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/policies/administrative/uw-health-administrative/procurement-services/1135.policy

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Policies,Administrative,UW Health Administrative,Procurement Services

UW Health Evaluation of Capital Clinical Equipment (11.35)

UW Health Evaluation of Capital Clinical Equipment (11.35) - Policies, Administrative, UW Health Administrative, Procurement Services

11.35


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Administrative (Non-Clinical) Policy
This administrative policy applies to the operations and staff of the University of Wisconsin Hospitals and
Clinics Authority as integrated effective July 1, 2015, including the legacy operations and staff of
University of Wisconsin Hospital and Clinics and University of Wisconsin Medical Foundation.

Policy Title: UW Health Evaluation of Capital Clinical Equipment
Policy Number: 11.35
Effective Date: March 1, 2016
Chapter: Procurement Services
Version: Revision
I. PURPOSE

To establish the review process for evaluating capital clinical equipment prior to use in UW Health
facilities.

II. DEFINITIONS
A. Evaluation: Equipment that will be used in a clinical capacity at UW Health that is not already
owned, leased or rented by UW Health is considered an evaluation and subject to this policy.
B. Duration: The duration of an evaluation is defined as the minimum amount of time to gather
evaluative information. Most evaluations can be conducted in less than two (2) months. Longer
duration trials must be submitted with appropriate justification and may be reviewed for
appropriateness by the Technology Assessment Committee.
C. Capital Clinical Equipment: Equipment (estimated acquisition >$5,000) includes all
instruments, products or devices used for the diagnosis, monitoring or treatment of patients,
including corresponding supplies and software necessary to use such equipment. Short term
rentals and arrangements where supplies/disposables are purchased as a part of the equipment
evaluation is also included in this policy. Non-capital device, supply and medication samples are
governed by Administrative Policy 8.36-Control of Trial Supplies of Prescription Medication:
Samples, Drug Vouchers & Starter Supplies and/or Administrative Policy 11.19-Regulation of
Vendor Representatives and the Vendor Liaison Office.
D. Exclusions:
1. Existing equipment rentals or leases.
2. Equipment loaned to temporarily replace previously approved equipment.
3. Routine performance testing or acceptance processes.
4. Supplies, disposables, implants that do not meet capital budgeting threshold.
5. Equipment supplied as a part of IRB approved research and not used for clinical
purposes.
6. Equipment demonstrations or vendor fairs held in the UW Health Simulation Center.
E. Examples:
1. Physician or department wants to compare device A versus device B for a purchasing,
rental or lease decision.
2. Vendor wants to demonstrate their new FDA approved technology in a clinical setting.
3. Physician or department has a piece of FDA approved equipment for an IRB approved
study but would like to also use for clinical purposes.


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F. Abbreviations: Vendor Liaison Office (VLO), Technology Assessment (TA), and Clinical
Engineering (CE).
III. POLICY

Evaluation of clinical equipment must be reviewed and approved by VLO, TA, Procurement Services and
CE before use in UW Health facilities. In individual cases, Chief Operating Officer may waive
requirements for specific approval steps as long as all regulatory and safety requirements are met.

IV. FORMS USED
A. Evaluation of Clinical Equipment Internal Request Form (“Request Form”).
B. Standard Clinical Equipment Evaluation Agreement (“Standard Evaluation Agreement”).
V. PROCEDURE

All documentation will be saved electronically to a restricted folder that is read/write accessible by
approved representatives from Vendor Liaison Office (VLO), Technology Assessment (TA), Procurement
Services, and Clinical Engineering (CE).
A. Request Procedure: Clinical equipment evaluations must be requested by a clinical champion (i.e.
physician) and Hospital/Clinic Director (or above) responsible for the area where the equipment
will be used. The requester initiates the request by email, phone or in person to the Vendor
Liaison Office (VLO). They complete the Internal Request form and return it to the VLO. The
requester and physician champion must disclose any direct or indirect financial or other
relationship to the manufacturer, supplier, or lender of the equipment.
B. Review and Approval by UW Health Technology Assessment (TA) Program: The TA program
will evaluate the technology, issuing a waiver or a full committee review. If the equipment is
considered a new technology not already in place at UW Health, the request will be presented at
the monthly Technology Assessment Committee for full review.
C. Approval by UW Health Procurement Services Department: The Procurement Services
department is responsible for working with the department and vendor to execute the Standard
Clinical Equipment Evaluation Agreement. Note: Execution of the Standard Clinical Equipment
Evaluation Agreement is NOT considered an agreement to purchase the equipment.
D. Approval by UW Health Clinical Engineering: Clinical Engineering will complete electrical
safety checks on equipment, and verify FDA approvals. Equipment will be marked as checked,
RFID tagged if necessary and included into the medical equipment database as needed.
1. Clinical Engineering will review the internal Request form to ensure all review steps
have been completed prior to releasing the equipment for use.
E. Program Review: Yearly, all requests and deployed equipment will be reviewed to ensure
adherence to this policy. This will be coordinated by Technology Assessment.

VI. COORDINATION

Sr. Management Sponsor: SVP, Chief Operating Officer
Author: Director, Clinical Knowledge Management

Approval Committee: UW Health Administrative Policies & Procedures Committee





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SIGNED BY:

Ronald Sliwinski
President, University of Wisconsin Hospitals
Chief of Clinical Operations


Revision Detail:

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Next revision: 032019