Dataset Information

Using FDA reports to inform a classification for health information technology safety problems.

ABSTRACT:

Objective

To expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.

Design

HIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively 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.

Measurements

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

Results

A search of 899?768 reports from January 2008 to July 2010 yielded 1100 reports about HIT. After removing duplicate and unrelated reports, 678 reports describing 436 events remained. The authors 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 HIT problems was expanded by the addition of these four categories. Examination of the 436 events revealed 712 problems, 96% were machine-related, and 4% were problems at the human-computer interface. Almost half (46%) of the events related to hazardous circumstances. Of the 46 events (11%) associated with patient harm, four deaths were linked to HIT problems (0.9% of 436 events).

Conclusions

Only 0.1% of the MAUDE reports searched were related to HIT. Nevertheless, Food and Drug Administration reports did prove to be a useful new source of information about the nature of software problems and their safety implications with potential to inform strategies for safe design and implementation.

SUBMITTER: Magrabi F

PROVIDER: S-EPMC3240763 | biostudies-literature | 2012 Jan-Feb

REPOSITORIES: biostudies-literature

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Publications

Using FDA reports to inform a classification for health information technology safety problems.

Magrabi Farah F Ong Mei-Sing MS Runciman William W Coiera Enrico E

Journal of the American Medical Informatics Association : JAMIA 20110908 1

<h4>Objective</h4>To expand an emerging classification for problems with health information technology (HIT) using reports submitted to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.<h4>Design</h4>HIT events submitted to MAUDE were retrieved using a standardized search strategy. Using an emerging classification with 32 categories of HIT problems, a subset of relevant events were iteratively analyzed to identify new categories. Two coders th ...[more]

PMID: 21903979

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Project description:BackgroundThe contribution of usability flaws to patient safety issues is acknowledged but not well-investigated. Free-text descriptions of incident reports may provide useful data to identify the connection between health information technology (HIT) usability flaws and patient safety.ObjectivesThis article examines the feasibility of using incident reports about HIT to learn about the usability flaws that affect patient safety. We posed three questions: (1) To what extent can we gain knowledge about usability issues from incident reports? (2) What types of usability flaws, related usage problems, and negative outcomes are reported in incidents reports? (3) What are the reported usability issues that give rise to patient safety issues?MethodsA sample of 359 reports from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database was examined. Descriptions of usability flaws, usage problems, and negative outcomes were extracted and categorized. A supplementary analysis was performed on the incidents which contained the full chain going from a usability flaw up to a patient safety issue to identify the usability issues that gave rise to patient safety incidents.ResultsA total of 249 reports were included. We found that incident reports can provide knowledge about usability flaws, usage problems, and negative outcomes. Thirty-six incidents report how usability flaws affected patient safety (ranging from incidents without consequence, to death) involving electronic patient scales, imaging systems, and HIT for medication management. The most significant class of involved usability flaws is related to the reliability, the understandability, and the availability of the clinical information.ConclusionIncidents reports involving HIT are an exploitable source of information to learn about usability flaws and their effects on patient safety. Results can be used to convince all stakeholders involved in the HIT system lifecycle that usability should be considered seriously to prevent patient safety incidents.

Dataset Information

Using FDA reports to inform a classification for health information technology safety problems.

Objective

Design

Measurements

Results

Conclusions

Publications

Using FDA reports to inform a classification for health information technology safety problems.

Similar Datasets

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