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UWHC,UWMF,

Policies,Administrative,UW Health Administrative,Safety/Emergency Management

Product Recalls and Safety Alerts (12.46)

Product Recalls and Safety Alerts (12.46) - Policies, Administrative, UW Health Administrative, Safety/Emergency Management

12.46


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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 (UWHCA) as integrated effective July 1, 2015, including the legacy operations and
staff of University of Wisconsin Hospital and Clinics (UWHC) and University of Wisconsin Medical
Foundation (UWMF).
Policy Title: Product Recalls and Safety Alerts
Policy Number: 12.46
Effective Date: 06/01/2017
Chapter: Safety/ Emergency Management
Version: Revision


I. PURPOSE

To ensure the prompt notification and effective resolution of product recalls and safety alerts generated by
external or internal sources.

II. POLICY ELEMENTS

UW Health (UWH) departments will take immediate action when notified of a product recall or medical
device safety alert. Collaborative efforts will be mobilized to remove recalled product from the supply
chain and clinical environment and to conduct any necessary clinical follow up with patients and
physicians. Instructions to vendors regarding compliance with this policy are incorporated into UWH
Standard Contract Terms and Conditions. Medication recalls are handled separately as outlined in
Pharmacy policy 9.2 "Medication Recalls". Food recalls are handled separately as outlined in Culinary
Services policy 3.25 “Handling a Food Recall”.

III. INITIAL NOTIFICATION

A. External
1. Any product recall and safety alert notifications received by a UWH department must be
treated with priority and be hand delivered, faxed or emailed immediately to the Safety
Department administrative assistant. Email: uwhcrecalls@uwhealth.org.
a. Recalls can vary from items that need to be removed from service to item problems that
pose minimal hazard to patients or staff. Items may or may not be removed from service,
depending on the degree of danger posed and the ability to replace the item. On occasion
it may be necessary to notify physicians and patients that they received or were cared for
with recalled items. If patient notification is required, the Risk Management Department
is informed to assist with patient notification.
2. All notifications received by the Safety Department administrative assistant are assigned an
internal tracking number and are sent as a PDF via email within the next business day via
email to the UWH Recalls Group distribution list which includes designated representatives
(Directors) and an alternate within the following departments (and others as identified):
a. Procurement Services
b. Central Services
c. Materials Management


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d. Facilities & Engineering Services
e. Surgical Services
f. Radiology
g. Nursing
h. Special procedure units
i. Clinical Engineering
j. Clinical Labs
k. Home Health
l. Risk Management
m. Safety
n. UWH Joint Ventures (e.g. Madison Surgery Center, Transformations Surgery Center)
3. All follow-up actions taken must be communicated back via reply email to
uwhcrecalls@uwhealth.org as soon as possible for tracking and close out of notifications.
Minimally, this includes confirmation that the recall does or does not affect their department.
If affecting, the department must explain the action taken to resolve the recall or safety alert.
4. Any departments wanting to review previous Recall notifications may find them on the
Product Recalls Workspace, where a running list of product recalls is be maintained.

B. Internal
1. If a UWH employee or member of the medical staff discovers a problem* with a supply,
equipment, or a medical device, the Director of the affected department must be contacted
and a Patient Safety Net (PSN) report should immediately be completed. If the device, supply
or equipment has caused employee or patient harm, the manager or staff member should also
notify Risk Management via telephone at 261-1327.
a. *The item appears to be defective in manufacture, packaging or design and causes, or
seriously threatens to cause, harm to a patient or staff member. Defective items that
cause UWH to suffer economic losses only should be reported to the UWH supply chain
supplier (Procurement Services, Centrals Services or Materials Management) who will
attempt to obtain corrective actions from sales representatives.
2. When a defective item is encountered, report the device failure in the Patient Safety Net
(PSN) with corresponding lot, catalog, and serial numbers. When present, the FMIS or UWH
decal number should also be included in the PSN report. If able, save the packaging since
removal from stock may be an issue. If the defective item involves a piece of medical
equipment, notify clinical engineering so that the equipment can be quarantined and
evaluated along with supply items used with that equipment (i.e. IV pump, IV solution bag,
and tubing.).
3. If a device or supply is the possible cause of serious patient or staff harm, the product should
be sequestered as soon as possible and be brought to Risk Management after cleaning off
gross contamination and biohazard bagging. The product MAY NOT be given to the patient,
the physician, the sales representative or the Original Equipment Manufacturer (OEM). When
possible, we should not issue a patient charge for a defective item. The affected site liaison
should contact the appropriate UWH supply chain supplier for product replacement credit.
4. The Safety Department will consult with Risk Management to determine whether the product
should be reported under the Safe Medical Devices Act in compliance with Hospital
Administrative Policy 12.40.








