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Reduce Risk As Far As Possible (AFAP)

Discussion in 'ISO 14971 - Medical Devices Risk Management' started by Sam Lazzara, Mar 3, 2016.

  1. Sam Lazzara

    Sam Lazzara Member

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    Notified Body Technical File Review Question:
    The device is provided non-sterile. On the bright side, it does have established requirements for microbiological cleanliness. However, by not providing the device sterile, you are not reducing the risk "As Far As Possible" as required by the MDD 93/42/EEC Essential Requirement 2.

    Any clever answers for this?
     
  2. Marcelo Antunes

    Marcelo Antunes Active Member

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    I would ask the reviewer a questions: Does it mean that all devices that needs to be sterilized needs to be provided sterile? This does not make any sense.

    The problem here is the weird way the deviations were created and are being applied. If the "state of the art"is to have this device not sterilized (meaning, risk is considered acceptable, similar devices use the same solution, and a better solution would be disproportionate to the gain), it should be considered as far as possible.
     
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  3. yodon

    yodon Well-Known Member

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    That's a tough one. I'm a bit surprised that this doesn't come up more often. Clearly there ARE cases where cost makes it impractical to implement a control. Cross contamination could be greatly reduced if everything was gold plated. So I think, as Marcelo indicates, there has to be some consideration for state of the art and the scope of the device. The scope, in your case, only requires microbiological cleanliness, not sterilization.

    I'd be curious to hear how you respond and how things end up.
     
  4. MarkMeer

    MarkMeer Well-Known Member

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    On its face, this is unfortunately a pretty weak argument. What link is there between "state of the art" and reducing risk "as far as possible"? Just because devices are "state-of-the-art", certainly doesn't rule out the possibility of them being designed safer.

    Sam's situation is precisely what was predicted when these changes were made. What is the burden of evidence for "as far as possible"? What authority do individual regulators have to assess when risk has been mitigated "as far as possible", when there are ALWAYS additional measures that can be taken?
     
  5. Marcelo Antunes

    Marcelo Antunes Active Member

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    This is not an argument, as it would need a lot of studies, justification and the like to act like one.

    You mean, formally? One example would be the text of the directive itself?

    "Whereas the essential requirements and other requirements set out in the Annexes to this Directive, including any reference to ‘minimizing’ or ‘reducing’ risk must be interpreted and applied in such a way as to take account of technology and practice existing at the time of design and of technical and economical considerations compatible with a high level of protection of health and safety"

    No, and that's where the part on "take account of technology and practice existing at the time of design and of technical and economical considerations"is important, otherwise, we would have a lot of super safe devices made of kilograms of gold (if gold would be a safety feature, for example) that no one would be able to buy. This is related to the concept I mentioned of disproportionate to the gain.

    I'm not sure if you really know why those changes are made. On thing is, these changes were made by a lawyer that interpreted the directives the way he wanted to interpret it. For example, there's a deviation that says that financial aspects should not be considerate. But the text I used above clear says that.

    The manufacturer always has the responsibility to demonstrate compliance, and thus that their devices are safe and effective and comply with directive requirements.
     
    Last edited: Mar 4, 2016
    Ronen E likes this.
  6. Ronen E

    Ronen E Well-Known Member

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    1. What is the device?

    2. Reducing that risk as far as possible could also be achieved by not placing that device on the market at all... The real question in reducing "as far as possible" is how little risk reduction is required before the risk at hand becomes negligible or undetectable. That - in my opinion - would constitute a state where the risk has already been reduced "as far as possible" (ie it can't be reduced any further in a meaningful way). If you can somehow rationalise that the specified microbiological cleanliness level has already brought the risk down to a level where additional reduction will not be meaningful or detectable, that should satisfy a reasonable* reviewer.

    *) May well not be the case!...
     
    Last edited: Mar 4, 2016
  7. Ronen E

    Ronen E Well-Known Member

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    Technically speaking, this paragraph is part of the directive's preamblele, which is part of the directive but is not legally binding. If it was, it would have been much easier to fight off that outrageous deviation...
     
