JAMIA: FDA reports inform health IT safety problems classification

Research in the September edition of the Journal of the American Medical Informatics Association found that while only 0.1 percent of Manufacturer and User Facility Device Experience (MAUDE) database reports searched were related to health IT, the FDA reports proved to be a useful source of information about the nature of software problems and their safety implications with the potential to inform strategies for safe design and implementation.

Farah Magrabi, PhD, from the Centre for Health Informatics, Australian Institute for Health Innovation, University of New South Wales, Sydney, and colleagues sought to expand an emerging classification for problems with health IT using reports submitted to the MAUDE database.

Health IT events submitted to MAUDE were retrieved using standardized search strategies. Using an emerging classification with 32 categories of health IT problems, a subset of relevant events were analyzed to identify new categories. Two coders then independently classified the remaining events into one or more categories. Free-text descriptions were analyzed to identify the consequences of events.

Descriptive statistics were measured by the number of reported problems per category and by consequence; inter-rater reliability analysis using the K statistic for the major categories and consequences.

"A search of 899,768 reports from January 2008 to July 2010 yielded 1,100 reports about health IT,” the authors reported. After removing duplicate and unrelated reports, 678 reports describing 436 events remained.

Magrabi and company identified four new categories to describe problems with software:

• Functionality;
• System configuration;
• Interface with devices; and
• Network configuration.

The authors' classification with 32 categories of health IT problems was expanded by these four categories. Examination of the 436 events revealed 712 problems, 96 percent were machine-related, and 4 percent were problems at the human-computer interface.

“Almost half (46 percent) of the events related to hazardous circumstances,” the authors wrote. “Of the 46 events (11 percent) associated with patient harm, four deaths were linked to health IT problems (0.9 percent of 436 events).

“Reports about equipment failure and hazards submitted by users and vendors are a useful source of information about the nature and safety implications of problems associated with software functionality, system configuration, interface with devices and network configuration,” the authors concluded. “Strategies for the safe design and implementation of software must focus on matching the user interface and functions to clinical tasks, as well as configuration to local clinical and technical conditions.”