FDAnews Device Daily Bulletin

Better Use of Existing Data Could Identify Safety Issues Sooner: CHOP Reports

June 29, 2017

The FDA could more quickly identify medical device safety problems through the use of existing administrative data, according to researchers at the University of Michigan’s Center for Healthcare Outcomes and Policy.

For example, issues with the Lap-Band gastric device could have been identified earlier by analyzing medical diagnosis codes and claims data going back to 2009, the CHOP researchers report.

Looking at simple measures such as payments for device removals and identifying trends earlier, could have saved about $1 billion between 2010 and 2014 on reoperations, they estimate. Regulators projected reoperation rates at 4 percent based on clinical trial data even as claims data put the figure at 50 percent.

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