Fwd: Off-label Use of IVB devices

[Chris Alston <alstonc@odrge.odr.georgetown.edu>]

>From: "Wilson, Lyle" <tl.wilson@BAYLORDALLAS.EDU>

>We are preparing for our first clinical IVB cases in cardiology using Ir-192
>and Sr-90.  I have been providing guidance to an AU who is preparing a
>sub-license amendment request.  One issue that has come up is off-label use.
>A representative from one vendor has suggested that off-label use will be a
>common occurrence and no big deal.  (Our Cardiologist's whole-heartedly
>agreed).  Our broad license amendment approval authorizes "general clinical
>use of IVB for the FDA approved devices under the premarket approval (PMA)
>as well as clinical research".   Would you interpret this to mean that use
>outside of PMA indications would fall under the category of research?
>(Although we are approved for research use as well, additional submissions
>would be required to our IRB and RSC, and be reflected on the AU's
>sublicense.)  Examples could be stepping the source train to treat a longer
>lesion length than indicated, or application to a non-stented artery.
>
>I am waiting for a response from the state, but would appreciate other's
>perspective as well.  Are there analogous circumstances in HDR?
>
>Thank you!
>
>Lyle
>
>T. Lyle Wilson, M.S., D.A.B.R.
>Director of Medical Physics, Radiation Safety Officer
>
>Baylor University Medical Center  <http://www.baylordallas.edu/>
>Department of Medical Physics, H-0539   Voice:  +1 214 820 7133


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