* What type of analytics can an organization run on FDA Maude database ?
As SteveK mentioned, it is a very useful tool for the post marketing survelliance, and risk management update. I use it also in the design stage when I would like to identify the potential risks and failures of the device to be taken into account for risk analysis, user requirements and technical specification.
Once I thought to use the database to explore the reliability (incident rate analysis) of the competitors products. The problem is as Robert mentioned that adverse events from the MAUDE database cannot be used to determine the rate of adverse events for a particular product or to compare adverse event rates between products. Manufacturers submit reports according to their interpretation of regulatory requirements and event reportability. For example, global or USA companies might submit more MDRs than small sized/out of USA companies as a result of internal compliance policy. What one company would consider as reportable, might not be reportable in interpretation of other company for the same type of device. Moreover, submission of the report does not mean the device caused the adverse event.
Nice resource on the problems with MAUDE system can be found here:
http ://www. fda gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM283555.pdf - DEAD 404 LINK UNLINKED
it mentions other challenges for the search in the MAUDE system:
- Duplicate and triplicate entries (follow-up reports),
? Blank narrative entries,
? Duplicate MDR ID numbers,
? Reports filed through the Alternative Summary Report (ASR) System not consistently updated to MAUDE
* Does FDA run analytics or mine the MAUDE data to help them capture signals, that flags that they need to go after an organization for Audit?
FDA has created the TPLC - total product life cycle database that combines data from various CDRH databases (data sources like MAUDE) to present an integrated record of premarket and postmarket activity for medical devices. The TPLC database integrates data by procode, a three-letter code associated with a generic type of medical device.
here is the link to the TPLC dabase - you can perform the search according to the device name or product code:
TPLC - Total Product Life Cycle
For specific product code you could see there the types of device problems and number of the problems reported according to each type.
Another important source of the information that might be useful for your research is FDA's report for one of specific types of product - you could see there the method for mining the MAUDE data and the Public Health Notification that was issued as results of large number of adverse event received, with recommendations how to mitigate the risks. http :// www .fda. gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM270402.pdf - DEAD 404 LINK UNLINKED
Regarding the signals for the audit - in my experience, I'm aware of 1 FDA inspection where the reason for inspection was lack of correlation in number of the user facility reports with the number of the manufacturer reports for the same cases. For that specific company there were about 20 user facility reports with 0 manufacturers reports for these cases as MDRs to FDA and the only reason for the FDA inspection was to inspect how that company responses, investigates and decides on the reportability for MDRs.