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  • 1.  Labeling and Risk Control

    This message was posted by a user wishing to remain anonymous
    Posted 23-Jun-2022 12:08
    This message was posted by a user wishing to remain anonymous

    Which of the following is correct per ISO 14971:2019? Or some combination thereof?

    1) Labeling cannot be used as a risk control method which reduces either severity or probability.
    2) Labeling can be used as a risk control method which reduces either severity or probability.
    3) Labeling can be used as a risk control method but can only reduce probability, not severity.
    4) Labeling can be used as a risk control method but given it is a low level of control it cannot be the sole control method to address an identified hazard.


  • 2.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 03:13

    Relevant to the answer is the fact that information for safety is the lowest priority risk control option per ISO 14971:2019, clause 7.1 (which could including the broad term "labeling").  Here one is pointed to ISO/TR 24971:2020, where clause 7.1.1 and the subsequent Annex D are of note.  In particular, 7.1.1 discusses the means by which each risk control option reduces risk (e.g., eliminating a hazard or preventing a hazardous situation from leading to a harm).  Annex D further notes that information for safety "should be used only device after the manufacturer has determined that (further) reduction by other measures is not practicable." With respect to the means by which such a control measure may reduce risk, it can at best reduce the probability of harm by giving users "clear instructions on what actions to take or avoid, in order to prevent a hazardous situation or harm from occurring."

    Note too, IEC 62366-1:2015+AMD1:2020 is helpful here with respect to usability and information for safety.  In particular, the manufacturer must ensure that such information is "perceivable by, [...] understandable to, and supports CORRECT USE of the MEDICAL DEVICE by USERS of the intended USER PROFILES in the context of the intended USE ENVIRONMENT."



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    Christopher Erwin
    Scottsdale AZ
    United States
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  • 3.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 09:51

    Labeling can be used as a risk control. The MDR and IVDR state that in GSPRs. BUT and there is always a but, you must verify the effectiveness of the risk control. What does that mean?

    Simply you should have a Usability Validation of your risk control in your IFU. That means you must have objective evidence from a Design (Usability) Validation activity that proves your risk reduction down to the level you claim. That means if you claim a severity or probability reduction you must have the objective evidence of that claim. Most often severity can only be reduced through a design change. Unless you have evidence for any risk control you cannot claim risk reduction. 


    Hopefully this exlanation will help. I did point to MDR and IVDR, but this process I described works for all regulatory systems. 



    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    Member, ISO TC 210 JWG1
    MEd, CQA, RAC, BSc, CQE, ASQ
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal ConsultantMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQ
    ------------------------------



  • 4.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 10:43

    Only 2) is correct. In ISO 14971:2019 labeling falls under information for safety and is a valid means of risk control. It may reduce severity, frequency of occurrence, or both.

    These questions have their origin in a misunderstanding of some of the content deviations in EN ISO 14971:2012. One content deviation said that the manufacturer must (try to) implement all three risk control measures and not stop when the residual risk is acceptable. This creates a requirement to use information for safety.

    Another content deviation says that disclosing residual risk does not reduce risk. This is true.

    Unfortunately, many Notified Bodies didn't understand the difference between information for safety and disclosing residual risk and equated them. The NBs would write non conformances for using information for safety to reduce risk, notwithstanding the other content deviation that required it.

    Fortunately, those dark days are behind us. The MDR changed the risk reduction hierarchy from  the MDD and helped eliminate the confusion.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 5.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 11:09
    Hi Dan, I was wondering if you could explain how information for safety could reduce the potential severity of harm for a given risk?

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    Christopher Erwin
    Scottsdale AZ
    United States
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  • 6.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 12:00
    A design change, the first option in option analysis, MAY reduce severity by impacting the hazard. The other two options, Precautions, and instructions do not impact severity.

    ------------------------------
    Edwin Bills MEd, CQA, RAC, BSc, CQE, ASQ
    Principal Consultant
    MEd, CQA, RAC, BSc, CQE, ASQ
    Overland Park KS
    United States
    elb@edwinbillsconsultant.comPrincipal ConsultantMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQMEd, CQA, RAC, BSc, CQE, ASQ
    ------------------------------



  • 7.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 16:06

    In my public risk management courses, I liked to use examples that are in the experience of the participants, even if not a medical device. The office copier serves well.

    Inside the copier is a fuser that fuses the copier powder to the paper. It must be hot to perform the task. While I don't know the normal temperature, let's assume it would cause a second-degree burn if touched while at the operating temperature.

    The manufacturer, having gone through the process, risk evaluation shows the need for risk control measures. I'll paraphrase them for simplicity.

    Inherent safety by design – Not feasible because the fuser must be hot. Cold fusion for a copier is not yet invented.

    Protective measure – Put a cover of the fuser with an interlock. When the cover is opened, the interlock breaks the heater circuit, and the fuser starts to cool.
    Reduces frequency of occurrence because the user will not normally come into contact with fuser.
    May not reduce severity because the fuser stays hot for some time.

    Information for safety – Put a sticker near the fuser that says, "Fuser remains hot for at least 7.5 minutes. Wait before coming into contact".
    Reduces frequency of occurrence because the user waits
    Reduces severity because without the information for safety the user could touch the fuser in the second-degree burn temperature range or in the first-degree burn temperature range.



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
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  • 8.  RE: Labeling and Risk Control

    Posted 24-Jun-2022 18:42
    In that example, I am still unclear on how the potential severity is actually reduced. The sticker in this case only can increase awareness of the burn risk, rather than prevent the user's exposure to the hazard. Much like a red light on a kitchen stove is intended to alert a person to a hot burner (even after turned off), it does not result in a lesser burn due to the the warning; however, it does become less likely that they will be exposed to the hazard.

    A design change that could monitor the temperature and prevent access to the component until it has reduced sufficiently would be inherent to design, but a sticker could not do this.

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    Christopher Erwin
    Scottsdale AZ
    United States
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