Selecting and using the most appropriate sterilization packing for use in the healthcare setting today is a challenging responsibility for healthcare professionals and has an impact on surgical instruments and medical devices, infection control and patient safety, and the healthcare facility’s bottom line.
A variety of sterilization packaging materials and types including wraps, pouches, and rigid container systems are available in varying sizes and configurations to package and sterilize surgical instruments, medical devices, and other reusable supplies and equipment. The proper selection, use, and performance of sterilization packaging systems is crucial to achieve sterilization of the package contents, maintain sterility of the contents until the package is opened for use, and permit removal of the contents without contamination.
Sterilization packaging systems that are of high quality and performance optimize the ultimate goal of infection control and patient safety. Products that have been validated for effective sterilization performance and provide a reliable barrier to microbial penetration and protection against contamination during handling and storage should be selected for use.
Regulatory Requirements
[COLOR=“seagreen”]The Food and Drug Administration (FDA) regulate all sterilization packaging systems used by healthcare facilities to package and sterilize surgical instruments, medical devices, and equipment. These include wrap, pouches, rigid containers, trays, and cassettes.
Sterilization packaging systems are classified as Class II medical devices and require a 510(k) for their intended use to be legally marketed. Manufacturers of sterilization packaging systems must submit a Premarket Notification 510(k) Submission to the FDA prior to marketing their product. The submission includes a completed application, extensive data, documentation of testing and validation studies, special labeling, intended use, and instructions for use.[/color]
EN ISO 11607 - 1 refers to the series of European standards EN 868 to demonstrate compliance of the materials used to EU requirements. For sterilization wraps, EN 868-2 applies.It contains a non-exhaustive list of requirements concerning Strength, drapability, non-toxicity, resistance to water and disinfectants, and surface resistivity.
For steam sterilization, the two main cycles of sterilization are done at a temperature of 121 ° C or 134 °C. To reduce the risks of NCTA (transmissible agents as Creutzfeldt Jakob), the recommended cycle is 134 ° C for 18 minutes.The sterilization cycle is adjusted to the loading requiring sterilization and in all cases includes an air evacuation phase to assure even distribution of the sterilizing agent into the loading. Separatetextiles from instrumentation, (it is recommended to prepare an homogenious load.)
Key Factors
The purpose of sterilization packaging systems is to provide a safe and effective method to package and protect instruments and other medical supplies and equipment for sterilization, transportation, storage, and aseptic presentation.
The prime functions for effective packaging systems are to:
• Permit sterilization of the package contents
• Maintain sterility of the contents until the package is opened
• Permit aseptic presentation of the package contents
Several essential performance characteristics of packaging include:
• Ability to withstand physical conditions of the specific sterilization process
• Adequate air removal; sterilant penetration and contact with the
contents; and evacuation of the sterilant
• Free of toxic materials or dyes; and be low-linting
• Adequate barrier to microorganisms and environmental contaminants
• Durability to resist tears and punctures
• Removal of the contents without contamination
Additionally, packaging systems should be easy to use and cost-effective.
Packaging Options
Packaging systems must be appropriate for the items being sterilized and compatible with the specific method of sterilization to be used, i.e. steam, ethylene oxide, hydrogen peroxide gas plasma, or ozone. However, all packaging types and materials are not appropriate for all devices or compatible with all sterilization methods. Each packaging system should be used in accordance with the manufacturers’ written instructions.
The correct choice and use of sterilization packaging is critical to achieve sterilization of the contents and maintain the sterility of the contents until used. Several materials and combinations of materials most commonly used for in-house sterilization packaging include woven textiles, non-woven materials, and rigid sterilization containers.
Other important standards are attached as a JPEG sheet.
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