How real-world evidence can really deliver: a case study of data source development and use

What is it about?

Real world clinical data have been used in the assessment of medical device effectiveness and safety, but this has generally been accomplished through registries and not using routinely collected electronic health records.
We have developed a database containing routinely collected electronic health record data combined with UDI associated medical device data for the evaluation of device safety. Additionally, we performed a demonstration analysis demonstrating the database's potential utility.
How might these results affect future research or surgical practice?
The methods used in creating our database are generalizable to all medical devices implanted in the interventional cardiology laboratory and in the operating room. The BUILD initiative is expanding the work to two other health systems. Additionally, future development will focus on orthopedic and other devices implanted in the operating room.


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