Radioactive Isotopes Degrade to Uselessness as Hospitals Wait

VIENNA, Austria, September 7, 2004 (ENS) - Denials or delays in international shipments of radioactive material, including short-lived isotopes used for medical diagnosis and treatment, are occurring more frequently, according to the United Nations nuclear agency.

Many countries import isotopes used to treat cancer, diagnose heart attacks or sterilize medical equipment. Hospitals and clinics depend on these international shipments to arrive on time, particularly if the isotope has a short half-life and must be sent by air.

The International Atomic Energy Agency (IAEA) said Friday that the issue will be covered at its upcoming annual General Conference opening September 20 in Vienna.

"If an airline or other transport provider refuses to take a shipment, or is unable to take a shipment, then this increases the prospect of someone missing a cancer treatment," said Michael Wangler, who heads the IAEA Safety of Transport of Radioactive Materials Unit.

While the precise number of denials occurring worldwide is not known, industry representatives have told the IAEA of increasing difficulties in delivering lifesaving isotopes that require urgent international transport.

"There is a risk that if more airlines do deny, particularly where few airlines serve key regions, then this does raise a serious issue. It potentially means that medical clinics and hospitals in specific areas are at risk from being denied essential medical supplies," Wangler said.

Louie Salazar uses the hot cell manipulators in the new Isotope Production Facility at the Los Alamos Neutron Science Center, Los Alamos National Lab, New Mexico. January 12, 2004 (Photo by LeRoy Sanchez courtesy LANL)

This involves a wide range of radioactive material used for applications such as pacemakers and other medical devices, food irradiation, checking for hairline fractures in pipelines, or controlling insects.

Thallium-201 is used for medical cardiac imaging, kidney studies, and tumor diagnosis; and molybdenum-99 is a short-lived radioactive isotope that is essential for many medical diagnostic tests. Calcium-44 is used in bone growth studies, Iridium-192 is used for nondestructive testing of construction and other materials, and americium-241 is used in smoke detectors.

Shipments of medical and industrial radioactive material are regulated by countries and the airline industry in accordance with the IAEA's international Regulations for the Safe Transport of Radioactive Material.

"Radioactive material is very safely transported, based on standards developed by the IAEA which have been operating for 43 years," Wangler said. What the current regulatory system lacks are enhanced efforts or separate treatment to facilitate the rapid distribution of medical isotopes when warranted."

Some airlines have policies against carrying any radioactive material, Wangler said. In other instances, a country's regulatory controls may make it very difficult for the airlines to meet needed requirements, creating bottlenecks that have effectively blocked shipments of isotopes.

Isotopes with short half lives, such as iodine used to treat and detect thyroid tumors, become useless if they miss a flight. Or if they miss a flight and make a later one, their use is limited.

In February 2004, the IAEA Secretariat convened an open-ended group of technical and legal experts to develop guidance on the import and export of radioactive sources to facilitate the implementation of the IAEA Code of Conduct on this issue.

Radioactive substances are used widely in modern medicine. Here a robot manipulator holds a vial of Yttrium-90 in a hot cell. (Photo courtesy Nuclear Medicine Research Council)

International transports of radioactive sources shipped by sea are also said to be experiencing delays and denials. Draft guidance was developed, but some of the experts said that, given the complexity of the issues involved, the draft guidance would need technical, legal and policy review by governments. The IAEA Secretariat sent the draft guidance to all member states for comment in April.

A follow up meeting of technical and legal experts was held in July 19 to 22, 2004, attended by 68 experts from 40 IAEA member states.

The experts reached a consensus on a draft guidance, but it is not legally binding. If approved by the IAEA General Council, it could become effective December 31, 2005.

The guidance is not intended to impede international cooperation or commerce, "as long as such cooperation and commerce does not contribute to the use of such sources for purposes that threaten safety and security," the guidance states.

Lead-shielded short term storage container for transport of radioactive isotopes. (Photo courtesy Los Alamos National Lab)

Prior to authorizing the export of the radioactive sources, the exporting state should give prior notification in writing and obtain consent from the importing state.

The exporting state should get confirmation from the importing state that the recipient is authorized to receive and possess the radioactive source or sources to be exported.

The exporting state should satisfy itself that the importing state has the appropriate technical and administrative capability, resources and regulatory structure needed for the management of the radioactive sources consistent with the IAEA Code of Conduct.

And exporting states should ensure that the export is consistent with existing international standards relating to the transport of radioactive materials.

Parallel provisions are outlined for importing states, which should also promulgate radiation protection legislation and regulations; designate and empower a regulatory body; establish a national register or inventory of radioactive sources; and establish a system for the notification, authorization and control of radioactive sources.

Each importing state should consider "the risk of diversion or malicious acts involving radioactive sources," on the part of the facility that wants to receive the radioactive source.

The radioisotope production facility at Reaktor Triga Puspati, Malaysia's nuclear research reactor. (Photo courtesy Malaysian Institute for Nuclear Technology)

While the experts reached agreement on the draft guidance containing these and other points, the group Chairman Steven McIntosh of Australia, said the experts generally believed that the guidance should go before the IAEA Board of Governors before it is presented to the General Conference later this month.

“Experts felt that, in order to give the Guidance a higher status, the draft should be submitted to the IAEA’s Board of Governors before its next meeting for its approval, together with the Chairman’s report,” said McIntosh.

On the issue of medical isotopes, the draft guidance provides some assurance that the diagnosis and treatment patients who need the radioactive substances will not be held up by security concerns. Exceptions to the rules can be made, it says, for "cases of considerable health or medical need, as acknowledged by the importing state and by the exporting state."

The scope of the "exceptional circumstances" provision was a point of contention, McIntosh said in his report. It was resolved by specifying that if "exceptional circumstances" do exist, the exporting state should obtain consent from the importing state, in accordance with paragraph 26 of the IAEA Code of Conduct.

Paragraph 26 states that "import or export may be authorized in exceptional circumstances with the consent of the importing State if an alternative arrangement has been made to ensure the source will be managed in a safe and secure manner."