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Device center studying adverse events related to children

This article was originally published in The Silver Sheet

Executive Summary

CDRH is conducting an in-depth study of adverse events with medical devices in younger patients, the first part of which was published online July 26 in the journal Pediatrics. FDA staffers analyzed visits to 100 U.S. emergency rooms between Jan. 1, 2004, and Dec. 21, 2005, by patients 21 years old or younger. Most device-related adverse events involve Class II, moderate-risk devices, according to results presented in the article. The 144,799 identified events involved devices from 13 medical specialties, including ophthalmology, cardiology and radiology, but the researchers concluded that it was two product categories that primarily contributed to the public health burden: ophthalmic devices - notably contact lenses - and physical medicine devices

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