title: How human factors lead to medical device adverse events.
authors.affiliation: Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, MD, USA.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Rich
mesh_terms: D004867:Equipment Design; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects*; D006804:Ergonomics / Q000379:methods / Q000523:psychology / Q000706:statistics & numerical data; D006272:Health Facility Environment; D006801:Humans; D011358:Product Surveillance, Postmarketing; D011597:Psychomotor Performance; D017751:Safety Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration