Inspection of Patient Related Equipment Procedure - Clinical ...

Effective Date: 1/2010, 2/2013
POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
Review / Revision: 11/97; 11/99; 1/00; 11/02; 1/04; 12/04, 1/06, 7/07, 1/10, 2/13
History
Policy:Devices used within the Duke University Health System will be inspected prior to patient
use to ensure safe and effective operation
Definitions:
Patient Care Equipment (Medical Equipment): Equipment intended to be used for diagnostic,
therapeutic, or monitoring purposes in a patient care environment regardless of ownership.
Appliances: Devices intended for staff use or personal care and not intended for therapeutic or
diagnostic purposes. Appliances are not intended to contact the patient. Included are, but not
limited to, hairdryers, coffee pots, curling irons, electric heaters, fans and computer equipment.
Preventive Maintenance Program: Regularly scheduled inspections and testing, including
clinical alarms, of patient care equipment determined and performed by Clinical Engineering.
Note: This policy does not apply to procedurally implanted devices such as implanted
pacemakers. The policy does not apply to durable medical equipment such as wheelchairs and
crutches.
Procedure:
Duke Owned Medical Equipment
o Clinical Engineering works with Procurement Services in the scheduling of
equipment deliveries.
o Clinical Engineering will perform an incoming inspection and evaluate the device
for inclusion into the Equipment Management Program.
o Note: Leased equipment provided under supply/consumables agreements will be
treated as Duke owned equipment
o Clinical Engineering will ensure that the new equipment is inspected for:
Presence of all accessories required for proper operation
Presence of Operator’s and Technical Service Manuals
Proper operation of equipment as specified in the performance
specifications in the manufacturer’s service literature
Clinical alarm functionality and audibility
Passage of electrical safety requirements as specified by NFPA, TJC, and
other applicable agencies
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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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POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
o Rental Equipment
Approved Vendors:
Rental equipment obtained from Duke Hospital approved vendors
may be taken directly to the patient care area for use. Approved
Vendor List.
Approved vendors have shown that they have programs in place to
ensure equipment has received all necessary safety inspection and
maintenance and is safe for use. Additionally, Duke Procurement
Services has assured that they meet Duke University Terms and
Conditions and that service representatives have RepTrack
competencies.
The vendor will label the device with their current inspection
sticker.
The caregiver will perform a visual check of the electrical cord,
housing, and all accessories prior to use to ascertain integrity and
assess any obvious breakage prior to the device being used on the
patient. If the device does not pass this check, the device should
not be placed in service and the Clinical Operations Director or
designee should be notified.
Non-Approved Vendors
Medical equipment rented from an unapproved vendor is allowed
only if appropriate maintenance documentation is provided prior to
the equipment being placed into use.
A Non-Hospital Owned Initial Inspection document will be
completed
A Non-Hospital Owned Acceptance Work Order will be completed
and a NH inspection sticker affixed.
Equipment exempt from Preventive Maintenance testing will
receive a “PM Exempt” sticker.
If assistance is needed with the check, Clinical Engineering may be
contacted during normal business hours, 7:30 a.m. - 4:30 p.m.
(DRH 7:00 – 4:00; DRAH 7:00 –3:30). For after hours, see After
Hours Policy CE-007. (After Hours)
DUH – 681-2525
DRH - 470-8184
DRAH - 954-3583
DPC’s/ PDC’s – 862-5379
Clinical Labs – 681-2525
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POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
o Research Equipment
Research equipment used on Duke patients should be inspected before use
and a Clinical Engineering Research # Assigned. The technician will:
Have a Research Clinical Engineering number assigned (R#) and
affixed
Have a Research acceptance document completed with the
appropriate contact information
Have a Research 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.
The technician will check the “other” box to denote Research
If research equipment falls under Investigational Review Board
(IRB) oversight then the IRB # will be provided on the acceptance
document.
Patient Owned Medical Devices
Use of personal medical equipment is discouraged. Patients can be
permitted to use their medical equipment if 1). a suitable Duke‐owned or
rental equivalent is not available, or 2). removing the patient owned
equipment is deemed clinically detrimental to the patient’s care , AND all
needed parts, accessories, and/or attachments are provided by the
patient/family AND the patient/guardian signs the Non‐Duke Owned
Medical Equipment Release Form. (Release Form Link)
Note: The decision as to clinical detriment is the responsibility of the
patient provider/caretaker.
Patient Owned Non-Medical Appliances
o Use of personal non-medical appliances by patients is discouraged. However, if
such an appliance is brought in to the hospital the patient’s caregiver will check
the appliance for safety.
o This check will consist of a visual check of the electrical cord and housing to
ascertain integrity and assess any obvious breakage.
o If the appliance does not pass this visual check, it should not be placed in service.
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POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
o The Patient is responsible for the operation of their appliance. The patient’s
condition must be considered when determining if appliance can be operated
safely.
o Should the caregiver need assistance with the check, Engineering & Operations
may be contacted at the contact numbers below:
DUH - 684-3232
DRH - 470-4159
DRAH - 954-3390
Equipment intended for use in a Clinical Laboratory Application:
o 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.
o Clinical Engineering will perform an incoming inspection and evaluate the device
for inclusion in the Equipment Management Program.
o Note: Leased Equipment, including Reagent Rentals – Equipment provided under
supply/consumables agreements for long term use will be treated as Duke owned
equipment
o Clinical Engineering will ensure that the new equipment is inspected for:
Presence of all accessories required for proper operation
Presence of Operator’s and Technical Service Manuals
Passage of electrical safety requirements as specified by NFPA, TJC, and
other applicable agencies
Compliance with labeling of equipment to ensure that equipment has been
evaluated for safety and suitability for intended use by a nationally
recognized testing laboratory
Determination of inclusion in the Equipment Management Program
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
Equipment Maintenance sticker.
All medical equipment used on Duke University Health System patients must be approved by
one of the approved NC Certification labs before being placed into use. If the device does not
have an approved label affixed it must have an approved IRB.
See Approved NC Laboratories below:
Accepted N.C. Testing Laboratories for Medical Equipment: (NCBCC January, 2012)
UL ___ NTS ___ ETL ___ CSA ___ MET___ Curtis Strauss ___ NSF ___ QPS ___ SGS ___
TUV ___
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POLICY AND PROCEDURE MANUAL
DUKE UNIVERSITY HEALTH SYSTEM
Clinical Engineering Policy
Inspection of Patient Related Equipment
(Hospital and Non-Hospital Owned)
Cross Reference:
Applicable Standards TJC EC.02.04.01 & EC.02.04.03
NFPA99
Policy Primary: Senior Director, Clinical Engineering
Scheduled Review Date: 1/2016
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