CHICAGO (Reuters) - A computerized tracking system that scans data might help in the difficult task of finding faulty medical devices, U.S. researchers said on Tuesday.
A test run of the system comparing data on seven heart devices used on patients in Massachusetts between 2003 and 2007 identified two products with potential safety problems.
Dr. Frederic Resnic of Brigham and Women’s Hospital said the study is meant to show it is possible to use electronic medical data collected in patient records or in registries collected by companies to track the safety of implantable medical devices.
Although companies are required to tell the U.S. Food and Drug Administration when a doctor or patient reports a problem with their device, many people believe only about 5 percent of these so-called adverse events get reported.
That leaves the FDA and others to piece together trends based on an analysis of insufficient data or anecdotes, said Resnic, whose study appears in the Journal of the American Medical Association.
Resnic said the existing process is like finding a needle in a haystack. Using a computerized tracking system could give regulators a magnet to help find that needle.
The group evaluated data on more than 74,000 heart procedures. They studied seven devices, looking for three common problems that could occur with each.
Two devices triggered a signal suggesting there might be a safety issue.
One was an older-model stent made by Boston Scientific Corp called the Taxus Express 2, which largely has been replaced by newer products. Stents are wire mesh devices placed into arteries to keep them open.
The other device, called Angio-Seal STS, is used to plug up holes made in leg arteries when doctors implant stents.
The findings do not mean there are problems with the devices, Resnic said. Instead, they simply give companies and regulators a good hint at where to look for problems.
“You’re giving them some tool to look at the performance of medical products that is hard to track in the real world,” Resnic said in a telephone interview.
He said there are thousands of potentially harmful medical devices that might benefit from an automated tracking system.
“If you have a smoke alarm that is constantly looking for smoke, you’ll find it,” he said.
Editing by John O’Callaghan
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