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Database System to Help FDA Earlier Identify Issues with Devices
FDA today unveiled the Sentinel System, a series of databases that will allow it to query a broad array of information to identify possible post-market adverse events. Rather than waiting for adverse-event reports to trickle in, the agency will now be able to proactively search databases and look for problematic patterns of side effects and adverse events. If the system works as envisioned, the agency would be able to identify problems and alert doctors and patients to them much more quickly than it can now.
May 22, 2008
1 Min Read
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This could prevent adverse events and save costs.No patient-specific data will be returned in the searches, so privacy issues should not be a concern.The effort will begin with a pilot program, using CMS's Medicare Part D database. Eventually, FDA will also be able to search other CMS databases, and databases from the private sector -- such as electronic medical records in hospital systems, and insurance-company databases.The agency has prepared a white paper explaining how the system will work.UPDATE: Thomas Gross, head of CDRH's division of postmarket surveillance, confirmed that the new system will not bring any extra regulatory requirements upon the device industry.
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