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  • 1.  Risk Vs Benefit - ISO 14971:2012

    Posted 17-Aug-2017 06:33
    Hi Team,

    I have prepared the Risk Management file recently along with cross functional team, to comply with ISO 14971:2012 requirements. 

    I am not very clear with the requirement for risk vs benefit. Is risk vs benefit statement required for every single hazard or overall risk vs benefit statement is enough?

    Please provide your suggestions. 

    Thanks in advance. 



    ------------------------------
    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
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  • 2.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 03:34
    ​Hello Silambarasan,

    according to ISO 14971:2012, a risk / benefit statement is required for each residual risk for which the identified risk region is above the acceptability criteria determined in your risk management plan (clause 6.5).
    In addition, a separate risk / benefit statement will be required regarding the overall residual risk, unless the overall residual risk is within the acceptability criteria laid out in the risk management plan (clause 7).
    These are two different things: even if each individual risk is determined to be acceptable based on risk / benefit considerations, this does not automatically imply the overall residual risk is too.

    Hope thishelps!
    Best regards,

    Laurent

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    Laurent Bernau, Ph.D.
    Sr. Regulatory Affairs Specialist
    Stryker Trauma & Extremities
    Selzach - Switzerland
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  • 3.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 10:34
    Hello Laurent & Silambarasan,

    Just to clarify, as Ed Bills mentions later, there needs to be a distinction between ISO 14971:2007 and EN ISO 14971:2012 where the latter adds Annex ZA.  You may have been commenting on the 2007 version, but since the original question mentions ISO 14971:2012, lets assume that the Annex needs to be considered (later Silambarasan mentions they will be marketing into the EU).

    By the way, I believe this is a very good question; one which I struggled with in interpreting Annex ZA.  With this addition, Section 4 b) is largely making reference to overall risk-benefit analysis according to Section 1 of Annex I to Directive 93/42/EEC.  Although the next section c) states: "Accordingly, the manufacturer must undertake the risk-benefit analysis for the individual risk and the overall risk-benefit analysis (weighing all risks combined against the benefit) in all cases.", I believe this is saying that a risk-benefit analysis is needed for when:
    1) an individual risk is not acceptable, per Section 4 a) stating '6.5 of ISO 14971 says: "If the residual risk is not judged acceptable using the criteria established in the risk management plan and further risk control is not practicable, the manufacturer may gather and review data and literature to determine if the medical benefits of the intended use outweigh the residual risk."', and
    2) the overall risk is either acceptable or not (what is addressed in Section 4 b)), since the second part of Section 4 a) focuses on overall risk: "Both quotes imply that an overall risk-benefit analysis does not need to take place if the overall residual risk is judged acceptable when using the criteria established in the risk management plan."

    I believe this rationale complies with both the Annex and the Consensus Paper Ed later mentions.  I suppose to be safe one might provide a rationale for why acceptable risks meet certain risk-benefit criteria in the risk management report to address an NB's concerns.

    Best of luck working this out with the NB since they are the ones putting their certification reputation on the line.

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    Rem Siekmann
    Principal Engineer
    Mentor OH
    United States
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  • 4.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 04:43
    Hi Silambarasan

    For medical devices in the EU, you will also need to consider the MDD 93/42/EEC. At the front of 14971 there is an 'Annex ZA' with a list of items ('Content Deviations') not covered in the 14971 standard, but required by the MDD.

    Look at 14971 (page 7 on my copy) Content Deviation 4:
    Part A adds context from 14971, which states that a risk-benefit-analysis isn't required for every risk (such as those with acceptable residual risk)
    Part B adds context from the MDD
    Part C -"Accordingly the manufacturer must undertake the risk-benefit-analysis for the individual risk and the overall risk benefit analysis... in all cases"

    Part C doesn't make reference to acceptability criteria, if you are working on a medical device for the MDD, I would make a statement about the risks-vs-benefits for every single risk.

    Kind regards,
    Chris.

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    Chris Barkway
    United Kingdom
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  • 5.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 05:55
    Hi Laurent,

    Thanks for your suggestions and views. 

    Yes, I agree with you that there is a requirement of risk vs benefit statement for any residual risk (AFAP and Unacceptable) above acceptance criteria. Additionally, overall risk vs benefit statement also a requirement. 

    But, in recent conversation with NB, they asked for risk vs benefit statement to all residual risks which are in acceptable risk level as well. Is it really require to give Risk vs Benefit for residual risk under acceptance level?

