5/7/2023 0 Comments Residual risk![]() ![]() However, the risk acceptability criteria for residual risks should be based on the benefit of the product. Residual risks should be evaluated using the same methods you use to evaluate individual risks. How to Approach Residual Risk Analysisĭuring this process, you will perform a benefit-risk analysis on individual residual risks that do not meet your risk acceptability criteria, as well as on the overall residual risk. In the case of risk assessment, there is little point in focusing on residual risks if practicable actions cannot be taken to mitigate them. However, “practicable” is a word and means something that can actually be put into practice, whereas “practical” means something that is useful or matter-of-fact. You may see the word “practicable” in ISO 14971 and ISO 24971 and assume it is a typo. ![]() This includes known and foreseeable risks, including intentional and unintentional misuse of your device. Collectively, those small vulnerabilities may allow a hacker easier access to penetrate the software than initially thought and control the device, causing harm to the patient.Ĭlauses 7.4 and 8 of ISO 14971:2019 – the international risk management standard – emphasize the need to evaluate residual risk, noting that it should “be evaluated in relation to the benefits of the intended use of the medical device.” Likewise, Annex I of the EU Medical Device Regulation (2017/745) says that you should “ reduce risks as far as possible” without adversely impacting the benefit-risk ratio. While some risks remain, they are determined to be acceptable. Individual vulnerabilities might be analyzed, evaluated, and mitigated as far as possible. An example of this might be cybersecurity threats for an insulin pump. It is entirely possible that individual risks might meet your risk acceptance criteria on their own but not when evaluated in aggregate. Residual risk analysis takes individual risks that meet your acceptance criteria and examines the risk they pose individually as well as all risks in aggregate. If you want an in-depth primer on the entire medical device risk management process, start here. This article focuses specifically on residual risk. ![]()
0 Comments
Leave a Reply. |