President Barack Obama’s top doctor in charge of implementing a nationwide push to adopt electronic medical records said reports of deaths from EMR malfunctions may be more sizzle than steak.
Dr. David Blumenthal, the National Coordinator for Health Information Technology at the U.S. Dept. of Health and Human Services, told a crowd in Boston April 29 that his agency has concluded a preliminary investigation into reports of some 260 HIT-related adverse events over two years, including 44 reported injuries and six deaths.
Blumenthal said that although an advisory committee concluded that more information was necessary, he called the evidence of the reports “anecdotal and fragmented” at best.
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The investigation stemmed from a February report on the Huffington Post Investigative Fund website that the Food & Drug Administration was considering tighter regulation on EMRs after receiving word of several adverse events over a two-year period.
The website cited testimony given by the FDA’s Center for Devices & Radiological Health chief Dr. Jeffrey Shuren to the Health Information Technology Policy Committee Feb. 25. Shuren said the adverse events fell into four categories: Errors involving the confusion of one patient’s records with another’s, or the mistaken combination of two patients’ medical files; the loss of information or the corruption of data; medication and/or dosing errors; and software incompatibility issues.
The FDA does not enforce regulatory requirements for EMRs or other forms of HIT, though they are considered medical devices under the federal Food, Drug and Cosmetic Act. But Shuren hinted that more regulation may be necessary.
While the remarks garnered a lot of attention, Blumenthal said his department is confident that its mission remains unchanged in trying to push all healthcare establishments to adopt EMRs as a standard practice.
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“The committee said that nothing it had found would give them any pause that a policy of introducing EMR’s could impede patient safety,” he said.
Blumenthal, a former primary care physician at Mass. General Hospital, was the keynote speaker at a national conference on Healthcare Information Technology hosted by Gov. Deval Patrick.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
