Inspection of Patient Related Equipment Procedure - Clinical ...

POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
Compliance with labeling of equipment to ensure that equipment has been
evaluated for safety and suitability for intended use by a nationally
recognized (and North Carolina approved ) testing laboratory
Determination of inclusion in the Equipment Management Program
o Upon satisfactory completion of the inspection, a Clinical Engineering number
tag (CE #) will be affixed in a visible location on the device. Equipment requiring
periodic maintenance will also receive a Clinical Engineering maintenance
sticker. Equipment exempt from Preventive Maintenance testing will receive a
“PM Exempt” sticker.
o User departments are responsible for reporting to Clinical Engineering any
equipment delivered directly to their department.
o Should equipment fail to pass inspection, Clinical Engineering will inform the
user department of the failure and will not certify the device for use.
o Clinical Engineering will work with DUHS Education Services and the end users
to determine the need for in-service education and make appropriate
recommendations for training. It is the user department’s responsibility to
schedule any required training prior to the device being placed in service.
o Note: Equipment for the analysis of body fluids, cells or tissues must be approved
by the Office of the Executive Director, Clinical Laboratories, prior to being
placed in service.
Non Duke Owned Medical Equipment
o Loaner/Evaluation/Physician Owned Equipment
Over 30 Days – Equipment brought into the clinical environment as a
loaner or for clinical evaluation for a period of 30 days or more will:
Have a Non-Hospital Owned Clinical Engineering number
assigned (NH#) and affixed
Have a Non-Hospital Owned Acceptance document completed
Have a Non-Hospital Owned Acceptance work order completed
and an NH inspection sticker affixed
o Life Support Equipment will have a 6 Month Next Due
Date Interval Assigned
o Non-Life Support Equipment will have a 12 Month Next
Due Date Interval Assigned
o Equipment exempt from Preventive Maintenance testing
will receive a “PM Exempt” sticker.
Under 30 days - Equipment brought into the clinical environment for on
loan or for clinical evaluation for a period less than 30 days will:
Have a Non-Hospital Owned Acceptance form completed
Have a Non-Hospital Owned Acceptance work order completed
and an NH inspection sticker affixed.
Note: All service loaners managed by Clinical Engineering will
follow procedures under this section
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