Post-marketing device safety surveillance

Contemporary Clinical Trials

Volumn 32, Issue 3, 2011, Pages 307-308

  Vidi, Venkatesan D ^a   Matheny, Michael E ^b,c,d   Resnic, Frederic S ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

^b Veterans Administration   (United States)

^c VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^d VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DEVICE APPROVAL; DEVICE RECALL; DEVICE SAFETY; EDITORIAL; FOOD AND DRUG ADMINISTRATION; PATIENT SAFETY;

EQUIPMENT SAFETY; HUMANS; PRODUCT SURVEILLANCE, POSTMARKETING; REGISTRIES;

EID: 79953050784     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.02.002     Document Type: Editorial

References (9)

1. Steinbrook R. The controversy over Guidant's implantable defibrillators. N Engl J Med Jul 21 2005, 353(3):221-224.
2. Hauser R.G., Kallinen L.M., Almquist A.K., Gornick C.C., Katsiyiannis W.T. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm Jul 2007, 4(7):892-896.
3. Hanley J.A., McNeil B.J. The meaning and use of the area under a receiver operating characteristic (ROC) curve. Radiology Apr 1982, 143(1):29-36.
4. Newcombe R.G. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med Apr 30 1998, 17(8):857-872.
5. Kessler D.A. Introducing MEDWatch. A new approach to reporting medication and device adverse effects and product problems. JAMA Jun 2 1993, 269(21):2765-2768.
6. Mehran R., Leon M.B., Feigal D.A., et al. Post-market approval surveillance: a call for a more integrated and comprehensive approach. Circulation Jun 29 2004, 109(25):3073-3077.
7. O'Shea J.C., Kramer J.M., Califf R.M., Peterson E.D. Part I: Identifying holes in the safety net. Am Heart J Jun 2004, 147(6):977-984.
8. Spanos C., Poolla K. Multivariate Control and Model-Based SPC (Lecture 15). EE290H F03 Lectures 2003.
9. Welke K.F., Ferguson T.B., Coombs L.P., et al. Validity of the Society of Thoracic Surgeons National Adult Cardiac Surgery Database. Ann Thorac Surg 2004 Apr, 77(4):1137-1139.