POLICY AND PROCEDURE MANUALDUKE UNIVERSITY HEALTH SYSTEM

Medical Equipment Management Plan

2013

Page 1

POLICY:

To define the types of equipment supported by the Clinical Engineering department.To establish responsibilities for equipment maintenance and support.

PURPOSE:

To provide a quality oriented clinical equipment service management program which meets operational,financial and regulatory requirements.

PROCEDURE:

Clinical Engineering shall:

A. Repair, maintain, or manage the maintenance of diagnostic, therapeutic, and monitoringequipment used to treat Duke University Health System patients.

B. Test and ensure the operating safety of clinical equipment utilized at Duke University Hospitalaccording to requirements set forth by JCAHO, OSHA, NFPA, and other appropriate regulatoryagencies.

C. Maintain a facility Equipment Inventory List for the devices specified above.

D. Perform and document all required safety, corrective and preventive maintenance actions for thedevices specified above. Clinical alarms will be tested for functionality and audibility during thePM inspection.

E. Affect immediate and timely repair of all clinical equipment found to be malfunctioning and/oroperating outside the required safety standards.

F. Maintain a paperless Historical Data File for each listed device to include all repair andmaintenance actions performed.

G. Provide documentation, upon request, to each using area detailing all work accomplished and theequipment status.

H. Inspect all Clinical Equipment prior to its initial use and at intervals to be identified utilizing aRisk Based evaluation system.

I. Provide a quality assurance program to validate the performance of the Clinical Engineeringprogram. (RE: CE-012)

J. Continually review, monitor and when appropriate, address any and all pertinent regulatorychanges, including but not limited to:

1. FDA (Safe Medical Devices Act) (RE: Policy CE-009)2. JCAHO3. NFPA4. OSHA5. Other Regulatory Agencies

POLICY AND PROCEDURE MANUALDUKE UNIVERSITY HEALTH SYSTEM

Medical Equipment Management Plan

2013

Page 2

RISK FACTOR CRITERIA FOR INCLUSION IN THE EQUIPMENT MANAGEMENT PROGRAM

The following criteria will be used to determine if a piece of equipment will be included inEquipment Management Program. The three factors that will be measured to determine inclusioninto the Equipment Management Program are: Equipment Function, Clinical Risk and CorrectiveHistory.

1. Equipment Function: This is best defined as the role the equipment may play in patient care andHospital/Departmental support. The area which particular pieces of equipment serve shall beconsidered when evaluating equipment function using the table below.

EQUIPMENT FUNCTION TABLE

Life Support 9Critical Therapeutic 8Critical Diagnostic 7Essential Therapeutic 6Essential Diagnostic 5Ancillary Therapeutic 4Ancillary Diagnostic 3Miscellaneous Therapeutic 2Miscellaneous Diagnostic/Other 1

2. Clinical Risk: Considers the question of the possible consequences to patients and staff in theevent of equipment failure, which could result in death, injury, misdiagnosis, disruption ofservices or loss of critical materials using the table below.

CLINICAL RISKS TABLE

Patient Death 7Patient or Operator Injury 6Inappropriate Therapy, Misdiagnosis 5or loss of Critical MaterialsDisruption of Patient Services 4Minimal Risk 3No Risk 1

3. Corrective History: The number of corrective work requests that have occurred with the specificdevice in the last 12 month period. This number may range from 1 to 5, based upon the tablebelow:

POLICY AND PROCEDURE MANUALDUKE UNIVERSITY HEALTH SYSTEM

Medical Equipment Management Plan

2013

Page 3

CORRECTIVE HISTORY TABLE

Corrective Factor Number of Corrective Actions (12 Month Period)1 0-1 Actions2 2-3 Actions3 4-5 Actions4 6-7 Actions5 8 Actions and above

The corrective history factor is added to the equipment function factor and the clinical risk factorto determine the total risk factor. The risk factor total is used as a part of the system to assigndevices into high risk, medium risk or low risk categories. The tier system provides an ongoingprocess for evaluating the level of preventive maintenance support and inclusion into theprogram.

TIER LEVEL TABLE

Risk Factor Total Description15 and above High Risk

10-14 Medium Risk3-9 Low Risk (No PM)

When a device is first added to the equipment database, a default corrective history factor of 1 isautomatically assigned. As corrective work requests are attached to the asset throughout the lifeof the asset, the corrective history factor from 1 to 5 may be adjusted to the equipment functionand clinical risk values to complete the risk factor total described as above. As this total riskfactor increases, the threshold from one tier to another may occur.

4. The Clinical Engineering Technical Support Manager will ensure the following:

A. All clinical equipment is evaluated for inclusion in the program.

B. Include in the program, any equipment that exceeds a total risk factor of 9.

C. All clinical equipment risk factors are consistently applied throughout the database.

D. Maintain a database of equipment to be included in the program.

Reviewed: November 1999, January 2000, November 2002, January 2004, January 2007, January 2010,February 2013

Revised: November 2002, June 2003, January 2004, January 2007, January 2010