Medical Devices: How reliable is the FDA’s stamp of approval?
Keywords:
MedicineReferences
1. Malsel, W. Medical Device Regulation: An Introduction for the Practicing Physician. Annals of Internal Medicine 140 296-302 (2004).
2. O’Keeffe, K. The Rise of Medtech: Medical Device and Diagnostic Industry. http://www.mddionline. com/article/rise-medtech (2011).
3. Brucker, A.J. Age-Related Macular Degeneration Retina 29, S2-S4 (2009).
4. Jager, R.D., Mieler, W.F. & Miller, J.W. Age-Related Macular Degeneration. New England Journal of Medicine 358, 2606-2617 (2008).
5. Evans, K., Law, S.K., Walt, J., Buchholz, P. & Hansen, J. The quality of life impact of peripheral versus central vision loss with a focus on glaucoma versus age-relat- ed macular degeneration. Clinical Ophthalmology 3, 433-445 (2009).
6. Topouzis, F., et al. Association of diabetes with age- related macular degeneration in the EUREYE study. British Journal of Ophthalmology 93, 1037-1041 (2009).
7. Lane, S.S. & Kuppermann, B.D. The Implantable Miniature Telescope for macular degeneration. Current Opinion in Ophthalmology 17, 94-98 (2006).
8. 8Hudson, H.L., et al. Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration: 1-Year Results. Ophthalmology 113, 1987-2001 (2006).
9. Ma, X.M., et al. Drug-eluting stents. Internation Jour- nal of Clinical and Experimental Medicine 3, 192-201 (2010).
10. Moore, D.R. & Shannon, R.V. Beyond cochlear im- plants: awakening the deafened brain. Nature Neuro- science 12, 686-691 (2009).
11. Ivory, J.P., Summerfield, J., Thorne, S., Lowdon, I.M.R. & Williamson, D.M. Total hip replacement. Quality in Health Care 3, 114-119 (1994).
12. Browne, J.A., Bechtold, C.D., Berry, D.J., Hanssen, A.D. & Lewallen, D.G. Failed Metal-on-Metal Hip Arthroplasties: A Spectrum of Clinical Presentations and Operative Findings. Clinical Orthopaedics and Related Research® 468, 2313-2320 (2010).
13. Srinivasan, A., Livine, B.R. & Jacobs, J.J. Metal-on-metal articulation in total hip arthroplasty: update. Current Orthopedic Prac- tice 22, 231-235 (2011).
14. Cohen, D. Revision rates for met- al on metal hip joints are double that of other materials. BMJ 343, d5977 (2011).
15. Ollivere, B., Duckett, S., August, A. & Porteous, M. The Birming- ham Hip Resurfacing: 5-year clinical and radiographic results from a District General Hospital. International Orthopaedics 34, 631-634 (2009).
16. Sedrakyan, A., et al. Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal
of evidence. BMJ 3443, d7434 (2011).
17. Pandit, H., et al. Pseudotumours associated with metal-on-metal hip resurfacings. The Journal of Bone and Joint Surgery 90, 847- 851 (2008).
18. Lavigne, M., et al. Comparison
of Whole-Blood Metal Ion Levels in Four Types of Metal-on-Metal Large Diameter Femoral Head Total Hip Arthroplasty: The Potential Influence of the Adapter Sleeve. The Journal of Bone & Joint Surgery 93, 128-136 (2011).
19. Delaunay, C., Petit, I., Learmonth, I.D., Oger, P. & Vendittoli, P.A. Metal-on-metal bearings total hip arthroplasty: The cobalt and chromium ions release concern. Orthopaedics & Traumatology: Surgery & Research 96, 894-904 (2010).
20. Langton, D.J., et al. Early failure of metal-on-metal bearings in hip resurfacing and large-diam- eter total hip replacement. The Journal of Bone and Joint Surgery 92-B, 38-46 (2010).
21. Nyggard, I. What Does “FDA Approved” Mean for Medical Devices. Obstetrics & Gynecology 111, 4-6 (2008).
22. Deyo, R.A. Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice. Journal of The Ameri- can Board of Family Medicine 17(2004).
23. Medical Devices. Vol. 2011 http://www.fda.gov/MedicalDe- vices/default.htm (U.S. Food and Drug Administration, 2011).
24. Institue of Medicine. Medical De- vices and the Public’s Health: The FDA 510(k) Clearance Process
at 35 Years. (National Academy of Sciences, Washington D.C., 2011).
25. Zuckerman, D.M., Brown, P. & Nissen, S.E. Medical Device Recalls and the FDA Approval Process. Archives of Internal Medicine 171, 1006-1011 (2011).
26. Zuckerman, D.M., Brown, P. & Nissen, S.E. FDA Recalls Not as Alarming as They Seem: In Reply. Archives of Internal Medicine 171, 1044-1046 (2011).
27. Suter, L.G., et al. Medical Device Innovation - Is “Better” Good Enough? The New England Jour- nal of Medicine 365, 1464-1466 (2011).
2. O’Keeffe, K. The Rise of Medtech: Medical Device and Diagnostic Industry. http://www.mddionline. com/article/rise-medtech (2011).
