New version BS EN ISO 14971:2012 released - July 2012

rob73

looking for answers
#1
BSI have now released BS EN ISO 14971:2012, more informative references between the standard and MDD 93/42EEC have been added, specifically:
*Treatment of negligable risks
*Discresionary power of manuf. as to the acceptability of risks
*Risk reduction "as far as possilbe" VS "as low as reasonably possible"
*Discretion as to whether as risk benifit analysis needs to tkae place
*Discretion as to the risk control option/measures
*Deviation as to the first risk control method
*Information of the users influencing the residual risk

Rob
 
Elsmar Forum Sponsor

Chrisx

Involved In Discussions
#2
I notice that the reference on CEN still says ISO 14971:2007 in parentheses and the ISO website still cites ISO 14971:2007. Is this really a significant change to the standard or is this just a change to the preamble to address the formal objection made to this standard? It sounds like this might be a simillar case as EN ISO 13485:2012. Does anyone know?
 

Chrisx

Involved In Discussions
#4
It sounds like more political nonsense, with no real improvement in safety. So, it is no longer acceptable to reduce risks to as low as practicable. Now, I have to reduce risk to as low as possible. I guess this means sampling is no longer acceptable, as 100% inspection would further reduce the risks. New products are inherently riskier then exisiting products. So much for innovation, it is not as low a risk a possible. For process validation, a sample size based on a 95/95 confidence interval is no longer possible. It is not as low a risk as possible. It has to be 99.9999/99.9999 with a sample size of 10 million units. Sounds like more stuff created by politicians with no idea what risk management really is. Did anyone ever consider the impact of "as low as possible", or did it just sound neat. If ALARP is good, then ALAP must be even better. :bonk::sarcasm:
 

Chrisx

Involved In Discussions
#6
Thanks for providing the document. However it seems to be a rather impractical approach. I now have to consider all negligible risks, even if it is unlikely. This would seem to be an endless and impossible task. For example, do I have to consider that someone might try to fix their house with our spine pedicle screws. What if part of the house falls downs, because a pedicle screw is desinged to hold bone together, not houses. Do I have to consider that someone might heat our screws up with a blowtorch and then stick them up their butt. There are an endless number of negligible risks that are very unlikely to occur and nearly impossible to mitigate. Maybe I don't understand what they mean by this document, but to me it seems impossible to comply.

The conclusion that information given to the user to reduce risk is not a risk mitigation is nonsense, but I guess I can comply with this one. However, it means I will no longer consider risk when deciding what warning or contraindications in the IFU. This would seem to be counterproductive in reducing risk. How else do I decide what to put in the IFU, except by copying what is in my competitors IFU. IMHO, the people who asked for this clearly don't understand risk management and are more interested in polics and playing I gotcha rather then ensuring the safety of medical devices. It is in my opinion sad to see ISO 14971 damaged in this manner.
 
M

MIREGMGR

#7
I think this is territory that will have to be re-visited if/when US FDA and EU authorities ever decide to proceed toward harmonization. My view was that the common interpretation of the previous version of ISO 14971 was consistent with the US FDA approach to regulation, and the ZA re-interpretation moves the standard quite far from that prior consistency in important ways.

My view is that the prior interpretation of ISO 14971 and what I understand to be the past US FDA view of risk management are greatly preferable to the ZA approach, and by implication the straitjacket-precise interpretation of 93/42/EEC that ZA requires, in regard both to being applicable and supervisable in ways that achieve the most healthcare for a given societal economic cost, and to avoidance of intellectual dishonesty or willful ignorance on the part of regulatory participants.
 
M

MIREGMGR

#8
I do my best to be charitable about the limitations of a standards creation process that is implemented by real people, but to my thinking, the current state of Annex ZA is pretty inadequate as a work product.

"Content Deviations", item 3(b) says that the MDD requires "risks to be reduced 'as far as possible' without there being room for economic considerations."

Except that's not what the MDD says.

Annex I Section 2, for instance, requires that device designs "must conform to safety principles" (which thereafter are enumerated, beginning with "eliminate or reduce risks as far as possible"), but conditions this requirement by going on to state "taking account of the generally acknowledged state of the art."

When I went to engineering school, we were taught that the "state of the art" in science was what is physically and chemically possible...a purely theoretical definition...but that the "state of the art" in engineering additionally requires determination of functional optimality and economical feasibility as judged by the organization to which the engineer is responsible. I doubt very much if well taught engineering students learned otherwise a hundred years before me, and I'm pretty confident that engineering students still learn that today.

Scientists create theoretical understanding. Engineers create real products and services...including medical devices. I've yet to hear of a medical device company or a national health system that isn't affected by economics.

So how did the committee that settled on the wording of Annex ZA arrive at "...without there being room for economic considerations"?

If the author of those words worked for me and presented that as a draft, we would have had a little talk about reading comprehension and how much medical care could be provided in a cost-no-object system, and they would have gone back to do it again.
 
W

wrodnigg

#9
Yes, I also do not agree with all of the stipulations in the new annex ZA of the 14971 standard.

They omitted some important words in their reference of clause 1. and 2. of Annex I MDD.

I can clearly see their intention, but from my point of view, they went too far...

And yes: it is just a non binding annex. So it is up to the justification of the manufacturer to convince me... ;)
 

Sam Lazzara

Trusted Information Resource
#10
Here here MIREGMGR! And there is more!

The "Whereas" MDD Preamble also makes mention of economical considerations, so I too think it is a bit strong for EN ISO 14971:2012 Content Deviation 3b) to state "without there being room for economic considerations".

MDD Preamble
“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;”

And, doesn't EEC stand for "European Economic Community"?
 
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