Silver makes it better. Silicone makes it best. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

Transcription

1 Silver makes it better. Silicone makes it best. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

2 COMPLICATIONS

3 A BROAD-SPECTRUM REAL SOLUTION for catheter complications. Complications due to indwelling catheters are a fact of life. Infection, stricture, encrustation and hypersensitivity are only some of the complications facing your urological patients. At DOVER Urologicals, we recognize proper catheter selection and insertion technique are critical. With a comprehensive system of urological products that address every facet of catheterization care, we offer an unmatched broad-spectrum solution that can help reduce the incidence of complications. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

4 COMPLICATIONS Encrustation Encrustation is a significant cause of catheter failure. The silicone-based DOVER catheters took a statistically significant longer time to block [occlude] than did latex-based Bardex catheters. Sabbuba N, Stickler D. Report of Encrustation Performance of Foley Catheters in a Laboratory Model of the Catheterized Bladder Cardiff School of Biosciences (December 2002). TYPE OF CATHETER MEAN TIME TO BLOCKAGE IN HOURS BARDEX LUBRICATH BARDEX IC DOVER SILICONE DOVER SILVER 30.5 HOURS 29.8 HOURS 53.7 HOURS 51.7 HOURS Average mean time to block ± 1 SD. Statistically significant in vitro study. As bacteria is inevitably associated with the encrustation and blockage, retention can facilitate ascending infection of the urinary tract, culminating in episodes of pyelonephritis, septicaemia and shock. Cross-sections of Bardex IC Catheter. Source: Sabbuba N, Stickler D. Morris NS, Stickler DJ. Encrustation of indwelling urethral catheters by Proteus Mirabilis biofilms growing in human urine. Journal of Hospital Infection (1998) 39: Incidence of urethritis Urethritis Urethritis is a major source of patient discomfort and contributes to a breakdown in tissue integrity % 2% 0 LATEX SILICONE Peer-reviewed, published, clinical in vivo study Source: Nacey JN, Tulloch AGS, Ferguson AF. p<0.01 Of those with latex catheters 22% developed urethritis, compared with 2% of those in the silicone catheter group. This difference is statistically significant (P<0.01). In all cases the urethritis developed during the first 12 hours of catheterization and continued for 5 to 12 days. Nacey JN, Tulloch AGS, Ferguson AF. Catheter-induced Urethritis: A Comparison Between Latex and Silicone Catheters in a Prospective Clinical Trial. British Journal of Urology (1985) 57:

5 Stricture Stricture reduces the ability of a patient to void which may lead to bladder distention, kidney failure and other major complications. Thus the overall incidence of urethral stricture in the group with latex catheters was 5.2% when followed up for between 15 and 24 months compared with 0% in those with silicone catheters followed up for between 12 and 28 months. On the basis of our two series, we suggest that Incidence of stricture silicone catheters be used routinely for short-term 10% catheterization in men undergoing bypass surgery. Ferrie BG, Groome J, Sethia B, Kirk D. Comparison of Silicone and Latex Catheters in the Development of Urethral Stricture after Cardiac Surgery. British Journal of Urology (1986) 58: Weaver and others have noted the direct relationship of pyuria and urinary tract infections to recurrent strictures. As our study developed it was found that urinary tract infections could be eradicated earlier postoperatively in the patients who had a Silastic [silicone] catheter than in those who had a latex catheter. Urethral stricture was found in 59 of 478 male patients who had undergone open-heart surgery between June 79 and December 81.. The stricture epidemic stopped after change of the latex catheters to silicone-ones. Ruutu M, Alfthan O, Heikkinen L, Jarvinen A, Konttinen M, Lehtonen T, Merikallio E, Standertskjold-Nordenstam CG. Unexpected urethral strictures after short-term catheterization in open-heart surgery. Scand J Urol Nephrol. (1984);18(1):9-12. Silicone catheters did not influence cell growth, which correlates with the finding that no new stricture cases were seen after the latex catheters were replaced with silicone ones. Ruutu M, Alfthan O, Talja M, Andersson LC. Cytotoxicity of latex urinary catheters. Br J Urol. (Feb 1985);57(1): % 5.2% LATEX COMPLICATIONS Wise H II, Engel RME, Whitaker RH. Treatment of Urethral Strictures. The Journal of Urology (1972) 107: Urethral stricture Normal urethra 0% SILICONE Peer-reviewed, published, clinical in vivo study. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

