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

[Susan L Gawarecki <loc@icx.net>]

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.



Software made by privately held Multidata Systems International of St.

Louis "reportedly contributed to 28 patients receiving excessive amounts

of radiation at a medical facility in Panama City, Panama, in 2001.

Several patients died," the Food and Drug Administration said in a

statement.



A 2001 FDA warning about the incident said five deaths had been

attributed to the radiation overexposure.



The FDA, in its statement Wednesday, said it inspected the company

several times between April 1993 and September 2001 and found "extensive

and persistent deficiencies" in manufacturing practices.



The company did not file prompt reports to the FDA after it became aware

its products may have caused or contributed to deaths or serious injury,

the agency said.



A consent decree with the FDA requires the firm to stop manufacturing

and distributing about 20 medical devices related to radiation therapy

until it satisfies the agency it has fixed its problems, FDA spokeswoman

Sharon Snider said.



"Multidata Systems has a nine year history of violations and failure to

correct them," FDA Commissioner Mark McClellan said in a statement.

"Despite repeated warnings, the company continued to manufacture its

medical devices in a way which put the public health at risk. This

cannot be tolerated."



Officials at Multidata were not immediately available for comment.



Multidata initiated a recall of its radiation treatment planning

software in September 2001 but did not complete the recall until earlier

this year,  the FDA said.

-- 

.....................................................

Susan L. Gawarecki, Ph.D., Executive Director

Oak Ridge Reservation Local Oversight Committee

102 Robertsville Road, Suite B, Oak Ridge, TN 37830

Toll free 888-770-3073 ~ www.local-oversight.org

.....................................................

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