Medical Equipment Management Plan

7/27/2019 Medical Equipment Management Plan

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Revised: December, 2005

NYU HOSPITALS CENTER

MEDICAL EQUIPMENT

MANAGEMENT PLAN

Eric Rackow, M.D. 4/27/06

President

Max Cohen, M.D. 4/26/06

Chief Medical officer

John P. Harney 4/27/06

Executive Vice President & Chief Operating Officer

Sandra Iberger 5/21/06

Vice President & Chair Environment of Care Committee

Amy Horrocks 4/19/06

Vice President

Azhar Siddiqui 4/18/06

Director, Clinical Engineering


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NYU Hospitals Center

Medical Equipment Management Plan (MEMP)

Revised: December, 2005

Table of Contents

Subject Page

Purpose 1

Scope 2

Fundamentals 2

Objectives 3

Responsibilities

1. The Board of Trustees2. The President of NYU Hospitals Center3. 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 Engineering7.

The Senior Administrative Director of Clinical Laboratories andManager of Anatomic Pathology

8. The Director of Radiology9. The Director of Nuclear Medicine (or designee)10.The Director of Radiation Safety11.The Directors of Quality Assessment and Improvement and Risk

Management

12.Department Heads13.Staff who rent, lease or borrow medical equipment14.Staff

4

4

4

4

4

6

7

8

9

9

10

11

11

11

11

12

JCAHO

Standard

EC 6.10

EC 6.20

EC 9.10

Processes

1.

Written Plan2. Selecting and Acquiring Medical Equipment3. Risk Criteria for Inventory of Medical Equipment4. Strategies for Maintaining Medical Equipment5. Scheduled Maintenance6. Medical Equipment Hazard Notices and Recalls7. Safe Medical Device Act Reporting8. Emergency Procedures1. Inventory of Medical Equipment2. Testing Before Initial Use3. Maintenance of Life Support Equipment4. Maintenance of Non-life Support Equipment5.

Sterilizer Performance Testing6. Testing of Dialysis Water

Performance Monitoring

Annual Evaluation

1212

13

15

16

21

22

24

24

25

25

25

2626

26

28

Orientation and Training of Staff

Orientation and Education of Medical Equipment Users

28

30


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Page 1

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

theMedical Equipment Management Plan (MEMP) is to describe how NYUHCs

programs meet JCAHO requirements.

TheMEMP supports a safe patient care and treatment environment by managing risks

associated with the use of clinical equipment technology. TheMEMP 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 theMEMP 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 thisMEMP, which focuses on patientsafety.

TheMEMP 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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Page 2

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 Childrens 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 AvenueThe Hospital for Joint Diseases maintains a separateMedical Equipment ManagementPlan, which is consistent with this plan.

TheMEMP 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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Taken into consideration are regulatory requirements, manufacturers recommendations,

and professional experience and judgment. Inspection intervals are established based

upon regulatory and/or manufacturers recommendations, known risks and hazards.

Intervals can also be changed by statistical data showing that a longer interval would notadversely 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,

theMEMP establishes procedures for researching and selecting new medical equipmenttechnology.

TheMEMP 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.

TheMEMP establishes processes for managing those aspects of clinical equipment that

have a potential to harm patients and staff.

OBJECTIVES

The main objectives of this writtenMEMP 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 thatmeets the needs and preserves the safety of patients and patient care providers.

To increase operational reliability and functionality of medical equipment throughpreventive 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.


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To manage medical equipment by use of PM, calibration, testing and inspection ofthe equipment; and by maintaining documentation of the status of the equipment.

To collect information about problems, failures, malfunctions and user errors, toallow 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 equipmentmanagement, 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 TrusteesResponsible for:

Reviewing information and reports from the EOC Committee, HospitalAdministration and other hospital personnel about medical equipment and acting

on them as needed.

Communicating concerns about medical equipment to Hospital Administrationand other appropriate personnel as needed.

2. The President of NYUHCResponsible for:

Allocating the resources needed to comply with theMEMP. 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 ExecutiveCommittee of the Medical Board (ECMB), and forwarded from that committeethrough the hospitals 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 PresidentsResponsible for:


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Reviewing information and reports about EOC issues, and acting on them asneeded.

Ensuring Department Heads meet their responsibilities for implementing theMEMP.

4. The Chair of the Environment of Care (EOC) CommitteeResponsible for:

Leading the EOC committee in its efforts to ensure that NYUHC has an effectivemedical equipment management program.

Championing EOC committee recommendations about medical equipment to theExecutive VP for Hospital Administration and senior leadership.

