WHAT'S KNOWN ON THIS SUBJECT:To our knowledge, national estimates and characterization of MDAEs in the pediatric population have not been reported. WHAT THIS STUDY ADDS:The authors characterized the first national estimates of MDAEs from EDs in the pediatric population. The scope and severity of these MDAEs underscore the need for more-intensive preventive efforts. abstract OBJECTIVES: The purposes of this study were to provide national estimates of emergency department (ED) visits for medical deviceassociated adverse events (MDAEs) in the pediatric population and to characterize these events further.METHODS: ED medical record reports from the National Electronic Injury Surveillance System All Injury Program database from January 1, 2004, through December 21, 2005, were reviewed. MDAEs among pediatric patients were identified, and data were abstracted. National estimates for pediatric MDAEs were determined according to medical specialty, device category and class, injury diagnosis, and patient characteristics and outcome. RESULTS:The total estimated number of pediatric MDAEs during the 24-month period was 144 799 (95% confidence interval: 113 051-183 903), involving devices from 13 medical specialties. Contact lenses accounted for most MDAEs (23%), followed by hypodermic needles (8%). The distribution of MDAEs according to medical specialty varied according to age subgroup. The most-prevalent types of injuries included contusions/abrasions, foreign-body intrusions, punctures, lacerations, and infections. The most-frequently affected body parts were the eyeball, pubic region, finger, face, and ear. The majority of pediatric MDAEs involved class II (moderate-risk) devices. The incidence of pediatric MDAEs decreased with increasing age from early to late childhood and then spiked after 10 years of age. More girls than boys were affected at older ages (16 -21 years) and more boys than girls at younger ages (Յ10 years). Hospitalizations were more likely to involve invasive or implanted devices. CONCLUSIONS:This study provides national estimates of pediatric MDAEs resulting in ED visits and highlights the need to develop interventions to prevent pediatric device-related injuries. Pediatrics 2010; 126:247-259