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FDA Investigates CT Radiation Overdose In Multiple States, Facilities

This article was originally published in The Gray Sheet

Executive Summary

FDA is investigating hundreds of cases of radiation overexposure from computed tomography (CT) imaging scans to determine whether the overdoses were caused by human error or a problem with the devices

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The number of medical device recalls initiated by manufacturers last year hit an all-time high, likely caused in part by over-reporting of recalls by wary firms that were dinged in the past by FDA for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” an agency official says.

FDA Blames Over-Reporting For Record-High Recall Count In 2013; Looks To Root Causes

The number of medical device recalls initiated by manufacturers last year hit an all-time high, according to an analysis by “The Silver Sheet.” FDA says the increase resulted in part from over-reporting of recalls by wary firms that were dinged in the past by the agency for not reporting. “Once a firm has been cited by an investigator, it is a wonderful reporter of recalls after that,” FDA official Ann Ferriter said in an interview. “They report a disproportionate number of recalls.” Meanwhile, the agency looks to root causes for answers. Failing to conduct thorough root cause investigations “sends a message to the FDA that maybe you do not have control over your recall,” CDRH Recall Branch Chief Ron Brown says.

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The "Image Wisely" campaign is designed to rally imaging providers behind offering only necessary scans, while researchers strive to get a better handle on exposure trends and cancer risks.

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