Harmful health IT malfunctions

The FDA has received 260 reports in the last two years submitted voluntarily about health IT malfunctions that had the potential to cause harm to patients, including reports of 44 injuries and six deaths. The problems include accessing the wrong patient’s record; overwriting one patient’s information with another’s; loss, corruption or errors in vital patient data; errors in data analysis, such as listing of medications at incorrect doses; and incompatibility in vendor software systems.

As the system moves towards a paperless state, errors will result from medical professionals having to scan multiple pages of electronic data instead of going directly to the area in question, according to a Wellsphere study. Currently, the FDA has authority to regulate health IT software as a medical device but has not fully exercised that authority. “To date, FDA has largely refrained from enforcing our regulatory requirements with respect to health IT devices,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

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This alert is provided in conjunction with National Patient Safety Awareness week, March 7-13.