SILVERTOUCH FOLEY CATHETER

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SILVERTOUCH FOLEY CATHETER THE STANDARD FOR SILVER Important National Initiatives 2009 CDC Guidelines for Prevention of Catheter Associated UTIs APIC Vision 2012 Joint Commission National Patient Safety Goals SHEA Strategies to Prevent Catheter Associated Urinary Tract Infections SCIP Measure 9 Compendium of strategies by CDC and SHEA

Important National Initiatives on Catheter Associated Urinary Tract Infections CAUTI A Compendium of Strategies by SHEA and the CDC to Prevent Healthcare-Associated Infections in Acute Care Hospitals Category A - Good evidence to support a recommendation for use A-I Evidence from randomized trial Maintain a sterile, continuously closed drainage system. Consider other methods for management, including condom catheters or in-and-out catheterization,when appropriate. A-II Evidence from well designed clinical trial Provide and implement written guidelines for catheter use, insertion, and maintenance. Maintain unobstructed urine flow. A-III Evidence based on opinions of authorities Ensure that supplies necessary for aseptictechnique catheter insertion are available. Implement a system for documenting the following information in the patient record: indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal. Ensure that there are sufficient trained personnel and technology resources to support surveillance of catheter use and outcomes. Educate healthcare personnel involved in the insertion, care, and maintenance of urinary catheters about CAUTI prevention, including alternatives to indwelling catheters and procedures for catheter insertion, management, and removal Properly secure indwelling catheters after insertion to prevent movement and urethral traction. SCIP Measure 9 Removal of urinary catheters This new measure states that urinary catheters are to be removed during the first or second day after surgery. The risk of urinary tract infection and bacteremia increase when a catheter remains in place for more than two days. Although this measure pertains primarily to inpatient cases, surgery departments will need to establish protocols for a physician order and a method of documenting catheter removals. APIC Vision 2012 APIC will emphasize prevention and promote zero tolerance for health careassociated infections and other adverse events. Joint Commission 2008 National Patient Safety Goals Reduce the risk of healthcare-associated infections. Encourage patients active involvement in their own care as a patient safety strategy. 2 1-800-MEDLINE www.medline.com

Important National Initiatives on Catheter Associated Urinary Tract Infections CAUTI 2009 CDC Guidelines for the Prevention of Catheter Associated UTIs Category IB Strongly Recommended, Supported by Theoretical Rational Insert catheters using aseptic technique and sterile equipment Properly secure indwelling catheters Insert catheters only for appropriate indications Minimize urinary catheter use Perform hand hygiene Mai ntain a sterile, continuously closed drainage system Maintain unobstructed urine flow Do not use systemic antimicrobials routinely to prevent CAUTI Remove the catheter as soon as possible postoperatively, preferably within 24 hours Category IC Required by Regulations Keep the catheter and collecting tube free from kinking Provide and implement evidence-based guidelines that address catheter use, insertion, and maintenance Ensure that healthcare personnel are given periodic in-service training Ensure that supplies necessary for aseptic technique for catheter insertion are available Category II Weak Recommendations Consider alternatives to indwelling catheters Consider using the smallest bore catheter possible Avoid bladder irrigation Do not change indwelling catheters or drainage bags at arbitrary fixed intervals Consider using an antimicrobial/antisepticimpregnated catheters only after implementing a comprehensive strategy does not reduce rates of CAUTI. Silicone may be preferable to other catheter materials to reduce the risk of encrustation Document the following in the patient record: indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter SHEA Strategies to Prevent Catheter-Associated Urinary Tract Infections in Acute Care Hospitals Outcomes associated with CAUTI Urinary tract infection is the most important adverse outcome of urinary catheter use. Bacteremia and sepsis may occur in a small proportion of infected patients. Morbidity attributable to any single episode of catheterization is limited, but the high frequency of catheter use in hospitalized patients means that the cumulative burden of CAUTI is substantial. Risk Factors The duration of catheterization is the most important risk factor for development of infection. Limiting catheter use and, when a catheter is indicated, minimizing the duration the catheter remains in situ are primary strategies for CAUTI prevention. Catheter materials Reviews of silver-coated and other antibacterial urinary catheters consistently conclude that evidence does not support a recommendation for the uniform use of such devices. Silver-alloy catheters may decrease bacteriuria but have not been shown to decrease symptomatic infection or other undesirable outcomes. Some of the variability in outcomes reported in trials of silver catheters may be related to whether the comparator catheter is silicone or latex. 1-800-MEDLINE www.medline.com 3