6 Hypersensitivity Latex, when used in direct patient contact, can be a significant source of irritation. The ideal materials should be biologically inert, chemically stable in urine without any release of toxic contaminants and resistant to encrustation. Pariente FL, Bordenave L, Jacob F, Bareille R, Baquey C, Le Guillou M. Cytotoxicity Assessment of Latex Urinary Catheters on Cultured Human Urothelial Cells. European Urology (2000) 38: There is a wide range of catheter materials available and the material selected should be chosen for the following characteristics: comfort, presence of latex-sensitivity, ease of insertion and removal, and ability to reduce the likelihood of complications such as urethral and bladder tissue damage, colonization by micro-organisms, and encrustation Newman, D. Incontinence Products and Devices for the Elderly. Urologic Nursing (August 2004) 24: No. 4. Page 316. Closed System A closed system provides a barrier to bacterial introduction into the urinary tract and should include all points of contamination including the drain spout. Intraluminal contamination occurs by the reflux of microorganisms gaining access to the catheter lumen from failure of closed drainage or contamination of urine in the collection bag. Maki D, Tambyah P. Engineering Out the Risk of Infection with Urinary Cathethers. Emerging Infectious Disease (March - April 2001) 7: No. 2; 1-6. Patients managed by a non-sealed catheter had 2.7 times the risk for a UTI than those managed by a sealed system. Platt R MD, Polk B Frank MD, Murdock B, Rosner B. Mortality Associated with Nosocomial Urinary Tract Infection. The New England Journal of Medicine (1982) 307:

7 Five Point Care System DOVER Urological products address Kunin s four points* but don t stop there. Our Five Point Care System extends to a focus on education in sterile technique, to help prevent the entry of bacteria into the drainage system at any of the four points. 1. DOVER 100% Silicone Foley Catheters Silver makes it better. Silicone makes it best. 2. Durable Plastic Tamper Evident Seal 3. MONO-FLO Anti-Reflux Device 4. SPLASHGUARD II Drain Spout 5. Ensuring Aseptic Technique Premium Prepping Components * Kunin CM. Urinary Tract Infections (1972, 5th Edition) COMPLICATIONS COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

8 RELIABILITY & FUNCTION

9 IT S NOT JUST HOW IT S MADE. IT S HOW it works. Proven construction and materials matter. Proven performance matters even more. When you select the market leading DOVER 100% Silicone Catheters, you have chosen products that are fabricated from materials that out-perform latex. The result? The extrusion molding process, combined with the unique properties of silicone, provide larger internal lumens, greater resistance to shaft collapse and improved flow. DOVER Urological Products work better because they are made better. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

10 Construction For unparalled patient comfort and consistent clinical performance, today s silicone provides larger internal lumens, stronger catheter walls, better flow rates and true French sizes all in a biocompatible material. RELIABILITY & FUNCTION DOVER 100% Silicone Catheter A desirable property of silicone catheters compared to latex catheters is improved durability. Silicone catheters may be better suited to patients who have undergone urologic procedures that may require vigorous irrigation or aspiration of clots. The silicone shaft tubing is less prone to collapse during manipulation compared to latex tubing. Gonzalgo M, Walsh PC. Balloon Cuffing and Management of the Entrapped Foley Catheter. Urology (2003) 61: BARDEX Lubricath Catheter

11 Improved Flow 24Fr, 30cc 2 Way Foley Cross-section of DOVER Silicone Catheter 16Fr, 5cc 2 Way Foley 500 ml/minute Bardex Latex Catheter 21% More Flow DOVER 100% Silicone Catheter Cross-section of Bardex Lubricath Catheter 18Fr, 5cc 2 Way Foley 800 ml/minute Bardex Latex 18Fr 5cc 55% More Flow DOVER Silicone 18Fr 5cc 2000 ml/minute % More Flow Bardex 2-way Latex 24Fr 30cc DOVER 2-way Silicone 24Fr 30cc RELIABILITY & FUNCTION Source: Data on file* True French Sizes (16Fr) Actual French Size DOVER 16 F Bardex 16 F DOVER 16 F Bardex 16 F DOVER 16 F Bardex 16 F DOVER 16 F Bardex 16 F 10 TIP BALLOON SHAFT 4 SHAFT 8 Place Measured Source: Data on file* Catheter O.D. Comparison: DOVER 16Fr vs. Bardex 16Fr DOVER Urologicals superior silicone manufacturing process provides consistent and accurate catheter sizing compared to the Bard latex line. 16Fr DOVER Silicone +/- 2.5 Fr 16Fr Bardex Lubricath +/- 5.2 Fr COATINGS PRODUCT INFORMATION

