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Cellulosic Textiles as Wrapping Material in Medical Sterilization

Apart from protective and hygienic purposes, cellulosic medical textiles are often used for wrapping medical material in sterilization. For this specific purpose, cellulosic textiles have to provide protection against penetration of microorganisms and maintain sterility of the package content prior to its use. This type of use in sterilization has not been tested until now and the function of the microbial barrier system has not been proven as yet. Furthermore, no testing method for this specific type of use exists. The University of Zagreb, Faculty of Textile Technology, Clinical Department for Sterilization and Medical Surveillance of Employees as well as The Department of Clinical and Molecular Microbiology, University Hospital Centre Zagreb have been working together on the thesis of this work. They have developed new methods for testing permeability and durability of the microbial barrier intended for testing multiple use medical cellulosic textiles, employed primarily as wrapping materials in sterilization. The method for testing permeability of the microbial barrier in dry conditions can also be applied for testing permeability of microorganisms in uniforms of the medical staff. The efficiency and durability of the microbial barrier, conditioned by different process parameters, were determined. Maximum number of the washing and sterilization cycles was defined with respect to the loss of functionality or barrier properties. Bacterial spores of the Bacillus genus were used (Geobacillus stearothermophilus and Bacillus atrophaeus) as the only dry form of microorganisms whose primary purpose is biological control of sterilization. This work is of special interest since microorganisms in dry form were used as opposed to the suspensions of different types of microorganisms used in similar research. Testing was conducted after 1, 10, 20, 30 and 50 washing and sterilization cycles under real hospital conditions. The durability of the microbial barrier of medical textiles was tested after 1, 2 and 3 months of storage in controlled conditions. Three-layer textile laminate PES/PU/PES, in accordance with the mentioned standards, was used as a reference material to determine the efficiency of the newly developed methods. The results showed that certain degree of bacteria penetrate the cellulosic medical textiles when contaminated with an extreme quantity of aerobic bacterial spores. On the other hand, the bacteria did not penetrate the three-layer textile laminate PES/PU/PES. Based on the results obtained, it can be concluded that medical cellulosic textiles used in real hospital conditions after 50 washing and sterilization cycles and 3 months of storage possess excellent properties of a microbial barrier, since the sterilized material remained uncontaminated, and as such they could be used as a microbial barrier system for wrapping in sterilization. The cellulosic medical textiles used can provide safe protection against contamination after sterilization even if they are not standardized in compliance with the HRN EN 868-02:2010 Packaging materials for terminally sterilized medical devices. Part 2: sterilization wrap -- requirements and test methods, or the international standard EN ISO 11607-1:2010 Packaging for terminally sterilized medical devices, part 1: requirements for materials, sterile barrier systems and packaging systems.

cellulose, multiple-use medical textiles, microbial barrier, sterilization, Geobacillus stearothermophilus, Bacillus atrophaeus

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