Part I: Identifying holes in the safety net

American Heart Journal

Volumn 147, Issue 6, 2004, Pages 977-984

  O'Shea, J Conor ^a   Kramer, Judith M ^a   Califf, Robert M ^a   Peterson, Eric D ^a  

^a DUKE CLINICAL RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

RAPAMYCIN;

CARDIOVASCULAR SYSTEM; CONFERENCE PAPER; DATA BASE; DEFIBRILLATOR; DEVICE INFECTION; DRUG ELUTING STENT; EVALUATION; FOOD AND DRUG ADMINISTRATION; FREQUENCY ANALYSIS; HEALTH CARE PERSONNEL; HEALTH CARE POLICY; HEALTH PROGRAM; HOSPITAL; HUMAN; MARKETING; MEDICAL INSTRUMENTATION; NURSING HOME; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RISK FACTOR; SAFETY; STETHOSCOPE; SURGICAL MASK; THROMBOSIS; UNITED STATES;

DEVICE APPROVAL; EQUIPMENT FAILURE; EQUIPMENT SAFETY; MANDATORY REPORTING; MYOCARDIAL REVASCULARIZATION; RISK ASSESSMENT; STENTS; SURGICAL INSTRUMENTS; THORACIC SURGERY; UNITED STATES;

EID: 3042817495     PISSN: 00028703     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ahj.2004.03.001     Document Type: Conference Paper

References (30)

1. Kessler L, Richter K. Technology assessment of medical devices at the Center for Devices and Radiological Health. Am J Manag Care 1998;4:SP129-35
2. Medical Device Amendments of 1976. Pub L No. 94-295, 90 Stat 539, 1976
3. Federal Food, Drug and Cosmetic Act of 1938. Pub L No. 75-717, 52 Stat 1040, 1938, as amended 21 USC §301 et seq, 1988
4. Safe Medical Devices Act of 90. Pub L No. 101-629, 104 Stat 4511, 1990
5. FDA Modernization Act. Pub L No. 105-115, 111 Stat 2296, 1997
6. Medical Device User Fee and Modernization Act of 2002 (October 16, 2002). Publ L 107-250. HR.5651.EH. Available at: http://frwebgate.access.gpo.gov/cgi- bin/getdoc.cgi?dbname=107_cong_bills&docid=f:h5651eh.txt. Accessed December 9, 2002
7. US Food and Drug Administration. 21 CFR 860.3 Medical Device Classification Procedures: Definitions. Available at: http://frwebgate.access. gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=860&SECTION=3&YEAR= 2002&TYPE=TEXT. Accessed December 9, 2002
8. Federal Food, Drug and Cosmetic Act of 38. Pub L No. 75-717, 52 Stat 1040, 1938, as amended 21 USC §301 et seq, 1988. Section 513. Classes of Devices
9. Gross T.P., Kessler L.G. Medical device vigilance at FDA. Stud Health Technol Inform. 28:1996;17-24
10. Kessler D.A. Introducing MEDWatch a new approach to reporting medication and device adverse effects and product problems. JAMA. 269:1993;2765-2768
11. Food and Drug Administration. Designing a Medical Device Surveillance Network. FDA Report to Congress. Rockville (Md): US Food and Drug Administration; September 1999
12. FDA Enforcement Report Index. Available at: http://www.fda.gov/opacom/ enforce.html. Accessed December 9, 2003
13. Maisel W.H., Sweeney M.O., Stevenson W.G., et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 286:2001;793-799
14. McEnany M.T., Wheeler E.O., Austen W.G. Survival following fracture of strut from mitral prosthesis with disc translocation. J Thorac Cardiovasc Surg. 78:1979;136-139
15. O'Neill W.W., Chandler J.G., Gordon R.E., et al. Radiographic detection of strut separations in Bjork-Shiley convexo-concave mitral valves. N Engl J Med. 333:1995;414-420
16. Hutter J.C., Long M.C., Luu H.M., et al. Prediction of the shelf life of cellulose acetate hemodialyzers by Monte Carlo simulation. ASAIO J. 47:2001;522-527
17. Lucas A.D., Kalson J.A., Hutter J.C., et al. Identifying toxic degradation products in cellulose acetate dialyzers. J Biomed Mater Res. 53:2000;449-456
18. Schaff H., Carrel T., Steckelberg J.M., et al. Artificial Valve Endocarditis Reduction Trial (AVERT) protocol of a multicenter randomized trial. J Heart Valve Dis. 8:1999;131-139
19. Schaff H.V., Carrel T.P., Jamieson W.R., et al. Paravalvular leak and other events in silzone-coated mechanical heart valves a report from AVERT. Ann Thorac Surg. 73:2002;785-792
20. Frazier O.H., March R.J., Horvath K.A. Transmyocardial revascularization with a carbon dioxide laser in patients with end-stage coronary artery disease. N Engl J Med. 341:1999;1021-1028
21. Bridges C.R. Myocardial laser revascularization the controversy and the data. Ann Thorac Surg. 69:2000;655-662
22. Allen K.B., Dowling R.D., Fudge T.L., et al. Comparison of transmyocardial revascularization with medical therapy in patients with refractory angina. N Engl J Med. 341:1999;1029-1036
23. Peterson E.D., Kaul P., Kaczmarek R.G., et al. From controlled trials to clinical practice monitoring transmyocardial revascularization use and outcomes. J Am Coll Cardiol. 42:2003;1611-1616
24. Sapirstein W., Zuckerman B., Dillard J. FDA approval of coronary-artery brachytherapy. N Engl J Med. 344:2001;297-299
25. Peterson E.D., Lansky A.J., Anstrom K.J., et al. Evolving trends in interventional device use and outcomes Results from the National Cardiovascular Network database. Am Heart J. 139:2000;8-207
26. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data: the Novoste Beta-Cath System. November 3, 2000. Available at: http://www.fda.gov/cdrh/pdf/p000018.html. Accessed November 15, 2002
27. Food and Drug Administration, Center for Devices and Radiological Health. Summary of Safety and Effectiveness Data: the Cordis Checkmate System. November 3, 2000. Available at: http://www.fda.gov/cdrh/pdf/p990036.html. Accessed November 15, 2002
28. Serruys P.W., Degertekin M., Tanabe K., et al. Intravascular ultrasound findings in the multicenter, randomized double-blind RAVEL (Randomized study with the sirolimus-eluting Velocity Balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions) trial. Circulation. 106:2002;798-803
29. Moses J.W., Leon M.B., Popma J.J., et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 349:2003;1315-1323
30. Altman LK. The Doctor's World: Doctors Look for Source of Stent Complications. New York Times. November 18, 2003;Health & Fitness:F5