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Discussion

Stryker Ex-Fix

I can't seem to get a pat answer. The Stryker Ex-fix system only contains parts for the external fixation, not technically an implant. All implants/wires come in another set. So if I need to flash the system, do I run a biological or not? Would you do a 25 minute flash cycle?

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To tell you the truth all of our Ex-Fix sets we get from the vendors are complete, nothing needed to them. I guess if you HAD to flash then yes a biological should be run. This, IMHO, is only because you are running k-wires thru the skin and into the bone. Even tho they aren't considered an implant, because they will come out eventually, I always worry about infections. Synthes has a nice set that comes in a big box that has everything needed in it. All sterile. Nice system.

Yes, flash them with a bio. Shodobe is correct in his assessment that since the rods go through bone, it is technically considered an implant. Even though these external fixators come out eventually, the rods are recorded (in our paperwork anyway) with serial numbers just like any other implant.

Look at it from this point of view: screws come out sometimes because the hardware is bothersome to the pt. The bone has long since healed and they no longer need the internal fixation. It's already a no-brainer that these are implants. Same thing with ex-fixes. Yes, they come out, but they are still invasive, so a bio must be run.

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Well see that's the point, the pins are completely separate, it purely the external fixation device. Nothing in the system is inserted into the bone. So the scrub tech tried to run a 10 minute cycle. I finally got ahold of our educator at work and she mentioned that you may want to do 25 purely based on the amount of instrumentation/heaviness of the load because we use a gravity system, not pre-vac. Those Stryker reps were morons and couldn't tell me what the manufacturer recommendations were and I can't find them on-line. For now, I'm going to run a 25 minute gravity cycle and no biological per our OR educator.

I am close friends with a Stryker rep. Let me ask him and I will get back to you regarding this issue.

I can't wait until I know what the hell all this means. :D

OK-I asked a Stryker rep and his answer is not pat either. He said that it is purely up to each individual hospital and the policies that they have in place for implants. However, since you are talking only about the external device (the clamps and rod ends), you are right, they are not implants. So you would NOT have to run a biological on the tray itself. (At first I thought you meant the actual rods, but now I see that you are only asking about the instrumentation and the clamps...my mistake!)

Your educator is correct when she told you that you should run a 25 minute cycle on the instrumentation set simply because of the number of pieces in the set.

I hope this makes everything more clear. You are doing exactly what you are supposed to do :)

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