Summary
Background: The US FDA has been collecting information on medical devices involved in significant
adverse advents since 1984. These reports have been used by researchers to advise
clinicians on potential risks and complications of using these devices.
Objective: Research adverse events related to the use of Clinical Information Systems (CIS)
as reported in FDA databases.
Methods: Three large, national, adverse event medical device databases were examined for reports
pertaining to CIS.
Results: One hundred and twenty unique reports (from over 1.4 million reports) were found,
representing 32 manufacturers. The manifestations of these adverse events included:
missing or incorrect data, data displayed for the wrong patient, chaos during system
downtime and system unavailable for use. Analysis of these reports illustrated events
associated with system design, implementation, use, and support.
Conclusion: The identified causes can be used by manufacturers to improve their products and
by clinical facilities and providers to adjust their workflow and implementation processes
appropriately. The small number of reports found indicates a need to raise awareness
regarding publicly available tools for documenting problems with CIS and for additional
reporting and dialog between manufacturers, organizations, and users.
Keywords
Electronic health records - information systems - mandatory reporting - medical errors
- United States Food and Drug Administration
