Gender Differential in National Estimates for Medical Device-Associated Adverse Events from Emergency Departments

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.