Review and state of the art on radiation sterilization of medical devices

Abstract

Review and state of art of radiation sterilization Radiation as a sterilization method was designed in the years 1950–1960. The decade afterwards the application for sterilization of medical products and devices was developped. Extensive studies performed on both the physical, chemical and (micro) biological aspects revealed the requirements for safety and efficacy. These efforts were highly stimulated by the IAEA and resulted in a elegant sterilization method. In product manufacturing, where sterilization represents a final step in the production sequence, radiation has eversince reached its widest application in the field of medical devices. As a spin off it initiated new ideas and approaches towards sterilization in general. Consequently sterility was redefined in terms of a probabilistic concept (10-6) and the bioburden determination method was introduced as a tool for both quality control and potential instrument for dose setting. However these refinements also created controversies, whereby the dose requirements became divided for Europe and North America. Moreover studies recently performed in Europe suggest even a further extension of this opinion gap. Detailed studies, on the clinical effects of low dose treated products (12.5 – 17.5 kGy) are needed to counterbalance the dose suggestions extracted from statistically based dose determinations (> 28 kGy ) and the microbiological resistance determinations ( > 28 – 30 kGy). Dose setting based on risk classification could be considered for distinct product categories. In the mean time a general acceptance of the originally, in the early seventhies, established minimum dose of 25 kGy would seem a reasonable compromise. As the interest for radiation sterilization as the favourable, non polluting and simple method is increasing rapidly over the last five years, both gamma- and beta driven sterilization plants will be needed. Harmonization on sterilization dose therfore requires high priority.