打字猴:1.700625044e+09
1700625044
1700625045 对于我这名外科医生来说,美利坚合众国没有国家关节注册系统是不合情理的。一个自由资本主义者也可以认识到美国医学的每个利益相关者都必须更上一层楼。世界上有11个国家或地区跟踪每例全膝关节和全髋关节置换手术,正是它们提醒了美国患者和制造商“关节表面置换系统”髋关节发生的严重问题。建立美国关节注册系统是大势所趋,但是在该系统正式出现之前,我可以向读者们保证,监管工作会继续严格执行。非预期后果定律说明,1996年的《健康保险携带与责任法案》实际上在保护患者隐私的同时,使结果的追踪变得更加复杂,但是相关部门正在为建立国家及国际性的关节注册系统进行认真的准备工作。美国食品和药品监督管理局的国际骨科注册联盟于2010年启动,以协调14个国家或地区的注册系统相互配合,但讽刺的是,创建并领导国际联盟机构的国家本身却没有全国性注册系统。
1700625046
1700625047 当然,美国的关节注册系统不应该仅仅追踪膝关节和髋关节的置换。数以百万计的患者植入了起搏器、心脏瓣膜、人工耳蜗、分流器、导液管、刺激器、锚、脊椎融合器、器官和电子植入物,对于他们来说,一套真正的监督系统是决定生死的。我们根本无法探知植入革命带来的可能性,无论植入物是合金、聚合物还是组织,无论它是大块金属,还是注射型纳米机器人,接受植入的患者一定要相信,关注最终结果评估 的医疗植入系统正在追踪着每一个植入物的性能表现。
1700625048
1700625049 [1] Philip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation (Chapel Hill: University of North Carolina Press, 2004), p.ix.
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1700625051 [2] Ibid., p.3.
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1700625053 [3] Ibid., p.x.
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1700625055 [4] Ibid., p.xi.
1700625056
1700625057 [5] “社会丑事揭发派”(muckraker)是一战前美国的一群报刊记者、编辑和作家,搜集并揭露社会黑暗面,曝光工业、商业与政界的腐败丑闻。——编者注
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1700625059 [6] David G reenberg, “How Teddy Roosevelt Invented Spin,” Atlantic, Jan. 24, 2016, https://www.theatlantic.com/politics/archive/2016/01/how-teddy-roosevelt-invented-spin/426699/. Accessed October 9, 2019.
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1700625061 [7] Ibid.
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1700625063 [8] Philip J. Hilts, Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation (Chapel Hill: University of North Carolina Press, 2004), p.24.
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1700625065 [9] Ibid., p.55.
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1700625067 [10] Ibid.
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1700625069 [11] Ibid., p.93.
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1700625071 [12] Ibid.
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1700625073 [13] Carol Rados, “Medical Device and Radiological Health Regulations Come of Age,” FDA Consumer Magazine, Jan.–Feb., 2006, https://www.fda.gov/aboutfda/whatwedohistory/productregulation/medicaldeviceandradiologicalhealthregulationscomeofage/default.htm. Accessed October 9, 2019.
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1700625075 [14] Meryl Gordon, “A Cash Settlement, but No Apology”, New York Times, Feb. 20, 1999,http://www.nytimes.com/1999/02/20/opinion/a-cash-settlement-but-no-apology.html. Accessed October 9, 2019.
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1700625077 [15] I. D. Learmonth, C. Young, C. Rorabeck, “The Operation of the Century,” The Lancet, 2007, 1508–19.
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1700625079 [16] G. K. McKee, J. Watson-Farrar, “Replacement of arthritic hips by the McKee-Farrar prosthesis,” Journal of Bone and Joint Surgery, 1966, 48 B:245, 59.
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1700625081 [17] D. Cohen, “Out of joint: The Story of the ASR,” British Medical Journal, May 14, 2011, 342:d2905.
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1700625083 [18] https://www.depuysynthes.com/asrrecall/depuy-asr-recall-usen.html. Accessed October 9, 2019.
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1700625085 [19] C. Delaunay, “Registries in Orthopaedics,” Orthopaedics & Traumatology: Surgery & Research, 101 (2015), S69–S75.
1700625086
1700625087 [20] P. Slatis and B. Veraart, “Goran Carl Harald Bauer: 1923–1994,” Acta Orthopaedica Scandinavica, 65: 5, 491–8, 1994.
1700625088
1700625089 [21] Barry Meier, “A Call for a Warning System on Artificial Joints,” New York Times, July 29, 2008.
1700625090
1700625091 [22] Australian Orthopedic Association. National Joint Replacement Registry, annual report 2007. AOA, 2008.
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1700625093 [23] D. Cohen, “Out of joint: The Story of the ASR,” British Medical Journal, May 14, 2011, 342:d2905.
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