Health Information Technology May be to Blame for Six Deaths

Washington, DCElectronic Medical Records (EMRs) may be to blame for six deaths and hundreds of adverse events, according to a report by the Huffington Post.

The site apparently obtained information in advance of testimony from Center for Devices and Radiological Health chief Jeffrey Shuren, asking for an investigation into whether or not software programs should face similar regulatory hurdles as medical devices.

Apparently, the FDA has so far received 260 reports of adverse events believed to be related to health information technology (HIT) over the previous two years, including 44 reports of injuries and the six fatalities.

There is concern that because the adverse events reports are voluntary they may not accurately reflect the scope of the problem, in that many more people may have suffered HIT-related problems and not reported them to the FDA.

The alleged adverse events fall into four categories, namely, 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.

Examples include incidents involving the failure of patient records to display properly so that drug allergy information may not appear, or the EMR may be overwritten due to a database error. Another example includes operating room software freezing during surgical procedures.

"The FDA recognizes the tremendous importance of HIT and its potential to improve patient care," Shuren wrote. "However, in light of safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety."