Mallinckrodt disregarded radiation danger, federal inspectors say

[GlennACarlson@aol.com]

Posted: Friday, June 23, 2000 | 3:32 p.m. 

Mallinckrodt disregarded radiation danger, federal inspectors say
By Virginia Baldwin Gilbert Of the Post-Dispatch
http://www.stlnet.com/postnet/stories.nsf/ByDocId/0C9F809606FDC9F886256907006E
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Officials at Mallinckrodt Inc.'s plant in Maryland Heights allowed workers to 
handle unshielded radioactive material and did not take seriously the 
overexposure to workers' fingers, federal inspectors said Friday. 

Jamnes Cameron, who headed the inspection team from the Nuclear Regulatory 
Commission, said, "The NRC was very surprised anyone would see as an 
acceptable practice handling unshielded sources" of radioactive material. 

Cameron's comment came after a public meeting in Maryland Heights where the 
commission released the results of its inspection of the plant, at 2703 
Wagner Place and 11480 Warnen Road. 

The plant makes and ships radiopharmaceuticals - radioactive materials used 
by hospitals and clinics for diagnostic medical tests. 

"We take these issues very seriously," said Brad Fercho, president of 
Mallinckrodt's imaging division. "Our goal is to operate in such a manner 
that worker safety is held in the highest regard."

Cameron said after the meeting he was satisfied that plant employees now 
understand the importance of avoiding fingertip exposures. 

Investigators for the commission and Mallinckrodt discovered at least three 
areas of the plant where workers touched unshielded radioactive products. But 
more importantly, they found that company officials underestimated the 
seriousness of employees routinely touching radioactive materials without the 
proper shielding. 

Such underestimation "seemed to be inherent in their operation," Cameron 
said. "It was held by virtually every employee, supervisor and manager at the 
plant." 

The practices came to light after a worker in the Molybdenum generator lab 
accidently exposed his thumb and forefinger to as much as 40 times the annual 
radiation limit for workers. The exposure lasted less than a minute, 
investigators believe, and was limited to the fingertips. 

The worker's name has not been released. 

The incident came to light only after a higher-than-normal amount of 
radiation was noted on the worker's monitoring badge, worn as a ring on his 
opposite hand. 

Investigators recreated what the worker did - he lifted a radioactive 
container out of its shield - and estimated that he had received as much as 
2,400 rems in those few seconds. The annual cumulative exposure limit for 
radiation workers' fingers is 50 rems. The annual cumulative exposure for a 
worker's "whole body" - described as anything above the knees or elbows - is 
5 rems. 

Inspectors criticized the company for relying on ring monitors to pick up 
exposure to workers' fingertips and for assuming that, if an exposure did not 
register on the ring monitor, it was acceptable. 

After Mallinckrodt reported the Molybdenum worker's overexposure, it 
investigated and reported problems in two other areas, the labeling 
department and the sterility testing lab. 

In both areas, workers were routinely touching unshielded products. The 
radiation doses were smaller than the Molybdenum worker's overexposure, but 
they occurred more often and over a much longer period of time. 

In all, 14 more workers in the two areas were found to have suffered 
overexposures as much as 12 times the annual maximum. Some of the workers 
were overexposed for several years in a row. 

The commission inspectors evaluated eight categories of the company's 
operations and worker protection against radiation overexposure. 

They found the company satisfactory in its descriptions of what happened, in 
its response to the first exposure discovered and in the calculations used to 
estimate the doses that were not adequately measured at the time. 

The inspectors found the company unsatisfactory in five of the eight 
categories: 

Mallinckrodt did not do a good job of evaluating manufacturing processes for 
worker exposure.  Supervisors and workers alike had developed "work-arounds" 
when equipment or procedures did not work, and little thought was given to 
whether these work-arounds exposed workers. 

The company's dose reduction committee was focused on lowering the whole body 
exposure - limited to 5 rems a year - and paid scant attention to extremity 
exposure. 

On-the-job training was sadly lacking, especially in emphasizing the 
necessity not to handle unshielded radioactive material. Temporary contract 
employees - whose salaries were paid by an agency rather than Mallinckrodt - 
were put at particular risk, because they did not have the same access to 
written descriptions of work procedures as regular employees. 

The company's program of auditing production did not look at the work-around 
under use in the Molybdenum lab. It had identified the problem of 
hand-labeling some vials of radioactive material, but nothing had been done 
about it. 

The company did not learn from three previous overexposures in the Molybdenum 
lab. "None of the root cause investigations found problems" with the 
work-around that led to the overexposure. In two of the previous cases, plant 
officials knew workers had handled unshielded materials. 

Cameron said the inspectors also noted "an apparent reluctance to change" 
work procedures that exposed workers. 
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