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Recall of the United HealthCare Picis PulseCheck Emergency Department Software

Posted Oct 02 2013 12:00am

I believe that one of the major current healthcare safety threats is that makers of EHR software are not forced to report safety issues to the FDA. Drug and medical device manufacturers are required to do so. A recent article about a recall of the Picis ED PulseCheck software used in hospital emergency departments makes this same point (see: UnitedHealth Recalls Digital Health Record Software ). Below is an excerpt from it:

UnitedHealth Group...has recalled its [ Picis ED PulseChecksoftware 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....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] 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....

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.....

[M]akers of digital health record software [other than UnitedHealth Group] said they also disclose issues. Cerner voluntarily discloses to the FDA recall and other public-safety issues involving its electronic records....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.

I have blogged extensively about safety issues pertaining to EHRs as well as gag and non-disclosure clauses in hospital EHR contracts with vendors (see:  Concern Over Epic EMR Go-Live in Contra Costa, CaliforniaSutter Health System EHR Crash Reported by Nursing UnionSome of the Details Behind the Maine Medical Center/Epic EHR Meltdown ). Given that Epic now covers the majority of patients in the country, one might expect more regulatory oversight over the company's EHR software. Here's some documentation about the breadth of patient coverage by the Epic software from the CEO during the inauguration of a new company auditorium in Verona, Wisconsin:

Few spaces were empty Tuesday morning for Epic chief executive Judy Faulkner’s presentation [in the company's new 11.400 seat auditorium]. As she usually does, Faulkner wore a costume reflecting the conference theme, also Deep Space. Dressed as a Na’vi from the movie “Avatar,” Faulkner — who declined to be photographed — wore a striped blue turtleneck sweater and tights, with a brown leather jumper, beads, and pointy, blue ears as she listed Epic’s accomplishments.“We’ve just gone over the 51 percent mark. You take care of a little over half of the patients in this country,” Faulkner said. 

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