    ------------------------------
    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
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  • 6.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 06:06
    Hi Chris,

    Thanks for the clarifications. 

    Yes, I am working on a medical device meeting MDD requirements. I agree that there is a statement in content deviation as "Accordingly the manufacturer must undertake the risk-benefit-analysis for the individual risk and the overall risk benefit analysis... in all cases". 

    But, does it mean even for a residual risk under acceptable level should have risk benefit analysis? 

    Please give your views on it. 

    Thanks,

    ------------------------------
    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
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  • 7.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 18-Aug-2017 08:11
    Silambarasan,

    For this and other questions I would refer you to  a document created by a Notified Body group several years ago.  While not finalized, it is the best available to answer questions on EN ISO 14971:2012 (and no there is not a ISO 14971:2012, just an EN ISO 14971:2012) is 
    available on line for free (unlike the standard) at Team-NB.org.  Look for:

    Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012

    Version 1.1 October 13th, 2014

    the 
    link is: http://www.team-nb.org/wp-content/uploads/2015/05/documents2014/NBRG_WG%20RM_Interim_NBmed_Consensus_Version_140812_1_1.pdf

    Their recommendation is:

    At the end of the risk management process the manufacturer shall perform a risk‐ benefit analysis for individual risks that are not acceptable according to the criteria explained in content deviation 2 and for which further risk reduction is not possible. In any case the manufacturer shall perform an overall risk-benefit analysis considering all individual risks to provide a rationale for overall risk acceptance.

    While not recognized by all Notified Bodies, I find most accept the statements in this document, especially those whose representatives are named in the workgroup members listed on the Content page.



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    Edwin Bills RAC, MA
    Principal Consultant
    Edwin Bills Consultant
    Overland Park KS
    United States
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  • 8.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 19-Aug-2017 14:26

    Since ISO 14971:2012 is not a standard, it is not clear how to answer the question. The answer differs between ISO 14971:2007 and EN ISO 14971:2012 Annex ZA.

     

    For ISO 14971:2007, as described in Clause 6.5, the manufacturer my encounter a situation where an individual residual risk is unacceptable and further risk control measures are not practicable. Then the manufacturer may try to determine if the benefit outweighs the individual residual risk. If the medical benefits outweigh the individual residual risk, then the manufacturer may proceed.

     

    In this case, a risk/benefit analysis is rare, because the manufacturer seldom encounters the triggering situation (unacceptable residual risk and no additional risk reduction measures).

     

    The situation changes with EN ISO 14971:2012 Annex ZA. The content deviations inform the manufacturer when the MDD differs from ISO 14971:2007. In this instance, Content Deviation 4 applies. The content deviation concludes that the manufacturer must undertake the risk-benefit analysis for the individual risk … in all cases.

     

    In this case, each individual residual risk must have a risk/benefit analysis; one is required "in all cases". There is no requirement that each one be unique. Similar individual residual risks, arising from different hazards, hazardous situations, and harms, may have the same risk/benefit analysis.

     

    There are two important issues. The first is whether the conclusion in Content Deviation #4 logically follows from Annex I, Section 6. Since that deals with "undesirable side-effects", I have a hard time reaching the conclusion.

     

    The other issue is the Consensus Paper which suggests "a risk‐ benefit analysis for individual [residual] risks that are not acceptable according to the criteria explained in Content Deviation #2 and for which further risk reduction is not possible". This implies acceptable risks don't require a risk/benefit analysis, but it doesn't state that position.

     

    In addition, it brings in Content Deviation #2, which starts by saying that ISO 14971:2007 says that only non-acceptable risks have to be integrated into the overall risk-benefit analysis. I expected the conclusion to affirm that risk/benefit analysis applies to both acceptable and unacceptable risks, but the conclusion is not a straight line from the premises.

     

    Because Content Deviation #4 says, in all cases, I would consider failure to cover all cases (both acceptable and unacceptable residual risk) as a non-conformance to MDD Annex I, Section 6 as described in Content Deviation #4.

     

     



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    Dan O'Leary
    Swanzey NH
    United States
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  • 9.  RE: Risk Vs Benefit - ISO 14971:2012

    Posted 21-Aug-2017 00:16
    Thanks Mr. Edwin Bills and Mr. Dan O'Leary for the detailed answers. I am pretty much clear now.

    Thanks all  


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    Silambarasan Subramanian
    Senior Engineer - Quality & Regulatory Affairs
    Schiller Healthcare
    India
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