Unintended consequences of the potential phase-out of gamma irradiation

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.

The Influence of the Preservation Method and Gamma Irradiation Sterilization on TGF-β and bFGF Levels in Freeze-Dried Amnion Membrane (FD-AM) and Amnion Sponge

“…It is recommended for use in biological tissue due to its ability to inactivate microorganisms without a significant rise in temperature of the irradiated material. Moreover, gamma irradiation also has a high penetrability so that the tissue can be sterilized even if it is in bulk after the final packaging [9].…”

“…e commonly used method for radiation sterilization is by using gamma ray from Co-60 since it is practical, dependable, predictable, and has a high penetrability so the tissue can be sterilized even after its final packaging [3,9]. As stated in ISO 11137 [10], sterilization of medical equipment can be carried out at a dose of 15 kGy or 25 kGy, depending on the product's initial bioburden, the number of a product's microorganism content [3].…”

Sterilization of Objects, Products, and Packaging Surfaces and Their Characterization in Different Fields of Industry: The Status in 2020

“…A complete phasing out of gamma irradiation comes with possible consequences; a very recent study on this topic was published in 2018. [75] In general, radiation sterilization can be applied to products before packaging such as dairy products or after packaging such as meat. [76][77][78] Gamma ray sterilization has been the conventional terminal sterilization method before the introduction of chemical sterilants or the development of hygienic filling standards.…”

“…A complete phasing out of gamma irradiation comes with possible consequences; a very recent study on this topic was published in 2018. [ 75 ] In general, radiation sterilization can be applied to products before packaging such as dairy products or after packaging such as meat. [ 76–78 ]…”

Máscaras de proteção respiratória: Reflexões sobre a regulação e eficiência do processo na pandemia de COVID-19

“…A esterilização pode ser feita mediante a aplicação de calor seco ou úmido, agentes gasosos, por filtração esterilizante, através de radiações ionizantes e não ionizantes, entre outros (Archanjo et al, 2012;Sobecc, 2013;Chou et al, 2018;Goveia et al, 2007;Luqueta, 2010).…”