Inspection of Patient Related Equipment Procedure - Clinical ...

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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. Page 4
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 ___ Page 5
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