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Standard, contaminated instrumentation that is sharp must be transported com- pletely covered in a closed container, or in a cart that is puncture-resistant, leak-proof and labeled as biohazardous. Non-sharp contaminated items can be transported in a leak proof container marked as biohazard. The acceptable labeling methods required by OSHA are the biohazard label or a red bag.


Decontam room


Instrumentation should only be cleaned in the decontamination room, including loaner instrumentation. The decontamina- tion room should have all of the necessary decontamination equipment, cleaning im- plements and cleaning chemistries to thor- oughly clean instrumentation. Personnel must wear the required personnel protec- tive equipment (PPE) to be protected from biohazardous material. (See figure 1.) The standard PPE is: • Hair covering/cap • Fluid-resistant face mask • Fluid-resistant gown with sleeves (for example, a back- less gown, jumpsuit, or surgi- cal gown)


• Eye protection • Utility gloves that are durable to prevent tearing and leaking


• Liquid-resistant shoe covers should be worn if there is possibility of shoes becoming contaminated with bodily fluids.


Instrumentation should be


cleaned following the instru- ment manufacturer’s instruc- tions for use (IFU) in conjunction with the detergent’s IFU and processing equipment IFU.


After instrumentation is thoroughly cleaned, it must be thoroughly rinsed to remove residues. The quality of rinse water is very important, as the rinse water should not leave any residues on the instrumenta- tion.


Drying should be performed using clean lint-free cloths and instrument-grade air. Instrumentation that has areas with dif-


ficult to reach areas such as lumens, joints or crevices should undergo ultrasonic cleaning. Ultrasonic cleaning is designed for fine cleaning and only used after the gross soil has been removed. Instruments should be disassembled and in the open position. Instrumentation should be placed in metal baskets with enough holes to allow for the ultrasonic cleaning action to get to all areas of the instrument. Just as the cleaning solution in sinks needs to be changed fre- quently, so does the ultrasonic cleaner. The ultrasonic manufacturer’s IFU should be followed. Instrumentation pro- cessed through the washer disinfector should have the gross debris removed and be in the open position, placed so that the water can access all areas of the instrument. Multi-level instrument sets should be placed separately in the washer. Instruments should not be crowded. The spinning arms should be checked for obstruction. The detergents used should be compatible with both the washer and in- strumentation.


Figure 1


Best practices recommend that instrumen- tation is disassembled and opened as it goes through the cleaning process. All lumened items should be brushed and flushed using the correct size and type of brush until the lumen is cleaned. Only clean, lint free cloths, sponges and brushes are used. Once these cleaning implements become soiled, they should be replaced. The cleaning solution is changed frequently such as after each instrument set or as the solution becomes soiled.


The cleaning solution should be prepared and maintained following the detergent manufacturer’s IFU. Detergents have recommended dilution and some deter- gents, such as enzymatic detergents, have recommended temperatures that must be maintained.


Cleaning equipment should be tested at least


weekly; preferably daily to assure it is per- forming correctly using cleaning verifica- tion tests. There are numerous variables that can affect the cleaning ability of mechanical washers; to assure they are functioning properly verification testing is recom- mended. In addition, the mechanical clean- ing equipment IFU should be reviewed and followed. Some manufacturers recommend routine preventative maintenance be per- formed.


Preparation & sterilization After instrumentation has been cleaned it is ready for inspection and assembly. Preparation and packaging are performed in a clean environment. There should not be any instrumentation that has not undergone the cleaning process in this area. Instrumen-


SELF-STUDY SERIES


tation is inspected for functionality and cleanliness. Lighted magnification should be available. Instrumentation must be dry. If absorbent material must be used it must be nonlinting. Lumened instruments should be dried using instrument grade air. Instrument sets should be assembled so that the sterilant can reach all surfaces. The sets should not be too dense and the tray weight should not weigh more than 25 pounds. All jointed instruments should be in the open or unlocked position, multi-part instrumentation should be disassembled, unless the IFU states otherwise. Plastic-peel pouches should not be placed in instrument sets. Before double pouching with plastic peel-peel pouches, the manufacturer IFU should be consulted to assure they have been validated for this practice. Type 4, 5, or 6 chemical indicators are placed in the areas most resistant to the sterilization process, which may not necessarily be the center of the instrument set.


Instrumentation is packaged using packaging that has been validated for the method of sterilization to be used. To differ- entiate processed from unprocessed pack- ages, a Type 1 chemical indicator is placed on the exterior of each package, unless the interior chemical indicator is visible such as in a peel-pouch package.


The sterilization method selected is based


on the instrument IFU. It is important to completely review the IFU as some items may require a specific type of cycle such as a dynamic air removal or an extended sterilization cycle.


The sterilizer is loaded so that adequate space is left between items to allow for air removal, penetration of steam into each package, and steam evacuation. Basins and solid bottom pans should be positioned in the same direction and in a manner that al- lows for easy drainage. Plastic-peel pouches should be placed on their sides. If the load contains an implant, a biological process challenge device (PCD) which also contains a Type 5 chemical integrator is processed with the load to indicate that conditions for sterilization were met. The implant should be quarantined until the biological indicator results are known. Non-implant loads are monitored using a Type 5 or Type 6 chemical indicator or biological indicator PCD. All items in each load are assigned a lot control number and each item is labeled with that lot control number. A record with these lot control numbers is kept for all of the items in each load.


The sterilization cycle is selected and the cycle begins. At the end of the cycle the


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Self-Study Test Answers: 1 . B, 2 . A, 3 . C, 4 . A, 5 . C, 6 . B, 7 . A, 8 . C, 9 . A, 10 . D


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