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Medical Device Reports: A Source of Usability Issues?

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Keywords Are Vital to Finding Helpful Information on Use Error

Designing Usable Devices

Medical Device Reports (MDRs) are descriptions of adverse events caused by medical devices. MDRs are used by the FDA to compile data on medical device issues in the field and monitor trends across device types and facilities. User facilities (hospitals, nursing homes, clinics) are required to report incidents involving death or injury to the FDA using this vehicle. MDRs are searchable through the FDA's MDR web site (www.fda.gov/cdrh) and are open to the general public.

MDRs can be a valuable source of usability issues with particular classes of medical devices. Many MDRs contain the phrase "user error", which refers to a diverse set of actions that include inappropriate use, mental lapses, lack of training, carelessness, misunderstanding of labeling or instructions, etc. Although the text accompanying most MDR cases varies in length and quality, we can look at usability issues that may be underlying the reported "user error" instances.

During Risk and Hazard Analysis activities, the use of the MDR database, available at the FDA's CDRH website, provides a profile of use error problems for given device types. Getting the search terms right is crucial to narrowing the "hits" down to a useful number. We have found that the terms that are most helpful in isolating usability problems are: user error, user, error, training, misunderstanding, confusion, programming error, labeling, forgot, display, user interface, usable, alarms, error message, and user manual. This is not a comprehensive list, but it will get you started in the right direction.

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