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Matrix team develops process to spot safety problems

This article was originally published in The Silver Sheet

Executive Summary

CDRH's matrix team has developed a process to help staff spot post-market safety problems and decide when action is necessary. The team - representing multiple offices and product areas within the center - began testing the process this spring. "The goal is to learn which pieces of information we need to react to, [and] hopefully set up a system so that it's not really a reaction, but a response at an early stage," says Jonathan Sackner-Bernstein, associate director of CDRH's post-market operations. The "signal escalation process" includes training staff to recognize safety signals in anything from adverse event reports, to scientific papers, to device modification submissions; using IT to track and trend the signals; employing risk-based decision tools to prioritize signals; and moving high-priority items into the hands of everyone working in that product area. Matrix leaders hope to have about half the center staff trained on the process by this fall, at which point refinements will be made ("The Silver Sheet" January 2009)
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