RE: REALLY an NRC EVENT??

["Perrero, Daren" <Perrero@idns.state.il.us>]

Some additional thoughts... a couple of colleagues have pointed out that I
may have been mislead by the NRC Event Report. Mr. Tyree may have really hit
the nail on the head in that the INFORMATION ONLY report, actually provided
no real information.  

In addition to the unknown status of the sources' containment, its not clear
from the notice if the source involved is a prototype or a source available
to medical researchers. Only the brachytherapy source manufacturer's name is
mentioned.
Nor does it reveal the circumstances around the use of the source (damage
during routine handling, an anomaly during dosimetry evaluation or
destructive testing for safety evaluation) only the general heading of
"investigational use".  

The use of the manufacturer's name and the investigational use signaled a
medical application issue in my mind.  I wonder how many other Medical RSO's
are lead to the same conclusion.  Based on a different perspective I am
curious as to the details surrounding this notification and the results of
the leak test to establish if the source was indeed leaking.

In Illinois, licensee's are required to report leaking sources within 5
days.

-----Original Message-----
From: Perrero, Daren [mailto:perrero@idns.state.il.us]
Sent: Tuesday, August 01, 2000 8:55 AM
To: Multiple recipients of list
Subject: RE: REALLY an NRC EVENT??


In this particular case the licensee has, IMHO, provided information that is
of great value to the regulated community.  Just enough detail has been
provided such that if you are familiar with the source you will recognize
that it is a device used in part of an ongoing clinical trial to determine
the efficacy of intravascular radiation therapy immediately following
angioplasty in a procedure which the FDA has determined to be of
"significant risk".  The notification may be premature, but given its use,
if I was the RSO, I would opt for conservatism as well.

I will say, however, based on my understanding of the device, the
containment safety systems involved should prevent the spread of significant
contamination in the cardiac-cath lab.

Daren Perrero
Health Physicist
perrero@idns.state.il.us


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