Affiliation:
1. Office of Surveillance and Biometrics, Center for Devices and Radiological Health, and
2. Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland
3. Office of Pediatric Therapeutics, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland; and
Abstract
OBJECTIVES:
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 144799 (95% confidence interval: 113051–183903), 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 (≤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.
Publisher
American Academy of Pediatrics (AAP)
Subject
Pediatrics, Perinatology and Child Health
Reference28 articles.
1. US Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. Available at: www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/default.htm. Accessed March 31, 2010
2. Age limits of pediatrics;American Academy of Pediatrics, Council on Child and Adolescent Health;Pediatrics,1988
3. Food and Drug Administration. Food and Drug Administration Amendments Act (FDAAA) of 2007. Available at: www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm. Accessed November 12, 2009
4. Device safety and effectiveness in the pediatric population: a US FDA perspective;Samuels-Reid;Expert Rev Med Devices,2009
Cited by
30 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献