By Virginia Baldwin Gilbert
Of The Post-Dispatch

June 8, 2000

Mallinckrodt Inc. on Wednesday placed the manager of its Maryland Heights plant on "indefinite leave" during an investigation into radiation exposure of at least 15 workers there.

"We regret these incidents have occurred," said Brad Fercho, president of Mallinckrodt's imaging group. Company officials declined to name the manager.

The Post-Dispatch reported Wednesday that a continuing investigation by the company and the Nuclear Regulatory Commission is raising concern about how employees at the plant have been handling radioactive materials and how they have been monitored for exposure.

Fercho said Wednesday that an independent team of Mallinckrodt employees with expertise in manufacturing and nuclear medicine will examine all the procedures in the plant for safety. Plans had been in place to put the manager on leave as soon as the team was assembled and were not a result of the article, he said.

"We're not looking for a scapegoat here," Fercho said. "We want to make sure we've honestly and accurately assessed all aspects of the manufacturing processes and protocols at the Maryland Heights facility."

The plant manager is still an employee, Fercho said. "He's being paid. We felt it was important to ensure we get an absolutely unencumbered assessment" of operations at the plant.

Mallinckrodt began checking practices and procedures of all departments at the plant at the beginning of April.

On March 31, a worker's finger and thumb were exposed to 40 times the limit of radiation exposure for workers for an entire year. As required by law, Mallinckrodt notified the NRC, which brought a team of investigators into the plant for two weeks in May.

The NRC has investigated and fined the company for prior violations, including $55,000 in fines in 1997 for a worker over-exposed and shipping contaminated products.

The commission will release its findings at a public meeting June 23. Fines would be determined in a second phase.

The plant, which consists of two buildings at 2703 Wagner Place and 11480 Warnen Road, makes radiopharmaceuticals - mainly radioactive tracers used to highlight internal organs in X-ray and ultrasound procedures as well as devices that pharmacy or hospital technicians can use to make those tracers.

In a letter to the NRC last week, Mallinckrodt acknowledged the safety gaps, specifically in the labeling department and in the department that tests the sterility of vial samples before shipment.

"We're not trying to sugarcoat it," said Roy W. Brown, director for regulatory compliance for Mallinckrodt.

According to Mallinckrodt's own investigation, the causes of exposures included:

* Not fixing a labeling machine for 3 milliliter vials, leaving employees to label the vials by hand. Exposures due to hand labeling go back at least to 1995 and range from 53 rems to 591 rems a year on 10 employees. The total annual exposure limit for a radiation worker is 50 rems. Most of the employees were exposed over the annual dose for several years in a row.

* Not providing remote handling tools and syringe shields to workers in the sterility area. This resulted in four employees being exposed to a range of 68 to 96 rems a year. Two of the four were exposed to amounts above the annual limits for each of three years. Two were exposed for a year.

* Not following the recommendations of two internal audits that identified a problem with employees handling radioactive vials without pro per shielding. The company's response to the audits had been that using the shields would produce false positive readings, which could prevent the shipment of "an entire batch of material," and cause problems with requirements of the Food and Drug Administration.

According to its letter to regulators, Mallinckrodt has already made some changes. The labeler was fixed and is being used. Syringe shields and longer needles were ordered, and employees were told not to handle unshielded products. Fingertip monitoring badges have been devised and are being tested to replace ring badges that didn't pick up all the radiation workers were receiving.

"Only three companies in the world manufacture radiopharmaceuticals," Fercho said. "This is a complicated business, and it involves handling, manufacturing and distribution. We take this seriously. It's an important product, a necessary component in treating people."