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Adverse Medical Device Events Involve Children Most, Study Shows

 A study released today by the Cincinnati Children’s Hospital Medical Center and published in the Journal of Hospital Medicine has found that the very devices that are helping children with complex conditions are also creating adverse medical device events (AMDEs) with their young patients as well.

 A study released today by the Cincinnati Children’s Hospital Medical Center and published in the Journal of Hospital Medicine has found that the very devices that are helping children with complex conditions are also creating adverse medical device events (AMDEs) with their young patients as well. The retrospective study’s objective was to describe the prevalence and nature of adverse medical device events (AMDEs) in 44 free-standing tertiary care children’s hospitals in the United States. Using data from the Pediatric Health Information Systems (PHIS), researchers analyzed medical information from 2004-2011.The study, conducted on 4.1 million patient admissions, found that 3.3% (136,465, or over 12,000 AMDEs per year), involved at least one adverse event related to a medical device. Of these AMDEs 75.5% involved children with complex medical conditions. The largest age group (40% of those with AMDEs) involved children age 2 or younger. Researchers found that two devices together represented 44% of the AMDEs in the study - vascular access devices (such as central venous lines) and nervous system devices (often involving shunts designed to drain excess cerebral spinal fluid from the brain).

The researchers also commented that because of how information is labeled in the PHIS system, they suspect their data actually underestimates the prevalence of AMDEs. While the PHIS system did allow researchers to identify which types of devices were more prone to adverse events, it did not let them identify whether the AMDEs were caused by factors such as biological reactions to devices, human error, malfunction, or other factors. The system did allow them to identify which types of devices were more prone to adverse events.
 
In a press statement, Patrick Brady, lead study author and a physician in the Division of Hospital Medicine at Cincinnati Children’s Hospital Medical Center says, “Medicine and pediatrics have made amazing advances over the last couple of decades that have resulted in children with congenital diseases and prematurity living longer, so this issue is a by-product of that success.” Brady adds there has been relatively little research into how medical devices may expose these children to additional risks, especially when considering the devices are foreign objects to the human body and subject to mechanical problems or causing infections. Also, researchers note that most medical devices are designed for adults and have to be adapted for use in children.
 
“Although our study cannot answer too much of the ‘why’ for these events, it does point out that AMDEs are not rare and the burden falls largely on young children with complex chronic conditions,” Brady says. “This is a somewhat early step that will allow our team and other researchers to start asking questions about what causes these events, how to predict them, and how we can design interventions to decrease their frequency.”

 
-Chris Wiltz, Associate Editor, MD+DI
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