Patient safety problems associated with heathcare information technology: an analysis of adverse events reported to the US Food and Drug Administration.

Farah Magrabi, Mei sing Ong, William Runciman, Enrico Coiera

Research output: Contribution to journalArticlepeer-review

28 Citations (Scopus)


The objective of this paper is to analyze healthcare information technology (HIT) events associated with patient harm submitted to the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. We examined the problems in 46 relevant events submitted to MAUDE from January 2008 to July 2010 to identify natural categories of problems from a clinical perspective. CPOE and PACS were involved in 93% of the events. Adverse events were associated with medications in 41%, clinical processes in 33%, radiation in 15% and surgery in 11%. There were four deaths. Strategies to improve the safety of HIT should focus on designing safe user interfaces, integrated checks of key identifiers and decision support, and engineering safer clinical processes.

Original languageEnglish
Pages (from-to)853-857
Number of pages5
JournalAMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium
Publication statusPublished or Issued - 2011
Externally publishedYes

ASJC Scopus subject areas

  • Medicine(all)

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