Company:Philips Healthcare
Date of Enforcement Report 7/23/12
Philips Healthcare Recalls Faulty Patient Data Exchange System
Philips Healthcare is recalling a faulty patient data exchange system after finding that the tool sometimes sent incomplete cardiology reports to patients’ electronic health records, the Wall Street Journal’s “CIO Journal” reports.
About the Problem
The issue occurred when clinicians typed data into the summary field for a heart test report and then pressed the “enter” button to start a new paragraph, which sometimes caused the text entered below that point to be omitted from a patient’s EHR. Physicians receiving the cardiology report were unaware that the data were missing, thus raising the risk of misdiagnosis or “incorrect treatment decisions,” Philips wrote in a letter to hospitals.
About 200 health care facilities in over a dozen countries — including the U.S. — have deployed Philips’ Xcelera Connect system. There are no reports of patients having been harmed by the defect, according to a company spokesperson.
Company Response:
Philips first issued the recall of the 226 Xcelera Connect systems in June, three months after a health care facility first reported the issue to FDA. The company now is in the process of updating the 226 systems affected.
Bryan Schnepf, a senior marketing manager at Philips, said, “When we identified the problem, we took action and fixed it.” He added that hospitals can continue using the Xcelera Connect system if they are aware of the problem and are careful not to use the “enter” button when typing data into heart test reports.
Highlighting Larger Issue
Experts note that Philips’ recall highlights the risks associated with health IT software malfunctions.
Ross Koppel — a researcher at the University of Pennsylvania who studies the use of EHR systems — said that health IT software errors occur “all the time,” adding, “The problem is the dangers are so vast because people’s lives are at risk.”
To prevent life-threatening software errors, Koppel recommended that hospitals employ a permanent, full-time observation team of IT experts and clinicians to monitor EHR software and identify flaws (Schectman, “CIO Journal,” Wall Street Journal, 7/20).
Read more: http://www.ihealthbeat.org/articles/2012/7/23/philips-healthcare-recalls-faulty-patient-data-exchange-system.aspx#ixzz21eFyunYZ
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