Association for the Advancement of Medical Instrumentation (AAMI) Conference and Expo 2006 Presentation About MedSun Project
MedSun: Newsletter #7, September 2006

Three perspectives on the MedSun Project and its impact on medical device safety were presented during the Association for the Advancement of Medical Instrumentation (AAMI) Conference and Expo 2006, which was held June 24–26, in Washington, D.C.

The first perspective was that of Terrie Reed, FDA MedSun Device Safety Program Manager, who discussed MedSun’s adverse event reporting function and provided an overview of past reporting methods and regulations. She reviewed the challenges faced by FDA with traditional health care facility medical device adverse event reporting and explained that the need to respond to these issues served as a basis for the MedSun Project. MedSun works to improve report quality by developing interactive relationships between MedSun sites and the FDA. This communication presents opportunities to focus on high-risk products, to follow products to market, and to raise awareness of design issues associated with human factors. Ms. Reed also covered future MedSun goals related to specific MedSun subprojects: HeartNet, which will focus on electrophysiology and cardiac catheterization laboratory products; LabNet, which will spotlight laboratory devices; and an effort under development that will concentrate on medical products used for pediatric care (KidNet).

A second point of view was expressed by Cheryl Spencer, a Biomedical Engineer with FDA's contractor for MedSun, Social & Scientific Systems, Inc. Ms. Spencer reviewed the MedSun Project objectives—to improve the likelihood of detecting device problems, to understand events in clinical settings related to device use, and to share device safety information with the clinical world. She then explained the administrative elements of MedSun reporting and provided details on how MedSun facilitates information flow between the FDA and users. Ms. Spencer described the secure online reporting system capabilities; presented an overview of the report sections; and offered examples of high-quality, complete reporting. She explained that MedSun includes manufacturers in the reporting process by forwarding a copy of each report to the specific manufacturers as appropriate. Each incoming report is reviewed by skilled MedSun staff, including registered nurses with expertise in cardiac surgery care, neonatal and pediatrics care, and intensive care; biomedical engineers with a wide range of device experience; and a physician.

Their critical reviews of reports received often lead to work with FDA specialists on development of safety tips, audioconferences, and articles for the MedSun News. In addition, certain reports are earmarked for discussion with specialists such as those at ECRI. Glenn Scales, Patient Safety Specialist in the Department of Clinical Engineering of Duke University Health System, presented a third perspective, that of an active, hospital-based MedSun Representative. He emphasized the benefits from MedSun, the importance of selecting appropriate staff to report online, and training reporters and other clinical staff in what information is needed for complete reporting. Mr. Scales identified several minor challenges encountered during start-up of his MedSun activities, including integrating voluntary reporting system data into MedSun.

To maximize use of the feedback MedSun provides to participating sites, Duke University Health
System now incorporates the MedSun News and the FDA Patient Safety News into a broadcast to various departments. Mr. Scales noted that another key benefit is having FDA device-specific recall information sent directly to the reporter, enabling reporters to quickly find items of interest.

He said he and his staff also appreciate the ease of online reporting; the access to all reports in a central location; and the ability to broadcast a question, concern, or success story using the MedSun Device Safety Exchange.

Following their discussions, the presenters engaged in a question-and-answer session with the audience. In addition to this formal presentation, MedSun project staff also had the chance to meet with AAMI members informally at the project exhibit.


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