Medical Equipment Management Program
Content
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
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 monitoring
equipment used to treat Duke University Health System patients.
B. Test and ensure the operating safety of clinical equipment utilized at Duke University Hospital
according to requirements set forth by JCAHO, OSHA, NFPA, and other appropriate regulatory
agencies.
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 the
devices specified above. Clinical alarms will be tested for functionality and audibility during the
PM inspection.
E. Affect immediate and timely repair of all clinical equipment found to be malfunctioning and/or
operating outside the required safety standards.
F. Maintain a paperless “Historical Data File” for each listed device to include all repair and
maintenance actions performed.
G. Provide documentation, upon request, to each using area detailing all work accomplished and the
equipment status.
H. Inspect all Clinical Equipment prior to its initial use and at intervals to be identified utilizing a
“Risk Based” evaluation system.
I.
Provide a quality assurance program to validate the performance of the Clinical Engineering
program. (RE: CE-012)
J. Continually review, monitor and when appropriate, address any and all pertinent regulatory
changes, including but not limited to:
1.
2.
3.
4.
5.
FDA (Safe Medical Devices Act) (RE: Policy CE-009)
JCAHO
NFPA
OSHA
Other Regulatory Agencies
Page 1
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
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 in
Equipment Management Program. The three factors that will be measured to determine inclusion
into the Equipment Management Program are: Equipment Function, Clinical Risk and Corrective
History.
1.
Equipment Function: This is best defined as the role the equipment may play in patient care and
Hospital/Departmental support. The area which particular pieces of equipment serve shall be
considered when evaluating equipment function using the table below.
EQUIPMENT FUNCTION TABLE
Life Support
Critical — Therapeutic
Critical — Diagnostic
Essential — Therapeutic
Essential — Diagnostic
Ancillary — Therapeutic
Ancillary — Diagnostic
Miscellaneous — Therapeutic
Miscellaneous — Diagnostic/Other
2.
9
8
7
6
5
4
3
2
1
Clinical Risk: Considers the question of the possible consequences to patients and staff in the
event of equipment failure, which could result in death, injury, misdiagnosis, disruption of
services or loss of critical materials using the table below.
CLINICAL RISKS TABLE
Patient Death
Patient or Operator Injury
Inappropriate Therapy, Misdiagnosis
or loss of Critical Materials
Disruption of Patient Services
Minimal Risk
No Risk
3.
7
6
5
4
3
1
Corrective History: The number of corrective work requests that have occurred with the specific
device in the last 12 month period. This number may range from 1 to 5, based upon the table
below:
Page 2
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
CORRECTIVE HISTORY TABLE
Corrective Factor
1
2
3
4
5
Number of Corrective Actions (12 Month Period)
0-1 Actions
2-3 Actions
4-5 Actions
6-7 Actions
8 Actions and above
The corrective history factor is added to the equipment function factor and the clinical risk factor
to determine the total risk factor. The risk factor total is used as a part of the system to assign
devices into high risk, medium risk or low risk categories. The tier system provides an ongoing
process for evaluating the level of preventive maintenance support and inclusion into the
program.
TIER LEVEL TABLE
Risk Factor Total
15 and above
10-14
3-9
Description
High Risk
Medium Risk
Low Risk (No PM)
When a device is first added to the equipment database, a default corrective history factor of 1 is
automatically assigned. As corrective work requests are attached to the asset throughout the life
of the asset, the corrective history factor from 1 to 5 may be adjusted to the equipment function
and clinical risk values to complete the risk factor total described as above. As this total risk
factor 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:
Revised:
November 1999, January 2000, November 2002, January 2004, January 2007, January 2010,
February 2013
November 2002, June 2003, January 2004, January 2007, January 2010
Page 3
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
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 monitoring
equipment used to treat Duke University Health System patients.
B. Test and ensure the operating safety of clinical equipment utilized at Duke University Hospital
according to requirements set forth by JCAHO, OSHA, NFPA, and other appropriate regulatory
agencies.
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 the
devices specified above. Clinical alarms will be tested for functionality and audibility during the
PM inspection.
E. Affect immediate and timely repair of all clinical equipment found to be malfunctioning and/or
operating outside the required safety standards.
F. Maintain a paperless “Historical Data File” for each listed device to include all repair and
maintenance actions performed.
G. Provide documentation, upon request, to each using area detailing all work accomplished and the
equipment status.
H. Inspect all Clinical Equipment prior to its initial use and at intervals to be identified utilizing a
“Risk Based” evaluation system.
I.
Provide a quality assurance program to validate the performance of the Clinical Engineering
program. (RE: CE-012)
J. Continually review, monitor and when appropriate, address any and all pertinent regulatory
changes, including but not limited to:
1.
2.
3.
4.
5.
FDA (Safe Medical Devices Act) (RE: Policy CE-009)
JCAHO
NFPA
OSHA
Other Regulatory Agencies
Page 1
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
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 in
Equipment Management Program. The three factors that will be measured to determine inclusion
into the Equipment Management Program are: Equipment Function, Clinical Risk and Corrective
History.
1.
Equipment Function: This is best defined as the role the equipment may play in patient care and
Hospital/Departmental support. The area which particular pieces of equipment serve shall be
considered when evaluating equipment function using the table below.
EQUIPMENT FUNCTION TABLE
Life Support
Critical — Therapeutic
Critical — Diagnostic
Essential — Therapeutic
Essential — Diagnostic
Ancillary — Therapeutic
Ancillary — Diagnostic
Miscellaneous — Therapeutic
Miscellaneous — Diagnostic/Other
2.
9
8
7
6
5
4
3
2
1
Clinical Risk: Considers the question of the possible consequences to patients and staff in the
event of equipment failure, which could result in death, injury, misdiagnosis, disruption of
services or loss of critical materials using the table below.
CLINICAL RISKS TABLE
Patient Death
Patient or Operator Injury
Inappropriate Therapy, Misdiagnosis
or loss of Critical Materials
Disruption of Patient Services
Minimal Risk
No Risk
3.
7
6
5
4
3
1
Corrective History: The number of corrective work requests that have occurred with the specific
device in the last 12 month period. This number may range from 1 to 5, based upon the table
below:
Page 2
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Medical Equipment Management Plan
2013
CORRECTIVE HISTORY TABLE
Corrective Factor
1
2
3
4
5
Number of Corrective Actions (12 Month Period)
0-1 Actions
2-3 Actions
4-5 Actions
6-7 Actions
8 Actions and above
The corrective history factor is added to the equipment function factor and the clinical risk factor
to determine the total risk factor. The risk factor total is used as a part of the system to assign
devices into high risk, medium risk or low risk categories. The tier system provides an ongoing
process for evaluating the level of preventive maintenance support and inclusion into the
program.
TIER LEVEL TABLE
Risk Factor Total
15 and above
10-14
3-9
Description
High Risk
Medium Risk
Low Risk (No PM)
When a device is first added to the equipment database, a default corrective history factor of 1 is
automatically assigned. As corrective work requests are attached to the asset throughout the life
of the asset, the corrective history factor from 1 to 5 may be adjusted to the equipment function
and clinical risk values to complete the risk factor total described as above. As this total risk
factor 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:
Revised:
November 1999, January 2000, November 2002, January 2004, January 2007, January 2010,
February 2013
November 2002, June 2003, January 2004, January 2007, January 2010
Page 3
