Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

[Marcelo Antunes]

Hello all

ISO TC 210 / IEC TC 62A - JWG 1 - Application of risk management to medical devices - had a meeting this week in Lubeck, Germany.

The main discussion was regarding the (internal as it is still a working draft) comments to ISO TR 24971, the guidance on the application of ISO 24971.

There were a lot of discussions, changes and removals, but in the end I think we managed to get a good revised document. For example, one of my main concerns, the chapter on how to use standards together with ISO 14971, was only slightly modified to correct an error, with the rest being kept.

A committee draft will be circulated for all National Committees in the following days so more people can comment on the work already done.


Another important discussion was the formal objection of the European Commission against ISO 14971. As with EN ISO 13485:2012, the solution in the future EN ISO 14971:2012 will be in the form of revised Annexes Zs (relating the standard to essential principles).

However, in the case of EN ISO 14971, there will be some "deviations" from the standard which in fact wil create a lot of problems to device manufacturers.

For example, one of the deviations is that, even though ISO 14971 says that for low, negligible risks, the manufacturer is not require to take any measure, the official interpretation of the directive (and which will be considered a deviation of the revised EN ISO 14971) is that all risk, regardless of being negligible or not, have to be reduced as much as possible. This creates a somewhat impossible situation in which manufacturers have to go after ALL risks, even the ones in which the probability is extremaly low or the severity is negligible.

And this is only one of the 7 "weird" deviations.

I'm really not sure how things will work out after the pblication of the revised standard.

Anyway, JWG 1 did decide that there's no need to revise ISo 14971 right now due to these interpretations fo the EU, which I think is a prudent position.

[yodon]

Thanks for the update. Always good to get a heads up. I'm wondering, though, if the following was a typo or Freudian slip or...

In Reply to Parent Post by Marcelo Antunes

The main discussion war regarding ...

[Marcelo Antunes]

Thanks for the update. Always good to get a heads up. I'm wondering, though, if the following was a typo or Freudian slip or...

Quote:
In Reply to Parent Post by Marcelo Antunes

The main discussion war regarding ...

Heh...maybe both :-)

[Adrian S]

Hey Marcelo,

thank you for your quick updates. I got like two questions though. 1. Is there a timeline, when 24971 will be released? 2. In your first post you wrote about 14971:2012, but then you said the comitee saw no need to revise right now. Will there be a 14971 revision in 2012 as far as you know? Kinda curious since 14971 is like my main standard at work.

Thanks in advance

Adrian

[Marcelo Antunes]

Hello Adrian and welcome to the Cove!

1. Is there a timeline, when 24971 will be released?

As it's a TS (not a TR as I mentioned before :-P) it's development is quicker than an standard, however, it will take at least more one or one and a half year, more or less.

2. In your first post you wrote about 14971:2012, but then you said the comitee saw no need to revise right now. Will there be a 14971 revision in 2012 as far as you know?
Adrian

I mentioned the EN version, which will have a revision in 2012. The ISO version won't.

[Adrian S]

Thanks Marcelo, now it makes more sense to me.

[Peter Selvey]

For example, one of the deviations is that, even though ISO 14971 says that for low, negligible risks, the manufacturer is not require to take any measure, the official interpretation of the directive (and which will be considered a deviation of the revised EN ISO 14971) is that all risk, regardless of being negligible or not, have to be reduced as much as possible. This creates a somewhat impossible situation in which manufacturers have to go after ALL risks, even the ones in which the probability is extremely low or the severity is negligible.

And this is only one of the 7 "weird" deviations.

The above appears to be absurd if we look at individual hazardous situations, which is the current structure of ISO 14971. However, as mentioned in previous posts, if the estimated "risk" includes the risk associated with the use of resources (increase cost of medical device, delay to market, disincentive to innovation), then it is perfectly reasonable (and desirable) to set an objective of reducing risk without limit.

In the case of "negligible" risks, most likely the application of risk management resources will increase risk (cost, delay, disincentive), and as such the risk can be considered already minimized; no action is required.

The real difference (and concern from Europe) comes in the risk/benefit area, where under ISO 14971 as long as the benefit exceeds the risk, a manufacturers can justify no further effort, because they set their own criteria. And in fact this happens frequently in the real world.

True story: a hearing aid manufacturer places a new high powered 145dB model on the market, at the request of doctors. When asked about the risk of hearing damage, they found clinical literature that showed already around 6% of patients with hearing aids suffer further hearing loss due to their hearing aids. But, the manufacturer argued, without the hearing aid the brain's auditory part shuts down (the brain starts to use it for other purposes). So, given the benefit exceeds the risk by a high factor (more than 10:1), the manufacturer considered no further action is necessary.

This complies with ISO 14971.

But, on basic principles it is wrong.

Let's assume that by putting some simple intelligence into the hearing aid the amount of hearing damage could be reduced. Hearing damage is a function of sound level and time. So, we could limit the daily amount of peak output, or better still integrate daily exposure and reducing the output if daily limits are exceeded. Let's further assume this new software could reduce the incidence of patient damage from 6% to 2%.

Clearly, the a small amount of resources in software development would be well justified.

So, it should be obvious that "acceptable risk", or "risk/benefit" are not very good criteria for deciding if risk should be reduced. Rather, it is simply a case determining if the application of resources can get a significant reduction in risk, a "bang for your buck" so to speak.

What about the remaining 2%? If the manufacturer can demonstrate that trying to reduce the 2% further would cause excessive complications (excessive cost, or excessive limitation of the output), then the residual risk should be deemed acceptable. But, even at 2% the risk is high and should be subject to constant review, including review of new technology, clinical literature and the like.

This I think is what the Europeans are trying to get at.

[Marcelo Antunes]

Not that I disagree with what you said Peter, but my impression from what I´ve heard and read was that the EC (or at least the guys that dealt with the ISO 14971 problem in the EC) were not going this way - thinking about the use of resources.

Just an example on another one the deviations:

a) Annex D.8 to ISO 14971, referred to in 3.4, contains the concept of reducing risks "as low as reasonably practicable" (ALARP concept). The ALARP concept contains an element of economic consideration.

b) However, the first indent of Section 2 of Annex I to Directive 93/42/EEC and various particular Essential Requirements require risks to be reduced "as far as possible" without there being room for economic considerations.

c) Accordingly, manufacturers and Notified Bodies may not apply the ALARP concept with regard to economic considerations.