Maintenance of Sterility - Essay Example

Introduction Maintenance of sterility for individually packed supplementary instruments and instrument sets packed in re-usable sterilization containers is very essential. Packaging of these instruments plays an important role in seeing to it that the sterilized instrument remains sterile until its use on the patient. Regardless of the keenness and safety that is observed when manufacturing these instruments, one cannot think of their sterility without thinking of the safety observed when packaging. The development and designing of a packaging system for sterilized medical devices is a complicated issue and a critical endeavor. The instruments to be packed and the packaging system should be combined to ensure that the product that is packed is safe both to the user and the patient. The work of the BS EN ISO 11607 is to specify standard materials that can be used to develop these products and the pre-formed systems that can be used in packaging systems that can be used to package these devices. It also defines the range of potential materials that are safe to use in producing the medical devices and the packaging bags. The designs for packaging systems and the methods for sterilizing these devices are contained also in the BS EN ISO 11607. The standard here describes the valid requirements for forming, sealing, and the whole process of assembling of the instruments that are manufactured. The document EN ISO 11607 specifies general requirements for all packaging materials. ISO 11607 part 1 specifies the sterile barrier system requirements, the packaging requirements, and the requirements for materials. The second part gives the requirements and validations for forming, sealing, and the process of assembling the devices. Part two of BS EN 868 gives the particular requirements for a range of commonly used materials. BS EN 868 series contains the requirement for particular materials contained in the European standards and also the pre-formed sterile barrier systems. Sterile Barrier System A sterile barrier system provides a microbial barrier and also allows aseptic presentation of the product unit at the point where it will be used. The two combined documents simply define the minimum packaging configurations (Molnlyske, 2007, p1). ISO 11607 is a package validation document for terminally sterilized medical devices and provides assurance that a medical device has been maintained in a sterile environment and has not been impacted by the Elements, manufacturing processes, shipping or storage. These standards apply regardless of the manufacturer of the instrument (McCarthy, 2002, p80). There exist process windows and specifications where a process window defines the manufacturing parameters under which the sterile barrier system will be produced. Specifications define the various properties and characteristics of the sterile barrier system, establishing limits where appropriate. Some properties that may be included in a specification are dimensional requirements, seal strength, and seal integrity to name a few. Part 1 of ISO 11607 defines the materials and designs that used in the production of the instruments while part 2 defines the processes, that is, the forming, sealing, and assembly process requirements. The device can therefore pass the package testing and validation or fail costly. The most critical processes are the forming and the sealing. A sterile barrier system is termed as a well defined system if it allows a medical device to be sterilized, maintains sterility and proves the device to be sterile until the time of use or the expiration date. The device is thus presented in an aseptic manner, safe to be used. There are some laid design requirements that guide the manufacturer toward the correct sterile barrier system to use. Sterile barrier system falls into two categories which are the reusable sterile barrier systems and the pre-formed sterile barrier systems (Schmelz, 2009, p11). The preformed sterile barrier system defines a partially assembled sterile barrier system that is prior to filling and final closure of the product. It requires only a closure seal upon device loading. Validation of the sealing process is fundamentally very simple to implement especially when sealing devices comply or machines comply with the appropriate requirements. Sterile containers are designed to be repeatedly used and they belong to the group of preformed sterile barrier system. The use of reusable containers for sterile packaging allows systematic organization of sterile goods in a safe and economic manner (Tim, 2008, p1). ISO 11607 offers a specific definition concerning a sterile fluid path which is a special case when it comes to sterile barrier systems. In this system, fluids flow through a lumen; the critical characteristic is that the inside of the tube is sterile. This is quite different from a typical medical instrument which ensures that the outside of the instrument is sterile. The closure system must ensure that sterility is maintained until the point of use. When many sterile fluid path systems are packaged in pouches, it is important to determine in each case what is providing the sterile barrier and to make sure that the package is labeled accordingly. According to the clauses in these documents, a sterile barrier system family will be made with common materials using a common process but be of different sizes. Also, performance testing should be conducted on sterile barrier systems that represent the range of variation that will be seen in the sterile barrier system. Protective Packaging Protective packaging is used to protect damage of the sterile barrier system and its contents from the point that they are being assembled to the point that they are being used. Continuing efforts to see to it that devices are properly and protective packaging has taken place led to the development of the documents ISO 11607 and EN 868 by the international organization for standardization. Single-use packaging system is the best as it offers high level sterility, safety and efficiency. After the devices have been manufactured, they are cleaned and sterilized so as to eliminate any germs or harmful elements that could be contained in the devices. A barrier is then required to protect the cleaned and sterilized