Brinker wanted Cardiac Pathways, once the procedure was established practice, to conduct post-market surveillance, which meant keeping a running casualty list and periodically reporting it to the FDA. You’d find out how risky it was once doctors across the country started doing the procedure by the hundreds. Just get it out there and let them start doing it and see what happens.
“Do you mean,” asked Dr. Simmons, “a follow-up on the alive or dead thing?”
Just so, said Brinker.
KevinMD has posted an excerpt from Dan Walter's alarming book, Collateral Damage: A Patient, a New Procedure, and the Learning Curve. Read it here.