OCTOBER - 20228In My OpinionENSURING PACKAGING MATERIALS AND STERILIZATION ARE COMPATIBLEAs product development continues in the medical device space, packaging and sterility assurance are being viewed through an innovative lens. The innovation lens provides fresh insight, casts a new light over the market, which inspires innovation excellence. Environmental concerns, cost savings, and speed have led medical device manufacturers to research and better understand various sterilization modalities. There are various types of sterilization equipment and multiple packaging materials to consider. Care must be taken to ensure the materials are compatible with the sterilization process. In selecting the materials for sterile barrier systems, it is important to understand the sterilization process that they will be subjected to and its limitations. It is essential that any detrimental effects of the process on the materials do not affect the overall functionality of the sterile barrier, subsequent storage, and usage of the device.Packaging MaterialsPackaging materials include wrapped perforated instrument trays, peel pouches of paper, plastic or paper/plastic, and sterilization wraps which can be either woven or unwoven. Packaging materials should be designed for the type of sterilization process being used and should be appropriate for the items being sterilized. Ensure that packaging materials are compatible with the sterilization process and have received FDA 510[k] clearance. Packaging materials (e.g., wrapped or peel pouches) allow penetration of the sterilizing agent and maintain sterility of the processed item after sterilization. Packaging must allow the packages to be opened easily and aseptically. Packaging must be permeable, water repellent, resistant to tears, and impermeable to microorganisms. After sterilization, the packaging must keep the instruments sterile until used.Sterilization TechnologiesMedical devices are sterilized in a variety of ways, including using moist heat (steam), dry heat, ethylene oxide gas, vaporized hydrogen peroxide, radiation and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).Steam Sterilization Steam sterilization allows sterilization of a wide range of materials. Steam is the preferred method for sterilizing critical medical and surgical instruments that are not damaged by heat, steam, pressure, or moisture. Steam sterilizers (autoclaves) are the most popular method of sterilization. If using steam sterilization, the packaging material requirements should allow steam to penetrate the package. One factor to consider is whether a gravity or prevacuum process is being used. If it is gravity, you do not want air entrapment between the package and the product. If that happens, it may not deliver the efficacy of sterilization you expect. If it is prevacuum, make sure you are using a packaging material that can withstand a very rapid evacuation process.Acceptable materials for steam sterilization are paper plastic, paper/plastic peel packages; sterilization wraps which can be either woven or unwoven.Foils are not compatible.Ethylene Oxide Gas (ETO)Ethylene oxide gas can sterilize heat or moisture-sensitive medical equipment without deleterious effects on the material used in the medical devices. However, ETO gas Ruth Plotkin Shumaker, BSN, RN, CNOR, Executive Director Perioperative Services, Regional One HealthByRuth Plotkin Shumaker
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