*Slides updated to include newer guidelines in February 2016 by Shelby Lassiter, BSN, RN, CPHQ, CIC

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1 *Slides updated to include newer guidelines in February 2016 by Shelby Lassiter, BSN, RN, CPHQ, CIC 1

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8 If the instrument is not clean, the organic soil can harbor embedded microorganisms. Organic soil can prevent the penetration of the disinfectant and cause the disinfection or sterilization process to be ineffective. Additionally, some disinfectants are inactivated by organic material. 8

9 2. IFUs should be obtained and maintained at all times where staff performing the decontamination processes can access them at any time. They should be read and studied by each person performing these functions. Understanding and following IFUs is essential to ensure the item is cleaned and disinfected or sterilized correctly and to prevent damage to the item. In some situations, it may be best to simplify the instructions into the form of a checklist but it is never OK to change the meaning of the IFUs. Doing so can damage the equipment, void any warranty, and prevent the item from being safe to use on patients. 4. There are three basic types of enzymes used in detergents: proteases, amylases, and lipases. Proteases are the most important type of enzyme to look for when choosing an enzymatic detergent for medical use because there is a high content of protein in most body fluids (including blood, tissue and mucous) which cannot be easily removed with regular detergents and water. Consult the manufacturer IFU on the item being processed to determine the best type of enzymatic detergent to use for presoaking a particular item. 9

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12 Biofilm is any group of microorganisms in which cells stick together on a surface. Typically, within minutes, a layer of bacteria adsorbs to the surface of the item. This changes the chemical and physical properties of the item. These adsorbed materials condition the surface of the item and appear to increase the probability of the attachment of planktonic, or free-floating, bacteria. The free-floating bacteria encounter the conditioned surface and form a reversible, sometimes transient attachment often within minutes. If the association between the bacterium and the item persists long enough, other types of chemical and physical structures may form which transform the reversible adsorption to a permanent and essentially irreversible attachment. The cells growing in a biofilm are physiologically different from free-floating cells of the same type of organism and have been shown to be up to 1,000 times more resistant to antimicrobial agents. Biofilms start when a few cells attach to an object, such as a surgical instrument. If they are not immediately removed from the surface, they can anchor themselves more permanently using cell adhesion structures, making them very difficult to remove. This can interfere with disinfection and sterilization of such items. In healthcare settings, the items most affected by biofilms are those with lumens, those with irregular or serrated surfaces, and those with difficult-to-reach surfaces. 12

13 Transport of contaminated instruments or equipment carries the potential to expose many individuals to potentially infectious materials. This includes staff, patients, and visitors. Items must be appropriately handled and transported to minimize risk of exposures during transport. Therefore, the following steps are to be taken: <go to slide>. 1. The required PPE depends on the exposure risk, e.g. the risk of splashing, risk of getting items on clothing, etc. and may include gloves, gown, facemask and eye protection. 2. Throw away any disposable items 3. In general, decontamination of items should not occur in patient care areas, with the exception of initial removal of gross soil. Incidentally, not following guidelines and policies around transport of contaminated items is one of the most frequent Joint Commission citations occurring right now. 13

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15 Different kinds of transport containers are available commercially. Acceptable containers include covered/enclosed carts, bins with lids, sterilization containers with solid bottoms, and/or disposable, impermeable bags. Such containers should be able to withstand repeated cleaning and disinfection, if not disposable. OSHA BBP laws (d)(2)(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping (d)(2)(xiii)(a) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility (d)(2)(xiii)(b) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard (d)(2)(xiii)(c) If the specimen could puncture the primary container, the primary container shall be 15

16 placed within a secondary container which is puncture-resistant in addition to the above characteristics 15

17 It is important to prevent drying of organic soil on items as dried material is much harder to remove and can interfere with disinfection and sterilization. In general, decontamination of items should not occur in patient care areas, except for the initial removal of gross soil with water (Step 3 previously described, and Step 6 here.) 16

18 OSHA BBP laws (d)(2)(xiii) Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping (d)(2)(xiii)(a) The container for storage, transport, or shipping shall be labeled or color-coded according to paragraph (g)(1)(i) and closed prior to being stored, transported, or shipped. When a facility utilizes Universal Precautions in the handling of all specimens, the labeling/color-coding of specimens is not necessary provided containers are recognizable as containing specimens. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility (d)(2)(xiii)(b) If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and is labeled or color-coded according to the requirements of this standard (d)(2)(xiii)(c) If the specimen could puncture the primary container, the primary container shall be placed within a secondary container which is puncture-resistant in addition to the above characteristics 17

