The U.S. Food and Drug Administration has provided additional details regarding radiation overdoses received by cancer patients at Panama's National Institute of Oncology between August 2000 and February 2001.
The agency said the 28 patients were being treated for colon, prostate, and cervical cancer, and that the overexposures ranged from 20%-100% over the prescribed dose.
Equipment used at the institute included a Theratron 780-C cobalt 60 teletherapy system manufactured by Theratronics of Ontario, Canada, and radiation treatment planning software manufactured by Multidata Systems International of St. Louis, the FDA said.
According to the report, the institute lacked treatment plan verification for radiotherapy patients. The overradiation occurred specifically as a result of the method used to enter beam-block data into the Multidata software, as well as the interpretation of the beam-block data by the Multidata software.
The FDA is investigating the incidents with the International Atomic Energy Agency (IAEA), the Pan American Health Organization (PAHO), the U.S. Nuclear Regulatory Commission (NRC), and Multidata to determine the cause of the overexposures and provide solutions. It is also investigating whether there have been similar problems in the U.S. or abroad.
The agency recommended the following additional sources of information:
The June 18 joint statement from the American College of Radiology,
American Society for Therapeutic Radiology and Oncology, and American
Association of Physicists in Medicine at:
http://www.aapm.org/announcements/01_06_18_Panama_Accident_Statement.pdf
The June 9 IAEA Report at: http://www.iaea.org/worldatom/Press/P_release/2001/panam_adv_info2.shtml
The June 6 U.S. Nuclear Regulatory Commission Information Notice (Supplement 1) at:
http://www.nrc.gov/NRC/GENACT/GC/IN/2001/in01008s1.pdf
The FDA said Multidata users with specific questions on the beam-block function should contact the company directly at http://www.multidata-systems.com.
In other news, Panamanian daily La Prensa has reported that another patient who received a radiation overdose at the institute, Rosa Vergara, died July 15. Vergara, a nun, was the 11th patient to succumb following treatment, and her body was autopsied against the wishes of her congregation.
Following a delayed autopsy of the 10th victim, Agustina Rios, a preliminary report has determined that radiation exposure accelerated her death, La Prensa said.
Finally, institute director Juan Pablo Barés said he has named an independent nuclear physicist to supervise the technicians who operated the cobalt machine used to treat pelvic cancer patients.
The 17 surviving patients remain under special observation status, Barés said. Some are staying at home, and are receiving regular visits from institute staff, according to La Prensa.
By AuntMinnie.com staff writers
July 23, 2001
Related Reading
Panama orders autopsies of radiation accident victims, July 5, 2001
Second stage of Panama investigation begins, June 7, 2001
Eight reported dead in Panama after radiation therapy, June 6, 2001
Investigation continues in fatal Panama radiation therapy accident, May 29, 2001
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