Anda di halaman 1dari 6

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

The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics
  > Medical Device Related Standards > ISO 14971 - Medical Device Risk Management Welcome, HN Kim.
You last visited: 8th May 2013 at 03:46 AM
Updates on ISO TS 24971 and formal objection of the European Commission to ISO Private Messages: Unread 0, Total 0.
14971

User CP  Photo Albums Blogs FAQ Community Calendar Posts Last 24 Hours Since Last Visit Search Quick Links Log Out

Elsmar Cove Forum Visitor Notice(s)

Please - When you see fighting, bickering, potential copyright issues, or any other problems in a discussion thread, note that every post has a 'Report this Post' button
in the upper right part of the post. Please use it to report problems. PLEASE - Do not start problems in a discussion thread by posting in the thread. By using the 'Report this Post'

button, the moderators and I are notified of the problem and will take care of the problem. Please click the big red X in the upper right corner to Acknowledge and
Dismiss this Notice.

Thank You!

Marc

Elsmar Cove Forum Sidebar Related Topic Tags Add Related Topic Tag(s) to this Thread

iso 14971 - medical device risk management, iso 24971 (iso 14971 guidance document), risk management and analysis

Search

Custom Search Page 1 of 3 1 2 3 >

Monitor the Elsmar Forum   Thread Tools Search this Thread Rating: Display Modes
Monitor New Forum Posts
19th April 2012, 06:49 AM   #1      
Follow Marc & Elsmar
Posts: 1,977
        
Marcelo Antunes Thanks Given to Others: 286
Thanked 1,480 Times in 800 Posts
Elsmar Cove Groups Addicted to standards Karma Power: 248
      Karma: 10972
Last Login: 19th May 2013
Sponsor Links Registration Date: Mar 2006
Location: São Paulo, SP, Brazil

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

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.

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

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.
__________________
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Last edited by Marcelo Antunes; 19th April 2012 at 07:57 AM.

Thank You to Marcelo Antunes for your informative Post and/or Attachment!

Angelika Hoess, gitgiv, J0anne, MIREGMGR, Pads38, Peter Selvey, RA Princess, Ronen E, sagai, SilkTie

Sponsored Links

19th April 2012, 07:39 AM   #2      

Posts: 556
yodon Thanks Given to Others: 367
Appreciated Information Resource Thanked 331 Times in 238 Posts
Karma Power: 96
  Karma: 4077
Last Login: 18th May 2013
Registration Date: Jun 2005
Donate and $ Contributor Location: Plano, TX
Forum Access Age: 53

Re: Updates on ISO TR 24971 and the forma objection of the European Comission to ISO

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...

Sponsored Links Quote:

In Reply to Parent Post by Marcelo Antunes


Courtesy Quick Links

The main discussion war regarding ...

Links that Elsmar Cove visitors


will find useful in your quest
for knowledge:
Thank You to yodon for your informative Post and/or Attachment!

Howard's Marcelo Antunes, MIREGMGR


International Quality Services
Sponsored Links
Atul's
Symphony Technologies

Marcelo Antunes' 19th April 2012, 07:59 AM   #3      


SQR Consulting
Posts: 1,977

Bob Doering's Marcelo Antunes Thanks Given to Others: 286


Thanked 1,480 Times in 800 Posts
Correct SPC - Precision Addicted to standards Karma Power: 248
Machining   Karma: 10972
Last Login: 19th May 2013
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil
NIST's Engineering Statistics
Handbook
Re: Updates on ISO TR 24971 and the forma objection of the European Comission to ISO
IRCA - International Register
Quote:
of Certified Auditors
Thanks for the update. Always good to get a heads up. I'm wondering, though, if the following was a
SAE - Society of Automotive typo or Freudian slip or...
Engineers
Quote:
Quality Digest Portal In Reply to Parent Post by Marcelo Antunes

IEST - Institute of The main discussion war regarding ...


Environmental Sciences and
Technology
Heh...maybe both :-)
ASQ - American Society for __________________
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

Quality

Thanks to Marcelo Antunes for your informative Post and/or Attachment!

MIREGMGR

19th April 2012, 08:35 PM   #4      

Posts: 7
Adrian S Thanks Given to Others: 6
Getting Involved (6 to 9 Posts) Thanked 0 Times in 0 Posts
  Karma Power: 5
Last Login: 21st August 2012 Karma: 10
Registration Date: Apr 2012

Re: Updates on ISO TR 24971 and the forma objection of the European Comission to ISO

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

19th April 2012, 08:41 PM   #5      

Posts: 1,977
Marcelo Antunes Thanks Given to Others: 286
Thanked 1,480 Times in 800 Posts
Addicted to standards Karma Power: 248
  Karma: 10972
Last Login: 19th May 2013
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil

Re: Updates on ISO TR 24971 and the forma objection of the European Comission to ISO

Hello Adrian and welcome to the Cove!

