title: Feasibility of proactive medical device surveillance: the VA Clinical Assessment Reporting and Tracking (CART) program.
abstract: BACKGROUND
  Timely identification and reporting of medical device problems is critical to postmarket device surveillance programs to maximize patient safety. Cardiac catheterization laboratories are high-device utilization areas well suited for device surveillance.
  
  
  OBJECTIVE
  To demonstrate the feasibility of the national VA Clinical Assessment, Reporting, and Tracking (CART) system, embedded in the electronic health record of all 76 VA cardiac catheterization laboratories, to document unexpected problems with medical devices at the point of care.
  
  
  METHODS
  We evaluated 260,258 consecutive cardiac catheterization and/or percutaneous coronary intervention procedures on 175,098 Veterans between August 2006 and February 2012. Unexpected device problems (UDPs) encountered for any equipment used during a procedure were entered by clinicians at the point of care as part of regular care documentation. All UDPs were reviewed in collaboration with the FDA to ascertain the likelihood of a device defect (eg, in manufacture or design) and/or contributing to a procedural complication (level I, unlikely; level II, possibly; level III, likely).
  
  
  RESULTS
  Of the 260,258 procedure reports, 974 (0.37%) UDP's were reported by 71 (92.2%) of the 76 VA hospitals. After triage, 739 (75.9%) were deemed level I, 196 (20.1%) level II, and 39 (4.0%) level III. Of the 39 level III reports, 12 (30.7%) are in the submission phase as a FDA MedWatch report. The number of monthly UDP reports increased significantly from 2006 to 2012 (P<0.001).
  
  
  CONCLUSIONS
  Leveraging a clinical application embedded in the electronic health record and in collaboration with FDA, a proactive national cardiac device surveillance program has been successfully implemented in the VA.
authors: VA Eastern Colorado Health Care System, Department of Medicine, CART Coordinating Center, University of Colorado Denver, Denver, CO 80220, USA. thomas.tsai@va.gov
authors: Thomas T
authors: TT
authors: Tsai
authors: Tamara L
authors: TL
authors: Box
authors: Hans
authors: H
authors: Gethoffer
authors: Gregory
authors: G
authors: Noonan
authors: Paul D
authors: PD
authors: Varosy
authors: Thomas M
authors: TM
authors: Maddox
authors: Stephan D
authors: SD
authors: Fihn
authors: Thomas P
authors: TP
authors: Gross
authors: Robert L
authors: RL
authors: Jesse
authors: John S
authors: JS
authors: Rumsfeld
mesh_terms: D006328:Cardiac Catheterization / Q000295:instrumentation*; D016009:Chi-Square Distribution; D004282:Documentation; D057286:Electronic Health Records; D005240:Feasibility Studies; D006801:Humans; D061214:Patient Safety; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D014481:United States; D014493:United States Department of Veterans Affairs; D014486:United States Food and Drug Administration