Pronovost, who directs the Johns Hopkins Armstrong Institute for Patient Safety and Quality, tells me that the FDA effort represents "a whole new paradigm shift, that patients have valuable input and information." The FDA site actually says, "Wanted: Consumers to Report Problems."
Why now? I asked. What was the FDA's tipping point?
"I don't know for sure," Pronovost replied. "But physician reporting [of adverse events from devices and drugs] is pretty low. It's like most medical mistakes. Only a small fraction of what goes wrong really gets reported. I think the FDA probably realized they were missing a whole piece of the story, one they were just closing their eyes to.
"If you think about how so many devices have gone wrong, like pacemakers and [artificial] hips. Who is going to be both most interested and most knowledgeable that an event occurred? By far it's the patient. It doesn't mean the patient is going to know all the facts about it, but boy, they're sure going to know when something happened and what went wrong. That information could trigger further investigations."
He gave me four reasons why reporting from the usual suspects, hospitals and doctors and device manufacturers, has been lackluster.
1. Event reporting requires that providers "see the event as a preventable rather than inevitable. Too often in healthcare, we just assume stuff goes wrong, that things break down or sometimes don't work, and that's just the way things go," he says.