Quote:

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.

Quote:

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.
__________________
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!
Last edited by Marcelo Antunes; 20th April 2012 at 10:14 PM.

Thanks to Marcelo Antunes for your informative Post and/or Attachment!

Ronen E

19th April 2012, 09:05 PM   #6      

Posts: 7
Adrian S Thanks Given to Others: 6
Getting Involved (6 to 9 Posts) Thanked 0 Times in 0 Posts
  Karma Power: 5
Last Login: 21st August 2012 Karma: 10
Registration Date: Apr 2012

Re: Updates on ISO TS 24971 and formal objection of the European Comission to ISO 149

Thanks Marcelo, now it makes more sense to me.

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

9th May 2012, 09:45 AM   #7      

Posts: 629
Peter Selvey Thanks Given to Others: 35
Appreciated Information Resource Thanked 474 Times in 324 Posts
  Karma Power: 86
Last Login: 17th May 2013 Karma: 4719
Registration Date: Oct 2009
Location: Japan / Ise

Re: Updates on ISO TS 24971 and formal objection of the European Comission to ISO 149

Quote:

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.

Thanks to Peter Selvey for your informative Post and/or Attachment!

Ceres

9th May 2012, 10:34 AM   #8      

Posts: 1,977
Marcelo Antunes Thanks Given to Others: 286
Thanked 1,480 Times in 800 Posts
Addicted to standards Karma Power: 248
  Karma: 10972
Last Login: 19th May 2013
Registration Date: Mar 2006
Location: São Paulo, SP, Brazil

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

Re: Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14

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:

Quote:

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.

__________________
I'm a moderator on the medical device forums, so if you need help with something, feel free to ask!

Thank You to Marcelo Antunes for your informative Post and/or Attachment!

Adrian S, Peter Selvey

Page 1 of 3 1 2 3 >

Lower Navigation Bar

The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical
  Device Related Standards > ISO 14971 - Medical Device Risk Management
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

Do you find this discussion thread helpful and informational?


+1   Recommend this on Google

Share

Bookmarks

Facebook Digg Google StumbleUpon

Quick Reply

Message:

Please click one of the Quick Reply icons in the posts


above to activate Quick Reply.

Options
Quote message in reply?

Post Quick Reply Go Advanced

« Previous Thread | Next Thread »

Visitors Currently Viewing this Thread: 1 (1 Registered Visitors (Members) and 0 Unregistered Guest
Visitors)

HN Kim

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]
Updates on ISO TS 24971 and formal objection of the European Commission to ISO 14971

Forum Posting Settings

You may post new threads


You may post replies
You may post attachments
You may edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Forum Rules

Similar Discussion Threads

Last Post
Discussion
Thread Starter Forum Replies or Poll
Thread Title
Vote

Registering
Medical
23rd
Products in
March
Canada - DIN AbsoluteBeginner Canada Medical Device Regulations 5
2012
EN 14971 vs.
07:44 PM
CAN/CSA-ISO
14971

European
Commission
6th March
Questions
MIREGMGR ISO 14971 - Medical Device Risk Management 7 2012
Risk
12:01 AM
Management
Standard

European
Commission
19th
calls for
February
action Ronen E EU Medical Device Regulations 1
2012
following PIP's
03:44 AM
Breast
Implant Saga

BS EN ISO
24th
14971:2009
November
replaces BS DRDDO ISO 14971 - Medical Device Risk Management 37
2011
EN ISO
05:15 PM
14971:2007

En 550/554 -
6th
The European
August
Commission Aaron Lupo ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems 2
2002
Standards
04:58 AM
Harmonization

The time now is 12:51 AM. All times are GMT +9.
Your time zone can be changed in your UserCP --> Options.

Contact Marc - Elsmar Cove Home Page - Privacy & DMCA/Copyright Information - Terms of Service - Top

The Deming PDCA Cycle ISO 9001 QMS Implementation FMEA Information APQP Information

Auditing Information 8-D Problem Solving Statistics Error Proofing (Poka Yoke) Brainstorming

Identifying Waste Pull Systems Lead Time Reduction Planned Maintenance Quick Setup

Discovering Change Process Capability - Cp vs. Cpk Histogram Animation Process Loop Animation Taguchi Loss Function

Fishbone / Cause and Effects Animation    

Marc Timothy Smith - Elsmar.com


8466 LeSourdsville-West Chester Road, West Chester, Ohio 45069-1929
513 341-6272

http://elsmar.com/Forums/showthread.php?t=54095[2013-05-20 오전 12:54:42]