Scientific Publications by FDA Staff

J Hosp Med 2013 Jul;8(7):390-3

Prevalence and nature of adverse medical device events in hospitalized children.

Brady PW, Varadarajan K, Peterson LE, Lannon C, Gross T

Our objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in tertiary care children's hospitals. In our retrospective cohort study of patients at 44 children's hospitals in the Pediatric Health Information System (PHIS), we included all inpatient stays with an AMDE-related diagnosis from January 1, 2004 to December 31, 2011. We identified AMDEs by diagnoses that specified a device in their definition. We included events present on admission as well as those complicating hospital stays. We described the characteristics of these admissions and patients, and stratified analysis by device category and presence of a complex chronic condition. Of 4,115,755 admissions in the PHIS database during the study period, 136,465 (3.3%) had at least 1 AMDE. Vascular access and nervous system devices together represented 44.4% of pediatric AMDE admissions. The majority (75.5%) of AMDE admissions were of children with complex chronic conditions. The most common age group was patients aged 2 years or less at the time of their first AMDE-related admission. AMDEs occur commonly in a population cared for in tertiary children's hospitals. Research to more specifically delineate AMDEs and their predictors are next steps to understand and improve device safety in children.