devices from contamination until when they are used (Canon, 2006, p1). This means that the package of a device that has been sterilized is essential and necessary. Several aspects have to be considered before choosing any packaging material to be used for packaging. The device to be packaged has to be considered first before choosing any material to use for packaging the device. BS EN 868 series provides the requirements for particular materials to be used. BS EN ISO 11607-1 in conjunction with BS EN 868 PART 2 acts as a means of ensuring that the European directives concerning medical devices are kept up to standard and the essential requirements are followed and maintained. The choice of material to be used and the packaging system design are influenced by the nature of medical device, the intended use, sterilization methods, the expiry date, methods to be used in transporting the device, and the storage methods. Some devices are sharp, others are heavy, others are brittle, etc. The material used for packaging should not contribute to the harmfulness of the device being packaged by may be releasing harmful substances, or by going through some change during sterilization. The material used for package should be soft to allow easy package but on the other hand should be strong enough to ensure safety of the device. The material should not create pinholes and should clearly show damages to the device in case there is some damage. Another important aspect is the possibility of aseptic opening to the packed device (Diane, 2009, p1). Others include that the material itself should not allow passage of harmful substances to the packaged device. The packaged medical device should also be stable and the material used to manufacture the packaging device should be stable. The way that the device has been packed is another factor and the recommendation is that no micro organisms should be able to penetrate the material during transport and storage of the device (John, 1997, p45). Devices Used For Packaging The most commonly used devices for packaging of the sterilized medical devices are pouches, header bags, lidding materials, rollstocks, die cut insert cards, overlap bags for IV solutions, and bulk bags for pharmaceutical materials. Pouches both peelable and non-peelable can be designed for all conventional sterilization methods and are mainly used for storage of terminally sterilized medical devices. They have several types of opening features which depend on the device being packaged. Bulky devices are packaged and sterilized using header bags. The header bags can also be used as a second barrier layer for trays. Lidding materials provide an aseptic opening feature and also facilitate sterilization. This is because of the way they are sealed in a thermoformed tray containing a sterilizable medical device. Overwrap bags offer unique packaging solutions during delivery of drugs. Packaging Systems Packaging systems defines the configurations for both the sterile barrier system and those for the protective packaging. ISO 11607 describes a packaging system of a medical device as the combined efforts seen in the designing of the sterile barrier system and the process of protective packaging (Chris, 2004, p125). The whole process from the materials to be used for packaging through the pre-formed sterile barrier systems to the protective packaging try to ensure the sterility of medical devices until when they reach their point of use. It is very essential as it combines the whole process thus ensuring that not a single step has been left in between in the process of coming with the correct device and the way in which it is packaged. Conclusion ISO 11607 part 1 and 2 and EN 868 part 2 have made major contributions using the standards they contain which ensure that sterility for individually packed supplementary instruments and instrument sets packed in re-usable sterilization are up to standard. Part one of ISO 11607 describes the particular requirements for the materials to be used and the sealing process while the second part defines the validation guidelines for the packaging process. The second part of EN 868 defines the test methods and the particular requirements for a range of materials used for manufacturing the medical devices and the packaging bags. These two documents precisely define the sterile barrier system which defines the configurations that are used to ensure that the product are free from germs and allows for aseptic presentation of the product at the point of use. The documents recognize the critical nature of sterile barrier systems by considering them as an accessory or a component of some medical devices. A sterile barrier system is divided into preformed sterile barrier system and reusable sterile barrier system. The documents also define protective packaging that prevents damage to the packaged product and the sterile barrier system from when they are being delivered to the time they are being used. Packaging systems are also defined which contain the overall process from the sterile barrier system to protective packaging. The system ensures that the devices maintain the laid standards and they are safe both to the medical practitioner and to the patient. References Canon communications, (2006): 1. Pharmaceutical & Medical Packaging News, Retrieved from Newshttp://www.devicelink.com/pmpn/webcasts/reducing_part1q.htm; on 17-July-2009. Chris, B. M. (2004): 124-128. Healthcare Products and their Safety. Cambridge: Cambridge University Press. Diane, H. F. (2009):1. Medical Device Packaging. Retrieved from http://www.vanderstahl.com/the_sterile_barrier_system.html; on 17-July-2009. John, T. S. (1997): 44-51. US Food and Drug Administration. Oxford: Oxford University Press. McCarthy, J. B. (2002): 76-84. Packaging Systems by the International Organization for Standardization. New York: Blackwell Publishers. Molnlyske, H. C. (2007): 1. Sterile Barrier Systems. Retrieved from http://www.molnlycke.com/au/Surgical-products/AUSNZ/Packaging-/Sterile- Barrier-System-/; on 17-July-2009. Schmelz, U. G. (2009): 11-15.infection Control and Hospital Epidemiology. Chicago: University of Chicago Press, Tim, G. B. (2008): 1. Sterilization: Past and Future, retrieved from http://www.wfhss.com/html/educ/articles/educarticle_0002.htm; on 17-July-2009. Read More