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Recalled Equipment and Supplies in the Perioperative Areas (2.3.23)

Recalled Equipment and Supplies in the Perioperative Areas (2.3.23) - Policies, Clinical, UW Health Clinical, General Care and Procedures, Procedures

2.3.23


UW HEALTH CLINICAL POLICY 1
Policy Title: Recalled Equipment and Supplies in the Perioperative Areas
Policy Number: 2.3.23
Category: UW Health
Type: Ambulatory and Inpatient
Effective Date: April 14, 2017

I. PURPOSE

This policy will establish an efficient and effective method for responding to manufacturer recalls and
medical device safety alerts by establishing a system-wide approach.

II. POLICY ELEMENTS

A. Direct to the attention of the OR Materials Coordinator(s) and the Surgical Services Supervisor (s)/Manager
responsible for products immediately upon receipt of a recall or safety alert notices.
i. Recall or safety alert notification(s) could arrive in the form of electronic (Email/Fax/PSN), written,
or verbal communication from Nursing or Central Services staff, company representative, or UW
Health Safety Department, which manages the recall process.
B. Determine if we have the described affected items. Central Supply, American Family Children’s Hospital,
University Hospital Inpatient and Outpatient Surgery, and the American Center operating room and supply
core areas will be checked as well as other areas as applicable.
i. Check and record catalog numbers, serial numbers or lot numbers, and quantity as indicated.
C. Refer to UWHC policy #12.46, Product Recalls and Safety Alerts for specific recall instructions. Hospital
notifications and documentation are explained.
i. Recall information must be forwarded to the Director of Life Safety for UW Health via email at
uwhcrecalls@uwhealth.org. Recall tracking registration and additional forwarding to other
departments as necessary.
D. Develop a plan of action within 24 hours of notification. Individuals (i.e. Surgical Services
Supervisors/Managers and surgeons) affected by the recall should be notified and consulted with to
establish a plan that incorporates patient needs, manufacturer’s recommendations, and alternative
substitutions available.
E. Documentation should be maintained by the OR Materials Coordinator in a file as follows:
i. UW Health Recall #, date received, description of product, manufacturer, description of problem,
and action taken.
ii. Record of any items in the department that were affected by the recall.
iii. UW Health response to the manufacturer.
iv. A copy of UW Health Surgical Services response to the manufacturer should be sent to the Safety
and Risk Management Departments for tracking of responses and closure of alert.
F. Return products to the manufacturer with a return material request form.
i. Segregate affected products and consult with Risk Management before allowing any returns.

III. COORDINATION

Author: Directors, Surgical Services Departments
Senior Management Sponsor: SVP/Chief Nurse Executive
Reviewers: Surgical Materials Coordinator; Director, Risk Management; Director, Life Safety; Sr. Risk
Management Consultant
Approval committees: Surgical Services Policy and Procedure Committee; UW Health Clinical Policy
Committee
UW Health Clinical Policy Committee Approval: March 20, 2017

UW Health is a cohesive, united and integrated academic medical enterprise comprised of several entities.
This policy applies to facilities and programs operated by the University of Wisconsin Hospitals and Clinics
and the University of Wisconsin Medical Foundation, Inc., and to clinical facilities and programs
administered by the University of Wisconsin School of Medicine and Public Health. Each entity is
responsible for enforcement of this policy in relation to the facilities and programs that it operates.







UW HEALTH CLINICAL POLICY 2
Policy Title: Recalled Equipment and Supplies in the Perioperative Areas
Policy Number: 2.3.23

IV. APPROVAL

Peter Newcomer, MD
Chief Clinical Officer

J.Scott McMurray, MD
Chair, UW Health Clinical Policy Committee

V. REFERENCES

UWHC policy #12.46, Product Recalls and Safety Alerts

VI. REVIEW DETAILS

Version: Original
Last Reviewed: April 14, 2017
Next Revision Due: April 2020
Formerly Known as: Surgical Services departmental policy #4.07