1. The Dover Silicone Solution Story
And how to use it to your advantage!

2. History
Silicone material has been used in a number of medical devices for past 30+ years.
A number of studies have been completed showing superior results of silicone foley catheters vs. latex foley catheters.
Tyco Healthcare’s premise is that the Dover 100% Silicone Foley Catheter will provide the patient with better results from a complication, function, and potentially, reduced UTI’s than a latex or latex IC catheter.
Thank you for taking some time to meet with me today. I understand you are considering an evaluation of the Bard Latex IC Foley Catheter. I would like to present some information today that we hope will allow you to consider a superior, more cost effective alternative to Bard’s Latex IC Foley Catheter. We want to introduce you to the Dover 100% Silicone Foley Catheter.
Probes:
What factors are driving your decision to trial/convert to the
Bard Latex IC Foley Catheter?
Who is the champion on this decision? Urologist, Infection
Control, Nursing?
Who is supporting the trial? Who is not supporting the trial?
What is your infection rate today? What is your anticipated
rate reduction %?
How will you monitor and verify the rate reduction %?
 We would like to present some information that we feel supports the use of Dover 100% Silicone Foley Catheters. This switch will provide you with equal or better results when compared to use of the Bard Latex IC Foley Catheter.

3. LATEX MATERIAL
Natural rubber latex is a substance produced by a rubber tree. It is organic and porous.
Composed of polyisoprene rubber, water, and low levels of different proteins.
As latex is manufactured into products, chemicals are added to improve its properties. Manufacturers attempt to remove these during a leaching process, but some remain in product.
Chemicals in latex are toxic and can cause skin irritation, rash and an allergic reaction.
Do you have a latex policy in place at your institution?
Have you considered 100% Silicone Foley Catheters in the past?
What are your thoughts on Dover 100% Silicone Foley Catheters?
How do latex Foley catheters fit into your latex policy?

4. LATEX MATERIAL
Latex allergy is human body’s response to proteins and chemicals in latex.
Type I: immediate reaction to proteins
Type IV: delayed reaction to chemicals
Immune system reacts to allergens.
Latex is inexpensive and easy to manufacture by utilizing a dipping process.
Material tends to deteriorate over time.

5. SILICONE MATERIAL
Silicone material is non-toxic, inert, with no active properties.
Man-made material from organic and inorganic substances.
Silicone holds it shape and does not expand when in contact with water or urine.
This leads to less trauma upon removal
Silicone is strong and walls of silicone catheters can be manufactured with a smaller width, improving urine flow rate.
This will reduce the incidence of encrustation.
Manufactured by extrusion, easier to hold its french size.
Material won’t deteriorate over time.
Are there other medical devices utilized in your facility that are composed of 100% silicone?
Typical ones include surgical implants, central venous catheters, gastrostomy tubes, and dialysis catheters.

6. “CYTOTOXICITY OF LATEX URINARY CATHETERS” British Journal of Urology - 1985
“The full silicone catheters were non-toxic…..:”
“…. there is now considerable evidence of the cytotoxicity of latex catheters and all medical personnel should be aware that adverse urethral reactions ”
“This explains why the various labels “siliconized”, “coating contains silicone”, or “silicone treated” did not prevent against cytotoxicity ”
“Urologists should advise hospital staff to switch to silicone or plastic catheters despite their higher cost until better quality control of latex catheters has been established.”
This study discussed the positive aspects of silicone material and the negative aspects of latex materials.
Does this support the latex policy at your institution?
Do you agree with the authors of this study that latex material may be a poor choice for a medical device, especially for a foley catheter?

7. URETHRITIS
Irritation and inflammation of a patient’s urethra following catheterization.
This condition can lead to urethral stricture or closing of urethra.
Can also lead to decreased urine flow.
Latex causes more urethritis than silicone.
Is this (urethritis or inflammation) a concern for you and your patients who may receive a latex foley catheter?

8. “CATHETER-INDUCED URETHRITIS: A COMPARISON BETWEEN LATEX AND SILICONE CATHETERS IN A PROSPECTIVE CLINICAL TRIAL” British Journal of Urology
“Of those with latex catheters 22% developed urethritis, compared with 2% of those in the silicone catheter group.”
“…. urethritis following short-term catheterization may be significantly reduced by the use of silicone catheters.”
“When one considers the problems of urethritis and stricture seen with latex catheters, the silicone catheters, despite their greater cost, should be considered cost effective and used for short-term catheterization.”
Given the minimal (if any) cost difference between Bard latex catheters and a Dover 100% silicone catheters, do you feel a 100% silicone catheter is a good option for your patients?
Given the substantial cost increase between a Bard Latex IC catheter and a Dover 100% Silicone catheter, does it make sense to investigate the Dover catheter?

9. URETHRAL STRICTURE Closing or narrowing of urethra.
Can be caused by urethritis of urethra.
Foley catheter is a common cause of problem.
Typically requires catheter or surgical intervention.
PROBES:
Does this additional complication (urethral stricture) cause additional concern for the patient?
Who bears the added cost to treat this complication?
A second catheter insertion or a stent may be required to treat the stricture that has developed.

10. “COMPARISON OF SILICONE AND LATEX CATHETERS IN THE DEVELOPMENT OF URETHRAL STRICTURE AFTER CARDIAC SURGERY” British Journal of Urology
Patients who had latex catheters had an incidence of urethral stricture of 5.2%.
Patients who had a silicone catheter had no incidence of urethral stricture.
“... we suggest that silicone catheters be used routinely for short-term catheterization in men undergoing cardiac bypass surgery.”
If you add in the additional cost to treat a urethral stricture, the advantages of silicone material seem apparent.

