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Original Article

Quality assurance of joint replacement Legal regulation and medical judgement

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Pages 1-33 | Published online: 08 Jul 2009

References

  • Abbott L. Quality and competition. Columbia University Press, New York 1955
  • Ahnfelt L, Herberts P, Andersson G B J. Registration of complications in total hip arthroplasties. Acta Orthop Scand 1988; 59: 353–56
  • Ahnfelt L, Herberts P, Malchau H, Andersson G B J. Prognosis of total hip replacement. Acta Orthop Scand 1990; 61(Suppl 238)1–26
  • Amstutz H C, Thomas B J, Jinnah R, Kim W, Grogan T, Yale C. Treatment of primary osteoarthritis of the hip. A comparison of total joint and surface replacement arthroplasty. J Bone Joint Surg (Am) 1984; 66: 228–41
  • 1983, Arrêté du 9 décembre 1982. Journal Officiel du 5 janvier
  • Arrêté du 23 mai 1984. Journal Officiel du 29 juin 1984
  • Arrêté du 24 février 1987: Prothèses internes articulaires. Journal du 11 mars 1987
  • Atkinson J R, Jobbins B. Properties of engineering materials for use in the body. An introduction to the biomechanics of joints and joint replacement, D Dowson, V Wright. Mechanical Engineering Publications Ltd, London 1981; 161–71
  • Bauer G C.H. What price progress? Failed innovations of the knee prosthesis. Editorial. Acta orthop Scand 1992; 63: 245–246
  • Burstein A H. The uncemented arthroplasty: new rules for design for the femoral component. Non-cemented total hip arthroplasty, R H Fitzgerald, Jr. Raven Press Ltd. 1988; 335–38
  • Calltorp J. Consensus development conferences in Sweden, effects on health policy and administration. Int J Technology Assessment in Health Care 1988; 4: 75–88
  • Chamley J. Letters to the editor: Tissue reactions to polytetrafluorethylene. The Lancet 1963; 1379
  • Christel P. The regulation of orthopaedic devices in France. J Biomed Mater Res: Applied Biomaterials 1989; 23(A1)2–7
  • Commission Nationale d'Homologation. Approval procedure for medical devices in France: benefits from clinical testing. Officiel document, French Department of Health. 1987
  • Commission of the European Community. Draft for a Council Directive on medical devices, COM 287 def-SYN 353, August 23 1992: European Community Publication Journal C 237 of September 12 1992
  • Council of the European Community. Resolution of May 7 1985, European Community Publication Journal of June 4 1986: Nr. C 136
  • Cook S D, Barrack R L, Thomas K A, Haddad R J. Quantative analysis of tissue growth into human porous total hip components. J Arthroplasty 1988; 3: 249
  • Cox W E. Product life cycles as marketing models. The Journal of Business 1967; 40(4)375–84
  • Crosby Ph. Quality is free. New American Library, New York 1979
  • Department of Health and Social Security. Quality assurance, the manufacturer registration scheme. Her Majesty's Stationary Office. 1988, nr. 11
  • Dhalla N K, Yuspeh S. Forget the product life cycle concept. Harvard Business Review Jan/Feb, 1976; 102–12
  • Dobelle W N. Minimizing the adverse effects of the Medical Device Amendments of 1976 on innovation in artificial organs research. Artificial Organs 1977; 1: 65–75
  • Donawa M E. The control of medical devices in the United Kingdom. Medical Device Technology August/September, 1992; 8–11
  • Douley R L, Engel C, Müller M E. Automated scanning and digitizing of roentgenographs for documentation and research. Clin Orthop 1992; 274: 113–119
  • Duncan M. The control of sterile medical devices and surgical products in the United Kingdom. Proceedings of the EUCOMED conference “Regulation of medical devices and surgical products in Europe,”, BrusselsBelgium, 1987, 5–8
