The safety and clinical effectiveness of medical devices are closely associated with their specific use in clinical treatments. Assuring safety and the desired clinical effectiveness is challenging. Different people may react differently to the same treatment due to variability in their physiology and genetics. Thus, we need to consider the outputs and behaviour of the device itself as well as the effect of using the device to treat a wide variety of patients. High-intensity focused ultrasound systems and radiation therapy machines are examples of systems in which this is a primary concern. Conventional monolithic assurance cases are complex, and this complexity affects our ability to address these concerns adequately. Based on the principle of separation of concerns, we propose separating the assurance of the use of these types of systems in clinical treatments into two linked assurance cases. The first assurance case demonstrates the safety of the manufacturer's device independent of the clinical treatment. The second demonstrates the safety and clinical effectiveness of the device when it is used in a specific clinical treatment. We introduce the idea of these separate assurance cases, and describe briefly how they are separated and linked.
翻译:医疗装置的安全性和临床效力与其在临床治疗中的具体用途密切相关。确保安全和预期的临床效力具有挑战性。不同的人由于其生理学和遗传学的变异性,可能对相同的治疗作出不同的反应。因此,我们需要考虑医疗装置本身的产出和行为,以及使用该装置治疗各种病人的效果。高度密集的超声波系统和辐射治疗机器是主要关切的系统的例子。常规单一保证案例是复杂的,这种复杂性影响到我们充分解决这些关切的能力。根据将关注问题分开的原则,我们建议将临床治疗中使用这些类型的系统的保证分为两个相互联系的保证案例。第一个保证案例表明制造商装置的安全性,独立于临床治疗。第二个保证案例显示了在特定临床治疗中使用该装置时的安全性和临床效力。我们介绍这些单独的保证案例的概念,并简要描述它们是如何分离和联系在一起的。