Emergency department visits for medical device-associated adverse events among children.
OBJECTIVE
The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated 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 (< or =10 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.
Wang
Cunlin
C
Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Silver Spring, MD 20993-0002, USA. cunlin.wang@fda.hhs.gov
Hefflin
Brock
B
Cope
Judith U
JU
Gross
Thomas P
TP
Ritchie
Mary Beth
MB
Qi
Youlin
Y
Chu
Jianxiong
J
D000293:Adolescent; D002648:Child; D001330:Electronic Data Processing; D004632:Emergency Medical Services / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D004869:Equipment Safety / Q000706:statistics & numerical data*; D005260:Female; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010372:Pediatrics / Q000706:statistics & numerical data*; D017678:Sex Distribution; D016896:Treatment Outcome; D014947:Wounds and Injuries / Q000145:classification / Q000453:epidemiology* / Q000534:rehabilitation*; D055815:Young Adult