  • Ebramzadeh E, Sarmiento A, Llinas A, Zahiri C. Effect of stem design and material on the log-term radiographic behavior of THR. Washington, DC 1992; 300, Trans. 38th ORS
  • Editorial. Quality control of implants. Acta Orthop Scand 1987; 58: 477–78
  • Edwards C D. The meaning of quality. Quality Progress 1968; 37–41
  • Engh C A, McGovern M F, Bobyn J D, Harris W H. A quantitative evaluation of periprosthetic bone-remodeling after cementless total hip arthroplasty. J Bone Joint Surg 1992; 74: 1009–1020
  • Engh G A. Failure of the polyethylene bearing surface of a total knee replacement within four years. J Bone Joint Surg (Am) 1988; 70(7)1093–96
  • Faro L M.C. De Wet op de medische hulpmiddelen, een evaluatie-onderzoek. Erasmus Universiteit Rotterdam, the Netherlands, Beleid en Management Gezondheidszorg. 1986
  • Faro L M.C. De kwaliteit van implantaten in juridisch perspectief, reguleringsscenario's voor de totale heupprothese. Thesis, Erasmus Universiteit Rotterdam, The Netherlands 1990
  • Food and Drug Administration. Guidance for the preparation of premarket notifications for ceramic ball hip systems. Rockville April 27, 1989
  • Food and Drug Administration. Zimmer USA, premarket approval of biological ingrowth anatomic stem fiber metal total hip system. Federal Register 1989; 54(97)22019
  • Feigenbaum A V. Total quality control. Mc Graw Hill, New York 1961
  • Feith R, Megens H. The ceramic total hip prothesis (Type Mittelmeier). Acta Orthop Scand 1986; 57: 390
  • Freeman M A.R. Total surface replacement of hip arthroplasty. Clin Orthop 1978; 134: 2–4
  • Freeman M A.R, Bradley G W. ICLH surface replacement of the hip. An analysis of the first 10 years. J Bone Joint Surg (Am) 1983; 65: 405–11
  • Gartland J J. Orthopaedic clinical research, deficiencies in experimental design and determination of outcome. J Bone Joint Surg (Am) 1988; 70: 1357–64
  • Garvin D A. Managing quality, the strategic and competitive edge. Free Press, New York 1988
  • Gezondheidsraad. Rapport betreffende toezicht op de hoedanigheid van medische materialen, waaronder hier worden verstaan metalen voorwerpen, bestemd voor plaatsing in het lichaam. 's Gravenhage. 1963
  • Gilmore H L. Product conformance cost. Quality Progress June, 1974; 16–21
  • Goodfellow J. Knee prostheses - one step forward, two steps back. J Bone Joint Surg (Br) 1992; 74: 1–2
  • Griffin J P. Medicines control within the United Kingdom. Medicines: regulation, research and risk, J P Griffin. Queen's University, Belfast 1989; 1–27
  • Gross M. A critique of the methodologies used in clinical studies of hip-joint arthroplasty published in the English-language literature. J Bone Joint Surg (Am) 1988; 70: 1364–76
  • Guaspari J. “I know it when I see it”, a modern fable about quality. Amacom, New York 1985
  • Harris W H. Advances in total hip arthroplasty: The metalbacked acetabular component. Clin Orthop 1984; 183: 4
  • Hauptman O, Roberts E B. FDA regulation of product risk and its impact upon young biomedical firms. J Prod Innov Manag 1987; 4: 138–48
  • Head W C. Wagner surface replacement arthroplasty of the hip. Analysis of fourteen failures in forty-one hips. J Bone Joint Surg (Am) 1981; 63: 420–427
  • Higson G. Nonlegislative approaches to the control of medical devices. Proceedings of the First International Conference of Medical Device Regulatory Authorities. June, 2–61986. Pan American Health Organisation, World Health Organization, Washington, D C
  • von Hippel E. The dominant role of users in the scientific instrument innovation process. Research Policy 1976; 5: 212–39
  • Huiskes R, Strens P HG E, van Heck J, Slooff T JJ H. Interface stresses in the resurfaced hip. Finite element analysis of load transmission in the resurfaced hip. Acta Orthop Scand 1985; 56: 474–478
