Practicable or not, that's the question for risk control
Insights from a Let's Talk Risk! conversation with Ian Sealey
Note: this article highlights key insights gained from a conversation with Ian Sealey as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below.
The term practicable is used in ISO 14971, the International Standard for application of risk management to medical devices, in the context of risk controls1 and benefit-risk analysis of an individual residual risk2.
In practice, this “term” causes a lot of confusion! One source of this confusion appears to stem from the fact that the standards uses the “term” practicable as part of a requirement, but also suggests that the “word” practicable may be a part of the manufacturer’s policy for establishing criteria for risk acceptability.
There is, however, no formal definition of the “term” practicable in the standard. As a result, there is a lot of debate in the medical device risk management community about what practicable is, what it is not, and how it is different from a practical approach to risk controls. Note that there is no mention of the word practical either in the standard; however practitioners may easily confuse these terms as noted in Annex C of ISO/TR 24971, the guidance on application of ISO 14971, in the context of risk control3:
One possible approach is to consider the practicability of the risk control measures. Practicability (being practicable) refers to risk control options that are considered viable or capable of being put into practice. This should not be confused with practicality (being practical), which refers to measures that are useful or convenient. Practicability has two components, namely practicability and economic practicability.
The inclusion of economic practicability within the scope of the term practicable, as noted above, is also likely to cause a lot of confusion for risk practitioners in the industry. One area where this may become particularly relevant is in subclause 4.2, where the top management at a medical device manufacturer is required to define and document a policy for establishing the criteria for risk acceptability. Note 1 in this subclause provides the following clarification:
The manufacturer’s policy for establishing criteria for risk acceptability can define approaches to risk control: reducing risk as low as reasonably practicable, reducing risk as low as reasonably achievable, or reducing risk as far as possible without adversely affecting the benefit-risk ratio. See ISO/TR 24971 for guidance on defining such policy.
Ian points out that Notes in the standard are not normative; that is they do not constitute the requirements of the standard. They are meant to only clarify and indicate a potential approach for conformance. The word can used in Note 1 above, for example, is intended to express a possibility or capability.
It should be noted that whilst ISO 14971 and ISO/TR 24971 may give non-normative guidance on the interpretation of the “word” practicable for the purpose of a manufacturer’s policy, there is no guidance on the interpretation of the “term” practicable for the purposes of uncontrolled risks and benefit-risk analysis of uncontrolled risks, or risks that remain unacceptable after risk control.
The medical device regulation in the European Union (EU-MDR) requires the “reduction or risks as far as possible without adversely affecting the benefit-risk ratio”.
In the context of EU-MDR, and Note 1 of ISO 14971 referenced above, there is currently a lack of consensus in the industry about how far manufacturers must go when considering risk control options in order to conclude that no further risk controls are practicable. Some in the industry have an understanding that EU-MDR requires the blanket “reduction of all risks as far as possible without adversely affecting the benefit-risk ratio”. Ian disagrees.
Ian shares that there is not a consolidated view on this topic right now. That is why there is a need for a continued conversation on this topic to understand various regulatory requirements and available guidance. As practitioners, we are often challenged to find the most optimal solution, that is not only compliant, but also helps us in satisfying the needs of our patients and doctors in a cost effective way. This is one of the reasons for our weekly Let’s Talk Risk! conversations where we can learn from each other and help build a better understanding of these difficult topics.
We will continue to explore this topic in future Let’s Talk Risk! conversations and articles.
Listen to the recording of our conversation above and don’t miss the audience Q&A portion where many interesting ideas and practical tips were shared.
About Ian Sealey
Ian Sealey is currently a medical device regulatory consultant providing regulatory, quality, technical, policy and training services to multinationals and startups. He has previously held engineering positions in both private and the public sectors. He served as a medical device specialist to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and was appointed to the position of Assistant Secretary at the Department of Health. He holds a BEng(Hons) in Medical Engineering and is a BSI qualified ISO 13485:2016 Lead Auditor.
About Let’s Talk Risk! with Dr. Naveen Agarwal
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this article are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
See Clause 7.1 in ISO 14971:2019
See Clause 7.4 in ISO 14971:2019
See section C.4 in Annex C of ISO/TR 24971:2020