The Player RosterBy John McCormick | Posted 2004-03-04 Email Print
Additional reporting by Berta Ramona Thayer in Panama
As software spreads from computers to the engines of automobiles to robots in factories to X-ray machines in hospitals, defects are no longer a problem to be managed. They have to be pred
Physicist, National Cancer Institute (NCI), Panama
Saldaña is one of three physicists charged with second-degree murder in Panama for entering data into Multidata’s software that produced inaccurate amounts of time for patients to be treated with a Cobalt-60 beam. She continues to work at the hospital because, she says, “If we did not work, the patients would die.”
Garcia is one of seven cancer patients who survived the radiation overdoses at the institute in 2000. Overall, 21 patients have died. He is a party to lawsuits against Multidata International Systems and MDS, the owner of the Cobalt-60 therapy machine, in both Panama and the U.S.
Dr. Juan Pablo Bares
Bares sought international help to understand the causes of the overdoses after the hospital realized in March of 2001 they had occurred. Bares offered to resign after the overdoses became public in 2001, but the hospital board refused to accept his resignation.
Services Manager, ProMed
ProMed solicited a bid from Multidata on a referral from General Electric Medical Systems because the NCI couldn’t afford the treatment-planning software offered with the Cobalt-60 teletherapy machine. Jorge says it is the only time ProMed has done business with Multidata.
Special Superior Deputy Prosecutor
Arboleda led the investigation into the causes of the overdoses for Panama’s Ministry of Health and is now prosecuting the physicists. He says his office had little experience with software and his staff has had to learn on the job.
General business manager
Conley, a 13-year veteran of the radiation-therapy systems company, oversees product sales and marketing. He’s unflappable when pressed about the role of the company’s software in the radiation accidents in Panama and maintains that they would not have happened if the staff at the NCI had followed the manual and verified the software’s results before treating patients.
Roestel runs the privately held company, which he founded in 1979. He’s been working in the radiation-treatment software industry since the late 1960s. Business manager Conley calls him a pioneer in the field and says he was one of the first people in the country to work on computerized radiation-treatment systems.
Timothy Ulatowski Director
A 30-year veteran of the FDA, and one of the few people to wear a tie in the CDRH office, Ulatowski is a direct, to-the-point manager who oversees a number of FDA operations, including enforcement of medical-device and radiological-health laws and regulations. He holds a B.S. in microbiology and an M.S. in biomedical engineering.
Software and Part 11 Compliance Expert
Murray is the CDRH’s primary advisor on all aspects of software, including validation, policy, and classification. He holds an undergraduate degree in electrical engineering and a graduate degree in computer science; he can explain the complexities of medical devices and their software in lay terms.