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![Catheter Cleaning and High Level Disinfection Instructions The Centers for Disease Control (CDC) recommends the use of a probe cover or condom to reduce the level of microbial contamination when a probe cover is available[1]. It is also recommended that all catheters and probes require cleaning and high level disinfection to be performed after each use or as otherwise permissible by region/country/institution guidelines and/or standards where the product is being used. [1] Centers for Disease Control (CDC), Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC). The below table provides a multi-step process necessary to ensure optimal cleaning of the following catheters: ManoScan ESO Catheter ManoScan ESO Catheter with Extended Tip ManoScan ESO Z Catheter ManoScan ESO Catheter, SD Regular ManoScan ESO Catheter, SD Small ManoScan ESO 3D Catheter # Procedure 1 Removal from Patient 2 Cleaning Rinse (1 of 3 rinse cycles) Potable tap, filtered or sterile water may be used. 3 Cleaning Detergent Adhere to Example: Enzol® (Reference list below) Cleaning Detergent Instructions 4 Cleaning Rinse (2 of 3 rinse cycles) Potable tap, filtered or sterile water may be used. 5 High Level Disinfection (HLD) Example: Cidex® OPA Adhere to HLD (Reference list below) Instructions (except Sporox II immerse for 45 min.) 6 Cleaning Rinse (3 of 3 rinse cycles) Potable tap, filtered or sterile water may be used. 7 Dry 8 Storage Solution Duration Temperature Action • Remove ManoShield™ per IFU. • Cover the “Y” section and connector area with a water-proof element to avoid moisture during the entire cleaning process. 3 minutes 3 minutes 3 minutes Less than 113° F / 45° C • Thoroughly rinse external surfaces using a continuous flow of water. Adhere to Cleaning Detergent Instructions • Ensure the entire sensing portion of the probe is submerged in detergent. • Soak probe as per the detergent instructions. Less than 113° F / 45° C • Thoroughly rinse external surfaces using a continuous flow of water. Adhere to HLD Instructions • Ensure the entire sensing portion of the probe is submerged in HLD solution. • Soak probe as per the HLD instructions. Less than 113° F / 45° C • Thoroughly rinse external surfaces using a continuous flow of water. • Visually inspect catheter to ensure moisture is not present before storing. • The probe may be lightly padded dry avoiding direct pressure to the sensors. • Do not dry using excessive gripping, bending, or pulling in the sensor area. • Store dry catheter in protective case. Cleaning Detergents: Enzol® Enzymatic Detergent, Aniosyme DLT, Bodedex® Forte, and Matrix™ Biofilm Remover. High Level Disinfection (HLD) Solutions: Cidex® Plus, Cidex® OPA, Tristel™ Trio Wipes, Korsolex™ Basic, Korsolex™ Ready to use, Gigasept™ FF, Sekusept™ Plus, Sporox™ II (at 45 min.), Stabimed®, Korsolex™ Extra, Korsolex™ FF, Nuova Farmec Opaster, Soluscope D, Deconex® 53 Plus, and MetriCide™ OPA Plus. DO NOT USE: Rapicide®, Sterilox™, Parson’s soap, hydrogen peroxide, Endo-Spor, Sporox, Steris Washer, Gigasept Instru AF, Anioxyde 1000, and Actanios Prion. Given Imaging does not assume liability for damage due to unapproved cleaning processes and/or damage due to the use of unapproved disinfection solutions or detergents. 2987-11](https://images.bioclinicalservices.com.au/zeuog60icwlg5qwzmz408gu2lrs2/320w/Given%20Imaging%20-%20Medtronic%20-%202987-11%20-%20ManoScan%20Catheter%20Cleaning%20and%20High%20Level%20Disinfection%20Instructions.png)
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Catheter Cleaning and High Level Disinfection Instructions The Centers for Disease Control (CDC) recommends the use of a probe cover or condom to reduce the level of microbial contamination when a probe cover is available[1]. It is also recommended that all catheters and probes require cleaning and high level disinfection to be performed after each use or as otherwise permissible by region/country/institution guidelines and/or standards where the product is being used. [1] Centers for Disease Control (CDC), Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC). The below table provides a multi-step process necessary to ensure optimal cleaning of the following catheters: ManoScan ESO Catheter
ManoScan ESO Catheter with Extended Tip
ManoScan ESO Z Catheter
ManoScan ESO Catheter, SD Regular
ManoScan ESO Catheter, SD Small
ManoScan ESO 3D Catheter
#
Procedure
1
Removal from Patient
2
Cleaning Rinse (1 of 3 rinse cycles)
Potable tap, filtered or sterile water may be used.
3
Cleaning Detergent
Adhere to Example: Enzol® (Reference list below) Cleaning Detergent Instructions
4
Cleaning Rinse (2 of 3 rinse cycles)
Potable tap, filtered or sterile water may be used.
5
High Level Disinfection (HLD)
Example: Cidex® OPA Adhere to HLD (Reference list below) Instructions (except Sporox II immerse for 45 min.)
6
Cleaning Rinse (3 of 3 rinse cycles)
Potable tap, filtered or sterile water may be used.
