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New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Reporting

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Chrisx

Involved In Discussions
#2
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

It is an interesting guidance, but I think it is lacking when addressing reusable instruments in the orthopedic industry. Orthopedic devices are often sold in "loaner" cases that are returned to the manufacturer for replenishment of the consumed implants. Often, I would like to replace the instruments with ones that have undergone a product enhancement or simply have excessive wear. Is the replacement of components of these returned cases considered a recall? They are afterall in commercial distribution. Is replacing a worn bone screw driver a reduction in risk? I think yes, a worn driver has an increased risk of slipping in the screw head. According to this guidance FDA would classify this as a reportable recall, because I am reducing risk by replacing a worn instrument.

Often, I am replacing instruments that have a spare in the case. The reality is instruments do break. Surgeons hit them with excessive force with hammers that are larger then the ones provided in our case or otherwise misuse the instrument. For this reason, we always have spare instruments in the case. If I replace the instrument with a product enhacement to reduce the likelilhood of breakage, is this a reduction in risk? I'm not really sure. There is always a spare instrument in the case, so the risk is minimal. The procedure can be completed with the spare instrument. Does anyone else have any experience in managing this situation?

Thanks for any input
 
M

MIREGMGR

#3
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

The above-mentioned Guidance is a draft. You might want to call or email Ron Brown and initiate a dialogue so that your concerns might be addressed in the final Guidance.
 

pkost

Trusted Information Resource
#4
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

It is an interesting guidance, but I think it is lacking when addressing reusable instruments in the orthopedic industry. <snip>

I think the guidance addresses these issues quite well and with a quick read, to my satisfaction. It notes that if the level of safety performance was achieved, cleared and approved then the device is not in violation. (line 225-230)

Therefore, if you know that it is going to undergo wear and tear (which you should do) and that it as a service of life of x number of uses, then it is not a recall if you do not have to replace before x number of uses.
 

Chrisx

Involved In Discussions
#5
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

Certainly, the guidance can be applied to my products. I just think it could be a little clearer. Maybe an example in the guidance using orthopedic "loaner" cases. It is afer all found throughout the orthopedic industry and I am sure many people have the same question.

Unfortunately, answering all the "ifs" is not so simple. In many cases the instrument failure is not related to wear, but rather to excessive force applied by the surgeon. In this case, the number of uses has no bearing on whether the device failure makes the device violative.

Even wear is not an easy question to answer. We have many bone screw drivers that are being replaced with titanium nitride coated tips to reduce wear and extend life. These products are class I and therefore were never cleared and not subject to 510(k). It does not seem that such an activity should be construed as a recall, but the guidance would seem to suggest that it is a reportable recall.

What I probably need to do is right an HHE for each product enhancement documenting that the enhancement does not reduce risk because there is a spare instrument readily available to the surgeon. I would be curious to see if other people think this is a defensible argument.
 

pkost

Trusted Information Resource
#6
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

Unfortunately, answering all the "ifs" is not so simple. In many cases the instrument failure is not related to wear, but rather to excessive force applied by the surgeon. In this case, the number of uses has no bearing on whether the device failure makes the device violative.

Even wear is not an easy question to answer. We have many bone screw drivers that are being replaced with titanium nitride coated tips to reduce wear and extend life. These products are class I and therefore were never cleared and not subject to 510(k). It does not seem that such an activity should be construed as a recall, but the guidance would seem to suggest that it is a reportable recall.
Both of these points should have been considered and mitigated as best as possible in the inital design. The residual risk should the have been accepted.

When I developed orthopaedic instruments I always worked on the following premise....if a surgeon can hit it with a mallet, he/she will hit it with a mallet. Excess force was factored into our risk assessment and mitigated whereever possible. It is therefore known and predicted - therefore only an enhancement and not a recall.

The same can be said for wear and tear
 

Chrisx

Involved In Discussions
#7
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

Of courese, if everything had been done right the first time I wouldn't have to consider whether these are recalls or product enhancements. Unfortunately, this is what I inherited. To be sure, there is much improvement that is needed in risk management. Thanks for your advice.:thanx:
 
M

MIREGMGR

#8
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

It does not seem that such an activity should be construed as a recall, but the guidance would seem to suggest that it is a reportable recall.
Certainly such actions on your part are removals or corrections, depending on circumstances. Have you discussed with your District's Recall Coordinator whether they should be considered recalls?

I don't think FDA is particularly eager to clog up their system by categorizing normal activity (replacement of not-reasonably-preventable breakage or wear-and-tear, or voluntary product upgrades) as Recalls.
 

Chrisx

Involved In Discussions
#9
Re: New Draft FDA Guidance to distinguish b/w Recall and Product Enhancement & Report

I think it is not so simple. I do not think one can assume that because a reusuable instrument is replaced with a new design to address breakage, this automatically is a recall. I think if this were the case, there would be many more recalls in the orthopedic industry.

In some cases, product enhancements were made on the basis of a single instrument breakage. The complaint history over two years only has one repeat incident of breakage. We have not classified either breakage as an MDR. I think it is hard for me to envision this as a recall. I think they are at an acceptable level of risk, but this should be supported by the risk management file. For now, the best I can do is conduct an HHE.

The previous poster is correct. Our risk management file should spell out the acceptable risk for these events. This would support our decision that our actions are not recalls. To be sure, there is a lot of improvement needed in our risk management files.
 
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