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CS Solutions
with Ray Taurasi
Editor’sNote: Your questions can be e-mailed to
jakridge@hpnonline. CS Question: If a hair is found in an instrument tray that was sterilized in Central Processing, would that tray still be considered sterile? In other words, isn’t the hair sterile as well? CS Answer: Sterile or not a hair found in a set of instruments is not acceptable.The entire set is suspect and should not be used. You can’t be sure if there may have been more hairs that were undetected in the set. One would have to question the quality of the entire set’s processing. An undetected hair on an instrument could end up in the patient and as a foreign body could cause very serious adverse conditions and risks to the patient’s welfare. CS Question: I know that we are not supposed to use muslin or non-woven wrap in flash sterilization. Why is this? CS Answer: Both Muslin and non-woven wraps do provide an effective barrier for steam and gas sterilized items. When these wraps are used for steam pre-vacuum and gravity displacement sterilization it is imperative that all air entrapped within the package must be eliminated to allow intimate contact with the steam sterilant. The pre vacuum (dynamic air removal) sterilizer accomplishes this with the use of a vacuum. The gravity displacement cycle relies on the principle of gravity to draw the air from the wrapped goods and sterilizer chamber. To accomplish complete air removal from wrapped goods could require significant time, up to 30 minutes or more in a gravity cycle. When employing flash sterilization the time required to accomplish proper pre-vacuum or gravity air removal may not be available or reasonable. Failure to remove the entrapped air could result in inadequate sterilization. CS Question: What is the significance and difference between bioburden and biofilm as it relates to sterilization? CS Answer: Bioburden refers to the amount of microbial contamination; or viable microorganisms present on objects prior to sterilization. Biofilms are microscopic organisms that even in the presence of water solutions adhere and cling to surfaces. Biofilms exude a thin resistant layer of microorganisms (bacteria), which can coat the various surfaces of medical devices. The resistant biofilm coating presents a barrier preventing disinfectants, antimicrobials and sterilants from achieving the required direct and intimate contact with contaminated surfaces. Thorough cleaning is the critical first step in the sterilization process. Cleaning agents and detergents must be carefully selected to address the types and forms of soils likely to be found on medical devices including biofilms. Procedures and policies should be developed that will ensure the expedient handling of soiled goods in order to minimize the time between use and reprocessing. Rapid attention may decrease the formation of biofilms and reduce the proliferation of microorganisms and bio burden. Biofilms and excessive bio burdens may present too great of a challenge for the routine and established sterilization parameters used in common practice. CS Question: My hospital is in the process of building an offsite clinic approximately an hour away and I have been given the task of trying to find some used sterilization equipment. What is the difference between refurbished and remanufactured equipment and what are the legal responsibilities of the seller? CS Answer: Considering the critical nature and impact that sterilization equipment can have on employee and patient safety it is essential that you purchase such equipment from a reliable source. There are reputable companies and manufacturers that deal in the sale of used, refurbished and remanufactured medical equipment. Be certain to research and obtain references before sealing any deals. There are differences in meaning between refurbished and remanufactured as well as FDA requirements. A remanufactured device is basically a new (remade) device and the original manufacturer is devoid of any responsibility. Original claims, FDA clearances, validations and the like are nullified. When purchasing a remanufactured sterilizer, be certain the company who did the re-manufacturing is a registered facility with the FDA and that a 510(k) is on file for commercial distribution. The labeling furnished will provide the intended use instructions, and validations. If the equipment / sterilizer is called refurbished or reconditioned, then the FDA considers that the device must fully meet the original equipment manufacturers (OEM’s) specification, to include all components, parts, electronics, valves, plumbing, operations and ultimate performance. CS Question: How many different kinds of chemical indicators are required in CPD? Is it possible to standardize on one that will handle all needs? CS Answer: Chemical indicators (CIs) are one of the essential tools in monitoring the sterilization process. Chemical indicators involve a system that reveals / monitors a change in one or more of the defined required parameters in the sterilization process based on either a chemical or physical change. Chemical indicators therefore are designed for a specific type of sterilant or sterilization process. Since most hospitals utilize more than one type of sterilant or sterilization process and it is essential to monitor different aspects of the process there is not one single chemical indicator that can be used for all purposes. Chemical Indicators (CIs) grouped into 5 classes – • Class I – process indicators (e.g. autoclave tape) • Class II – special tests (e.g. dynamic air removal) • Class III – single parameter indicator • Class IV – multi parameter indicator • Class V – integrators correlate to BIs |
June
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