Mallinckrodt worker in Pa. is overexposed to radiation

[GlennACarlson@aol.com]

Posted: Friday, July 7, 2000 | 8:10 a.m. 
http://www.postnet.com/postnet/stories.nsf/ByDocID/D09121F541D0B9CF86256915003
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Mallinckrodt worker in Pa. is overexposed to radiation
By Virginia Baldwin Gilbert of the St. Louis Post-Dispatch

Federal officials have identified another Mallinckrodt worker overexposed to 
radiation.

A pharmacist at Mallinckrodt's radiopharmacy in Harrisburg, Pa., was exposed 
to 60 rems of radiation to his hands and fingers between February and May. 
The cumulative limit for extremities -- defined as below the elbows or below 
the knees -- is 50 rems a year.

"This is a rare event," said Mohamed Shanbakay, a regional branch chief of 
the Nuclear Regulatory Commission.

Senior commission officials are considering enforcement options -- including 
inspecting all Mallinckrodt pharmacies in the country, Shanbakay said.

Mallinckrodt notified the commission June 30 about the overexposure. A team 
from Mallinckrodt's headquarters in St. Louis will go to Harrisburg next week 
to investigate the cause, said company spokeswoman Barbara Abbett.

"We have not seen this kind of exposure in our region for several years," 
Shanbakay said Thursday, a day after he inspected the site.

In the region that oversees St. Louis, however, such overexposure is not new. 
Last month, a federal inspection team confirmed that 15 workers at 
Mallinckrodt's plant in Maryland Heights were overexposed to radiation 
ranging from just above the annual maximum to 40 times the limit. Some 
workers suffered exposures over the limit two or three years in a row.

The Maryland Heights plant makes radioactive tracers, which are used to 
diagnose a number of diseases, including heart problems and cancer.

Some products are shipped directly from the plant. Others are dispensed to 
hospitals and clinics through Mallinckrodt's 37 U.S. pharmacies.

The pharmacist in Harrisburg, a new hire, was exposed when he withdrew 
radioactive liquid from a vial into a syringe. Federal inspectors found he 
worked too slowly and he held the vial and syringe incorrectly. 

But a worse problem was Mallinckrodt's failure to monitor the worker after 
his increased exposure was first identified in February, Shanbakay said. 

The worker's two radiation monitoring badges, worn as rings on each hand, 
were sent to a vendor for analysis, called a dosimetry reading. Ordinarily, 
such readings are returned in a couple of weeks. 

The worker's March results were not returned until June 8, and showed an 
exposure of 26 rems - half the yearly limit in one month. His April results - 
showing 13.1 rems - arrived at the company on June 23, and the May badge - 12 
rems - on June 29. 

"We hold Mallinckrodt responsible," Shanbakay said. "Getting a dosimetry 
reading two months after the fact is unacceptable. 

"They already knew they had a problem. That makes (the delay) even worse." 

The region's inspectors have examined records for all 11 workers at the 
pharmacy and are now looking at the other six pharmacies in the region. 

Shanbakay praised pharmacy procedures that kept workers' whole body exposures 
well under the regulatory limits. But, as with the Maryland Heights plant, 
the company was not as rigorous with extremity exposures. 

"We are looking at how Mallinckrodt responds. They owe us a report," due July 
30, he said. 

Until the company team investigates, "We don't want to go any further than to 
say that we are aware we didn't have this information in the timely way we 
should have," Mallinckrodt's Abbett said. 
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