Children with complex conditions often must rely on medical devices to survive, but, because most are designed for adults, life-saving technologies can also expose kids to additional risks, according to a study.
In a new Journal of Hospital Medicine report, researchers looked at 7 years of data from 4.1 million pediatric patients, finding that 3.3% experienced at least one adverse medical device event (ADME), adding up to more than 12,000 complications per year. And while the registry data don't specify the types of adverse event, vascular access devices and nervous system implants accounted for 44.4% of all complications.
"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," study author and Cincinnati Children's physician Patrick Brady said in a statement. "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."
The results come as regulators and devicemakers take a hard look at how technology affects kids. Late last year, a Circulation: Arrhythmia and Electrophysiology study found that children with implanted defibrillators reported quality-of-life scores in line with kids who have serious congenital heart disease, well below the average figures for adults. Similarly, the FDA is working to strengthen post-market surveillance of pediatric medical devices in hopes of improving outcomes for kids, and the agency has recently amended its draft guidance on radiation exposure for children.
The issue has been something of a call to action for Cincinnati Children's, and the hospital has teamed up with Israel's Ben-Gurion University to develop three new child-friendly medical devices, planning to invest $100,000 in each project to get started. In the same vein, Children's Healthcare of Atlanta and the Georgia Institute of Technology teamed up to create a $20 million research partnership to develop devices specifically for pediatric care.
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