Foley catheter Silver ions provide antimicrobial action Silver ions have long been recognized for their broad-spectrum antimicrobial action. Ionic silver is effective against gram-positive and gram-negative bacteria, as well as fungi. Ionic silver hydrophilic catheter coatings can be very effective against the most common and serious UTI pathogens, including MRSA, VRE, E. coli, Candida albicans, Staph aureus, Pseudomonas, Klebsiella, and others.* Silvertouch catheters incorporate the power of silver through a patented process that binds silver ions to the catheter s lubricious coating. The Zone of Inhibition (ZOI) diameter is a measure of the effectiveness of a compound. The larger the clear area, the more effective the compound. Culture Strains Medline Silvertouch Competitor X Competitor Y Escherichia coli 5 0 0 Pseudomonas aerginosa 5 0 0 Klebseilla pneumoniae 5 0 1 Enterbacter cloacae 5 0 0 Citrobacter koseri 5 0 1 Proteus Mirabilis 0 0 0 Enterococcus faecium (VRE-A) 2 0 0 Enterococcus faecalis 2 0 0 Saprophyticus 7 0 1 Stapylococcus aureus (MRSA) 25 0 6 Candida albicans 5 0 0 Table 1. The diameters (mm) of grown inhibition zones produced by Silvertouch catheter when tested against a variety of microorganisms. Laboratory testing d ata available upon request. 4 1-800-MEDLINE www.medline.com

Medline s Silvertouch Foley catheter Competitive silver based catheter Biofilm formation Bacteria formation on the catheter surface is inevitable. Bacteria will locate a suitable environment and attach themselves. Once this occurs, microcolonies will form, called biofilm. The images above show Medline s Silvertouch Foley catheter compared to another silver based catheter on the market. From the images, you can see that due to Medline s ionic bonded silver ions, less biofilm has formed on the Silvertouch catheter surface. Better Lubricity Reduces Friction Catheter Brand Initial Value After 7 Days % Change Medline Silvertouch 0.13 0.09 31% decrease in friction Competitor X 0.11 0.15 36% increase in friction Competitor Y 0.13 0.25 92% increase in friction Figure 4. After 7 days incubation in artificial urine, the coefficient of friction of the Silvertouch Foley catheter was significantly lower than that of other commercial catheters. Laboratory testing d ata available upon request. Coefficient of Friction 0.3 0.25 0.2 0.15 0.1 0.05 0 Initial Value After 7 Days Medline Competitor X Competitor Y Silvertouch Hydrophilic coating ensures patient comfort An important parameter in clinical use of urinary catheters is their surface lubricity. Lubricity is typically characterized by a coefficient of friction, which is the ratio of the frictional force between the catheter and the patient. A lubricious, hydrophilic coating significantly reduces the friction between the catheter surface and the urethral mucosa. Some lubricious coatings can dissipate quickly once they are in contact with the urethral mucosa; other coatings can flake away. The unique process of covalently bonding polymers to the surface of the Medline Silvertouch catheter assures that the coating will remain on the surface. In fact, tests show that the lubricity on Silvertouch catheters actually improves over time. 1-800-MEDLINE www.medline.com 5

Silvertouch Foley Catheters Look for the green! Why are Silvertouch catheters green? The brilliant color is visual evidence of the silver hydrophilic coating on each catheter. Latex-Free Silvertouch catheters are latex-free, offering patient and caregiver safety, with the advantages of a 100% silicone catheter. Ordering Information Item Number Description Pkg Silvertouch Foley Catheters DYND141014 14Fr 10ml 10/ cs DYND141016 16Fr 10ml 10/ cs DYND141018 18Fr 10ml 10/cs DYND141020 20Fr 10ml 10/cs DYND141216 16Fr 30ml 10/cs DYND141218 18Fr 30ml 10/cs DYND141220 20Fr 30ml 10/cs Silvertouch Foley Catheter Trays DYND140214 14Fr 10ml 10/cs DYND140216 16Fr 10ml 10/cs DYND140218 18Fr 10ml 10/cs Silvertouch Foley Catheter Trays with Securement Device DYND140216S 16Fr 10ml 10/cs DYND140218S 18Fr 10ml 10/cs Silvertouch Foley Catheter Urine Meter Trays DYND140414 14Fr 10ml 10/cs DYND140416 16Fr 10ml 10/cs DYND140418 18Fr 10ml 10/cs We initiated exclusive use of the Silvertouch Foley catheter for all of our patients requiring catheterization. We were very excited after two months of use when we saw no catheterassociated urinary tract infections in our patients using the Silvertouch. As the months progressed we continued to see fantastic results. At the end of five months we saw a consistent pattern of zero catheter associated urinary tract infections. * Jackie Kassler RN, ADON St. Vincent s Rehabilitation Hospital *Surveillance Study on file Silvertouch Foley Catheter Urine Meter Trays with Securement Device DYND140416S 16Fr 10ml 10/cs DYND140418S 18Fr 10ml 10/cs Silvertouch Foley Catheter Tray 6 1-800-MEDLINE www.medline.com

