Policies,Administrative,UWMF,UWMF-wide,Safety,Utilities - Equipment Management

Reporting of Device-Related Adverse Events and Other Product Problems (126.005)

Reporting of Device-Related Adverse Events and Other Product Problems (126.005) - Policies, Administrative, UWMF, UWMF-wide, Safety, Utilities - Equipment Management


UW Medical Foundation

Subject: Reporting of Device-Related Adverse Events & Other Product Problems
Effective Date: 7/19/12 Approved: Steve Sibley, VP Clinic Ops
Supersedes Policy Date: Revision #
Distribution: Uconnect


To provide guidance related to mandatory legal requirements associated with medical
device adverse events. To report medical device failures that may have contributed to a
death or serious illness/ injury in a timely manner. To provide information regarding
options for voluntarily reporting other device-related adverse events and product

A. Mandatory Reporting – Under the Safe Medical Devices Act (SMDA), user
facilities MUST directly report a device-related death or serious illness/ injury
suffered by either patient or employee in the course of their duties. This is
considered a Mandatory MedWatch Report to the Food and Drug Administration

Device-related events include those resulting from device failure, malfunction,
improper or inadequate device design, manufacture, labeling, user error, or the
failure to service or maintain a medical device. Reporting of medical device
adverse events will be jointly accomplished by the site manager, Safety &
Security Manager, Risk Management and Legal.

B. Voluntary Reporting – The FDA encourages, but does not require, user facilities
to report to the manufacturer device-related adverse events that do not result in
death or serious illness/ injury. If product problems result in quality, performance
or safety concerns, Risk Management and Legal will be notified. If advised by
Legal, the Safety & Security Manager is responsible for voluntary reporting once
information is received regarding a device failure.

A. Medical Device – means anything used in treatment or diagnosis that is not a
drug or biologic (e.g. blood). Equipment, instruments, implants, disposable
devices, components, accessories, reagents, etc. are considered medical
devices. This definition includes devices intended for use in the diagnosis of
conditions other than disease (such as pregnancy), and in-vitro diagnosis
products (including those previously regulated as drugs).

B. Serious Illness/ Injury – means an illness or injury that:
a. Is life threatening.
b. Results in permanent impairment of a body function or permanent damage
to a body structure.
c. Necessitates medical or surgical intervention to preclude permanent
impairment of a body function or permanent damage to a body structure.
C. Reporting Mechanisms – means any of the following:
a. Patient Safety Net (PSN) occurrence reporting system.
b. Telephone call directly to Safety & Security Manager.

Whenever the facility becomes aware of information that reasonably suggests that a
medical device has or may have caused or contributed to a serious adverse event or
that any product may pose quality, performance or safety concerns, the occurrence
shall be handled in the following manner:
A. The healthcare personnel involved shall immediately:
a. Report the incident to their site manager.
b. Notify the patient’s physician. If the event affected the employee, have the
employee complete a PSN and Injury Form.
c. Remove/ sequester the device and related supplies/ packaging.
d. Submit a Patient Safety Net report. Include as much information as
possible including manufacturer, model number, serial number and lot
e. Remove gross contamination from device and place in a biohazard bag
without changing device settings or removing tubing, if applicable.
f. Deliver all items to Safety/ AOB 414; including original packaging if

B. The site manager shall:
a. Immediately notify Clinic Operations, Risk Management & Legal of the
event. Risk Management will engage the Safety & Security Manager as
b. Begin an immediate investigation.
c. Perform a follow-up evaluation of the incident.

C. The Safety & Security Manager shall (in collaboration with Risk Management/
a. Be responsible for coordinating the submission of the SMDA mandatory
reports within 10 working days after knowledge of this event.
b. Follow-up with the individual reporter when submitting a voluntary report to
the manufacturer.
c. Maintain the required medical device files for both mandatory and
voluntary reports on all investigations of possible device-related events.