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IV. RECALL PROCEDURE

A. Recall is received by Safety Department administrative assistant. Recall is date/time stamped as
soon as it’s received. Recall is assigned an internal tracking number (current year – numerical,
example 2014-4). The Recall is scanned as a pdf which is forwarded as the Recall notice.
B. Within the next business day an email with the Recall notice shall be sent to the UWH Recalls
Group distribution list. FDA accepts that recalls received on Fridays or Holidays will be sent the
following business day.
C. At least one person from each department on the distribution list shall respond to the recall email
within 48 hours with status of the recall in their department, even if they do not have the product
in question.
D. The Recall response card shall be completed and returned. Recall notices generally require a
recall response card to be returned to the company issuing the recall.
1. If the recall originated in a department other than through the Executive Assistant, one of the
contacts on the distribution list shall complete the recall response card and return to the
Executive Assistant.
2. If the recall originated from the Executive Assistant, the Executive Assistant will complete
the response card.
3. Recall response cards will be scanned and saved, then returned to the issuing company by the
Executive Assistant
E. The recall information is entered into an Access database (J/Admin/Shareall/Angela/Recall
Updated). (The H4/8 Administrative Assistants have access to the Access database through the
shared drive.)
F. The Recall notice shall be uploaded to the UWH Product Recalls Workspace.
G. Email responses and copies of the response cards are saved by the Safety Department
administrative assistant on the J/Safety drive with the recall in a folder on the shared drive
organized by year.
H. After close out of a Recall notification, product disposition and actions will be uploaded to the
Product Recalls Workspace for tracking and review.

V. LOCATION OF RECALL INFORMATION

Recall information can be found on the UWH Product Recalls Workspace on U-Connect.


VI. DEPARTMENTAL RESPONSIBILITIES
A. Procurement Services:
Procurement Services staff will contact company representatives to ask what departments
typically use the recalled product, the best-known substitute, and where a picture of the item can
be found (such as on their internet site). Procurement Services shall check PeopleSoft and any
available usage reports for recalled or safety alert items purchased by UWH departments.
1. If there is a record of the purchase of the affected item, Procurement Services will notify the
item users of the recall or safety alert with the recommended response from the supplier. If
Procurement Services provided the affected product to a non-UWH entity, the department
will give notice to the item user with recommended response from the supplier.
B. Central Services/Materials Management:
When notified of a product recall, Central Services/Materials Management will initiate the
removal of the recalled product (if required) from all storage sites and clinical areas that are
stocked by Central Services/Materials Management. If a product could potentially be stored in
areas that are not stocked by Central Services/Materials Management (patient rooms, cabinets,


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drawers, lab coat pockets, etc.), Inpatient Nursing Administration and Clinics Administration will
ensure that all areas are free of all affected product(s).
1. If Central Services/Materials Management provided the affected product to a non-UWH
entity, the department will give notice to the item user with the recommended response from
the supplier.
C. Clinical Engineering:
A Biomedical technician will search equipment database for affected equipment and arrange
repair or removal.
D. Inpatient Nursing and Clinics:
Inpatient Nursing Administration and Clinics Administration will coordinate the removal of
recalled product from areas not stocked by Central Services/Materials Management (patient
rooms, offices, etc).
E. Safety and Risk Management:
The Safety Department will notify the above departments immediately of product recalls and
safety alerts. The Safety Department will consult with Risk Management to determine whether
the product should be reported under the Safe Medical Devices Act in compliance with Hospital
Administrative Policy 12.40. The Safety Department in collaboration with Risk Management will
monitor and track the process including patient notification by the affected departments and other
follow-up activities, including response back to company.

V. COORDINATION

Sr. Management Sponsor: VP, Facilities & Support Services
Author: Director, Safety
Reviewer: UWH EOC Safety Committee

Approval Committee(s): UW Health Administrative Policy and Procedure Committee


SIGNED BY

Elizabeth Bolt
UW Health Chief Administrative Officer


Revision Detail
Previous revision: 07/17/2014
Next revision: 06/01/2020