Creating a “Tag and Sequester” Program at UCLA Medical Center
MedSun: Newsletter #2, March 2006

Abstract:
Utilizing MedSun sub-contract funds, UCLA Medical Center developed an improved “tag and sequester” program to help identify and isolate defective medical devices. The STAR Response Program (Stop, Tag, And Report) was created after eliciting staff feedback at inservices and an exposition. A system-wide roll-out of this program at UCLA Medical Center, Santa Monica-UCLA Medical Center and the UCLA Neuropsychiatric Institute and Hospital is currently being evaluated.

Identifying the Problem:
Despite multiple policy guidelines stipulating to "not use" and "not discard" defective devices, these devices continued to be used and discarded at UCLA Medical Center. Both clinical and financial incentives existed to improve the existing “tag and sequester” system being employed to identify and isolate malfunctioning devices. In addition to the potential harm that can occur to patients and healthcare workers when defective devices are not properly identified and repaired, defensible cases can also be lost as the result of “missing” devices. In May 2005, UCLA received MedSun funding via a sub-contract to raise staff consciousness about medical device safety, develop tag and sequester related labels, and implement a consolidated procedure. In August 2005, Nursing leadership hired an experienced consultant to design and help implement the “tag and sequester” program.

Obtaining Staff Input:
Beginning in August 2005, in order to better define the problem with the existing tag and sequester policy and procedure, elicit staff input on how to fix the problem, and generally raise staff understanding about the need to identify and isolate defective devices, a staff awareness campaign was initiated. The MedSun PowerPoint presentation, Improving Patient Safety by Reporting Problems with Medical Devices** was shown at regular staff meetings. In 30 days, presentations were delivered at 45 staff meetings.

In September 2005, the staff awareness campaign culminated in a two-day UCLA-MedSun Expo, in the cafeteria areas of UCLA Medical Center and Santa Monica-UCLA Medical Center.

•Three MedSun posters** were displayed in addition to other posters that were developed.
•Video presentations (Recognize, Remove and Report** from MedSun and the Safe Medical Devices Act by Medfilms, Inc.) and a 100-slide PowerPoint show "looped" continuously.
•Winners of the "Design a Tag" competition were announced and received $100 gift certificates.
•Participants who completed a "Which are Not Medical Devices?" quiz received $3 coffee gift cards.
•A local radio station promoted the event

Tag and Sequester Policy Development: STAR Response Program:
A consolidated policy and procedure called the STAR Response Program (Stop, Tag, And Report) was designed and developed in response to feedback received during the staff awareness campaign. The STAR program involves:

•Definitive identification and orientation of first responders. All device users were designated and oriented as first responders in device related events.
•Affixing clear and sequential first response instructions in the form of a Device Malfunction First Response tag (see below) to each device. This tag was created to eliminate confusion and uncertainty about what to do when the device failed and to redirect the initial instinctual response of device users to attempt impromptu “workarounds” and self-repair efforts that can undermine safe device management.
•Orienting and educating all device users. The purpose, location and responsibilities associated with medical device identification tags were clarified to ensure organization-wide knowledge, understanding and competency with device-related risk reduction strategies.

Lessons Learned/Conclusions:
The Risk Management Department is currently working with Clinical Engineering, Safety, Nursing, and hospital leadership to create and roll out a system-wide tag and sequester policy and procedure encompassing medical equipment, medical devices, and surgically implanted devices. The STAR Response Program will be modified as needed to meet the demands of the greater hospital community. A brief overview of the project will be presented at the University of California’s 2006 Risk Summit so that other University of California medical centers may learn from this experience.

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*The Process Flow and Tag and Sequester labels that were developed as a result of this project have been made available to all MedSun facilities by UCLA Medical Center and Garry M. Walsh, Healthcare Consultant

**To order the above mentioned slide show, video or posters contact SSS at: medsun@s-3.com. See Educational Materials tab on this website for mentioned slide show.


MedSun Newsletters are available at www.fda.gov/cdrh/medsun