient Care Devices. Assigning each Nuclear Medicine Patient Care Device, or class of devices, a preventive maintenance 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 the Joint Commission and the SMDA of 1990. -7-

NYU Hospitals Center Medical Equipment Management Plan 12. Director of Radiation Safety Responsible for: Ensuring all x-ray imaging equipment used by Radiology and any other clinical service is subject to acceptance testing and subsequent scheduled radiation safety and quality assurance testing under the supervision of licensed Medical Physicists from the Radiation Safety Department as required by the NYS and NYC Health Codes. Such testing addresses the issue of whether the equipment is in compliance with the requirements of Article 175 of the NYC Health Code and is operating within the performance tolerance specified by the manufacturer. 13. 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 to investigate, document, and report 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. 14. 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 the Joint Commission 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. 15. Staff who rent, lease or borrow medical equipment Responsible for: Ensuring that all equipment is brought to Clinical Engineering to be evaluated for inclusion into the MEMP -8-

NYU Hospitals Center Medical Equipment Management Plan Ensuring that all accessories and manuals needed for the functional testing of the equipment are available to Clinical Engineering. Ensuring that equipment is brought back to Clinical Engineering for periodic preventive maintenance if it stays at NYUHC until the next preventive maintenance due date. Promptly notifying Clinical Engineering when equipment is returned or removed from NYUHC. 16. All personnel who work at NYUHC Responsible for: 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.

MEDICAL EQUIPMENT MANAGEMENT POLICIES AND PROCEDURES

The primary policies and procedure for the management of medical equipment are located in the Clinical Engineering Administrative Policy and Procedure Manual.

MANAGING MEDICAL EQUIPMENT RISKS

1. Written medical equipment management plan (EC.01.01.01, EP7) This management plan describes key processes NYU Hospitals Center has implemented in order to effectively manage the effective, safe and reliable operation of medical equipment. The plan is evaluated annually. It also is reviewed and updated as often as needed, but at least once every 3 years. 2. Selecting and acquiring medical equipment (EC.02.04.01, EP1) The hospital solicits input from individuals who operate and service equipment when it selects and acquires medical equipment. The hospital’s Supply Chain Management (SCM) department is responsible for the purchase of all medical equipment. Clinical Engineering provides guidance and direction in the selection of medical equipment through active involvement in the NYUHC capital process. Clinical Engineering also works with department managers and SCM to assist in the selection and purchase of non-capital medical equipment. Clinical Engineering works with departments to provide average life expectancy, inventory, and information on equipment that has had extensive repairs or is no longer -9-

NYU Hospitals Center Medical Equipment Management Plan supported by the manufacturer. NYUHC also subscribes to ECRI, a consumer research agency specializing in medical equipment. This service provides valuable research and comparative tools for use in requesting medical equipment. 3. Written inventory of medical equipment (EC.02.04.01, EP2) The hospital maintains a written inventory of selected medical equipment (including all life support equipment) categorized by physical risk associated with use and equipment incident history and evaluates new types of equipment before initial use to determine whether they should be included in the inventory. All electrical patient care equipment regardless of ownership is included in the MEMP. Clinical Engineering maintains a database documenting all equipment identified in the MEMP. Siemens maintains an inventory of all imaging equipment with Clinical Engineering having an oversight of the maintenance activities. The Electrical Shop, in conjunction with Hill-Rom (a bed manufacturer) manages the inventory and service of patient beds. Items are inspected prior to use in accordance with all applicable policies and procedures. This includes hospital owned equipment as well as loaner, demo, and physician-owned. Identification of medical equipment with clinical alarm systems is also completed during the initial inspection process to ensure proper placement in the medical equipment management program. SCM requests that all medical equipment be delivered to Clinical Engineering, with the exception of large installed pieces, e.g., Radiology rooms, Lab Analyzers. Clinical Engineering ensures an incoming inspection on equipment includes verification of accessories, manuals, electrical safety, and operation in accordance with all applicable policies. At this time, Clinical Engineering will also assess the piece of equipment or system for inclusion in the equipment management program. 4. Written procedures for inspection, testing, and maintenance (EC.02.04.01, EP3) The hospital identifies the activities, in writing, for maintaining, inspecting, and testing for all medical equipment on the inventory. Clinical Engineering uses a combination of maintenance strategies on equipment included in the medical equipment management program. Clinical Engineering uses predictive maintenance for repairs such as battery replacement. Clinical Engineering uses interval-based inspections (scheduled preventive maintenance) for those items that are have a Severity Index of 10 or above or as determined by Institutional experience. Clinical Engineering uses metered maintenance, based on hours of use, for items such as ventilators. Clinical Engineering also performs corrective maintenance as requested by user departments or as required because of discoveries during scheduled preventive, metered maintenance or departmental rounds. The checklists for the maintenance of all medical equipment under the MEMP are stored under in the equipment respective database files and are serviced using a combination of manufacturers’ recommendations and our own experience with the equipment. However, the manufacturers’ recommendations for schedules parts replacements are strictly followed. - 10 -