12 COATINGS

13 DOVER 100% Silicone Foley Catheters represent the very latest in catheter technology. Its OMNION silver ion technology, coupled with a hydrogel coating on both the internal and external surfaces, slowly releases ionic silver particles. Testing shows a substantially longer elution time compared to competitive catheters. When compared to the Bardex IC catheter, DOVER Silver catheters with OMNION technology release higher concentrations of silver ions during the first three days and provide consistent elution over a longer period. DOVER catheters feature a proprietary combination of silicone and silver that can lead to reduced encrustation and a lower incidence of urethral irritation and stricture while eliminating latex allergy and toxicity concerns. SILVER MAKES IT BETTER. SILICONE makes it best. COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

14 Silicone vs. Bard IC Latex Silicone alone may provide comparable patient benefits as silver coated latex based catheters. The differences between the two groups were not significant. Thibon P, Le Coutour X, Leroyer R, Fabry J. Randomized multi-centre trial of the effects of a catheter coated with hydrogel and silver salts on the incidence of hospital-acquired urinary tract infections. Journal of Hospital Infection (2000) 45: In medium-term catheterization, the silver alloy catheter is equivalent to a silicone catheter with regard to bacteria. Verleyen P. De Ridder D, Van Poppel H, Baert L. Clinical Application of the Bard IC Foley Catheter European Urology (1999) 36: COATINGS Decreased inflammatory response, reduced urethral discharge and lower risk of ascending urinary tract infections have also been reported as advantages of silicone catheters compared to latex catheters. Gonzalgo M, Walsh PC. Balloon Cuffing and Management of the Entrapped Foley Catheter. Urology (2003) 61:

15 Silver Coatings OMNION silver ion technology coupled with a hydrogel coating on both internal and external catheter surfaces slowly releases ionic silver particles. Testing shows a substantially longer elution time of up to 30 days compared to Bardex IC catheters. When compared to the Bardex IC catheter, DOVER Silver catheters with OMNION technology releases higher concentrations of silver ions during the first three days and provides consistent elution over a longer period. Coupled with a slicker hydrogel coating on inert silicone material, the silver is truly available. Silver Concentration (ug) Source: Data on file* 16 FR DOVER SILVER BARD IC Day Each value is an average of three catheters. In Dr. Maki s research on Silver Coatings: New surface technologies that release far greater quantities of ionic silver or other antiinfective agents into the aqueous environment contiguous to the catheter surface might even prevent CAUTIs caused by intraluminal contaminants. Maki D, Tambyah P. Engineering Out the Risk of Infection with Urinary Catheters. Emerging Infectious Disease (March - April 2001). Hydrogel Coating Thickness Bardex IC Catheter DOVER SILVER Catheter Silver Elution Profile Psuedo Urine Silver Coated Catheter Friction Test Resistance Source: Data on file* DOVER SILVER COATINGS BARDEX-IC COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

16 PRODUCT INFORMATION

17 Representing the very latest in technology and performance, the DOVER Urologicals line of catheters is leading the way in improving clinical outcomes. With a 100% silicone platform and patented OMNION silver ion technology, our catheters truly support our belief that Silver makes it better, Silicone makes it best. PRODUCT INFORMATION AND ORDERING CODES COMPLICATIONS RELIABILITY & FUNCTION COATINGS PRODUCT INFORMATION

