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The validation of a radiation sterilization dose involves an initial sterilization dose determination as well as maintenance of that sterilization dose. The procedures for maintenance of the sterilization dose typically include the periodic use of two types of tests bioburden and dose audits. The details for the procedures are outlined in the ISO radiation sterilization standards. These documents also provide guidelines for recommended actions in response to the results of the two tests. The results for the dose audit are based on the number of positive tests of sterility (TOS) for products that have been irradiated at a verification or experimental dose. When the dose audit yields TOS positives, it is often thought that they indicate a sterilization failure and nonsterile product. The belief that any TOS positive is a failure is an incorrect assumption because of the statistical basis used for the determination of the sterilization dose. This article will outline the truth of what dose audit TOS positives mean in terms of the sterility assurance of product, as well as the consequences of TOS positives.Flexible endoscopes are implicated in deaths from healthcare-associated infections (HAIs), in particular antibiotic-resistant infections. This article analyzes whether terminal sterilization should be required as part of endoscope reprocessing to reduce or eliminate HAIs and thus improve patient safety. Reusable flexible endoscopes are processed to make them ready for clinical use by the processing department of the healthcare facility. Unlike most critical and semicritical medical devices, the final step of processing an endoscope is high-level disinfection and not terminal sterilization. This is because most flexible endoscopes come in contact with mucosal membranes (versus contact with direct blood stream) and cannot withstand sterilization. However, sterilization currently is performed by a small number of U.S. healthcare facilities on reusable flexible endoscopes with the belief that they are safer for use compared to flexible endoscopes that are high-level disinfected. Based on the analysis in this article, terminal sterilization is not a required or necessary step to eliminate HAIs.In the radiation sterilization arena, the question often arises as to whether radiation resistance of microorganisms might be affected by the energy level of the radiation source and the rate of the dose delivered (kGy/time). The basis for the question is if the microbial lethality is affected by the radiation energy level and/or the rate the dose is delivered, then the ability to transfer dose among different radiation sources could be challenged. This study addressed that question by performing a microbial inactivation study using two radiation sources (gamma and electron beam [E-beam]), two microbial challenges (natural product bioburden and biological indicators), and four dose rates delivered by three energy levels (1.17 MeV [gamma], 1.33 MeV [gamma], and 10 MeV [high-energy E-beam]). Based on analysis of the data, no significant differences were seen in the rate of microbial lethality across the range of radiation energies evaluated. In summary, as long as proof exists that the specified dose is delivered, dose is dose.The requirements for the irradiation of healthcare products have been well established and implemented across the globe for several decades. The ISO 11137 series of standards gives the user the road map for designing a radiation process that will routinely deliver the required sterility assurance level so that product consistently meets specifications. The latest addition to the ISO 11137 series of standards should provide much-needed guidance around establishing a highly reproducible process based on a statistical analysis of the validated state of control. Most industries refer to this as "process control."This article will discuss opportunities to improve the efficiency of cobalt-60 (Co-60) utilization within a gamma irradiator. It will show how redistributing the Co-60 within the source rack may lead to improved throughput or dose uniformity within a product. It presents examples of modifications to the equipment within the source pass; these include reduction in the carrier wall thickness and changes to the product stack size. selleck kinase inhibitor It will discuss the process of scheduling and present ideas of how to optimize both the order of the products and transitions between the products to maximize process efficiencies.This article details the evaluation conducted for the potential to reduce ethylene oxide (EO) exposure times using data from currently validated EO sterilization cycles. The candidate cycles used the overkill half-cycle approach detailed in Annex B of ANSI/AAMI/ISO 111352014. The overkill half-cycle approach is conservative and has been the method of choice with medical device manufacturers because of its ease of understanding. The analysis presented provides an understanding of the extent of this conservative nature. Based on the analysis, exposure time can be reduced and rapidly implemented. The reduction in the exposure time may improve the product EO residuals and allow for additional time for the EO processing chamber to be utilized and/or for additional off-gassing for the product, if needed.Due to its complexity, sterilization has been perceived by some professionals who lack sterility assurance expertise as a "black box" process. Historically, medical device manufacturers have selected one of the available industrial sterilization options dry heat, moist heat, gamma, or ethylene oxide (EO). The preselection of a sterilization modality (method) typically is made without understanding its impact based on qualified sterilization processes for existing products, capability, or resources required for the specific processes. Early engagement with sterilization subject matter experts (SMEs) can redirect the decision to preselect a legacy modality and help foster innovation and operational agility. Recent focus on supply chain flexibility and sustainability by the medical device industry has been affected by concerns surrounding cobalt-60 shortages and EO emissions. These factors drive the need for early involvement with sterility assurance SMEs in the product development process and the exploration of multiple sterilization modalities.
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