  • Huiskes R, Strens P, Vroemen W, Slooff TJ H. J. Post-loosening mechanical behavior of femoral resurfacing prostheses. Clin Mat 1990; 6: 37–55
  • Huiskes R. Validility of pre-clinical design analysis relative to endurance of cemented THA. 45th Assembly of SOA, Helsinki. Acta Orthop Scand 1990, Suppl. 237: 61
  • Huiskes R. Preclinical testing of noncemented total hip arthroplasty. Noncemented Total Hip Replacement, W Küsswetter. Georg Thieme Verlag, Stuttgart, New York 1990; 22–36
  • Huiskes R. Biomechanics of artificial joint fixation. Basic orthopaedic biomechanics V C Mow, W C Hayes. Raven Press, New York 1991
  • Jobbins B. General considerations in joint replacements. An introduction to the bio-mechanics of joints and joint replacement, D Dowson, V Wright. Mechanical Engineering Publications Ltd, London 1981; 151–61
  • Josefsson G, Lindberg L, Wilander B. Systemic antibiotics and gentamicin-containing bone cement in the prophylaxis of postoperative infections in total hip arthroplasty. Clin Orthop 1981; 159: 194–200
  • Judet J, Judet R, Lagrange J, Dunoyer J. Resection of the hip. Arthroplasty with acrylic prosthesis. E. & S. Livingstone, Edinburg and London 1954
  • Juran J M. Quality control handbook. Mc Graw Hill, New York 1974
  • Kahan J S. The ten-years record. Medical Devices and Diagnostic Industry June, 1986; 60–5
  • Kiratli B J, Heiner J P, McKinley M, Wilson M A, McBeath A A. Bone mineral density of the proximal femur after uncemented total hip arthroplasty. Anaheim, CA 1991; 545, Transact. 37th ORS
  • Kosekoff J, Kanousse D E, Rogers W H, McCloskey L, Winslow Monroe C, Brook R H. The effects of the National Institutes of Health consensus development program on physician practice. JAMA 1987; 258: 2708–13
  • Kuehn A A, Day R C. Strategy and product quality. Harvard Business Review Nov./Dec., 1962; 101–105
  • Leary J F.M. Mittelmeier ceramic total hip arthroplasty. J Arthroplasty 1988; 3: 87
  • Le Vay D. The history of orthopaedics. Camforth, England 1990
  • Liang M H, Katz J N, Phillips C h, Sledge C, Cats-Baril W. and the American Academy of Orthopaedic Surgeons Task Force on Outcome Studies. The total hip arthroplasty outcome evaluation form of the American Academy of Orthopaedic Surgeons. J Bone Joint Surg (Am) 1991; 73: 639–46
  • , Medical Device Amendments of 1976, Chapter V of the Federal Food, Drug, and Cosmetic Act of 1938. Pub. L. No. 94–295, 90 Stat. 539: codified at 15 US C par. 55 and 21 US C passim
  • 1986, Ministère de la Solidarité, de la Santè et de la Protection Sociale. Circulaire relative a l'homologation des produits et appareils à usage préventif, diagnostique ou thérapeutique. Paris le 20 avril
  • 1988, Ministère de la Solidarité, de la Santé et de la Protection Sociale. Commission Nationale d'Homologation. Procédure d'homologation des prothèses totales d'hanches. Paris, le 17 novembre
  • Mittelmeier H. Ceramic prosthetic devices. The Hip, R B Welch. C. V. Mosby, St Louis 1984
  • Mogensen A, Ekelund L, Hansson L I, Lidgren L, Selvik G. Surface replacement of the hip in chronic arthritis. Acta Orthop Scand 1982; 53: 929–936
  • Müller M E, Sledge C, Poss R, Schatzker J, Engel C, Paterson D. Report of the SICOT Presidential Commission on documentation and evaluation. International Orthopaedics (SICOT) 1990; 14: 221–29
  • Munchow O B. The term “quality”. Quality Review Bulletin September, 1986; 310–15
  • Munsey R R, Samuel F F, Jr. Medical device regulation in transition. 75th Anniversary Commemorative Volume of Food and Drug Law. Food and Drug Law Institute Series, Washington 1984; 350–79, Ed. The Food and Drug Law Institute
  • Nissen K, Introduction I., Judet J, Judet R, Lagrange J, Dunoyer J. Resection of the hip. Arthroplasty with acrylic prosthesis. E. & S. Livingstone, Edinburg and London 1954