3. Brucker, A.J. Age-Related Macular Degeneration Retina 29, S2-S4 (2009).
4. Jager, R.D., Mieler, W.F. & Miller, J.W. Age-Related Macular Degeneration. New England Journal of Medicine 358, 2606-2617 (2008).
5. Evans, K., Law, S.K., Walt, J., Buchholz, P. & Hansen, J. The quality of life impact of peripheral versus central vision loss with a focus on glaucoma versus age-relat- ed macular degeneration. Clinical Ophthalmology 3, 433-445 (2009).
6. Topouzis, F., et al. Association of diabetes with age- related macular degeneration in the EUREYE study. British Journal of Ophthalmology 93, 1037-1041 (2009).
7. Lane, S.S. & Kuppermann, B.D. The Implantable Miniature Telescope for macular degeneration. Current Opinion in Ophthalmology 17, 94-98 (2006).
8. 8Hudson, H.L., et al. Implantable Miniature Telescope for the Treatment of Visual Acuity Loss Resulting from End-Stage Age-Related Macular Degeneration: 1-Year Results. Ophthalmology 113, 1987-2001 (2006).
9. Ma, X.M., et al. Drug-eluting stents. Internation Jour- nal of Clinical and Experimental Medicine 3, 192-201 (2010).
10. Moore, D.R. & Shannon, R.V. Beyond cochlear im- plants: awakening the deafened brain. Nature Neuro- science 12, 686-691 (2009).
11. Ivory, J.P., Summerfield, J., Thorne, S., Lowdon, I.M.R. & Williamson, D.M. Total hip replacement. Quality in Health Care 3, 114-119 (1994).
12. Browne, J.A., Bechtold, C.D., Berry, D.J., Hanssen, A.D. & Lewallen, D.G. Failed Metal-on-Metal Hip Arthroplasties: A Spectrum of Clinical Presentations and Operative Findings. Clinical Orthopaedics and Related Research® 468, 2313-2320 (2010).
13. Srinivasan, A., Livine, B.R. & Jacobs, J.J. Metal-on-metal articulation in total hip arthroplasty: update. Current Orthopedic Prac- tice 22, 231-235 (2011).
14. Cohen, D. Revision rates for met- al on metal hip joints are double that of other materials. BMJ 343, d5977 (2011).
15. Ollivere, B., Duckett, S., August, A. & Porteous, M. The Birming- ham Hip Resurfacing: 5-year clinical and radiographic results from a District General Hospital. International Orthopaedics 34, 631-634 (2009).
16. Sedrakyan, A., et al. Comparative assessment of implantable hip devices with different bearing surfaces: systematic appraisal
of evidence. BMJ 3443, d7434 (2011).
17. Pandit, H., et al. Pseudotumours associated with metal-on-metal hip resurfacings. The Journal of Bone and Joint Surgery 90, 847- 851 (2008).
18. Lavigne, M., et al. Comparison
of Whole-Blood Metal Ion Levels in Four Types of Metal-on-Metal Large Diameter Femoral Head Total Hip Arthroplasty: The Potential Influence of the Adapter Sleeve. The Journal of Bone & Joint Surgery 93, 128-136 (2011).
19. Delaunay, C., Petit, I., Learmonth, I.D., Oger, P. & Vendittoli, P.A. Metal-on-metal bearings total hip arthroplasty: The cobalt and chromium ions release concern. Orthopaedics & Traumatology: Surgery & Research 96, 894-904 (2010).
20. Langton, D.J., et al. Early failure of metal-on-metal bearings in hip resurfacing and large-diam- eter total hip replacement. The Journal of Bone and Joint Surgery 92-B, 38-46 (2010).
21. Nyggard, I. What Does “FDA Approved” Mean for Medical Devices. Obstetrics & Gynecology 111, 4-6 (2008).
22. Deyo, R.A. Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice. Journal of The Ameri- can Board of Family Medicine 17(2004).
23. Medical Devices. Vol. 2011 http://www.fda.gov/MedicalDe- vices/default.htm (U.S. Food and Drug Administration, 2011).
24. Institue of Medicine. Medical De- vices and the Public’s Health: The FDA 510(k) Clearance Process
at 35 Years. (National Academy of Sciences, Washington D.C., 2011).
25. Zuckerman, D.M., Brown, P. & Nissen, S.E. Medical Device Recalls and the FDA Approval Process. Archives of Internal Medicine 171, 1006-1011 (2011).
26. Zuckerman, D.M., Brown, P. & Nissen, S.E. FDA Recalls Not as Alarming as They Seem: In Reply. Archives of Internal Medicine 171, 1044-1046 (2011).
27. Suter, L.G., et al. Medical Device Innovation - Is “Better” Good Enough? The New England Jour- nal of Medicine 365, 1464-1466 (2011).
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Published
2012-01-01
How to Cite
Payne, C. (2012). Medical Devices: How reliable is the FDA’s stamp of approval?. Trinity Student Medical Journal , 13(1), Page 23–26. Retrieved from https://ojs.tchpc.tcd.ie/index.php/tsmj/article/view/1812
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