Re: civil penalty for medical violation

[carol marcus <csmarcus@ucla.edu>]

At 09:06 AM 7/19/00 -0500, you wrote:
>The attached press release describes a penalty for failure to perform a
>required leak test on an eye applicator.  I'm surprised at a number of
>things:
>
>This is the 4th time the individual was cited for the same violation.
>Only now is the NRC calling this "willful."
>
>The NRC is imposing a civil penalty for this "wilful" violation.  Please
>note 10CFR20.2402(a):  "Section 223 of the Atomic Energy Act of 1954, as
>amended provides for criminal scanctions for willful violation ..."
>
>The press release did not state anything about the individual losing his
>license.
>
>It seems that the consequences of using a leaking applicator on a
>patient would be quite serious.
>
>Considering all of the above, I am astounded when medical hp's say that
>they are over-regulated.  You don't know when you have it easy.
>
>The opinions expressed are strictly mine.
>It's not about dose, it's about trust.
>
>Bill Lipton
>liptonw@dteenergy.com
>
>NRC PROPOSES $2,750 CIVIL PENALTY AGAINST DOCTOR IN PUERTO RICO FOR
>VIOLATION OF
>                           NRC REGULATORY SAFETY REQUIREMENTS
>
>The U. S. Nuclear Regulatory Commission has proposed a $2,750 civil
>penalty against Dr. Roberto Buxeda-Dacri, M.D., of
>Santurce, Puerto Rico for violation of NRC safety requirements involving
>failure to perform required periodic leak tests of the
>radioactive source in a device used in the medical treatment of eye
>conditions.
>
>NRC officials said Dr. Buxeda-Dacri was cited by the agency for this
>same violation during the last three NRC inspections at
>his facility, demonstrating what they termed a careless disregard for
>NRC requirements. The NRC said the fourth occurrence of
>the violation indicated that it was of a willful nature and that the
>civil penalty was proposed as a result.
>
>The device, called an eye applicator, is used in the medical treatment
>of eye conditions and contains a radioactive source of
>approximately 31 millicuries of Strontium-90. A leak test performed
>after the NRC's May 2 identification of the violation
>confirmed the absence of any leakage and that the violation did not
>result in any actual safety consequences.
>
>The licensee has 30 days from receipt of the Notice of Violation to
>either pay the civil penalty or to protest its imposition, in
>whole or in part.
>
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Dear Bill and Radsafers:

I am searching for data showing that these probes have leaked in the past.
If, after 40-50 years of experience there is little or no data showing
leaks, one can reasonably wonder whether the leak test requirement makes any
sense.  We do not talk about "possible" leaks in a technology that has been
around this long.  We talk about real data.  And, how much was the leak?
And if there was any, and a tiny bit of radioactive material got on the
canthus of the eye (the inner edge of the eye), it would quickly be washed
off and probably do no harm.  I want DATA.  Does anyone, including the NRC
people who follow Radsafe, have any?

It may be that NRC waited this long to do anything about it because it knows
that it has no data base to support this requirement in the first place.
This is typical of most NRC medical regulations, and it would not surprise
me if it applied here as well.

Ciao, Carol

Carol S. Marcus, Ph.D., M.D.
<csmarcus@ucla.edu>

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