NYU Hospitals Center Medical Equipment Management Plan 5. Criteria for inspection, testing, and maintenance (EC.02.04.01, EP4) The hospital identifies, in writing, frequencies for inspecting, testing, and maintaining medical equipment on the inventory based on criteria such manufacturers’ recommendations, risk levels, or current hospital experience. Clinical Engineering sets intervals for inspecting and testing equipment included in the management program by determining a risk ranking and assigning the appropriate preventive maintenance frequency. That risk ranking is comprised of a score for equipment function, failure risk, and corrective history. Using risk-based criteria (outlined in the table below), including equipment function and failure risk and corrective history, Clinical Engineering assigns equipment to a preventive maintenance frequency of quarterly, semi-annually, annually, or preventive maintenance upon repairs. All equipment regardless of the preventive maintenance frequency is included in the equipment management program. Corrective histories are also maintained for every piece of equipment. The inspection interval is based on the severity index, manufacturer’s recommendation, equipment incident history, and specific hospital experience. 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. The following shall be the minimum acceptable inspection interval standards derived from the table below: Severity index = 0 to 9 - Preventive maintenance upon repairs. Severity Index =10 to 15 - Annual preventive maintenance Severity Index =16 to 20 - Semi-annual preventive maintenance A.

Equipment Function

Category THERAPEUTIC (Devices that apply some form of energy)

Score 10

9 8

DIAGNOSTIC (Devices used to diagnose patient ailments)

7

Type Life Support; Radiation Therapy Surgical and Intensive Care Physical Therapy and Treatment Surgical & critical care monitoring; radiology systems

Definition Devices used to support life; devices used for radiation therapy Devices therapeutic in nature, but alone don’t support life Devices intended to treat a patient’s ailment Monitors & modules used in the surgical or critical care environment; radiology systems

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Examples Defibrillator, ventilator, Anesthesia machine, Heart Lung machine. Electrosurgical unit, laser Dialysis machine, infusion pump, traction unit, diathermy EEG machine, noninvasive blood pressure monitor, x-ray generator

NYU Hospitals Center Medical Equipment Management Plan Category

Score 6

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

5

4 3 2 1

B.

Type Additional physiological monitoring and diagnostics Analytical laboratory Laboratory accessories Computer and related Patient related Non-patient related; test equipment

Examples adult scale, tympanic thermometer, ultrasound unit

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

Physical Risk Associated With Clinical Application

Category PATIENT DEATH

Score 5

PATIENT OR OPERATOR INJURY INAPPROPRIATE THERAPY OR MISDIAGNOSIS MINIMAL RISK

4

NO SIGNIFICANT RISK

1

C.

Definition Devices not routinely used in critical care environment

3 2

Definition Failure of the device could result in the death of a patient 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

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 xray system Defibrillator, infusion pump, electrosurgical unit, traction unit Lab microscope, scales, general medical device Exam light, computer terminal, video camera

Exam light, computer terminal, video printer

Maintenance Requirements

Category EXTENSIVE

Score 5

ABOVE AVERAGE

4

AVERAGE

3

BELOW AVERAGE

2

MINIMAL

1

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NYU Hospitals Center Medical Equipment Management Plan The Director of Clinical Engineering shall obtain written approval from NYUHC’s EOC committee acknowledging the list of equipment types that are excluded from the preventive maintenance program, and thus will receive no periodic maintenance. 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. Clinical Engineering conducts periodic evaluations to determine the preventive maintenance frequency or the necessity and effectiveness of performing scheduled preventive maintenance on specific types of devices. Devices that have exceedingly low failure rates (less than 5% of all preventive maintenance performed per device type for the last 3 years), no preventive maintenance replacement parts, or do not require calibration may have their preventive maintenance frequency reduced or removed from the preventive maintenance schedule upon approval by the EOC committee. 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. Clinical Engineering assigns different colors of preventive maintenance stickers to equipment based on the preventive maintenance interval for that equipment. Based on these preventive maintenance intervals, annual preventive maintenance cycles are established for each location. 6. Safe Medical Devices Act Reporting (EC.02.04.01, EP5) The hospital monitors and reports all incidents in which medical equipment is suspected in or attributed to the death, serious injury, or serious illness of any individual, as required by the Safe Medical Devices Act of 1990. All equipment hazard notices and recalls are coordinated through SCM. Information on hazard notices or recalls that apply to medical equipment are sent electronically to all managers of departments or patient units that use medical equipment. Clinical Engineering will follow all applicable policies and procedures, including checking the Clinical Engineering database to determine the presence of affected equipment and completing and documenting any appropriate work. The Director of Risk Management has the overall responsibility of implementing and managing the hospital’s medical device reporting program. This includes establishing and maintaining a hospital-wide system for documenting medical device incidents, reviewing and analyzing all reportable incidents, and completing and submitting appropriate reports to outside agencies. Following an incident, NYUHC personnel will attend to the injured patient or employee as appropriate and sequester all equipment involved in the incident including accessories, packaging, etc. NYUHC personnel will report the incident to their immediate supervisor and notify Risk Management. The Electronic Reporting System (ERS) is also available on the intranet for reporting medical device issues. - 13 -

