Document Detail

Feasibility of Proactive Medical Device Surveillance: The VA Clinical Assessment Reporting and Tracking (CART) Program.
MedLine Citation:
PMID:  23407013     Owner:  NLM     Status:  In-Data-Review    
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.
Thomas T Tsai; Tamara L Box; Hans Gethoffer; Gregory Noonan; Paul D Varosy; Thomas M Maddox; Stephan D Fihn; Thomas P Gross; Robert L Jesse; John S Rumsfeld
Related Documents :
23538483 - Global cardiovascular device innovation: japan-usa synergies.
21540253 - Network gatekeeping: complementary medicine information on the websites of medical inst...
21098753 - Medication reconciliation during internal hospital transfer and impact of computerized ...
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Medical care     Volume:  51 Suppl     ISSN:  1537-1948     ISO Abbreviation:  Med Care     Publication Date:  2013 Mar 
Date Detail:
Created Date:  2013-02-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0230027     Medline TA:  Med Care     Country:  United States    
Other Details:
Languages:  eng     Pagination:  S57-61     Citation Subset:  IM    
*VA Eastern Colorado Health Care System, Department of Medicine, CART Coordinating Center, University of Colorado Denver, Denver, CO †Office of Analytics and Business Intelligence, VA Health Services R&D ‡VA Puget Sound Health Care System, Seattle, WA §Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD ∥VA Central Office, Washington, DC ¶Richmond VA Medical Center, Richmond, VA.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Evaluating patient access to Electronic Health Records: results from a survey of veterans.
Next Document:  Health Information Technology and Implementation Science: Partners in Progress in the VHA.