/policies/,/policies/administrative/,/policies/administrative/uw-health-administrative/,/policies/administrative/uw-health-administrative/safetyemergency-management/,

/policies/administrative/uw-health-administrative/safetyemergency-management/1247.policy

20170104

page

100

UWHC,UWMF,

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

SMDA Medical Device Tracking (12.47)

SMDA Medical Device Tracking (12.47) - Policies, Administrative, UW Health Administrative, Safety/Emergency Management

12.47

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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: SMDA Medical Device Tracking
Policy Number: 12.47
Effective Date: January 1, 2017
Chapter: Safety/Emergency Management
Version: Revision
I. PURPOSE

To provide guidelines to UW Health staff regarding the medical device tracking requirements of the Safe
Medical Devices Act (SMDA) and the related regulations of the Food and Drug Administration (FDA),
the federal agency that implements the SMDA. Under the SMDA and other federal law, manufacturers
may be ordered by the FDA to track certain medical devices to facilitate notifications and recalls in the
event the device is determined to pose serious health risks.

II. POLICY ELEMENTS
A. UW Health requires each department that uses medical devices designated by the FDA as
requiring tracking to maintain tracking records as specified by the FDA and the device
manufacturer.
B. Record requests regarding medical device tracking from manufacturers shall be forwarded to the
Director of Risk Management.
C. SMDA tracking requirements are not synonymous with medical device reporting (MDR)
obligations (see Hospital Administrative Policy 12.40-Reporting of Device-Related Adverse
Events & other Product Problems), investigational device exemption (IDE) requirements, or any
other FDA regulations. As such, SMDA tracking requirements in no way replace, limit, modify or
negate any obligations imposed under other statutory or regulatory acts.
III. TRACKED DEVICES
A. The FDA may require tracking of a medical device, the failure of which would be reasonably
likely to have serious adverse health consequences, or which is intended to be implanted in the
human body for more than one year, or which is a life sustaining or life supporting device used
outside a device user facility (such as a hospital).
B. The FDA issues a tracking order to each manufacturer who makes and distributes a device that
must be tracked. The manufacturer, in turn, must notify device purchasers of the tracking and
recordkeeping requirements associated with the device.
C. The regulation does not require that a patient give written consent to have a device tracked or to
release their identity to the manufacturer. A patient that receives a tracked device may refuse to
release or refuse permission to release their name, address, social security number or other

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identifying information for the purposes of tracking. Such refusal should be documented by the
product, model & serial number, and the information provided to the manufacturer.
D. The list of devices requiring tracking changes from time to time. UW Health staff should rely on
the device manufacturer for notification regarding those devices that require tracking. The
Director of Risk Management (263-9202) may also be consulted if there is a question regarding
the current list of devices requiring tracking.
IV. PROCEDURE
A. When UW Health is the final distributor of a tracked device:
1. Upon purchasing or otherwise acquiring any interest in a tracked device intended for use
by a single patient over the useful life of the device, the hospital department receiving the
device will collect, maintain, and report to the manufacturer the following information:
a. The hospital's name and address
b. The lot number, batch number, model number, and/or serial number of the
device, or other identifier used by the manufacturer to track the device
c. The date the device was received and
d. The person from whom the device was received (if known).
When a device is purchased by UW Health directly from the manufacturer, this
information will usually be known to the manufacturer, so no separate report by
UW Health will be required unless the manufacturer requests such a report.
2. Upon distribution of a tracked device for use in or by the patient, the hospital department
providing or implanting the device will collect, maintain, and report to the manufacturer
the following additional information:
a. The date the device was provided to or implanted in the patient
b. The name, address, telephone number, and social security number (if available)
of the patient
c. The name, mailing address, and telephone number of the prescribing physician
and
d. The name, mailing address, and telephone number of the physician regularly
following the patient if different from (c).
3. When applicable, appropriate hospital staff will collect, maintain, and report to the
manufacturer the following additional information:
a. The date the device was explanted and the name, mailing address, and telephone
number of the explanting physician
b. The date of the patient's death (if applicable) or
c. The date the device was returned to the manufacturer, permanently retired from
use, or otherwise permanently disposed of.
4. If provided, hospital staff will use forms supplied by the manufacturer to report tracking
information back to the manufacturer.
B. When UW Health is the multiple distributor of a tracked device:
1. Upon purchasing or otherwise acquiring any interest in a life-sustaining or life-supporting
device intended for use by more than one patient over the useful life of the device, the
hospital department receiving the device will collect, maintain, and report to the
manufacturer the following information:
a. The hospital's name and address
b. The lot number, batch number, model number, and/or serial number of the
device, or other identifier used by the manufacturer to track the device
c. The date the device was received and
d. The person from whom the device was received.
When a device is purchased by UW Health directly from the manufacturer, this

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information will usually be known to the manufacturer, so no separate report by
UW Health will be required unless the manufacturer requests such a report.
2. Each time the tracked device is distributed for use by a patient, the hospital department
providing the device will collect and maintain the following additional information:
a. The date the device was provided for use to the patient
b. The name, address, telephone number, and social security number (if available)
of the patient using the device
c. The location of the device
d. The name, mailing address, and telephone number of the prescribing physician
and
e. The name, mailing address, and telephone number of the physician regularly
following the patient if different from (d).
The above information is not required to be reported unless the information is
specifically requested by the manufacturer or the FDA. The hospital must
provide this information to the manufacturer within five days of the request and
to the FDA within 10 days of the request. The Director of Risk Management
(263-9202) should be immediately notified of such requests.
3. When applicable, appropriate hospital staff will collect, maintain, and report to the
manufacturer the date the device was permanently retired from use or otherwise
permanently disposed of.
4. If provided, hospital staff will use forms supplied by the manufacturer to report tracking
information back to the manufacturer.
C. Requests for information shall be handled in the following manner:
1. If a device manufacturer or the FDA requests information tracked under sections B.2
above, the Director of Risk Management will provide such information to the
manufacturer within 5 working days of the request, or to the FDA within 10 working
days of the request.
2. Upon written request by an authorized representative of a tracked device manufacturer,
the hospital shall make available for audit any records required under this policy.
3. The hospital shall make all information required under this policy, and all records and
information related to the events and persons identified in such records, available to FDA
personnel upon proper request.
D. The hospital staff should make an attempt to notify the device manufacturer (as identified on the
device) whenever a trackable device is explanted at the hospital, even if the device was not
implanted at the hospital. If the manufacturer of the explanted device cannot be identified from
the device itself, the hospital should make a good faith attempt to find out who the manufacturer
is and report the device's explantation. If the hospital cannot determine the identity of the
manufacturer, then a record of the explantation and attempt to identify the manufacturer should
be maintained in the hospital's tracking files.
E. Tracking records must be maintained for the useful life of the device, even if a patient is lost to
follow-up. The useful life of the device is defined as the time that a device is in use or in
distribution for use. The device manufacturer should be consulted if there is a question about how
long to maintain a tracking record.
F. There may be special tracking requirements for trackable devices that are loaned to or borrowed
by the hospital and then distributed to patients. The Director of Risk Management should be
consulted in such situations.
G. Questions regarding medical device tracking requirements should be directed to the Director of
Risk Management (263-9202).


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V. COORDINATION

Sr. Management Sponsor: VP, Facilities & Support Services
Author(s): Director, Risk Management; Director, Safety

Approval Committee(s): UW Health Environment of Care Safety Committee; UW Health Administrative
Policy and Procedure committee

SIGNED BY

Elizabeth Bolt
UW Health Chief Administrative Officer



Revision Detail

Previous revision: 012014
Next revision: 012020