UnitedHealth Group Inc. (UNH:US) has recalled software used in hospital emergency departments in more than 20 states because of an error that caused doctor’s notes about patient prescriptions to drop out of their files.
Certain versions of the software made by the largest U.S. health insurer had a bug that didn’t print information related to the medication and failed to add data to patients’ charts, according to a document filed with the U.S. Food and Drug Administration and posted July 29.
The technology is used in 35 facilities in states including California, New Jersey and Florida, the document shows. The recall began June 21. There were no reports of patient harm and each facility was notified and received a digital fix, said Kyle Christensen, a spokesman for the UnitedHealth division that makes the Picis ED PulseCheck software that was recalled.
The incident shows how software errors can create dangers for patients at a time when digital health records are being implemented as a cornerstone of President Barack Obama’s modernization of the nation’s health-care system.
The global market for electronics health records reached $24.2 billion last year and is expected to grow an average of 10 percent a year through 2015, according to Accenture Research. Leading companies include Epic Systems Corp., McKesson Corp. (MCK:US), and Cerner Corp. (CERN:US)
The Picis recall highlights how little information is disclosed about such issues, said Ross Koppel, adjunct professor of sociology and medicine at the University of Pennsylvania, who has studied errors in health information technology. While medical device companies are required to report safety issues to the FDA, makers of electronic health record software are under no such obligation, he said.
“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.”
Doctor’s notes are critical for some medications, as they contain directions about diet and use. Failure to include the instructions could lead to serious injury or death, Koppel said.
The adoption of digital health records, spurred by $27 billion that the Obama administration has set aside to help health-care organizations buy the systems and looming penalties for those that don’t upgrade, has dramatically reduced some common medical errors, as Bloomberg reported in June.
More than 17 million medication mistakes are now avoided in the U.S. each year because hospitals are using computerized systems for ordering prescription drugs, which reduce the risks from sloppy handwriting and dangerous drug combinations, according to a study published in February in the Journal of the American Medical Informatics Association.
An online database maintained by the FDA shows that Picis Inc., a Wakefield, Massachusetts-based company that UnitedHealth acquired in 2010 for an undisclosed price, has reported six recalls involving electronic health record software since 2009.
One incident in 2011 involved anesthesia-management software sold nationwide that in one instance displayed a patient’s medical information in another patient’s file. Another involved software sold worldwide where on an unspecified number of occasions, the program failed to display the discontinued status on medication orders. Others included glitches that caused a failure to display appropriate allergy interaction warnings, the freezing of administrative controls, and other issues.
Alleged flaws in electronic health records have led to lawsuits. Scot Silverstein, a doctor and health-care informatics professor at Drexel University, sued Abington Memorial Hospital in Pennsylvania in 2011 over the death that year of his 84-year-old mother. He blamed her death on a flaw in her electronic health record that he claims caused a critical heart medication to vanish from her file. One of the systems involved was made by Picis, according to his lawsuit. Picis is not being sued.
Linda Millevoi, a spokeswoman for Abington Memorial, declined to comment.
Picis disclosed the latest recall voluntarily, according to the FDA document.
“Picis completed a routine software update that resolved an issue in specific releases where some physician notes entered manually on a prescription were not included when the prescription was issued,” Christensen said in a statement. “Picis reported the resolution of this issue to clients and the FDA in the normal course of business.”
Other makers of digital health record software said they also disclose issues. Cerner voluntarily discloses to the FDA recall and other public-safety issues involving its electronic records, Gay Johannes, Cerner’s chief quality officer, said in a statement.
Barb Hernandez, a spokeswoman for Epic, declined to comment. Kris Fortner, a spokesman for McKesson, didn’t return messages for comment.
Koppel said reporting on snafus related to digital medical records is limited as some companies require health facilities to sign non-disclosure agreements and doctors and nurses are often puzzled by changes in complicated systems and aren’t aware of the technology’s role in errors. In 2005, he co-authored a study that found a widely used electronic prescription-ordering system contributed to 22 types of medication errors.
“When using the electronic health records, clinicians often feel we are sinners in the hands of an angry and capricious god -- what you could do yesterday you can’t do today, and you don’t know why there’s been a change in the program,” he said. “So you’re always going, ‘what the hell happened now?’”
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