Electronic patient registries can help medical device manufacturers track the safety of implantable devices and locate problematic units, according to new research on Massachusetts heart patients. But EHRs may be even better, suggest Brigham and Women's Hospital researchers, who published their findings in the Journal of the American Medical Association.
"While the number of data sources having features similar to those of the Massachusetts angioplasty registry are limited, such detailed clinical registries are becoming more widespread. In addition, alternative clinical data repositories, such as pooled data from increasingly available electronic health record systems as well as medical condition-specific clinical outcomes registries, may prove to be valuable resources for additional exploration of automated safety surveillance approaches," the study says.
The research team, led by Dr. Frederic Resnic, noted that only about 5 percent of adverse events with implantable medical devices ever get reported to the Food and Drug Administration. The FDA has to try to spot trends based on incomplete data or merely anecdotal evidence, a process that Resnic likens to finding a needle in a haystack, Reuters reports.
Trying to improve on this, Resnic and his colleagues devised a system to search the Massachusetts state registry to identify patterns of ailments that could be linked to specific models of devices. The system was successful in finding small differences in outcomes that cardiologists generally would not be able to detect.
"Not all alarms or alerts are going to be true positives, but this [could be] a way of communicating to public health [agencies] and to healthcare providers that there's some uncertainty [that] we must explore further," Resnic tells the Boston Globe. "The most important message of the paper is that ... automating safety surveillance for medical devices is really feasible and can be efficient and potentially useful in detecting low-frequency signals of safety concerns."