Health record push lacks FDA oversight, risks safety problems

The Huffington Post Investigative Fund: "As federal officials encourage the rapid expansion of electronic medical records to help doctors improve care and cut costs, they lack a reliable and systematic method for tracking the safety of these products, agency data and audits show. Instead, the Food and Drug Administration depends on a spotty warning system that can take a year to flag serious computer malfunctions and other software glitches. When it does learn about incidents that might cause harm, the FDA has failed to correct the problems, the data and audits show." One glitch involved an electronic medical record that inadvertently reversed an image, causing a surgeon to operate on the wrong side of a patient. The Investigative Fund examined 237 such incidents, of which 43 resulted in injuries and 6 in deaths (Schwartz and Schulte, 4/20).

In a separate story, the Investigative Fund reports, "Scores of reports on file with the Food and Drug Administration detail consequences to patients when an electronic medical record system fails. Those reports, reviewed by the Huffington Post Investigative Fund, show that a central function of the record systems, known as computerized provider order entry, or CPOE, has been linked to instances in which patients died or suffered serious injuries." The CPOE systems, a subset of electronic medical records, are required by the federal government for hospitals and doctors hoping to gain stimulus-funded incentives for adopting health information technology (Schulte and Schwartz, 4/20).

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This article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.