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Storing fecal transplant material


kirkaw

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What do folks know about storage of fecal transplant material? I've been told that we are ordering some and the OR clinical director wants to store it in the back-up freezer for tissue?.

Does anyone know if this is necessarily prohibited? If so, by whom and what is the standard?

Thanks!

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We store ours in the Chemistry/send out freezer, but I had the same concerns/questions when they initially proposed they store it in our bone freezer.  I live in NYS and they have a reg (52-5.9 (d) says "...Storage shall be in a freezer reserved for musculoskeletal or other tissue intended for transplantation, or blood intended for transfusion." 

 

Now...if you have a stand up freezer that has compartments- I am sure you could get around this but the thought of storing feces with my achilies tendons and fibulas kind of made me go "hmmmmmmm, that just doesnt seem right" 

 

I looked at the AABB regs to see if they said something similar and I couldnt find it. 

 

Hope that helps a little!  Have a great weekend!

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Ok...for those interested, I emailed the AABB accreditation folks about this and was told that the applicable standard is 5.1.8.1 regarding tissue storage. Specifically, Storing the fecal material in the backup freezer would be ok as long as there is segregation from the bone fragments and the storage temperature is suitable.Storing the fecal material in the backup freezer would be ok as long as there is segregation from the bone fragments and the storage temperature is suitable.

 

So there you have it...

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We have done this once or twice before.

 

We homogenise the donor samples in sterile 0.9% saline, then separate the solid food mass anaerobically (in CO2 - why kill the obligate anaerobes?) through an Endecotts 50 micron sieve shaker and centrifuge at 1800g for 8 mins. at 10C.  Then hydrate and centrifuge again.

 

We make up a storage medium of 50% sterile (0.9%) saline solution and 50% Glycerol (30%) solution.  The storage medium is run through the autoclave at 128C and cooled.

 

The centrifuged bacterial pellet is re-suspended in the glycerol storage medium (at 50/50) on the IKA shaker.  We store at -80C in a dedicated ULT freezer.  Our freezers keep 2,600 samples each and we have 3 freezers.......

 

Yes, I am talking about a lot of sh*t........ (do you see what I did there?)

 

We are incorporating storage under BS15189.

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Ah! the fan.........

 

I did not think it appropriate to mention this, but as someone else has started it .....

 

One day we placed a full sieve stack on the Endecotts in the fume cabinet to separate out some faecal material.  To paint this particular picture I will need to explain that the lower collector pan has a stainless steel 6mm spigot drilled in the side and fixed well above the maximum filtrate level.  We have also fabricated also another 6mm venting spigot in the centre of the lid so that we can connect the collector to the top sieve chamber with a 6mm clear tube in order to equalise pressures as the sample moves down through the sieves.

 

Stay with me here ......

 

The whole sieve stack is charged with CO2 to displace air and create an aerobic environment for the Obligate Anaerobes.

 

Still with me? ......

 

A "slightly" inexperienced lab rat was trying to be helpful by topping up the CO2 to the lower chambers by pulling off the top end of 6mm flexible tube and popping the CO2 gun into it, the aim being to add a little more gas to displace any air before the whole sieve stack was clamped down.

 

Who is already ahead of me (and still standing) ? .......

 

Being unfamiliar with the pressure, in goes gas ........ out comes homogenised stream of faeces vertically straight into the fume cab extractor fan.

 

Four lab techs almost unable to breath for laughing, all in unison screeched "oh no! the sh*t's hit the fan........"

 

....... took us weeks to get over it (and clean the fume cab.)

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We are also in New York.  I did call our regulatory agency to ask about storage requirements and was told that at this time they do not regulate fecal transplant material.  We have a compartmentalized freezer and store the product on the bottom shelf.  

 

The FDA has classified it as an investigational drug but our pharmacy did not want to manage it.  The organization decided that since we have the freezer capacity and a mechanism to track the product, it would be stored in the blood bank.  We manage it the same way we manage our tissue products.   Also, since it is a product that will be implanted into patients, they did not want the product stored in a chemistry or micro freezer with potentially hazardous patient specimens.

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