Re: regulations

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From:"Peter A. Takes" <> (by way of histonet)
To:histonet <>
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To my knowledge, no such regulation exists.  However, there may be state- or
institution-specific rules which apply.  Your institution's IRB should
know.  I believe dual use is done all the time in major research
institutions, both with processing equipment and diagnostic equipment.
There may be some case-specific restrictions, e.g., if you are working with
highly or potentially infectious materials.  Just make sure your equipment
cleaning SOPs are in order.
Much of the restrictions are often pathologist-based - we have worked with a
pathologist who will review animal tissue slides, but does not want them
processed in his lab.  Consequently, they are first processed in a vet path
lab and then the mounted slides are brought over.

This is a qualified response...I might be wrong, but have never encountered
any such formal rules to date.  Someone please correct me if I'm wrong.

Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Ph. 1-314-615-6964; Pager: 841-9351

Ronnie Houston wrote:

> Here's one for all you Regs buffs.
> Are there any regulations that state that you cannot use a piece of
> equipment for both human and research animals tissues?
> The point in question, particularly, is the cryostat (although I'd be
> interested in other histology equipment also).
> One of our clinicians is ranting and raving about us using our CM3000 to
> cut both human biopsies and animal tissues; not at the same time! This
> is despite the fact that we have been doing this practice for the last
> six years, and she knows this, and checked up with several pathologists
> and agencies before hand. But now she knows better!
> We always clean the cryostat and change the blade between tissues
> anyway, whether it be different biopsies, or animal.
> Thanks for any input.
> Ronnie Houston
> Cytochemistry & Molecular Pathoogy
> Texas Scottish Rite Hospital for Chidren
> Dallas

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