7 Dry
8
Storage
Solution
Duration
Temperature
Action • Remove ManoShield™ per IFU. • Cover the “Y” section and connector area with a water-proof element to avoid moisture during the entire cleaning process.
3 minutes
3 minutes
3 minutes
Less than 113° F / 45° C
• Thoroughly rinse external surfaces using a continuous flow of water.
Adhere to Cleaning Detergent Instructions
• Ensure the entire sensing portion of the probe is submerged in detergent. • Soak probe as per the detergent instructions.
Less than 113° F / 45° C
• Thoroughly rinse external surfaces using a continuous flow of water.
Adhere to HLD Instructions
• Ensure the entire sensing portion of the probe is submerged in HLD solution. • Soak probe as per the HLD instructions.
Less than 113° F / 45° C
• Thoroughly rinse external surfaces using a continuous flow of water.
• Visually inspect catheter to ensure moisture is not present before storing. • The probe may be lightly padded dry avoiding direct pressure to the sensors. • Do not dry using excessive gripping, bending, or pulling in the sensor area. • Store dry catheter in protective case.
Cleaning Detergents: Enzol® Enzymatic Detergent, Aniosyme DLT, Bodedex® Forte, and Matrix™ Biofilm Remover. High Level Disinfection (HLD) Solutions: Cidex® Plus, Cidex® OPA, Tristel™ Trio Wipes, Korsolex™ Basic, Korsolex™ Ready to use, Gigasept™ FF, Sekusept™ Plus, Sporox™ II (at 45 min.), Stabimed®, Korsolex™ Extra, Korsolex™ FF, Nuova Farmec Opaster, Soluscope D, Deconex® 53 Plus, and MetriCide™ OPA Plus. DO NOT USE: Rapicide®, Sterilox™, Parson’s soap, hydrogen peroxide, Endo-Spor, Sporox, Steris Washer, Gigasept Instru AF, Anioxyde 1000, and Actanios Prion. Given Imaging does not assume liability for damage due to unapproved cleaning processes and/or damage due to the use of unapproved disinfection solutions or detergents.
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CATHETER CARE PRECAUTIONS: 1. Given Imaging DOES NOT perform disinfection of gastrointestinal probes prior to shipment. Proper disinfection of a probe is the responsibility of the clinician prior to conducting the procedure. The following recommendations are intended to aid in the cleaning or disinfection of a Given Imaging catheter without causing damage. 2. DO NOT ultrasonically clean or other agitation, autoclave, use ionizing radiation, or use products containing glycerin while washing, cleaning, or disinfecting. This can permanently damage probes. 3. DO NOT clean the probes with strongly-alkaline cleaning agents such as Parson’s soap or strongly-oxidizing agents such as peracetic acid or hydrogen peroxide. Disinfectants such as Endo-Spor, Sporox and the Steris Washer use hydrogen peroxide as a primary agent in their formulation and will damage the probe. 4. DO NOT use synthetic detergents or petroleum-based soaps as these may be absorbed by the silicone and subsequently leach out during prolonged use. 5. DO NOT use silicone fluid or grease to lubricate the passage of the probe through the nares (nostril) or anus as these materials may swell and weaken the tubing and consequently compromise the integrity of the outer section of the probe. Water-based lubricants are acceptable for use. 6. DO NOT immerse the probe beyond the “Do Not Immerse” demarcation line near the proximal end of the probe (the end with the electrical connectors and vent orifice). This can permanently damage probes. 7. DO NOT pull on the outer sleeve of the catheter probe while cleaning. This can cause bunching of the outer sleeve and potentially damage the probe. 8. DO inspect for tears or damage in the exterior of the catheter. The inspection should be done before immersion of the catheter in reprocessing solutions to minimize further damage of the catheter to parts not designed for fluid exposure. 9. DO reference the ManoScan User Manual for additional information for catheter care precautions. 10.DO reference the ManoShield® Instructions for Use. 11. The ruled tubing and “Y” connector section of the probe may be cleaned with an antiseptic towelette or germicidal disposable Cloth. Adhere to the manufacturer’s guidelines when using antiseptic or germicidal towelette or cloth. Given Imaging recommends the following cleaning cloths and/or towelettes: Benzalkonium antiseptic (BZK) towelettes PDI, Sani-Cloth® Plus, germicidal disposable cloth PDI, Super Sani-Cloth® Plus, germicidal Wipes Accel PREVention™ surface disinfectant (applied to sterile wipe, cloth, or gauze) CLEANING VALIDATION REFERENCES: AAMI TIR12:2010 – Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. AAMI TIR30:2003 – A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. ISO 10993-17:2002 – Biological evaluation of medical devices – Part 17: Method for the establishment of allowable limits for leachable substances. ISO 13485:2003 – Medical devices – Quality management systems – Requirements for regulatory purposes. ISO14971:2007 – Medical devices – Application of risk management to medical devices. ISO 17664:2004 – Sterilization of medical devices – information to be provided by the manufacturer for the processing of resterilizable medical devices. United States Pharmacopeia (USP), current edition.
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