19 These questions are likely ones you will get from Joint Commission surveyors and they are good ones for oversight personnel to ask and assess regularly during gemba walks. 18

20 It is not possible to verify how all new, repaired, refurbished, and loaned instruments and devices have been handled, cleaned, inspected, or processed before receipt in the facility. Failure to clean, inspect, disinfect, or sterilize an item may lead to transmission of pathogenic microorganisms from a contaminated device and create a risk for patient injury, including surgical site infection (SSI). Inspecting instruments and devices upon receipt and before processing in accordance with the manufacturer s written IFU can help verify that there are no obvious defects and may prevent damaged or incorrectly functioning devices from being used in patient care. Persons may touch and contaminate instruments/devices without being aware of it. Instruments that were used may come in contact with unused items. Airborne microorganisms may come in contact with instruments that have not been used. Contamination of unused instruments on the sterile field can occur without the occurrence being noticed 19

21 Conditions of transport vary, and an event could occur during transport that could compromise sterility or cause damage to the instruments before they are received at the facility. Inspection verifies that the instruments have no visible defects or damage. Parameters of in house sterilization can be verified immediately after a cycle is complete. The using facility must have access to records of the sterilization process in the event of a recall. 20

22 Cleaning is a critical prerequisite for disinfection or sterilization and is to be performed as soon as is practical after use, meticulously and consistently. Cleaning may be performed manually, mechanically, or as a combination of these techniques. The cleaning method selected should be chosen based on the type of device and manufacturer recommendations. Dirty or used instruments must always be cleaned prior to disinfection/sterilization as well as new instruments and instruments that were opened but not used. (Even when sterilized instruments are opened but not used, there is no way to determine if they were handled with a contaminated glove or contaminated by splashing/droplets, so cleaning is still necessary.) In addition, instruments should be handled as though contaminated until processed through the full disinfection or sterilization cycle. 1 & 2: These instructions should contain information regarding the specific cleaning and/or disinfecting agent(s) recommended, cleaning tools/equipment needed, and methods to be used. These instructions are to be strictly followed at all times. If the instructions are unclear or incomplete, contact the manufacturer for clarity. All instructions obtained from the manufacturer/vendor must be in the form of a written statement; verbal instructions should not be accepted. Maintain the manufacturer s instructions on file, readily available to staff performing decontamination at all times. 21

23 Strictly follow manufacturer IFUs at all times. 21

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25 Whether cleaning is done manually or mechanically, these rules apply. Gembas are invaluable in monitoring these processes as there is often drift in practice around these tasks. 23

26 For this you need adequate lighting and consider a magnifying glass to ensure thorough cleaning and inspection. 24

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29 Disassemble instruments/items and ensure crevices, hinges, serrations, elevators, joints, etc. of each device is cleaned well. Visually examine items closely to ensure there is no visible debris left on item. You need to assess your decontamination area for lighting adequacy to ensure staff can visualize debris and to help them visually assess the equipment for damage. A magnifying glass for inspection of items should be considered. 27

30 As you can see from this diagram, endoscopes are highly complex devices with many ports and lumens that become heavily contaminated during routine use. Cleaning all lumens, channels, and removable parts is essential. Staff performing processing of such scopes need to be intimately familiar with how scope is designed and should have special, additional manufacturer training for each type of scope. Also, new AAMI guidelines require removable parts to be processed along with the scope with which they are used and should be stored together. 28

31 Extreme attention to detail and knowledge of how scopes are used by person processing instruments is essential. This is a picture of an EUS scope (Endoscopic ultrasound scope). The ultrasound transducer is integrated in the distal end of the endoscope which allows the close positioning of the transducer at the region of interest, providing tremendously increased resolution. They also allow biopsy of region of interest. All of this increases complexity in design and thus, complexity in reprocessing scope. Scopes should be taken through their full range of motion motions during the cleaning process to ensure all aspects, grooves, curvatures, nooks and crannies are cleaned well. 29

32 Providers may sometimes use a silicone spray/lubricant to lubricate endoscopes or laryngoscope blades to ease insertion when standard lubricants are ineffective. Such lubricants should be used if indicated but should not be used routinely. (E.g. Kospray, Silkospray ) Make sure person processing device knows if a silicone lubricant is used on the device so necessary cleaning steps can be followed. 30

33 It is critical to follow manufacturer IFU for rinsing after pre-soaking when manual cleaning is done 31

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35 The following references were used in the development of these slides. Congratulations! You have completed this module! 33

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