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Re: U.S. Says Firm Agrees to Halt Radiation Device Sales

Neither the NRC nor the FDA would not any direct roles in the the investigation of this situation, except as possible advisers and interested parties.  With regard to the FDA actions, treatment planning computers  are considered part of treatment planning medical devices, and have to meet approval of the FDA.
 
My understanding that there were problems at the therapy facility involved both human and computer.  As stated, staff review charts, but did not provide manual checks (hand calculations) of the irradiation plans. 
 
(Story time:  I worked at an oncology facility as a junior medical physicist.  While reviewing charts, I saw that the treatment plan for one patient was to have x treatmens supine and y treatments prone.  The treatments were being done in the reverse order, as the patient had back pain, the the technicians had repositioned the patient, but not the settings.  Since we were only 1/3 through the treatment plan, the settings were adjusted to ensure the tumor volume received the required dose.  Moral of the story:  qualitiy control checks are essential. )
 
 
The report about this incident can be found at http://www-pub.iaea.org/MTCD/publications/PDF/Pub1114_scr.pdf  There were three teletherapy devices, i.e., two Co-60 and one 18 MeV linear accelerator.

Susan L Gawarecki <loc@icx.net> wrote:
I thought RadSafers might be interested in the following article. I was
wondering about the relative roles that the FDA and NRC have in
regulating radiation devices. Also, since the cited deaths occurred in
Panama, did the NRC have any jurisdiction over a US company? Were there
domestic misadministrations attributed to the devices also? What were
these devices, anyway?

Susan Gawarecki

U.S. Says Firm Agrees to Halt Radiation Device Sales
Last Updated: 07 May 2003 20:31 BST

WASHINGTON (Reuters) - A maker of software that was linked to overdoses
of radiation given to cancer patients has agreed to stop marketing
radiation devices until it corrects problems connected with the devices,
U.S. regulators said on Wednesday.
. . .


-- John
John Jacobus, MS
Certified Health Physicist
e-mail: crispy_bird@yahoo.com

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