RADIATION STERILIZATION OF DISPOSABLE MEDICAL DEVICES.

Radiation sterilization is the application of ionizing radiation to penetrate an object - in this case a disposable medical device and its package - in a manner which is lethal to contained microorganisms. Sterilization is not accomplished by obliterating or removing the microorganisms but rather by rendering them incapable of growth. The two classes of radiation which could have sufficient energy to ionize matter are electromagnetic and particulate. An obvious prime requirement of the radiation selected for the sterilization of medical devices is that no radioactivity be induced. Eliminated from consideration then are protons, neutrons, alpha particles and electrons of energies above 10 million electron volts (MeV). The ionizing radiation finding use in radiation sterilization are gamma photons from cobalt 60 and cesium 137, and machine generated high energy electrons. Theory and practice of sterilization of medical devices and their packages by using the ionizing radiation are discussed in some detail. It is demonstrated that radiation sterilization of disposable medical devices is a demonstrably superior technique having great advantages in microbiological control reliability and great potential for technological innovation.