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Public MedSun Web Site Gives Information On Device Problems

This article was originally published in The Silver Sheet

Executive Summary

A NEW ALL-ACCESS MEDSUN WEB SITE goes live Nov. 16 to educate health care providers about device-related problems observed by hospitals in FDA's MedSun adverse event reporting network. Although the aim is to improve patient safety, the Web site may also help enhance communication between hospitals and manufacturers, says FDA MedSun Project Officer Marilyn Flack. She believes companies also will be interested in the information on the Web site because it will “give them an eye into the mind of FDA that month - things we thought were important that we're talking to the sites about.” Meanwhile, the agency is making headway on its postmarket transformation initiative, including planned changes to the MAUDE adverse event database and progress on risk communication issues.

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