![]() Manufacturers of medical devices fully understand the different sterilization options and select the best method for their products and business. High energy x-rays, although expensive to produce, have similar penetrating power and slow dose rate comparable to gamma radiation. ![]() E-beam is characterized by low penetration and high dose rates that performs best with light-density and uniformly simple, single packaged products. Manufacturers of medical devices are using ethylene oxide (EO) gas to sterilize many products that can withstand heat, pressure and moisture conditions of the sterilization process and is permeable to the gas.Īccelerators are machines used to generate electrons (e-beam) and x-rays, which are also ionizing radiation, used to sterilize medical devices. It is a very strong alkylating agent that stops cell reproduction and kills harmful microorganisms. The most popular alternative technology, ethylene oxide (EO) gas is used for sterilizing and decontaminating many products. It is ideal for complex devices with long lumens, sealed cavities and mated surfaces. Gamma irradiation is known as a “cold process” as the temperature of the processed product does not significantly increase.īecause of its excellent penetrating power, cobalt-60 enables treatment of products in their final hermetically sealed packaging, ensuring sterility until the product is removed from its package and put into use. For materials modification, the mechanism causes cross-linking of polymer chains, creating stronger molecular bonds or chain-scission for shorter polymer chains. For sterilization applications this has the effect of disrupting DNA, which renders any microorganisms present nonviable. ![]() Gamma rays from a source penetrate the targeted material and knock electrons from orbit. ![]() The How and Why of Cobalt-60Ĭobalt-60 is type of ionizing radiation. This underscores the important interdependent relationship between the gamma processing and medical device manufacturing industries. Overall sterilization of single-use medical device sterilization accounts for approximately 80% of the volume of product commercially processed with gamma radiation. The United States has just over 50% of the total cobalt-60 installed base contained in 51 commercial irradiation facilities. The worldwide installed base of cobalt-60 is approximately 260 million curies, contained in more than 160 large-scale gamma facilities. Other beneficial uses include food preservation, decontamination of packaging materials, sanitization of cosmetics, microbial reduction in pharmaceuticals and quarantine application of consumer products. Cobalt-60 plays an important role in the scientific community as well, from promising new stem cell research to the design and testing of components for the aerospace and nuclear energy industries. In addition to these important healthcare applications, cobalt-60 is also used for materials modification processes such as the cross-linking of large plastic automotive parts that are strong and flame-retardant. As well the Leksell Gamma Knife, using tiny cobalt-60 sources, is the premier non-invasive, radiosurgery method for treating brain disorders. An estimated 15 million cancer treatments are carried out each year in hospitals and clinics in over 80 countries using these machines, which enable reliable and affordable care for patients. alone, are sterilized by gamma irradiation.Ĭobalt-60 is also used as a radiation source in external beam therapy equipment. More than 40% of these products, equating to 200 million cubic feet per year in the U.S. These products, including syringes, catheters, surgical gloves, bandages, drapes, gowns and hundred of others must meet strict FDA regulations for sterility, to protect against patient infection. ![]() The United States currently produces 50% of the medical devices manufactured globally. Gamma irradiation is a very widespread application of nuclear technology for peaceful purposes, and positively impacts the lives of millions of people on a daily basis. Over the ensuing decades, the industry has not only grown in size, but also in its diversity and sophistication. In the mid-1950s, the rising demand for sterile single-use medical devices paved the way for the expansion of radiation processing and specifically gamma sterilization using cobalt-60. ![]()
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