RE: medical misadventures

["Vernig, Peter G." <Peter.Vernig@MED.VA.GOV>]

To those interested in misadministrations:



Initially the allowed variation was 10%.



At one time the NRC staff proposed to stop calling them misadministrations

and the Commissioners indicated that they felt a spade should be called a

spade.



In 1994 the allowed variation was increased to 20% of the prescribed dose

but between 10 and 20% were called "recordable events".  They must be

documented and investigated but are not reported to NRC at the time.  They

are reviewed by inspectors when they visit.



In the revised part 35 tentatively scheduled to be published in the Federal

Register in October the renaming is accomplished they will now be known as

"medical events" a medical event will be reportable.  Generally 20% is still

the standard but also 5 rem for whole body and 50 rem for organ or skin dose

is needed to make it a "medical event".



The "recordable event" is dropped in the revised regulation.



Editorial comment- Though I generally agree with the relaxation of many of

the prescriptive medical regulatory requirements I think recording events

over a certain threshold that are not medically significant but the result

of mistakes should be done, not for regulatory review but for quality

assurance reviews by the licensee.  I have not heard that NRC inspectors

have made a lot of citations out of recordable events so I guess I would be

in favor of leaving it in the regulation.



The Society of Nuclear Medicine and the American College of Nuclear

Physicians have been fighting adoption of the revised regulation because

they feel that diagnostic nuclear medicine is over regulated and the

revision does not substantially change that.  They managed to get the Senate

appropriations bill for the NRC to include language to prohibit use of funds

to enforce the revised part 35 if it is enacted.  The House version does not

include the language so a conference committee will resolve that.  The Bush

administration has stated it's position that the new regulation should be

enacted as it provides some relief from the current part 35.



More editorial comment- I do not have figures but I think Nuclear Medicine

does fairly well in significant misadministrations, meaning ones that cause

physical harm or significant risk of harm.



Another difference between power plant health physics and NM HP is that

radioactive materials and radiation is deliberately applied to humans in NM

which is not the case in power plants.  When there is a monumental mistake,

or rather series of mistakes, you get a Three Mile Island.  In NM when there

is a big enough mistake in therapeutic use you get a death.  These have been

relatively rare.



IS MORE REGULATION NEEDED?  In 1994 the FDA issued an advisory regarding

"occasional but at times sever radiation induced burns..." from

fluoroscopically guided procedures.  These procedures are generally

interventional procedures that require placement of a stent or other

invasive life saving procedures.  Without regulatory intervention that

advisory, a later follow up and the concern of the accreditation agency, the

Joint Commission on Accreditation of Health Care Organizations, fondly known

as JCAHO or Jake [8-}> means that many facilities now require training for

non-radiology physicians directing fluoroscopy procedures, recording of beam

times and dose estimates.  Note that at our facility most of the non

radiology physicians doing fluoro are doing procedures well under 30 minutes

of beam time.  Generally, there will be little risk of acute skin effects

below 2 hours of beam time.  There are a host of variables, not the least of

which is how much the area in the beam changes during the procedure.  As far

as I know there are no regulations requiring us to do anything about the

potential for fluoroscopy skin damage.



Any opinions expressed are mine alone and do not necessarily represent

those of the Denver VA Medical Center, The Department of Veterans

Affairs, or the U.S. Government.



Peter G. Vernig                

Radiation Safety Officer, VA Medical Center, 1055 Clermont St. Denver,

CO 80220, ATTN; RSO MS 115

303-399-8020 ext. 2447, peter.vernig@med.va.gov [alternate for business

- vernig.peter@forum.va.gov; private - peter_vernig@hotmail.com] Fax

303-393-5026 [8 - 4:30 MT service] Alternate Fax 303-377-5686



"...whatever is true, whatever is noble, whatever is right, whatever is

pure, whatever is lovely, whatever is admirable, if anything is found to

be excellent or praiseworthy, let your mind dwell on these things."

Paul





-----Original Message-----

From: Perrero, Daren [mailto:Perrero@IDNS.STATE.IL.US]

Sent: Thursday, September 06, 2001 12:29 PM

To: radsafe@list.vanderbilt.edu

Subject: RE: medical misadventures





Bill



The other side of this argument is that a fair number of human errors that

end up as medical misadminstrations are violations of regulations that have

no place being burdened upon licensees in the first place. No "major event"

has even occurred. The "errors", in fact, have no impact on the health of

the patient involved. The range of effectiveness for most therapeutic doses

are enormous and whether you are off by 20% or more is irrelevant to the

outcome, or better yet the administration of radiation is a means of

providing "additional assurance" that the main treatment method (i.e.,

surgery) is successful, yet by regulation the "error" is a reportable

misadministration. No harm, no foul, I say! 



The rad protection program at the facility is, more often than not, just

fine and the misadministration is not a valid indication of the quality of

work being done by the Med Physicist/RSO at these facilities.  Med HP's

spend their entire day trying to improve "human performance", but like

everyone else they have to allocate limited resources.  I would rather see

them spending their time with the CT Scanner, Mammography Unit and LINAC and

other X-ray sources since there are far more medical procedures conducted

with these forms of radiation than in the busiest Nuc Med Dept.



If its really about trust, and not dose, then I suggest the medical folk

stop being required to wave red flags when the patient impact is negligible

in the first place.



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