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Medical devices may create problems for children

Saturday June 15, 2013
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As modern medical advances help more children with complex conditions live longer, a significant number suffer from complications caused by medical devices that are also necessary for their survival, according to a study.

The researchers said the study underscores the continued need to improve care for this growing population of children by enhancing medical device safety practices and ensuring device design is suitable or adaptable for pediatric patients.

“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,” Patrick Brady, MD, MSc, the study’s lead author and a physician at the Division of Hospital Medicine at Cincinnati Children's Hospital Medical Center, said in a news release.

Brady said medical devices are a major factor in improved survival for children with complex medical conditions. But he added 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, most medical devices are designed for adults and have to be adapted for use in children.

As reported June 7 on the website of the Journal of Hospital Medicine, the researchers sought to describe the prevalence and nature of adverse medical device events in 44 free-standing tertiary care children's hospitals in the United States. Using data from the Pediatric Health Information Systems, the researchers analyzed medical information from 2004-11.

Of 4.1 million patient admissions during the study period, 3.3% (136,465) involved at least one adverse event related to a medical device. Although the number may seem small, Brady noted the researchers identified more than 12,000 adverse medical device events during each year of the study. And because of how information is labeled in the Pediatric Health Information Systems, the researchers suspect their data actually underestimates the prevalence of adverse medical device events.

PHIS also did not allow researchers to identify whether the adverse medical device events were caused by factors such as biological reactions to devices, human error, malfunction or other possible problems.

The system did allow the researchers to identify which types of devices were more prone to adverse events. The two most common device types associated with adverse events were 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). These two device types together represented 44.4% of adverse events in the study.

Also standing out in the data was that 75.5% of adverse events involved children with complex medical conditions, and the largest age group (40% of those with adverse events) involved children age 2 or younger.

“Although our study cannot answer too much of the ‘why’ for these events, it does point out that AMDEs [adverse medical device events] are not rare and the burden falls largely on young children with complex chronic conditions,” Brady said. “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.”

Read the study abstract: http://onlinelibrary.wiley.com/doi/10.1002/jhm.2058/abstract.


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