  8. Marcelo Antunes

    Marcelo Antunes Active Member

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    Yes, but this specific recital is related to the requirement that mentions state of the art:

    "
    The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
    In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
    – eliminate or reduce risks as far as possible (inherently safe design and construction),
    "

    And, as recitals are in practice interpretative tools, it should have been used together. Otherwise, we arrive at the situation mentioned - that you have to reduce risks even if it turns the product unmarketable. Then we go back to the discussion in balancing the risks and benefits, and clearly, and unmarketable device does not benefit anyone, even if it's super safe.
     
  9. Ronen E

    Ronen E Well-Known Member

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    In general I agree.

    The unfortunate difference between the preamble clause you cited earlier and the actual legal text from the directive's body, is that the legally-binding text lacks that all-important mention of economical considerations.

    I agree that when the deviations were put in place the preamble SHOULD have been considered, as it conveys the original legaislator's intent. But unfortunately it wasn't (at least effectively), and this is how we ended up with such an unwise requirement. :(
     
  10. Marcelo Antunes

    Marcelo Antunes Active Member

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    It also does note say what safety principles is, nor what state of the art is :rolleyes:
     
  11. MarkMeer

    MarkMeer Well-Known Member

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    I agree in principle...but it could be argued that this is not the case in Sam's situation.
    Relying on requirements for "microbial cleanliness" is demonstrably a less certain risk-mitigation than simply ("simply") providing the device as sterile.

    Regardless of the initial risk evaluation (even if negligible), the fact that one design (e.g. sterile) is, even to a tiny degree, more reliably safe than another design (e.g. cleanliness), makes the reviewer's observation legitimate under a "as low as possible" framework.

    If this is the case, it would seem that the only viable approach is to make an argument from a cost/benefit perspective, not a risk analysis.

    My concern is that "state of the art" rationales will lead to enforced conformity for things that are really not necessary.

    To continue the example, suppose the price of gold plummets so that it is now affordable to plate all devices in gold:
    - REVIEWER: why did you not use gold plating?
    - APPLICANT: because our risk-analysis demonstrated that the risk of microbial contamination is negligible.
    - REVIEWER: yes, but if it was gold-plated it'd be even less prone to microbial contamination, ergo you have not satisfied the requirement to reduce risk "as low as possible".
    - APPLICANT: (sigh) ok, we'll gold-plate our device.

    Perhaps you find this example absurd, and purely hypothetical. But to me this illustrates the reductio ad absurdum of the "as low as possible" and "state of the art" approaches.
     
  12. Ronen E

    Ronen E Well-Known Member

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    This is where I disagree. If that tiny degree doesn't make any real-world difference, there are no grounds for mandating anyone to follow. This is not a pure science or philosophic debate. If it was, of course your argument was right. But the issue at hand is a practical one at the end of the day, because it is about balancing between unsafe devices and unavailable devices. Both extremes are bad, so the goal is finding the happy medium. Hence, the focus should be not on which extreme is "right" (both aren't) but on where the optimum is.

    It's quite easy to follow the "as far as possible no matter what" argument to absurdities, considering many kinds of risks. If we stay with sterility, for example, there are many types of devices where microbiological cleanliness can be argued to be (and is actually mostly considered) beneficial to safety, yet are never sterilised nor seriously thought of as requiring sterilisation. Each of these could end up, in the hands of the unreasonable reviewer, as non-conforming unless they'd be sterilised. However, if that was to be followed as an overarching policy, many of those devices would become economically unviable and maybe even disappear from the market altogether - I'm sure that that would lead to an uproar against over-regulation that doesn't make any sense.
     
  13. Sam Lazzara

    Sam Lazzara Member

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    Does any one have a link to the latest draft of the new European medical device regulation? What does it say about reducing risk? Still AFAPing?

    For the 93/42/EEC MDD, the root(s) of the AFAP controversy are the Essential Requirements (ER) in Annex I that mention it - there appear to be 8 mentions of AFAP in the ERs.

