Policies,Administrative,UWHC,UWHC-wide,Environmental Safety

Reporting of Device-Related Adverse Events & other Product Problems (12.40)

Reporting of Device-Related Adverse Events & other Product Problems (12.40) - Policies, Administrative, UWHC, UWHC-wide, Environmental Safety


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Administrative (Non-Clinical) Policy
 UWHC only (Hospital Administrative-entity wide)  UWMF only (entity wide)
 UWHC Departmental (indicate name)  UWMF Departmental (indicate name)
 UWHC and UWMF (shared)
Policy Title: Reporting of Device-Related Adverse Events & Other Product
Policy Number: 12.40
Effective Date: June 1, 2015
Chapter: Environmental Safety
Version: Revision

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 problems.

A. Mandatory Reporting. Under the Safe Medical Devices Act (SMDA), user facilities including
hospitals, 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 (FDA).
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 accomplished by entry into
the Medical Product Surveillance Network (MedSun-FDA program) by Risk Management staff.
Risk Management staff will also be the UWHC designated FDA contact.
The SMDA additionally requires that, on an annual basis, user facilities provide to the FDA a
summary of all reports submitted to them and the manufacturers. The MedSun system meets the
requirements for annual and mandatory reporting to the FDA.
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.
The MedSun system allows for voluntary reporting. If product problems result in quality,
performance or safety concerns, Risk Management should be notified. Risk Management staff are
responsible for voluntary reporting once information is received regarding a device failure.
A. Medical Device. A medical device is 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

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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). Examples of medical
devices include hospital beds, heart valves, ventilators, patient restraints, x-ray machines,
defibrillators and bandages.
B. Serious Illness/Injury. An illness or injury that:
1. Is life threatening.
2. Results in permanent impairment of a body function or permanent damage to a body
3. Necessitates medical or surgical intervention to preclude permanent impairment of a
body function or permanent damage to a body structure.
C. Reporting Mechanisms.
1. Patient Safety Net (PSN) event reporting system.
2. Telephone call directly to Risk Management.
3. Medical Surveillance Network (MedSun system).

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:
1. Report the incident to their supervisor or department head.
2. Notify the attending physician for the patient.
3. Remove/sequester the device and related supplies/packaging.
4. Report the incident to Risk Management and Clinical Engineering.
5. Remove gross contamination from device and place in a biohazard container/bag without
changing device settings or removing tubing, if applicable.
6. Deliver all items to Risk Management/Clinical Engineering, as appropriate to device (i.e.,
catheter to Risk Management, ECG machine to Clinical Engineering).
7. Enter event in the PSN (Patient Safety Net) event reporting system utilizing the
equipment screen. Include as much information as possible including manufacturer,
model number, serial number and lot number. If possible, save packaging and provide to
Risk Management.
B. The supervisor or department manager shall:
1. Begin an immediate investigation.
2. Perform a follow-up evaluation of the incident.
C. The Director of Risk Management shall:
1. Be informed of any deaths, serious illness/injuries related to medical device failure
including all deaths in restraints, regardless of whether device in use failed.
2. Be responsible for coordinating the submission of a mandatory MedSun report within 10
working days after knowledge of this event.
3. Have Risk Management staff follow-up with individual reporter when entering a
voluntary report.
4. Have Risk Management staff maintain the required medical device files for both
mandatory and voluntary reports on all investigations of possible device-related

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Sr. Management Sponsor: SVP & General Counsel
Author: Director, Risk Management

Approval Committee: Administrative Policy and Procedure Committee


Ronald Sliwinski
President and CEO

Revision Detail:

Previous revision: 062012
Next revision: 062018