5. Environment of Care CommitteeResponsible for:

a. Reviewing, discussing and approving key documents and criteria developed byPlan Owners for their plans, including:

Written plansGoals and objectivesPerformance measuresAnnual evaluations of plan objectives, scope, performance and effectivenessSafety policies, and other key policies and procedures

b. Examining information, data and reports submitted by the Plan Owners, includingthe following:

Information on pertinent regulations, standards, guidelines and codes

Risk assessments and hazard vulnerability analysesReports from sub-committees, task forces and other committeesPerformance monitoring reportsHazard surveillance reportsIncident reportsReports of inspections by outside agencies; citations, summons and/or

violations

Statistical and anecdotal data on environment of care issuesDrill critiquesReports 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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e. Analyzing identified environment of care issues and developing recommendationsfor resolving them.

f. Referring issues/recommendations to appropriatepersonnel/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 issuesdiscussed, recommendations, actions taken and any follow-up.

6. The Director of Clinical EngineeringResponsible 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 allthe 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 andexpiration of PM on equipment,

records all Safe Medical Devices Act (SMDA) 1990 and all recall actions onPatient Care Devices, and

identifies equipment failures that are due to improper maintenance, operatorerror, abusive actions, and EMI activity or recall activity.

Establishing and maintaining a PM program for Patient Care Devices asdesignated 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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equipment incident history, including known SMDA 1990 activity and recallhistory,

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 inventorystatus 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/orRisk 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 theMEMP.

Establishing, implementing and maintaining a training program for patient careequipment 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 thatare available for use.

Establishing and maintaining an equipment management system for all theappropriate clinical laboratory devices (or using the Clinical Engineering system)

which:

assigns a unique identifier number to each device, serial number or controlnumbers


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documents all inspections (initial and PM) and all repair service performed onclinical 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 laboratorydevices.

Coordinating, implementing, and documenting the initial inspection of all clinicallaboratory 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. Screeningproposed purchases for maintenance concerns, applicable ECRI evaluation and


initiatives.

At the request of the Director of Quality Assessment and Improvement and/orRisk Management, assisting in the investigation, evaluation and documentation of

clinical laboratory devices involved in patient incidents, in accordance with theSMDA 1990 requirements.

Maintaining appropriate references, standards, specifications and other documentsin support of theMEMP.

Establishing, implementing and maintaining a training program for clinicallaboratory device maintainers that meet the requirements of JCAHO and the

SMDA of 1990.

8. The Director of RadiologyResponsible for:

Establishing and maintaining an inventory of all Radiological Imaging Devicesthat are available for use.

Responsible for providing regular PM and service reports to the Director ofClinical Engineering.

Establishing and maintaining an equipment management system for RadiologicalImaging Devices (or using the Clinical Engineering system), which:

assigns a unique identifier number to each device,


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documents all inspections (initial and PM) and all repair service performed onRadiological 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 ImagingDevices.

Assigning each Radiological Imaging Device, or class of devices, a PM schedule(annual, semi-annual, or quarterly) based on manufacturers recommendations

and other manufacturer or regulatory agency recommendations. The EOC

Committee shall approve such schedule.

Controlling, coordinating and documenting all repairs of Radiological ImagingDevices.

Coordinating, implementing, and documenting the initial inspection of theRadiological 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.



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.


Establishing, implementing and maintaining a training program for radiologicalimaging 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 ofClinical Engineering.


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Establishing and maintaining an equipment management system for all theNuclear 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 PatientCare Devices,

identifies equipment failures that are due to improper maintenance, operatorerror, abusive actions, EMI activity, or recall activity.

Establishing and maintaining a PM program for all Nuclear Medicine PatientCare Devices.

Assigning each Nuclear Medicine Patient Care Device, or class of devices, a PMschedule (annual, semi-annual, or quarterly) based on evaluation of the following

criteria:

The manufacturers recommendations and/or other manufacturer or regulatoryagency recommendations. The EOC Committee shall approve such schedule.

Controlling, coordinating and documenting all repairs of Nuclear MedicinePatient Care Devices.

Coordinating, implementing, and documenting the initial inspection of all NuclearMedicine 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 programand reporting activities;


hazard reports, recall history, and applicable institutional equipment

standardization initiatives;

At the request of the Directors of Quality Assessment and Improvement and/orRisk 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.


Establishing, implementing and maintaining a training program for NuclearMedicine Patient Care Device maintainers that meet the requirements of JCAHO

and the SMDA of 1990.

10.Director of Radiation SafetyResponsible for:


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Ensuring all X-ray imaging equipment used by Radiology and any other clinicalservice 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 ManagementResponsible for:

Ensuring that NYUHCs reporting policies and procedures address the steps to befollowed for reporting and resolving equipment related incidents.