    ER 1: The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. This shall include:
    — reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and
    — consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
    ER 2: ....eliminate or reduce risks as far as possible (inherently safe design and construction),...
    ER 8.1: The devices and manufacturing processes must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient, user and third parties.
    ER 11.1.1: Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to radiation shall be reduced as far as possible compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.
    ER 11.3: (regarding unintended radiation) Devices shall be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible.
    ER 12.1: Devices incorporating electronic programmable systems must be designed to ensure the repeatability, reliability and performance of these systems according to the intended use. In the event of a single fault condition (in the system) appropriate means should be adopted to eliminate or reduce as far as possible consequent risks.
    ER 12.6: Protection against electrical risks - Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks during normal use and in single fault condition, provided the devices are installed correctly.
    ER 12.8.2: Devices must incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy from an energy and/or substance source.

    Some mention "according to the intended use" or "compatible with the intended purpose" - little islands of sanity!

    By the way, my client's device is a suction catheter for use in the respiratory tract. The applicable (but MDD non-harmonised) standard is EN ISO 8836:2014 (ISO 8836:2014). The standard does not require the devices to be supplied STERILE. It does of course require suction catheters that are marked as STERILE to meet the applicable standards.
     
  14. Ronen E

    Ronen E Well-Known Member

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    Do the instructions for use require the end-user to sterilise or disinfect that catheter before use? If so, the relevant risk is a usability issue, not a sterility one. If not, and assuming that that catheter goes beyond the pharynx and/or into the nasal cavity, I must admit that at face value using such a catheter in an unsterile condition poses a non-negligible risk.

    I'm unfamiliar with ISO 8836. Does it say that where the catheter is supplied unsterile, it must be treated in some way before use?
     
  15. Sam Lazzara

    Sam Lazzara Member

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    Hi Ronen,

    Do the instructions for use require the end-user to sterilise or disinfect that catheter before use?
    No, and I agree the risk is non-negligible but so far the client has taken the position that sterilization in not required.

    8836 makes no mention of when/if device sterility is required, and makes no mention that is must be treated in some way before use. The standard has a section called "Requirements for suction catheters supplied sterile" that does not apply to catheters supplied non-sterile.

    Another related standard EN ISO 5361:2012 for tracheal tubes follows the same themes and also says that unless the tracheal tube is intended and marked as being for single use, instructions for cleaning and disinfection or sterilization and the maximum number or period of re-uses shall be marked on the tracheal tube package or on an insert. So, for single use devices there are no specific requirements related to cleaning, disinfection or sterilization.
     
    Last edited: Mar 6, 2016
  16. Peter Selvey

    Peter Selvey Member

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    I have been developing a broader "risk minimum theory" based risk/resources which relates to this thread. One day I will get around to consolidating and releasing, but essentially it helps to answer explain why "acceptable risk" (as per ISO 14971) does not work, and also creates a mathematical model that supports a minimum risk result that the EU so obviously desires. My current title is "Risk minimum theory - a mathematical model for common sense".

    There is a lot more to it, but essentially the part which relates to this thread requires two changes to the way we look at risk: the first is that while studying a particular situation (such as the one proposed by Sam), we should consider the risk of the whole medical device, rather than the individual situation. Second we need to consider the absence of benefit as a risk. These two changes create a natural risk minimum for every situation, and eliminates the need to define acceptable risk along with all its problems. If this minimum is achieved, we can say that the EU directive has been meet.

    In principle, we need to understand that the use of resources is always associated with an increase in risk. There are a number of mechanisms how this happens, any many of them impact the availability of the device to achieve the intended purpose. Even we have to accept that if a certain way is well established (state of the art), a manufacturer that tries to reduce the risk but then takes themselves out of the market is in effect increasing risk for their product (the theory goes on to show that such situations are best handled by using standards to drive improvements, rather than expecting too much from individual manufacturers; manufacturers though need to feed these issues through to standards committees, i.e. they cannot wash their hands completely).

