Application of Risk Management - ISO 14971:2007(E) Medical Devices

[WBubel - 2010]

ISO 14971:2007(E) Medical devices — Application of risk, March 1, 2007
I have just reviewed the new ISO 14971:2007 there seems to be major changes in the area of Risk Management. Specially in the Annex's

Annex A (informative) Rationale for requirements
Annex B (informative) Overview of the risk management process for medical devices.
Annex C (informative) Questions that can be used to identify medical device characteristics thatcould impact on safety.
Annex D (informative) Risk concepts applied to medical devices.
Annex E (informative) Examples of hazards, foreseeable sequences of events and hazardous situations.
Annex F (informative) Risk management plan.
Annex G (informative) Information on risk management techniques.
Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices.
Annex I (informative) Guidance on risk analysis process for biological hazards.
Annex J (informative) Information for safety and information about residual risk.

Has anyone else had a chance to look at it and what are your opinions as to its impact on existing risk management plans.

 

[Gert Sorensen]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I haven't read it yet, but it seems like a worth while excercise. I had better aquire it, just for the fun of it

 

[Marcelo]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hello, i´ve been accompanying the development of this edition from the beginning, and i think that the authors have done a wonderful job in updating the standard with the experience gaind from the application of the first edition. The annexes are an example, i think Annex D specially Annex E (i reaaly like table E.4 with the Examples of relationships between hazards, foreseeable sequences of events,
hazardous situations and the harm that can occur) will help people better understand the standard and in that way provide a better implementation in all levels.

 

[JohnM]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Does anyone have a reference that goes into the differences in some depth?

I did buy the new standard. Looks like some heavy duty reading. And I see it as a complete second edition, not just some ammendments.

 

[Madly RA'd Woman]

Re: ISO 14971:2007(E) Medical devices — Application of risk

If anybody gets a reference for John, I would love a copy, too. I have received webinar invites from AAMI if anybody needs a link.

Madly RA'd

 

[WBubel - 2010]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I've created a Draft of a Risk Management Report based on Annex E of 14971:2001. This document has not been checked or approved, I hope this might be used a guide.
Please look at it and make comments on it for this forum.

 

[victoriab65]

Re: ISO 14971:2007(E) Medical devices — Application of risk

I found a presentation on the web that includes an overview of changes:
"ISO 14971:2007 - What Hath the JWG1 Wrought?" Harvey Rudolph, Ph.D., Global Program Manager of Medical Devices, Underwriters Laboratories

Available from Certified Compliance Solutions with permission (Session 1 on March 16, 2007):

NOTE : The weblink is dead - Mar 8, 2009. Thanks Howste

(I have no affiliation with either CCS or UL.)

I am waiting to purchase the standard and was told by AAMI it is not yet available for purchase. Maybe May 1?

 

[JohnM]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Here's my first attempt at a summary. Please review and let me know what you think.

I need to dig into the risk report to understand the scope and frequency for this. We do risk analysis as part of design control and then revisit the risk annually or whenever something changes in the design or manufacture of the products. Also, of course we re-evaluate if the complaints exceed our acceptable criteria proportion.

The concept of overall residual risk is new. This needs a closer look.

Has anyone changed their SOP's yet based on this new edition of 14971?

Best regards to all,

John Minier

 

[Marcelo]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Hello WBubel

Good document!

But i think you really tried to make a guide to a risk management file, not to a risk management report. I´m saying this because you seem to mix the concepts in the document. For example, the POTENTIAL FAILURE, CAUSE OF
FAILURE, EFFECTS OF FAILURE, RESPONSE, RISK INDEX and ACTION TAKEN applies to hazardous situations, not to hazards... hazards are the general "problem", and the hazardous situations are the ways in which the problem can come to pass.

For example:

Patient leakage current is an energy hazard. Thare are X situations in which a potential failure (for example in a component) caused by, for example a wrong line voltage, can lead to a hazardous situation of a patient being exposed to a source of leakage current, which could lead to harm (effects, for example, shock or burn). If the risk of the hazardous situation (potential failure + potential situation + effects) is unacceptable, you have to control the risk (response - for example, limiting the impedance) taking an action, and after that verify that the risk is acceptable (risk index?).

This is the general proccess which have to be performed and recorded in the risk management file. The risk management report, on the other hand, is a summary of the risk management file (the stadard has been revised to remove the traceability requirement on the report because the sizae of reposrt, when you put all the hazardous situations - which are many many many - was too big, which was not the intention of the original requirement).

So, in my opinion, you shoul remove the POTENTIAL FAILURE, CAUSE OF
FAILURE and EFFECTS OF FAILURE (and page 3 too!) as they are not applied to the hazards described. Besides that, you doc lacks the information on implementation of the risk management plan, and the information about methods of obtaining production and post-production information (i´m assuming the RISK INDEX is the acceptable risk defined by the policy of 3.2 a), but i think you´ll have to explicit it better anyway - what you could to is to put a column on "overrall residual risk", and then compare it with the risk index.

Cheers!

 

[ron_whitehead - 2009]

Re: ISO 14971:2007(E) Medical devices — Application of risk

Does anyone have a copy of ISO 14971-: .