At this meeting FDA testimony was given by Jeffrey Shuren, Director of FDA’s Center for Devices and Radiological Health. Dr. Shuren noted several categories of health IT-induced adverse consequences known by FDA. This information was striking.
... In the past two years, we have received 260 reports of HIT-related malfunctions with the potential for patient harm – including 44 reported injuries and 6 reported deaths. Because these reports are purely voluntary, they may represent only the tip of the iceberg in terms of the HIT-related problems that exist.
Well, there's absolutely nothing to worry about, according to the Office of the National Coordinator and Dr. David Blumenthal. Nothing to see here. Move on.
Blumenthal has just reportedly stated that:
... [Blumenthal's] department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice. "The [ONC] committee [investigating FDA reports of HIT endangement] said that nothing it had found would give them any pause that a policy of introducing EMR's could impede patient safety," he said.
I ask a simple question:
- Are these the words to be reasonably expected from an academic physician/scientist?
Perhaps I'm a bit behind these postmodern times, but I once believed the perhaps now old-fashioned and obsolete view that a scientist would not base a conclusion of medical safety in national dissemination of drug, device, or whatever on some analysis of anecdotal data, whether 'preliminary' or final.
Due to reasons such as the lack of knowledge of FDA as a place to report HIT problems, as well as fear by clinicians in reporting HIT problems at all, the cited FDA data (260 HIT-related adverse events over two years, including 44 reported injuries and six deaths) is most certainly anecdotal and incomplete, and potentially (per FDA's Jeff Shuren, MD, JD) the "tip of the iceberg."
I would not take the FDA data to be anything but a possible red flag, not a source of truth, one way or the other.
For example, the scant reports of health IT bugs and defects -- many of which admittedly could cause medical error -- in another database, MAUDE, voluntarily submitted by just a tiny fraction of the HIT vendors, should give a scientist pause. They are a sentinel. (See my Oct. 2009 post "Our Policy Is To Always Have Unabashed Faith In The Computer ... Except When It Screws Up, And Then It's The Doctor's Fault" for several MAUDE database examples).
Obviously, the unreported, unrecognized (and therefore uncorrected) bugs and defects have the same potential. Those MAUDE reports alone should provide an impetus to call for full, rigorous, scientific, uncensored investigations on HIT safety, not make pronouncements on safety to a national audience.
(Feb. 2011 addendum - see my more recent post about MAUDE health IT defects reports at this link.)
Proof by lack of evidence is not what I was taught in medical school.
Blumenthal appears to be speaking not as a scientist, but as a marketer and (of course) politician.
This is quite disappointing.
However, as the man said, nothing to see here, move along.
By the way, I am assuming the "analysis" will be open to public scrutiny.