Adverse Device-Related Events Are Frequent in Children

Brian Hoyle

May 31, 2011 (Denver, Colorado) — Analysis of data from more than 5 million patients treated at more than 3 dozen hospitals throughout the United States has revealed a common prevalence of adverse medical-device events. This information could spur efforts to improve the safety of medical devices implanted in children.

The study results were presented by Patrick W. Brady, MD, from Cincinnati Children's Hospital, Ohio, here at the Pediatric Academic Societies and Asian Society for Pediatric Research 2011 Annual Meeting.

Most devices used in the medical treatment of children have been developed and tested in adults. Their performance and risks in children have been relatively poorly understood, Dr. Brady noted.

"The Institute of Medicine 2005 Consensus Report on Safe Medical Devices for Children noted an absence of robust surveillance for medical devices in children. Personally, I've seen amazing advances in therapeutics for children over the past decade, and wanted to work to improve our ability to minimize device problems for kids," Dr. Brady said in an interview with Medscape Medical News.

Dr. Brady and colleagues performed a retrospective cohort study of pediatric patient data from 42 hospitals throughout the United States, which were part of the Pediatric Health Information System database. The device-related data were stratified by device category/type, and the Kids' Inpatient Database was used to characterize the adverse medical-device events.

The researchers cast a huge net, analyzing 5,417,331 inpatient, observation unit, and/or ambulatory surgery visits. Of these patients, 137,431 (2.5%) experienced at least 1 adverse medical-device event, which resulted in 21,143 (3.0%) inpatient stays each year.

The bulk of the adverse events involved unspecified devices (65,929; 36.6% of the total). Adverse events involving vascular access devices (49,117; 27.3%) and nervous system devices (40,826; 22.7%) accounted for more than 50% of the pediatric cases.

On the basis of geography, the data revealed the relatively common occurrence of adverse medical-device events in infants receiving care at large children's hospitals, compared with smaller community hospitals, perhaps reflecting the greater surgical sophistication in the larger centers. However, device-related adverse-event occurrence was not infrequent in community hospitals.

Furthermore, the pattern of prevalence in the pediatric population was markedly different from that in the adult population, corroborating previous data that hinted that children are more at risk from device use than adults.

"Children may be particularly vulnerable to adverse medical-device events because of their small size and because, as they grow, the device needs to be able to grow with them or be replaced," Dr. Brady explained to Medscape Medical News.

"The data have certainly shed more light on this area. Now we have to figure out which devices are more of a concern with respect to their time of use," Stephen Downs, MD, director of general pediatrics and children's health services research at Indiana University School of Medicine in Indianapolis, told Medscape Medical News.

The authors and Dr. Downs have disclosed no relevant financial relationships.

Pediatric Academic Societies (PAS) and Asian Society for Pediatric Research 2011 Annual Meeting: Abstract 2820.3. Presented May 1, 2011.