It all starts with education and training Medline s Foley Catheter Management System follows evidence based practice and has an easy to remember acronym. E Evaluate Indications R Read Directions A Aseptic Technique S Secure Catheter E Educate Patient Medline s ERASE CAUTI prevention program is designed to meet the challenges healthcare professionals face with both clinical and educational resources. The program contains three distinct parts: 1. Unique Patented Tray Design: Promotes better processes 2. Education: Strategies to prevent CAUTI and a competency tool 3. Awareness Campaign: The Race to ERASE CAUTI It takes the right kind of products to ERASE Catheter Associated Urinary Tract Infections Silver ions have a broad-spectrum activity against gram-positive, gram-negative, aerobic, and anaerobic microorganisms. A number of studies have evaluated the effectiveness of antiseptic (silver) urinary catheters in preventing bacteriuria and CAUTI. A study performed at the Nebraska Medical Center looked at infection outcomes associated with the implementation of a silver urinary catheter. The study observed a significant decline in CAUTI rates. 6 Item Number Description Pkg Silvertouch Foley Catheter Management System Trays with Drainage Bag DYND160414 14Fr 10ml 10/cs DYND160416 16Fr 10ml 10/cs DYND160418 18Fr 10ml 10/cs Silvertouch Foley Catheter Management System Trays with Urine Meter DYND160514 14Fr 10ml 10/cs DYND160516 16Fr 10ml 10/cs DYND160518 18Fr 10ml 10/cs Silvertouch ERASE CAUTI Foley Catheter Management System Tray 1-800-MEDLINE www.medline.com 7

Foley catheter CDC Guideline for Prevention of Catheter-Associated UTI (Category I Recommendations) 1 Strongly recommends: Catheterize only when necessary Educate personnel in correct techniques of catheter insertion and care Emphasize handwashing Insert catheter using aseptic technique and sterile equipment Secure catheter properly Maintain closed sterile drainage Obtain urine specimens aseptically Maintain unobstructed urine flow Did You Know? CAUTI is the # 1 healthcare-associated infection (HAI), accounting for 40% of all nosocomial infections. 2 5% daily risk of CAUTI with short-term catheterization 3 1 in 4 patients receive an indwelling urinary catheter at some point during their hospital stay. 4 CMS reported in the 2008 Federal Register that in 2007 there were 12,185 CAUTIs, costing $44,043 per hospital stay. 5 References: 1 GUIDELINE FOR PREVENTION OF CATHETER-ASSOCIATED URINARY TRACT INFECTIONS 2008 DRAFT. Center for Disease Control and Prevention. http://cdc.gov. 2008 2 Catheter-related UTIs: a disconnect in preventive strategies. Physician s Weekly. 25(6), February 11, 2008. 3 Wong, Edward S. Guideline for Prevention of Catheter-Associated Urinary Tract Infections. Centers for Disease Control and Prevention. DHQP P3. 1981. 4 Saint S, Kaufman SR, Thompson M, Rogers MA, Chenoweth CE. A reminder reduces urinary catheterization in hospitalized patients. Jt Comm J Qual Patient Saf. 2005;31(8):455-462. 5 CMS, Proposed Changes to the Hospital IPPS and FY2009 rates; Available at http://edocket.access.gpo.gov/2008/pdf/08-1135.pdf. Accessed July 24, 2009 6 Rupp, M, Fitzgerald T, Marion N, Helget V, et al. Effect of Silver-coated Urinary Catheters: efficacy, cost-effectiveness, and antimicrobial resistance. American Journal of Infection Control. 2004:Vol 32, number 8: 445-450. Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Medline United States Medline Canada Medline México 1-800-MEDLINE (633-5463) 1-800-396-6996 01-800-831-0898 www.medline.com info@medline.com www.medline.ca canada@medline.com www.medlinemexico.com mexico@medline.com Some products may not be available for sale in Mexico or Canada. We reserve the right to correct any errors that may occur within this brochure. 2009 Medline Industries, Inc. Medline is a registered trademark and Silvertouch and ERASE CAUTI are trademarks of Medline Industries, Inc. ERASE CAUTI Foley Catheter Management System Tray design patents pending. MKT210104/LIT498/5M/TKZ6