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70,000 Children Per Year Injured by Medical Devices

Jul 26, 2010 | Parker Waichman LLP

Medical devices send tens of thousands of children and teens to the ER every year, according to researchers at the U.S. Food & Drug Administration (FDA). Their study appears online in the journal Pediatrics.

To reach their conclusions, researchers from the FDA’s Center for Devices and Radiological Health analyzed medical records from ER visits reported in a national injury surveillance system. Data from about 100 nationally representative hospitals resulted in an estimate of 144,799 medical device-related complications occurring during 2004 and 2005. That comes to about 70,000 injuries per year, the researchers said.

The study did not include device problems in children who were already hospitalized. It was the first to evaluate device-related injuries in children only.

Contact lenses topped the list of devices most likely to cause such injuries. They were associated with 34,000 problems during the two-year period detailed by the study. Injuries included eye infections and eye abrasions.

The most serious problems involved infections and overdoses involving implanted devices such as brain shunts, chest catheters, and insulin pumps. Other common problems included wounds from hypodermic needles breaking off in the skin; infections in young children with ear tubes; and skin tears from pelvic devices used during gynecological exams in teen girls.

Malfunction and misuse were often behind such injuries, the researchers said. They also noted that many devices intended for adults are used in children.

The researchers are now working to determine how and why the injuries occurred and also are examining the prevalence in adults. Depending on their findings, those efforts may eventually result in FDA device warnings.

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