Due to a bug in electronic health record software made by UnitedHealth Group, the company is recalling the technology. According to a document filed with the U.S. Food and Drug Administration and posted July 29, certain versions of the software contained an error that didn’t print medication information and failed to add data to patients’ charts, Bloomberg reported. The recall comes amid ongoing concern about software errors in electronic health records as the country’s healthcare providers seek to digitize systems.
The recall of UnitedHealth’s Picis ED PulseCheck software began June 21. The error caused doctor’s notes about patient prescriptions to disappear from their records, a flaw that could have serious consequences, experts noted. A total of 35 facilities across more than 20 states were affected. A spokesman for UnitedHealth said that there were no reports of patient harm and that each facility was notified of the issue and given a digital fix.
An ongoing challenge
While the effects of this error appear to have been minor, the recall underscores a number of concerns about the adoption of EHR software, Ross Koppel, an adjunct professor at the University of Pennsylvania specializing in health IT errors, told Bloomberg. Although medical device makers are required to report safety issues to the FDA, EHR software vendors do not face the same requirements.
“It’s admirable that the vendor reported this, but realize that this is one of the more obvious errors,” said Koppel. “Most are not as obvious and go unreported.”
Bloomberg noted that an online FDA database shows that Picis, which was acquired by UnitedHealth in 2010,has reported six recalls of EHR software since 2009. In one case, the software failed to display allergy interaction warnings, while another mistakenly showed patient information in another patient’s file. Such errors are not entirely uncommon. A 2012 Penn study of EHR-related safety events found that 10 percent led to “unsafe conditions.”
Another report from the American College of Emergency Physicians released earlier this year pointed to anecdotal data suggesting that such incidents are extremely common, HealthLeaders Media reported. However, due to clauses in vendor contracts, many healthcare providers are not allowed to disclose these errors, which could help prevent future problems.
“It doesn’t promote patient safety if you can’t talk about it,” Jesse Pines, MD, the report’s senior author, told HealthLeaders Media, “And if you do something that changes the EHR in a good way, you should be able to publish that so it can be disseminated to other systems.”
While the industry has been close-lipped about some of the errors, alleged flaws in EHR systems have been the basis of several lawsuits, Bloomberg reported. At the same time, a recent study published in the Journal of the American Medical Informatics Association found that more than 17 million medication errors are prevented annually in the U.S. due to the implementation of computerized drug ordering systems, suggesting that such software-related problems may be a relatively minor problem.
Nonetheless, the lack of reporting and coding standards for EHR software as compared to other health IT systems creates a challenge for ensuring such technology does not create a liability or lead to safety problems. By using tools such as static analysis software to catch errors, vendors can reduce the risk their systems could create, helping to mitigate the threat of legal action, public recalls or other damaging consequences. With the increased digitization of healthcare systems, this area of health IT is likely to come under growing scrutiny, and vendors will want to take the necessary steps to ensure flawless performance.
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