title: Ventilator-Related Adverse Events: A Taxonomy and Findings From 3 Incident Reporting Systems.
abstract: BACKGROUND
  In 2009, researchers from Johns Hopkins University's Armstrong Institute for Patient Safety and Quality; public agencies, including the FDA; and private partners, including the Emergency Care Research Institute and the University HealthSystem Consortium (UHC) Safety Intelligence Patient Safety Organization, sought to form a public-private partnership for the promotion of patient safety (P5S) to advance patient safety through voluntary partnerships. The study objective was to test the concept of the P5S to advance our understanding of safety issues related to ventilator events, to develop a common classification system for categorizing adverse events related to mechanical ventilators, and to perform a comparison of adverse events across different adverse event reporting systems.
  
  
  METHODS
  We performed a cross-sectional analysis of ventilator-related adverse events reported in 2012 from the following incident reporting systems: the Pennsylvania Patient Safety Authority's Patient Safety Reporting System, UHC's Safety Intelligence Patient Safety Organization database, and the FDA's Manufacturer and User Facility Device Experience database. Once each organization had its dataset of ventilator-related adverse events, reviewers read the narrative descriptions of each event and classified it according to the developed common taxonomy.
  
  
  RESULTS
  A Pennsylvania Patient Safety Authority, FDA, and UHC search provided 252, 274, and 700 relevant reports, respectively. The 3 event types most commonly reported to the UHC and the Pennsylvania Patient Safety Authority's Patient Safety Reporting System databases were airway/breathing circuit issue, human factor issues, and ventilator malfunction events. The top 3 event types reported to the FDA were ventilator malfunction, power source issue, and alarm failure.
  
  
  CONCLUSIONS
  Overall, we found that (1) through the development of a common taxonomy, adverse events from 3 reporting systems can be evaluated, (2) the types of events reported in each database were related to the purpose of the database and the source of the reports, resulting in significant differences in reported event categories across the 3 systems, and (3) a public-private collaboration for investigating ventilator-related adverse events under the P5S model is feasible.
authors.affiliation: Department of Emergency Medicine, Department of Anesthesia and Critical Care, Armstrong Institute for Patient Safety and Quality, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Julius Cuong
authors.initials: JC
authors.lastname: Pham
authors.affiliation: University HealthSystem Consortium, Chicago, Illinois.
authors.forename: Tamara L
authors.initials: TL
authors.lastname: Williams
authors.affiliation: Pennsylvania Patient Safety Authority, Philadelphia, Pennsylvania.
authors.forename: Erin M
authors.initials: EM
authors.lastname: Sparnon
authors.affiliation: Office of Surveillance and Biometrics.
authors.forename: Tam K
authors.initials: TK
authors.lastname: Cillie
authors.affiliation: Office of the Center Director, Center for Devices and Radiological Health, United States Food and Drug Administration, Silver Spring, Maryland. Hilda.Scharen@fda.hhs.gov.
authors.forename: Hilda F
authors.initials: HF
authors.lastname: Scharen
authors.affiliation: Pennsylvania Patient Safety Authority, Philadelphia, Pennsylvania.
authors.forename: William M
authors.initials: WM
authors.lastname: Marella
mesh_terms: D003430:Cross-Sectional Studies; D016208:Databases, Factual; D006801:Humans; D061214:Patient Safety / Q000706:statistics & numerical data*; D012308:Risk Management / Q000706:statistics & numerical data*; D012122:Ventilators, Mechanical / Q000009:adverse effects*
keywords: adverse events; common taxonomy; human factors; patient safety; public-private partnership; ventilator
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