WASHINGTON – Despite the promise of healthcare IT to reduce medical errors and improve care, a just-published article by the Huffington Post Investigative Fund has found that "scores of reports on file with the Food and Drug Administration detail consequences to patients when an electronic medical record system fails" and "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."
In their report, Fred Schulte and Emma Schwartz accessed the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, which compiles adverse events related to medical devices. Their investigation identified 237 reports related to health IT filed since January 2008.
Those incidents included a heart attack that was brought on by a ten-fold increase in a patient's prescribed dose after doctors misread the small print on a computer screen, and a patient who suffered seizures throughout the night after a computer failed to alert doctors and nurses that the patient had been moved to their ward.
The adverse events in the FDA database were attributed to software malfunctions, but also to "user error or the system’s lack of user friendliness."
Schulte and Schwartz spoke to experts who "worry that the prospect of stimulus funding – an estimated $5 million or more per hospital – encourages hospitals to install systems prematurely, possibly exposing patients to harm associated with software glitches and other system bugs."
Moreover, in a second piece to their investigation, the authors reported that "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… 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."
Both Cerner and GE Healthcare, whose products were linked to patient deaths in the MAUDE database, responded to the Investigative Fund's findings.
"Over the last decade… Cerner has voluntarily implemented post-market surveillance processes in accordance with the FDA regulations and has publicly disclosed issues that might impact public safety by reporting through the FDA’s MedWatch program," read the company's statement. "These reports are part of the public record. Cerner is one of the few HIT suppliers in the U.S. that voluntarily reports safety related incidents for non-FDA regulated medical devices."
"GE Healthcare holds nothing higher than its commitment to quality and safety," added that company. "We emphasize timely reporting of product issues, and appropriate corrective actions. The clinical environment in which healthcare IT products are used continues to evolve and develop. We are dedicated to examining and re-examining our software products to identify potential areas for improvement, and make proactive corrections prior to any issues occurring."