Complying with hospital procedure for to investigate, document and repors asnecessary 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 ofequipment related incident reporting and investigations.

12.Department HeadsResponsible for:

Implementing methods and procedures to assist department personnel incomplying with theMEMP.

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, privatelyowned, or other equipment prior to being put into use.

Ensuring that staff education and training on the operation of equipment isperformed 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 CareDevices 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 equipmentResponsible for:

Ensuring that all equipment is brought to Clinical Engineering for incominginspection,

Ensuring that all accessories and manuals needed for the functional testing ofthe equipment are available to Clinical Engineering.


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Ensuring that equipment is brought back to Clinical Engineering for periodicPMs if it stays at NYUHC longer than the next PM due date.

Promptly notifying Clinical Engineering when equipment is returned orremoved from NYUHC.

14. StaffResponsible 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 pertinentproblems.

PROCESSES

TheMEMP 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 inthe hospitals 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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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 afternegotiations 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 pre-

purchase 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 doesnt 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 possibleIf 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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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 theClinical 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. (Nonpatient 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. Presence of all accessories required for proper operation.2. Presence of Operators Manuals and Technical Service Manuals, and Schematics.3.

Proper operation of the equipment as specified in the performance specificationsin the manufacturers service literature.

4. Passage of electrical safety requirements as specified by NFPA, and otherapplicable agencies.

5. Inclusion into, or exclusion from, the Medical Equipment Management Program.6. 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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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 ControlNumber 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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Preventive Maintenance (PM) Medical equipment is subject to effective periodicmaintenance, 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 specificmedical 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 uponcriteria 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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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 conveniencedevices

physical risk maintenance (PM) incident history, and environment useEach 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:

Category Score Type Definition Examples

THERAPEUTIC(Devices that apply

some form of

energy)

10 LifeSupport;

Radiation

Therapy

Devices used to supportlife; devices used for

radiation therapy

Defibrillator,ventilator,

pacemaker, infant

incubator

9 Surgical and

Intensive

Care

Devices therapeutic in

nature, but alone dont

support life

Electrosurgical unit,

laser

8 Physical

Therapy and

Treatment

Devices intended to treat a

patients ailment

Dialysis machine,

infusion pump,

traction unit,

diathermy

DIAGNOSTIC(Devices used to

diagnose patient

ailments)

7 Surgical &critical care

monitoring;

radiology

systems

Monitors & modules usedin the surgical or critical

care environment;

radiology systems

EEG machine, non-invasive blood

pressure monitor,

x-ray generator

6 Additional

physiologica

Devices not routinely used

in critical care

adult scale, tympanic

thermometer,


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l monitoring

and

diagnostics

environment ultrasound unit

ANALYTICAL

(Devices primarily

used outside the

5 Analytical

laboratory

Devices used in the

clinical laboratory to

perform diagnostic testing

of specimens

blood gas analyzer,

clinical chemistry

analyzer, cell counter

patient care area

that provide

information

4 Laboratory

accessories

Devices used to prepare

specimens for analysis

shaker, centrifuge,

incubator, microtome

to assist in the

diagnosis of

patient.)

3 Computer

and related

Devices used to record,

print, gather, or distribute

data

computer, ticket

printer, QC system

MISCELLANEOUS 2 Patientrelated Devices related to patientcare, but not directly used X-ray view box,sterilizer, chair lift

1 Non-patient

related; test

equipment

Devices unrelated to

patient care

ECG simulator,

office equipment,

kitchen equipment,

UPS

B. PHYSICAL RISK ASSOCIATED WITH CLINICAL APPLICATION

Physical risk will be evaluated on a scale from 1 to 5 as follows:

Category Score Definition ExamplesPATIENT DEATH 5 Failure of the device could result

in the death of a patient

Defibrillator,

ventilator, anesthesia

machine

PATIENT OR

OPERATOR INJURY

4 Failure not likely to cause death

but may result in injuries

Hypo/hyperthermia

unit, laser,

electrosurgical unit

INAPPROPRIATE

THERAPY OR

MISDIAGNOSIS

3 Failure could result in

misdiagnosis or improper therapy

ECG machine, blood

gas analyzer,

centrifuge

MINIMAL RISK 2 Failure not likely to cause any

adverse outcome with the patientor affect safety of patients or staff

Gel warmer, heat

sealer, suction pump

NO SIGNIFICANT RISK 1 Failure will not cause an adverse

outcome with the patient or affect

patient or staff safety

Exam light, computer

terminal, video

printer


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C. MAINTENANCE REQUIREMENTSMaintenance requirements will be evaluated on a scale from 1 to 5 as follows:

