Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking
Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking
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DOI：
10.1111/j.1467-9930.2010.00337.x
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发表时间：
2011-04-01
期刊：
影响因子：
1.3
通讯作者：
Altenstetter, Christa
中科院分区：
文献类型：
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作者：
Altenstetter, Christa
平衡可接受的风险和患者护理新疗法产品的早期发布与患者的权利以及利益相关者（设备制造商和监管机构）的权利是一项复杂的任务。随着过去二十年的快速技术创新，为所有参与者提供一个平衡的声音是至关重要的，但紧迫感取决于你站在过道的哪一边：站在患者、外科医生、监管机构和设备制造商这一边；或者提供者和科学顾问。对医疗器械政治经济的回顾表明，为什么从临床评估和上市前检查到全球各种临床环境中的最终使用，患者安全问题在整个监管周期中是或应该保持存在的。目前纳米增强设备的关键问题是，是否可以通过更严格的监管要求和积极主动的措施来减少不确定性和感知风险，而不会扼杀创新和发展新的治疗方法。
Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders-device makers and regulators-is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers; or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and premarket checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients.