title: Patient safety problems associated with heathcare information technology: an analysis of adverse events reported to the US Food and Drug Administration.
abstract: 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.
authors.affiliation: Centre for Health Informatics, Australian Institute of Health Innovation, University of New South Wales, Sydney, Australia.
authors.forename: Farah
authors.initials: F
authors.lastname: Magrabi
authors.forename: Mei-sing
authors.initials: MS
authors.lastname: Ong
authors.forename: William
authors.initials: W
authors.lastname: Runciman
authors.forename: Enrico
authors.initials: E
authors.lastname: Coiera
mesh_terms: D003257:Consumer Product Safety; D016208:Databases, Factual; D004868:Equipment Failure; D033161:Government Regulation; D006801:Humans; D019300:Medical Errors / Q000401:mortality / Q000706:statistics & numerical data*; D008490:Medical Informatics / Q000331:legislation & jurisprudence / Q000592:standards / Q000706:statistics & numerical data*; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration