Abstract

The radioisotope cobalt-60 (Co-60) is important for commercial, medical, and agricultural applications. Its widespread use has meant that Co-60 can be found in less secured facilities, leading to the fear that unauthorized persons could obtain and use it to produce a "dirty bomb". This potential security concern has led to government calls for phasing-out Co-60 and other radiation sources, despite ongoing safety and security regulations for handling, transport and use of radioactive sealed sources. This paper explores potential implications of phasing out radioisotopic technologies, including unintended safety and cost consequences for healthcare and food in the US and globally. The use of Co-60 for healthcare and agricultural applications is well-documented. Co-60 is used to sterilize single-use medical devices, tissue allografts, and a range of consumer products. Co-60 is used in Gamma Knife treatment of brain tumors in over 70,000 patients annually. Co-60 is also used to preserve food and kill insects and pathogens that cause food-borne illness. Co-60 is effective, reliable, and predictable. Limitations of alternative sterilization technologies include complex equipment, toxicities, incompatibilities with plastic, and physical hazards. Alternative ionizing radiation sources for wide-reaching applications, including e-beam and x-ray radiation, have advantages and drawbacks related to commercial scale capacity, penetrability, complexity and reliability. Identifying acceptable alternatives would require time, costs and lengthy regulatory review. FDA testing requirements and other hurdles would delay replacement of existing technologies and slow medical innovation, even delaying access to life-saving therapies. A phase-out would raise manufacturing costs, and reduce supply-chain efficiencies, potentially increasing consumer prices, and reducing supply. These consequences are poorly understood and merit additional research. Given Co-60's importance across medical and non-medical fields, restrictions on Co-60 warrant careful consideration and evaluation before adoption.

Highlights

  • The list of single-use medical devices sterilized using Co-60 is lengthy, including surgical instruments, gloves, gowns, dressings, masks, catheters, laparoscopic equipment, implants, probes, and other objects that enter sterile tissue or the vascular system. Another major healthcare use of Co-60 is the sterilization of tissue allografts, including bone, skin, amniotic membrane and soft tissues used to treat severe burns, non-healing ulcers, and to facilitate organ transplants[1,2]. Co-60 is used to sterilize consumer products such as bottle teats for premature babies, medical bandages and a variety of personal health and hygiene products, and raw materials for cosmetics[3,4]

  • In a prospective cohort study in which physicians assigned and treated patients with either gamma knife radiosurgery or whole brain radiotherapy, the mortality rate was lower for Gamma Knife patients (74.4% vs. 97.1%), and the median survival time greater (9.5 months for Gamma Knife versus 8.3 months for whole brain radiotherapy patients)[32]

  • Though a strength, has meant that Co-60 can be found in less secured facilities. This potential security concern has led to calls to phase out Co-60 and other radiation sources

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Summary

21 Mar 2018 report report

San Diego Gamma Knife Center, San Diego, USA Radiological Technologies University VT, South Bend, USA. John Schreiner, Queen's University, Kingston, Canada Cancer Centre of Southeastern Ontario at the Kingston Health Sciences Centre, Kingston, Canada. Any reports and responses or comments on the article can be found at the end of the article. Identifying acceptable alternatives would require time, costs and lengthy regulatory review. FDA testing requirements and other hurdles would delay replacement of existing technologies and slow medical innovation, even delaying access to life-saving therapies. A phase-out would raise manufacturing costs, and reduce supply-chain efficiencies, potentially increasing consumer prices, and reducing supply. These consequences are poorly understood and merit additional research.

Introduction
Discussion
US Food and Drug Administration
11. Neville S
19. World Nuclear Association
26. US Food and Drug Administration: Guidance for Industry
35. International Atomic Energy Agency
Findings
38. International Atomic Energy Agency
Full Text
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