Article reprinted from "The Gray Sheet" - June 1, 2009
FDA's device center is developing a process to help staff spot post-market safety signals and decide when action is necessary. Find out more...
Inside The “Matrix”: Teaching Device Staff To Triage Safety Signals
Article reprinted from "The Gray Sheet" - June 1, 2009
FDA's device center is developing a process to help staff spot post-market safety signals and decide when action is necessary.
CDRH's Matrix 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," Jonathan Sackner-Bernstein, associate director of CDRH's post-market operations, said.
"In the past is that the center has had processes that were office-specific," he noted. "The overarching goal is to provide more consistency to how things are handled."
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 fall, at which point refinements will be made.
"We're describing the way multiple offices are going to interact and engage with each other around the identification and sharing of post-market safety concerns, " said Megan Moynahan, a Matrix leader in the cardiac electrophysiology and monitoring devices branch.
"It's a cultural shift, getting people who might not think of themselves as seeing post-market safety concerns and helping them realize that they have them in front of them," Moynahan said.
"People are good at doing their office-specific job. What's harder for them to realize is that things they are doing today are impacting people across the hall who are in another part of the center."
- Jessica Bylander
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