NYU Hospitals Center Medical Equipment Management Plan Clinical Engineering will assist Risk Management in conducting an investigation, evaluating the safety of the device, and determining whether the device should be impounded, repaired, further investigated, or returned to service. A summary of significant medical device incidents will be reported to the appropriate Patient Safety or EOC committee on at least a quarterly basis. 7. Emergency procedures (EC.02.04.01, EP6) The hospital has written procedures to follow when medical equipment fails, including using emergency clinical interventions and backup equipment. Emergency clinical interventions that are necessary if a piece of medical equipment fails are established by the equipmentusing department. The Clinical Engineering department is staffed 8:30 AM - 8:30 PM Monday through Saturday both campuses. Emergency coverage is provided on a 24 hour, seven-day-a-week basis through use of on-call telephone tree located with the Night and Weekend Administrators and with the hospitals’ operators. Users of medical equipment have several different methods of obtaining repair services. Users may notify Clinical Engineering of the need for service during regular rounds performed by the Clinical Engineering department, by calling the main shop phone number, by bringing the piece of equipment to the Clinical Engineering department, or by calling through the on-call system. Should a piece of medical equipment malfunction or fail, hospital staff should first ensure the safety of the patient, by removing the piece of equipment from service, label it, and notify Clinical Engineering through one of the methods listed above. The user establishes when and how to perform emergency clinical interventions when medical equipment fails. Backup equipment is available for many types of equipment within the user department and through loaners or spares maintained by Clinical Engineering.

INSPECTION, TESTING, AND MAINTENANCE OF MEDICAL EQUIPMENT

1. Testing before initial use (EC.02.04.03, EP1) Clinical Engineering is notified by Supply Chain Management or user departments when medical equipment is received into the hospital. Clinical Engineering performs an initial inspection including testing of clinical alarms, functional and electrical safety inspections (where applicable) in accordance with all applicable policies and procedures before initial use. Medical equipment identified for inclusion into the MEMP is assigned a Clinical Engineering control number. . Information from these inspections are documented and entered into a database. 2. Maintenance of life support equipment (EC.02.04.03, EP2) 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 - 14 -

NYU Hospitals Center Medical Equipment Management Plan management plan. A 100% preventive maintenance compliance rate is targeted for all equipment identified as Life Support Equipment. 3. Maintenance of non-life support equipment (EC.02.04.03, EP3) 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. 4. Performance testing of sterilizers (EC.02.04.03, EP4) Central Sterile department documents performance testing or biological cultures on all sterilizers used. This information is reported at their respective Quality Improvement Committee or Infection Prevention and Control Committee meetings. Facilities Management provides maintenance support on sterilizers at NYUHC and NYUHJD. Clinical Engineering provides quarterly reports on the preventive maintenances of the sterilizers to the EOC committee. 5. Testing of hemodialysis water (EC.02.04.03, EP5) Chemical testing of dialysis RO product water is performed quarterly. Bacterial and endotoxin measurements are completed monthly. Chlorine testing is done every four hours. Results are reported monthly to the Hemodialysis QA&I committee by Hemodialysis personnel. Medical equipment maintenance in the department is reported quarterly by Clinical Engineering to the EOC committee. Corrective action is taken for any value outside of AAMI limits.

MONITORING ENVIRONMENTAL CONDITIONS

1. Equipment problems, failures, and user errors (EC.04.01.01 EP1. EP10) The Director of Patient Safety manages the electronic incident reporting system. Personnel are trained to immediately report all medical and laboratory equipment incidents, regardless of severity. All medical and laboratory equipment management failures are investigated by Clinical Engineering reported to quarterly to the EOC committee. One indicator used by Clinical Engineering is the percentage of user errors to the number of corrective maintenance performed. The target has been set at ≥ 2%. If the percentage of user error goes above this threshold, Clinical Engineering investigates the causes and works with nursing leadership and Nursing Education to provide training to a staff or group of staff as appropriate. - 15 -

NYU Hospitals Center Medical Equipment Management Plan 2. Medical equipment damage (EC.04.01.01, EP5) Clinical Engineering tracks the damage to the hospital’s medical equipment through the user error percentage that is reported quarterly. The user error percentage includes error codes from improper use of equipment or accessories as well as equipment damage. When the user error metric goes above the target of 2%, Clinical Engineering investigates the causes and if codes for equipment damage are identified as the contributing factors for the increase in the metric, then the causes for the damage are investigated and corrected through education and/or manufacturers. 3. Other performance monitoring – see Environmental Safety Management Plan, pages 2021. 4. Annual evaluation – see Environmental Safety Management Plan, page 21.

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