  • Older J. A tribute to John Charnley (1911–1982). Clin Orthop 1986; 211: 23–9
  • Pedersen D R, Crowninshield R D, Brand R A, Johnston R C. An axisymmetric model of acetabular components in total hip arthroplasty. J Biomech 1982; 15: 305–315
  • Pirsig R M. Zen and the art of motorcycle maintenance. Bantam Books, New York 1974. Proceedings and Reports of Universities, Colleges, Councils and Associations: British Orthopaedic Association Annual Meeting 1954. J Bone Joint Surg (Br) 1954; 36: 507–10
  • Reinikainen M. Where goes Germany?. Medical Devices and Diagnostic Industry January, 1987; 28
  • Ritter M A, Keating E M, Faris P M, Brugo G. Metal-backed acetabular components of total hip replacement: does it reduce loosening?. Proc. 57th AAOS Mtg. 1990, 133
  • Robinson R P, Lovell T P, Green T M, Bailey G A. Early femoral component loosening in DF-80 total hip arthroplasty. J Arthroplasty 1989; 4: 55–64
  • Rothman R M, Cohn J C. Cemented versus cementless total hip arthroplasty. A critical review. Clin Orthop 1990; 254: 153–160
  • Rudicel S, Esdaile J. The randomized clinical trial in orthopaedics: obligation or option. J Bone Joint Surg (Am) 1985; 67: 1284–93
  • Ryd L. Micromotion in knee arthroplasty. A roentgen stereophotogrammetric analysis of tibial component fixation. Acta Orthop Scand 1986, Suppl. 220
  • Saha S, Saha P. Bioethics and applied biomaterials. J Biomed Mater Res 1987; 21(A2)181–90
  • Scales J. (1990) Arthroplasty of the hip using foreign materials: a history. Proceedings of the Symposium on Lubrication and Wear in Living and Artificial Human Joints. 1966. Institution of Mechanical Engineers, London, 181, Pt 3J: 63–84. Safe Medical Devices Act of 1990. Public Law 101–629, 67
  • Schreiber A, Jacob H AC. Loosening of the femoral component of ICLH double cup hip prosthesis. Acta Orthop Scand 1984; 55(Suppl. 207)
  • Sedel L. Normalisation, certification, homologation du matériel orthopédique. Cahiers d'enseignement de la SOFCOT 1987; 381–85
  • Sinha M N, Willborn W W.O. The management of quality assurance. John Wiley and Sons, New York 1985
  • Staff of House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce. 1983, Report on medical device regulation: the FDA's neglected child. 98th Congress, 1st Session. Comm. Print 98-F
  • Strens P HG E. Analysis of implant failure in the Wagner resurfacing arthroplasty. Doctoral dissertation, University of Nijmegen, The Netherlands 1986, Sunday Times. The Thalidomide children and the law. Andre Deutsch, London 1973
  • Thompson R J. Testimony, Senate Committee Report on the Medical Device Amendments of 1976, 94th Congress Report No. 94–33
  • Tuchman B W. The decline of quality. New York Times Magazine November 2, 1980
  • Tulp N JA. Polyethylene delamination in the PCA total knee. Material analysis in two failed cases. Acta Orthop Scand 1992; 63: 263–266
  • Tulp N JA. Wear and alignment in total knee replacement: an in vivo and laboratory study. Doctoral Dissertation, University of Nijmegen, The Netherlands 1993, in press
  • Wagner H. Surface replacement arthroplasty of the hip. Clin Orthop 1978; 134: 102–130
  • Waugh W. John Charnley, the man and the hip. Springer Verlag, London 1990
  • 1970; 53, Wet van 15 januari 1970, houdende regelen met betrekking tot medische hulpmiddelen (Wet op de medische hulpmiddelen). Staatsblad
  • Wright T M, Rimnae C M, Stulberg S D, Mintz L, Tsao A K, Klein R W, McCrae C. Wear of polyethylene in total joint replacement: Observations from retrieved PCA knee implants. Clin Orthop 1992; 276: 126–134
  • Wroblewski B M. 15–21 Year results of the Charnley low-friction arthroplasty. Clin Orthop 1986; 211: 30–5

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