Automation speeds clinical safety surveillance
by noreply@blogger.com (brian wang) from NextBigFuture.com on (#2A94J)
Using patient outcomes data from approximately 1,800 hospitals, the largest demonstration to date of automated safety surveillance of a medical device is reported in this week's New England Journal of Medicine.
Vanderbilt medical informatics researcher and internal medicine specialist Michael Matheny, M.D., MPH, M.S., and colleagues demonstrate the effectiveness of an automated web-based surveillance system for spotting potential safety problems with less delay.
Their demonstration concerns a device used to close the small hole left in an artery after the insertion and removal of flexible tubing, that is, the hole left after vascular catheterization.
After three quarterly data uploads from the National Cardiovascular Data Repository CathPCI Registry, the automated system found a statistical signal indicating a potential safety issue with a vascular closure device called the Mynx.
The study's final results were based on data from approximately 146,000 registry patients, half of whom got the Mynx.
"The takeaway is we were able to detect a safety signal fairly quickly. When it comes to post-market safety surveillance for medical devices, you have to be really timely in your safety alerting for it to matter. In our world, nine months is quick enough that if you could get the signal to the FDA, they could act on it," said Matheny, assistant professor of Biomedical Informatics, Medicine and Biostatistics.
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Vanderbilt medical informatics researcher and internal medicine specialist Michael Matheny, M.D., MPH, M.S., and colleagues demonstrate the effectiveness of an automated web-based surveillance system for spotting potential safety problems with less delay.
Their demonstration concerns a device used to close the small hole left in an artery after the insertion and removal of flexible tubing, that is, the hole left after vascular catheterization.
After three quarterly data uploads from the National Cardiovascular Data Repository CathPCI Registry, the automated system found a statistical signal indicating a potential safety issue with a vascular closure device called the Mynx.
The study's final results were based on data from approximately 146,000 registry patients, half of whom got the Mynx.
"The takeaway is we were able to detect a safety signal fairly quickly. When it comes to post-market safety surveillance for medical devices, you have to be really timely in your safety alerting for it to matter. In our world, nine months is quick enough that if you could get the signal to the FDA, they could act on it," said Matheny, assistant professor of Biomedical Informatics, Medicine and Biostatistics.
Read more