18 Product Information Single 100% Silicone Foley Catheters Item Description Each/Case DOVER Foley 8 Fr, 3cc 2-way DOVER Foley 10 Fr, 3cc 2-way DOVER Foley 12 Fr, 5cc 2-way DOVER Foley 14 Fr, 5cc 2-way DOVER Foley 16 Fr, 5cc 2-way DOVER Foley 18 Fr, 5cc 2-way DOVER Foley 20 Fr, 5cc 2-way DOVER Foley 22 Fr, 5cc 2-way DOVER Foley 24 Fr, 5cc 2-way DOVER Foley 26 Fr, 5cc 2-way DOVER Foley 18 Fr, 30cc 2-way DOVER Foley 20 Fr, 30cc 2-way DOVER Foley 22 Fr, 30cc 2-way DOVER Foley 24 Fr, 30cc 2-way DOVER Foley 26 Fr, 30cc 2-way DOVER Foley 18 Fr, 30cc 3-way DOVER Foley 20 Fr, 30cc 3-way DOVER Foley 22 Fr, 30cc 3-way DOVER Foley 24 Fr, 30cc 3-way 10 Foley Trays CURITY Trays Featuring: DOVER 100% Silicone Foley Catheter and CURITY Drain Bag with MONO-FLO Anti-Reflux Device, SPLASHGUARD II Drain Spout, SAFEGUARD Needleless Sampling Port, Purple Nitrile Gloves Item Description Each/Case 6144 Foley Tray 14 Fr Foley Tray 16 Fr Foley Tray 18 Fr 10 Urine Meter Foley Trays CURITY Trays Featuring: DOVER 100% Silicone Foley Catheter and PRECISION 400 Urine Meter with SPLASHGUARD II Drain Spout, SAFEGUARD Needleless Sampling Port, Purple Nitrile Gloves PRODUCT INFORMATION Item Description Each/Case 2004 Urine Meter Foley Tray 14 Fr Urine Meter Foley Tray 16 Fr Urine Meter Foley Tray 18 Fr 10 Foley Insertion Trays DOVER 100% Silicone Foley Catheter and Purple Nitrile Gloves Item Description Each/Case DOVER Insertion Tray 16 Fr DOVER Insertion Tray 18 Fr 20

19 Single 100% Silicone Silver Hydrogel Coated Foley Catheters Item Description Each/Case IC DOVER Silver Foley 12 Fr, 5cc 2-way IC DOVER Silver Foley 14 Fr, 5cc 2-way IC DOVER Silver Foley 16 Fr, 5cc 2-way IC DOVER Silver Foley 18 Fr, 5cc 2-way IC DOVER Silver Foley 20 Fr, 5cc 2-way IC DOVER Silver Foley 22 Fr, 5cc 2-way IC DOVER Silver Foley 24 Fr, 5cc 2-way IC DOVER Silver Foley 26 Fr, 5cc 2-way IC DOVER Silver Foley 18 Fr, 30cc 2-way IC DOVER Silver Foley 20 Fr, 30cc 2-way IC DOVER Silver Foley 22 Fr, 30cc 2-way IC DOVER Silver Foley 24 Fr, 30cc 2-way IC DOVER Silver Foley 26 Fr, 30cc 2-way IC DOVER Silver Foley 18 Fr, 30cc 3-way IC DOVER Silver Foley 20 Fr, 30cc 3-way IC DOVER Silver Foley 22 Fr, 30cc 3-way IC DOVER Silver Foley 24 Fr, 30cc 3-way 10 Foley Trays CURITY Trays Featuring: DOVER Silver 100% Silicone Foley Catheter and CURITY Drain Bag with MONO-FLO Anti-Reflux Device, SPLASHGUARD II Drain Spout, SAFEGUARD Needleless Sampling Port, Purple Nitrile Gloves Item Description Each/Case 6144IC DOVER Silver Foley Tray 14 Fr IC DOVER Silver Foley Tray 16 Fr IC DOVER Silver Foley Tray 18 Fr 10 Urine Meter Foley Trays CURITY Trays Featuring: DOVER Silver 100% SiliconeFoley Catheter and PRECISION 400 Urine Meter with SPLASHGUARD II Drain Spout, SAFEGUARD Needleless Sampling Port, Purple Nitrile Gloves Item Description Each/Case 7004IC DOVER Silver Urine Meter Foley Tray 14 Fr IC DOVER Silver Urine Meter Foley Tray 16 Fr IC DOVER Silver Urine Meter Foley Tray 18 Fr 10 Foley Insertion Trays DOVER Silver 100% Silicone Foley Catheter and Purple Nitrile Gloves Item Description Each/Case 2116IC DOVER Silver Insertion Tray 16 Fr IC DOVER Silver Insertion Tray 18 Fr 20 PRODUCT INFORMATION

20 Copies of cited articles available on request. * Data available on request DOVER, MONO-FLO, SPLASHGUARD II, CURITY, PRECISION and SAFEGUARD are U.S. registered trademarks of Tyco Healthcare Group LP or its affiliate. Dover Urological logo, Five Point Care, OMNION and Silver makes it better. Silicone makes it best. are trademarks of Tyco Healthcare Group LP or its affiliate. BARDEX, LUBRICATH and BARD are U.S. registered trademarks of BRC, Inc. 15 Hampshire Street Mansfield, MA For International locations please see Tyco 2005 H-5694 XXM 1/05