Larson Brian R, Jones Paul, Zhang Yi, Hatcliff John
Biomed Instrum Technol. 2017;51(5):380-389. doi: 10.2345/0899-8205-51.5.380.
The complexity of medical devices and the processes by which they are developed pose considerable challenges to producing safe designs and regulatory submissions that are amenable to effective reviews. Designing an appropriate and clearly documented architecture can be an important step in addressing this complexity. Best practices in medical device design embrace the notion of a safety architecture organized around distinct operation and safety requirements. By explicitly separating many safety-related monitoring and mitigation functions from operational functionality, the aspects of a device most critical to safety can be localized into a smaller and simpler safety subsystem, thereby enabling easier verification and more effective reviews of claims that causes of hazardous situations are detected and handled properly. This article defines medical device safety architecture, describes its purpose and philosophy, and provides an example. Although many of the presented concepts may be familiar to those with experience in realization of safety-critical systems, this article aims to distill the essence of the approach and provide practical guidance that can potentially improve the quality of device designs and regulatory submissions.
医疗设备的复杂性及其开发过程给生产安全设计和适合有效审评的监管申报资料带来了巨大挑战。设计一个恰当且有清晰文档记录的架构可能是应对这种复杂性的重要一步。医疗设备设计的最佳实践包含围绕不同操作和安全要求构建安全架构的理念。通过将许多与安全相关的监测和缓解功能与操作功能明确分离，设备中对安全最为关键的方面可以集中到一个更小、更简单的安全子系统中，从而便于更轻松地进行验证，并更有效地审评关于危险情况的原因已被检测并妥善处理的声明。本文定义了医疗设备安全架构，描述了其目的和理念，并给出了一个示例。尽管许多呈现的概念对于有安全关键系统实现经验的人来说可能并不陌生，但本文旨在提炼该方法的精髓，并提供可能提高设备设计和监管申报资料质量的实用指南。
