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Abstract #153288

Cunlin Wang, MD, PhD, Brockton Hefflin, MD, MPH, Danic Marinica-Dabic, MD, PhD, Nilsa Loyo-Berrios, PhD, MSc, and Jie Zhou, PhD. Center for Device and Radiologic Health, U.S. Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, 240-276-2368, cunlin.wang@fda.hhs.gov

Medical device-related adverse events (MDAEs) account for >1% of the annual injury-related visits to hospital emergency departments (EDs) in the U.S. Previous studies have demonstrated considerably higher frequencies of these adverse events in women compared to men. However, there are no published reports on the gender difference in MDAEs that describe the types of devices involved, severity of injuries, and patient characteristics. We investigated this issue using data from the National Electronic Injury Surveillance System (NEISS), a statistically representative sample of nationwide EDs used to collect data on product-related injuries. The study population consisted of all patients who visited NEISS EDs in 2004 for an MDAE. NEISS coordinators reviewed every ED record, identified MDAE cases, and abstracted patient, device, and event information. The data was then submitted to the FDA for quality control and weighted analyses to produce national estimates and associated variances of adverse events related to medical devices. Our results showed that women who visited EDs for MDAEs were more likely to be older, experience injury in public places, and have more severe injuries related to gastro-urologic and orthopedic devices. Men were more likely to experience injury at industrial sites or on a street/highway, have a larger proportion of MDAEs related to urological catheters, and more likely to be hospitalized if events were related with general medicine devices. This information will contribute to the development of targeted interventions, the appropriate allocation of health-care resources, and improvement of the FDA's premarket and postmarket review of medical device-related submissions.

Learning Objectives: Learning Objectives

Attendees will be able to
1) Define the scale of injury due to medical device-related adverse events from a nationally representative sample of Emergency Departments for both men and women. 2) Determine the major differences of medical device-related adverse events between men and women in event severity, patient’s characteristics, device involved and medical specialty.
• Understand the major limitation of current passive surveillance system in monitoring medical device-related adverse events, and the advantages and methodology of conducting active surveillance through nationally representative sample.

Keywords: Medical Devices, Emergency Department/Room

Presenting author's disclosure statement:

Any relevant financial relationships? No
Any institutionally-contracted trials related to this submission?


I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.

Injury Posters on Providers, Patients and Communities

The 135th APHA Annual Meeting & Exposition (November 3-7, 2007) of APHA