Category Score Definition Examples

EXTENSIVE 5 Devices that are predominantly

mechanical, pneumatic, or fluidic

in nature

Dialysis machine,

ventilator, anesthesia

machine, x-ray table

ABOVE AVERAGE 4 Devices that have mechanical,

pneumatic, or fluidic components,

but are primarily electronic in

nature

Infant incubator,

blood warmer, laser,

portable x-ray system

AVERAGE 3 Devices that need only

performance verification and

safety testing, primarily

electronic in nature

Defibrillator, infusion

pump, electrosurgical

unit, traction unit

BELOW AVERAGE 2 Devices that require less

extensive testing of performance

Lab microscope,

scales, general

medical device

MINIMAL 1 Devices that may require only

visual inspection

Exam light, computer

terminal, video

camera

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.

B. All equipment that receives a maintenance requirement score of 4 or 5

shall be included in the preventive maintenance program, regardless of theseverity index.

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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6. The Director of Clinical Engineering shall obtain written approval from the

hospitals EOC Committee acknowledging the list of equipment types that are

excluded from the preventive maintenance program, and thus will receive no

periodic maintenance.

7. 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 = 10 to 15 = annual periodic maintenance

required

Severity Index = 16 to 20 = semiannual periodic maintenance

required

B. 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 PMs 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

manufacturers recommendations. This policy may be extended to other highly

specialized devices where practical experience is limited.


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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 reduceuser 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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If there are no devices of the type identified in the alert or recall, the Director or designee

will:

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:

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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(b) Remind the caller that an incident report must be filled out and forwarded toeither the Nursing Department Quality Assurance Manager or the Risk

Management Department.

(c) Remind the caller that ALL ACCESSORIES, ATTACHMENTS, andDISPOSABLES such as tubing sets, infusion sets, leads, catheters, etc. are kept

with the equipment (including packaging).

(d) Maintain the chain of custody on Part B of the Defective Equipment Tag.(e) Sequester the device and accessories in the Clinical Engineering Directors office.(f) Inform Risk Management that the device has been delivered to Clinical

Engineering and has been sequestered.

(g) Upon approval of the Director of Risk Management, Clinical Engineering shallperform 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 RISKMANAGEMENT)

(h) A report of the inspection findings shall be filed in the appropriate device historyfile, and a copy of the report forwarded to Risk Management.

(i) Upon approval of the Director of Risk Management, the device shall be releasedfor 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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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 servicesMedical 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 ClinicalEngineering 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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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 testingof any medical equipment to be complete either by clinical engineering staff, or by the

manufacturers 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 theequipment 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 equipments 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 manufacturers recommendations and any incidenthistory data.

5. Sterilizer Performance Testing (EC.6.20.5)


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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 tests results are reviewed by central processing

and other user departments staff which log all this data in record books for eachsterilizer. 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. Thenumber 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 theEOC and one or more indicators that can be used to objectively measure the

performance of theMEMP. Clinical Engineering also recommends appropriatedata 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 theMEMP 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 AnnualEvaluations of theMEMP. 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 analyzesdata and periodically reports to the EOC committee. The frequency of reportingvaries depending on the indicators selected. However, data is reported at least

once a year as part of the Annual Evaluation of theMEMP.

If warranted (e.g., when conditions change), Clinical Engineering may changeindicators during the calendar year, as long as the EOC committee approves the

changes.


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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 measureof compliance. Clinical Engineering completes scheduled preventive

maintenance of life support equipment (defibrillators, ventilators, heart-lung

bypass machines, and pacemakers).

2. Preventive maintenance by of all equipment. Target >95% - A measure ofcompliance. Clinical Engineering completes scheduled preventive maintenance

of all medical equipment (including life support equipment).

3. Preventive maintenance by Radiology of all Radiology equipment. Target>95% - A measure of compliance. SIEMENS completes scheduled preventive

maintenance of all radiological medical equipment.

4. Operator / User Errors. Target 95%. A measure ofcompliance. Facilities Management completes scheduled preventive maintenance

of sterilizers per hospital policy.

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 ClinicalEngineering Department environmental rounds, which are conducted monthly inpatient care areas.

Collecting and analyzing data on all services provided by Clinical EngineeringDepartment on a monthly basis.

Annual Evaluation


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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 DepartmentThe 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 theMEMP 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 thePresident 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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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 asfailures and user errors.

Personal safety including use of protective equipment and other OSHArecommendations as specific to the job.

Clinical equipment technicians are trained on the maintenance of new equipment eitherby 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 appraisalprocess. 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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evaluating competency, and retraining of nursing personnel utilizing equipment. Other

non-nursing personnel are trained on equipment use when and if necessary.

Medical Equipment Management Plan

Documents

Transcript of Medical Equipment Management Plan