    Much of the theory works on the principle that Ronen E mentioned that for many situations risk tends to fall away to negligible without significant resources. Use of resources beyond this point only increases the risk, hence the risk can be considered to be minimized.

    For the particular example, I suspect the answer is that the risk is negligible with respect to the background risk of infection. I would be comfortable if the risk of serious infection from the device is less than 1/100 of the background risk of infection from a normal medical environment. At this level, using resources to try and reduce further is clearly a waste (increasing risk). A value of 1/10 background might warrant a short investigation or risk/resources; while 1/1 (same as background) should trigger detailed study of risk/resources, or evidence that the situation is broadly accepted, along with evidence of efforts to raise the issue with regulators.

    Again there is a lot more to the theory and one of the main targets is justifying a flexible approach where documentation for a particular situation can range from nothing through to detailed analysis. Other benefits are showing that the risk/benefit approach is fundamentally wrong; as well as showing how the acceptable risk model creates a bipolar behaviour not only in manufacturers, but in standards, third party assessment and regulators.

    One day ...
     
  17. Pads38

    Pads38 Member

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    Perhaps an option for Sam's problem would be to fully understand how the catheter is used and then how a sterile catheter would be used differently.

    A sterile catheter only stays sterile if used with aseptic technique - sterile gloves, sterile coverings etc etc. If Sam's catheter is for use in a less "controlled" setting then any benefit from being supplied sterile is lost and irrelevant.
     
  18. Sam Lazzara

    Sam Lazzara Member

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    Spot on Pads38. There are some interesting YouTube videos showing a 1 hand sterile / 1 hand non-sterile technique, by a nurse who is not garbed for sterile technique.
    Clearly they are trying to be as clean as reasonably possible for an ICU unit (not a sterile surgical suite).

    Check this video out - the technique is "kinda" sterile and in this video I believe the suction catheter has been terminally sterilized by the manufacturer.
     
  19. MarkMeer

    MarkMeer Well-Known Member

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    Good discussion! :)

    I think Ronen's spectrum of unsafe versus unavailable is problematic because making a convincing argument that additional risk-mitigating measures might unacceptably shift the balance towards "unavailable", would necessarily require scrutinizing market demand and the company's business model. Should regulators be in the business of making such decisions? Who are they to tell a business that the cost of adding some additional risk-mitigating feature will or will not make the device unsustainable economically?

    You talk of unnecessary use of "resources" being risk. ...but wouldn't that mean a different standard is applied to different companies based on the resources they have available?
    To return to the gold example: if two companies, one with huge resources, one with scarce are trying to manufacture identical devices, are we to say that the former SHOULD plate their device in gold (because the effect on their resources would be negligible), whereas the latter shouldn't have to (because they can make a strong case that their device would be unavailable - economically unfeasible - if they had to do so)?
     
  20. Ronen E

    Ronen E Well-Known Member

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    I didn't argue that regulators should be defining the optimum, I was merely arguing for the legitimacy of such middle-optimum - contrary to the current formal EU regulatory stance that the extreme of "reducing risk no matter what" is the right (and only) way. Once one agrees that the goal should be finding a middle-optimum, the next step is determining the principles and technique to find it. Peter's concepts represent a path in that general direction.

    I think you overlook an important element in Peter's argument (the way I understand it): He argues that there is, for any given device, an ABSOLUTE, single minimum risk point if you also fully and formally consider device availability. He also conceives that ANY wasted resources (ie resources invested in reducing use risk beyond the overall-risk minimum point) are a WASTE and thus increase availability risk (regardless of whether actual availability is detectably affected). If resources are invested unnecessarily they'd be deemed a waste regardless of the amount of resources available to the manufacturer. You could argue that that waste might be less painful for a certain manufacturer than for another; this doesn't affect the fact that it's still a waste in absolute terms.

    You could think of it graphically: If the vertical axis represents risk level and the horizontal represents resources invested in use-risk reduction, the use risk curve would be a downward sloping exponential curve while the availability risk curve would similarly be an upward sloping exponential one. The overall risk absolute minimum is where they intersect.
     
    Last edited: Mar 7, 2016

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