Effect of ANSI AAMI ISO 14971 2007

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					                               Advanced Quality Solutions, Inc.
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                                   Chapel Hill, NC 27514

    The Effect of ANSI/AAMI/ISO 14971:2007 on Your Risk Management Program

        The latest version of ISO 14971:2007 (“Medical devices – Application of risk
management to medical devices”) was approved on 5 December 2006 by the Association
for the Advancement of Medical Instrumentation (AAMI) and on 1 February 2007 by the
American National Standards Institute (ANSI). Finally published in May 2007 as
ANSI/AAMI/ISO 14971:2007, this 2nd edition is now officially recognized as the American
National Standard replacing the previous edition consisting of ANSI/AAMI/ISO 14971:2000
and Amd1:2003.

        As with all AAMI/ANSI/ISO standards, implementation for medical diagnostics
manufacturers is voluntary unless specifically adopted and/or required by government
regulatory agencies. Nevertheless, since the 14971:2000 has been established as a
recognized FDA Consensus Standard since May 2001 and has become the accepted
basis for best industry practice, the necessity to evolve one’s risk management program to
include appropriate elements of this new and improved 2nd edition is a “slam-dunk”... that
is, a “slam-dunk” in the Michael Jordan sense; not in the George Tenet sense.

       Overall, this latest edition merely improves and clarifies the original requirement
sections without dramatically changing the concepts and structure of the risk management
process. That means you should not have to drastically rework or restructure your risk
management policies and procedures (assuming you already have them and they are
already modeled after 14971:2000); you’ll simply need to assess and improve them as
necessary to incorporate the benefits of the 2007 edition. This should be especially good
news to those of you who went through the impact of transitioning your old 20-element ISO
9001:1996 (or 13485:1996) Quality System to address the newly structured Process
Approach defined in the 2003 revisions.

       In moderate detail, the most significant improvements for the 2007 edition include:
expanded definitions; a more comprehensive life cycle; specific top management
responsibilities; definitive requirements for the risk management plan; review of production
phase information; and numerous additions and enhancements to the Informative
Annexes. The most significant additions and enhancements to the Informative Annexes
include the following:
   Annex A: (Rationale for requirements) – this annex is a revision of previous Amd1:2003
    to provide understanding of rationale for revised requirements in 14971:2007
   Annex C: (Questions that can be used to identify characteristics that could impact on
    safety) – several questions were added and enhanced
   Annex D: (Risk concepts applied to medical devices) – extensive enhancements
    provide additional guidance on overall risk management concepts

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   Annex E: (Examples of hazards, foreseeable sequences of events and hazardous
    situations) – provides significant enhancements to concept model and the relationship
    between hazards, events, hazardous situations, and harm
   Annex F: (Risk management plan) – this new annex provides content guidance for
    developing the risk management plan
   Annex H: (Guidance on risk management for in vitro diagnostic medical devices) – was
    significantly expanded to provide guidance on application of risk management to IVD’s
   Annex I: (Guidance on risk analysis process for biological hazards) – was enhanced
    from original annex addressing toxicological hazards
   Annex J: (Information for safety and information about residual risk) – this new annex
    provides guidance related to communication of safety and residual risk information.

        Perhaps the most significant benefit to the medical diagnostics sector is Annex H:
Guidance on risk management for in vitro diagnostic medical devices. Originally identified
as Annex B in the 2000 edition, this new Annex H is significantly enhanced from a former
1-page brief to a meaty 17-page guidance document. The essential purpose of this annex
is to apply the substantive requirements of the standard’s main text (Sections 4 to 9) to the
unique application of IVD products. The annex describes the various risk management
activities from Risk Analysis through Production and Post-Production Monitoring in the
context of their application to IVD devices, and provides the reader with numerous
supporting examples. When properly applied, the enhanced Annex H should serve to
guide the IVD manufacturer to a more relevant application of 14971:2007 requirements; it
may even help you to identify inadequacies in your current risk management process and
ultimately improve your products.

       It is interesting to note that the 14971:2007 standard and all annexes other than
Annex H were developed by Technical Committee ISO/TC 210; while Annex H was
developed by a separate committee for Clinical Laboratory testing and in vitro diagnostic
test systems (ISO/TC 212). Now that’s a point to ponder for all you conspiracy theorists!
Good luck and give us a call if you need assistance establishing a risk management
program that will fulfill and benefit from the requirements of AAMI/ANSI/ISO 14971:2007.

                 Article Written for publishing in AMDM Newsletter by:

              Robert G. Lass (Vice President) and Jose A. Campo (President)
        of Advanced Quality Solutions, Inc. ( / 919-942-7922)

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