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How Far is “Possible” for Risk Management?

                                                                                                                                           

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from Rob Packard
at OMTEC 2014

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This article reviews a controversial interpretation of the medical device CE Marking requirements with regard to risk management: specifically, reducing risks as far as possible without any room allowed for economic considerations.

ISO 14971 is the risk management standard for medical devices. The U.S. FDA and Health Canada have both recognized the 2007 version of this international standard, but the European Commission has identified seven deviations from the Essential Requirements of the European Medical Device Directives. The seven deviations are identified in Annex ZA of EN ISO 14971:2012. The list of seven deviations, and hyperlinks to a technical review of each deviation, are provided below.

1. Treatment of negligible risks
2. Discretionary power of manufacturers as to the acceptability of risks
3. Risk reduction “as far as possible” vs. “as low as reasonably practicable”
4. Discretion as to whether a risk-benefit analysis needs to take place
5. Discretion as to the risk control options/measures
6. Deviation as to the first risk control option
7. Information of the users influencing the residual risk

The first four deviations apply to all three directives, but the last three are not specifically identified as deviations from the Active Implantable Medical Devices Directive. Compliance with the European Directives is required for CE Marking of medical devices, and the directives have not changed. Therefore, some manufacturers will have procedures and risk management files that already comply, while others may have corrective actions to take. The most challenging corrective actions are likely to be specific to the third deviation.

Deviation No. 3
The third deviation states, “various Essential Requirements require risks to be reduced ‘as far as possible’ without there being any room for economic considerations.” However, the concept of “economic considerations” is not mentioned anywhere in the Essential Requirements (e.g., Annex I of the Directives). In fact, the only place in the directives where the words “economic considerations” are actually used is in the preamble to the directives. Although this is not part of the Articles or Annexes in the directives, this clearly indicates that eliminating all possible economic considerations was not the Commission’s original intent.

The Active Implantable Medical Devices (AIMD) Directive does not mention “economic considerations” anywhere, and the other two directives contradict the wording of the deviation in EN ISO 14971:2012. The Medical Devices Directive (MDD) states that risk reduction “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.” The In Vitro Medical Devices Directive (IVDD) states, “whereas the essential requirements, including requirements to minimise and reduce risks, should be applied with discretion, taking into account the technology and practice at the time of design and technical and economic considerations compatible with a high level of protection of health and safety.”

Product Safety Standards
“As far as possible” is not the requirement for electrical medical equipment, because otherwise, devices that are safe in a single-fault condition would not be safe enough and the IEC 60601 series would not have been harmonized with the European directives. Other examples of product safety standards exist wherein the prescribed risk controls fall short of “as far as possible,” but these product safety standards represent the current “state of the art.”

ISO 22442-1, the standard defining the process for application of risk management to medical devices utilizing animal tissues, states that manufacturers shall comply with the relevant requirements of both ISO 22442-2 and ISO 22442-3. However, if there were no room for “economic considerations,” manufacturers would be forced to use only animal species that are BSE and TSE-free. Manufacturers would not be allowed to utilize collagen from BSE-free herds in New Zealand that were processed according to the ISO 22442 series of Standards. This is an extreme interpretation that is not consistent with the EU directives.

4 COMMENTS

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Rob Packard

01/23/2015 05:36 PM
Thank you for the comment Reza. The Notified Body Recommendation Group (NBRG) released a draft of a consensus paper related to the Z annexes for EN ISO 14971:2012 on June 25 of last year. You can download the draft document at the following link:

http://bit.ly/Consensus-Draft-14971

The draft is still not approved by the NBRG, but Reza is correct that the document is a more sensible way to apply risk management principles to medical device regulations.
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Reza Kharraziha

01/23/2015 10:15 AM
There is now however an interim Consensus Paper for the
Interpretation and Application of Annexes Z in EN ISO 14971: 2012 which makes far more sense and is in line with the expectations.
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