We must be careful here. If the product is not being sold in the EU, the applicable standard is ISO 14971:2007, which is the current international medical device risk management standard. If the product is being sold in the EU, the recently released EN ISO 14971:2012 is the applicable standard. The requirements are the same in both standards, and consist of Clauses 1-9 in ISO 14971.
The differences are in the informative annexes, ZA for medical devices, ZB for active implantable devices, and ZC for IVDs. In each of these annexes, CEN (the European standards body) has indicated that compliance with ISO 14971 does not meet the requirements of the directives, and explains the differences.
Major differences include:
1. ALARP may not be used as a risk management policy. It is not possible to include the use of economics in determining acceptable risk.
2. Each risk must be reduced until it is not possible to reduce the risk anymore. That is multiple risk controls must be applied until it may be shown (through documentation) that no further risk reduction is possible.
3. Information for Use cannot be used to reduce risk. Information is required to be provided for correct use, it is not a risk control. Only design for safety or safeguards are allowable risk control measures, and design for safety is the preferable risk control.
4. Each risk and the overall risk must have a documented benefit-risk analysis.
The best information for a manufacturer is provided by their Notified Body. The Notified Body has been given the responsibility by the directives for allowing devices to be placed on the market. Many have published documents identifying their expectations for manufacturers in supporting the placing of the device on the market.
For devices not requiring a Notified Body, a manufacturer can still refer to Notified Body websites for indication on how to meet the requirements of the directives.
Remember, the EN ISO 14971:2012 document does not add requirements to ISO 14971, the requirements it discusses are embedded in the directives and have been since the first directives were released. The 2012 documents were the product of a complaint by a national body, which indicated the harmonized standards (EN ISO 14971and EN ISO 13485) did not meet the requirements of the directives. And yes, there is a new EN ISO 13485:2012 with explanations of the shortcomings of ISO 13485. A company should be aware of that revised standard as well, by discussing their quality system with their Notified Body.
Just to complicate the situation, the directives are being reviewed for revision, and the game may change soon. Of course a transition period will follow the release of the new directives. But a word of caution here, the transition period for EN ISO 14971:2012 was one day.
Getting back to the original question, needle sticks. This hazardous situation has resulted in many new devices with various approaches to reducing needle sticks. The use of risk management can lead to a number of different ways to approach the reduction of risk. The use of a tool such as Fault Tree Analysis (FTA) in the risk management process can show in detail how a needle stick results. The use of FTA can provide the design team with locations in the process where the risk can be reduced or eliminated in the most efficient and least expensive manner. And there is not one method, but multiple ways of approaching the problem. Of course, the use of FTA will require clinical experts in the use of needles to develop an accurate Fault Tree.
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Edwin Bills RAC
Principal Consultant
Bilanx Consulting LLC
Member, AAMI QM/WG04 Risk Management committee
Sumter SC
United States
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Original Message:
Sent: 03-22-2013 03:32
From: Florian Tolkmitt
Subject: Risk Management for Needles (EN14971:2012)
Thanks for all the replies provided and for sharing your thoughts.
I like the way John put it. I understand that the level of risk that is deemed acceptable has to be determined by the manufacturer. However, this is the trouble we are in.
There is big discussion going on, on the safety aspects of needles in terms of needle stick safety. To my knowledge some states already require needle stick safety devices and prohibit the use on devices that do not have safety features to protect against needlesticks. So can we really determine that a simple cap is safe enough? Can we define, that a cap is our safety feature, when there are guidelines or even laws, that say that a cap is not enough to protect the user, especially after use of the needle.
Many needles are thrown into safety boxes without beeing protected by any means. This bears a problem in some situations:
-after use, the needle needs to be transported from the place of operation to the safety box
->it might fall down: when picking it up there is a hazard
->during transport there is a hazard as well
Again, I am happy to hear your views on this.
Many thanks in advance!
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de
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Original Message:
Sent: 03-07-2013 11:06
From: John Minier
Subject: Risk Management for Needles (EN14971:2012)
Florian,
As I read deviation #5 from Annex ZA it is saying that safety by design and protective measures in the device itself are the favored mitigations by priority. If you have protective caps on your product they count as mitigation. You can still claim labeling as further mitigation. It seems section c of #5 is saying that you don't stop at the cap if that mitigates risk to an acceptable level. They want you to apply all control options as long as they contribute to product safety.
This follows As Low As Reasonably Possible (ALARP) thinking on risk mitigation. With this you do not mitigate until risk is acceptable; you continue mitigate to a reasonable level. This is still your decision as to what comprises a reasonable level. Generally I believe it means that going too far with mitigation could add so much to the cost that the product cannot be sold for a reasonable profit.
I would be interested to hear what others think.
Regards,
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John Minier
Small Bone Innovations, Inc
Morrisville PA
United States
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Original Message:
Sent: 03-06-2013 09:01
From: Katharine Stohlman
Subject: Risk Management for Needles (EN14971:2012)
It is a bit frustrating to now exclude labeling as a means of risk mitigation....
That being said, don't underestimate the value of your packaging design as a risk mitigation component for your sharps. The package probably slows the release of the tip relative to the handle, either by a separate protector for the tip or by making the package holder (plastic tray?) for the needle assembly require a pull release for the handle and a sliding release for the tip, such that the pull action must happen before the sliding action. This is normal needle package design because it is also intuitively helpful for maintaining sterility of the tip. To further bolster this line of thinking you may want to make sure your "usability test" framework includes a question demonstrating that the user acknowledges that there was no user sharps injury or inadvertent tip contamination action during the opening of the package and subsequent use of the needle.
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Katharine Stohlman RAC
Waltham MA
United States
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Original Message:
Sent: 03-05-2013 06:03
From: Florian Tolkmitt
Subject: Risk Management for Needles (EN14971:2012)
Your opinion please!
We are a manufacturer of needles. We do have a great variety of different types of needles for all kind of applications.
Considering the correct application of risk management (with special focus on EU legislation and EN 14971:2012) are we now in a situation where we should withdraw all our needles that do not have inherent safety features from the market?
Applying risk management would mean: Risk mitigation by inherent design comes first. From my point of view there is a way of including safety features in each and every needle that we have. (Not considering usability at this moment because handling a safety needle is not as easy as a needle without safety features most of the time; but it is safer = lower risk.)
Looking forward to your input! Many thanks!
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Florian Tolkmitt
sfm medical devices GmbH
Germany
florian.tolkmitt@sfm.de
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