医疗器械验证中的临床方法分析

Clinical analysis methods of medical device verification

医疗器械通常经过直接或间接的物理途径,达到对疾病有效诊断及治疗的目的。而由于医疗器械诊疗方式的多样化,故存在应用风险,因此世界各国均采取了多种监管手段,以控制其应用的风险程度。医疗仪器的临床验证方式分为间接临床验证和直接临床验证。但目前仍有大量的生命信息监测技术尚无统一的参考标准,在实际的实施中只能以上述方式为参考。而模块化设计作为当今医疗器械产品开发的趋势,能够通过开发和使用统一的模块,并对模块的安全性和有效性加以验证,从而控制医疗器械开发成本。

[Abstract] Medical instruments can be used to diagnose and treat diseases through physical way directly or indirectly. Because of the diversity of ways, it also has the application risk. Therefore, different countries in the world have adopted various means of supervision to control the degree of risk and its application. Usually, the verification of medical instrument includes the direct clinical validation and indirect one. However, there is no norm reference standard for life information monitoring technology. In actual situation, we can only employ the above as the reference. As a trend of modern medical equipment product development, modular design can be developed and used. The modules of the safety and effectiveness of verification can then be used to control the cost of medical device development. [Key words] Medical equipment; Verification; Clinical method; Module