Re: civil penalty for medical violation

[Thomas Gray & Associates <tga@95net.com>]

carol marcus wrote:
> 
> 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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> >information can be accessed at http://www.ehs.uiuc.edu/~rad/radsafe.html
> >
> 
> 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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Carol-
During my time at Thomas Gray and Associates (21 years, we are a waste
broker/processor) I've disposed of probably 20 to 30 eye applicators. We
have found several (3 or 4 if memory serves me correctly)to be leaking.
While this is obviously not a representative sample, I would prefer that
the eye applicator used on my eyes be leak tested in accordance with the
regulations.  

Rich Gallego
Thomas Gray and Associates
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