11. ENCRUSTATION
Mineral Salts in urine form on the outside, inside, and balloon of a Foley catheter
This can lead to urethritis and stricture.
Encrustation may occur as bacterial cells, such as Proteus mirabilis, adhere to catheter, which may lead to a UTI.
May require frequent catheter flushing and/or removal, requiring nursing time and supplies.
Patients experience pain upon catheter removal.
Silicone catheters allow for larger internal lumens due to the strength of silicone catheter walls. Hence, they are less likely to become encrusted or blocked by bacteria and urine formations.
Latex material on the other hand is more likely to block or encrust due to smaller internal lumens. This can also lead to a reduced flow rate of urine through the catheter.
Does encrustation of latex catheters cause you concern?

12. ENCRUSTATION
Silicone catheters allow for larger internal lumens due to the strength of silicone catheter walls. Hence, they are less likely to become encrusted or blocked by bacteria and urine formations.
Latex material on the other hand is more likely to block or encrust due to smaller internal lumens. This can also lead to a reduced flow rate of urine through the catheter.
Does encrustation of latex catheters cause you concern?

13. URETHRITIS & ENCRUSTRATION
Irritation of Mucosa
Segregation of blood particles (as a pathologic reaction to inflammation) into bladder
Adherence to ‚rough‘ & ‚sticky‘ surfaces (Latex)
High Risk
Low risk
Is this (urethritis or inflammation) a concern for you and your patients who may receive a latex foley catheter?
Silikon
Latex

14. “WHICH INDWELLING URETHRAL CATHETERS RESIST ENCRUSTATION BY PROTEUS MIRABILIS BIOFILMS” British Journal of Urology
“The mean times to blockage ranged from 21 h for the Bard hydrogel/silver-coated latex catheter to 56 h for the Eschmann Folatex S all-silicone catheter.”
“Kunin et al …..concluded that the encrustation and blockage was significantly less with silicone catheters than with teflon-coated or latex catheters.”
“The internal diameter is thus not surprisingly a major factor in determining time to blockage.”
“Silver is a potent antibacterial agent but failed to block colonization by a mineralizing bacterial biofilm.” (Hydrogel/Silver-coated Latex Bard)
We have read in this article that P. Mirabilis is the strongest bacteria that can cause UTI.
We find it interesting that the Bard Latex IC catheter blocked most rapidly.
The all-silicone catheters took the longest time to blockage.

15. “ENCRUSTATION OF INDWELLING URETHRAL CATHETERS BY PROTEUS MIRABILIS BIOFILMS GROWING IN HUMAN URINE” Journal of Hospital Infection
“... the mean times to blockage ranging from 17.7 h (silver coated latex), 34 h (hydrogel-coated latex), 38 h (silicone coated latex) to 47 h (all silicone).”
“The internal diameters of the latex catheters were only 1.5 mm compared to the 2.5 mm of the all-silicone catheters.”
“It was not possible to conclude, however, that the silicone catheters were more resistant to encrustation, as it could well have been that their much larger central channels just took longer to block.”
This 1998 follow up study confirmed the findings of the 1997 study.
The Bard Latex IC catheter was once again the shortest time to blockage.
Larger diameter was seen as the biggest advantage of the all silicone catheters.

16. “RANDOMIZED MULTI-CENTRE TRIAL OF THE EFFECTS OF A CATHETER COATED WITH HYDROGEL AND SILVER SALTS ON THE INCIDENCE OF HOSPITAL-ACQUIRED URINARY TRACT INFECTONS” Journal of Hospital Infection
Compared 100% Silicone Foley catheter to a latex coated infection control catheter.
No difference in infection rates after 10 days of use. Total of 199 patients.
Conclusion:
“Overall, we feel that there is not enough evidence to conclude that catheters coated with silver salts and hydrogel give greater protection than classical catheters and to recommend widespread use.”
Study (only two available), comparing standard 100% silicone foley catheters to latex IC foley catheters, showing no advantage to an IC coating on a latex catheter vs. 100% silicone material alone.

17. “CLINICAL APPLICATIONOF THE BARDEX IC FOLEY CATHETER” European Urology – 1999 *First Trial Discussed In Article
“In the first trial,…. 18 patients with the Bardex IC catheter were compared to 17 patients with a silicone catheter after the same procedure. There was no significant difference in bacteriuria after 14 days (50.0 vs. 53.3%).”
They don’t provide details on infection rates earlier than 14 days, but we can assume there were no major differences, or these would have been represented.
The larger, second trial switched to a latex vs. latex IC catheter. We can assume this was done to emphasize the difference in a better light.
Given the information presented, we feel the most effective material to help prevent UTI’s is 100% silicone.
We do believe in the antimicrobial properties of silver, but feel 100% silicone alone is equal to a latex catheter coated with a silver agent.

18. CAUTI (Catheter Associated Urinary Tract Infection) Rate in Two Clinical Abstracts,(D.G. Maki, M.D.)
ROCM Release-NF® 100% Silicone Foley Catheter(IC)
ROCM Standard 100% Silicone Foley Catheter
Bard Latex IC Foley Catheter
Bard Standard Latex Foley Catheter
Infection Rate
5.3%
8.2%
15.4%
21.2%
Note the low rate of infection after 7 days(8.2%) for a standard silicone foley catheter. Note the higher infection rate(15.4%) for the Bard Latex IC Foley Catheter.

19. Discussion Points
There are two separate clinical studies that were completed by Dr. Maki, et al at University of Wisconsin, using different catheters but a similar clinical protocol.
In Bard Study “A Novel Silver-Hydrogel-Impregnated Double Blind Trial” compares a Bard Latex IC Foley to a Bard Standard Latex Foley (non-IC). Infection rates are seen on previous slide are stated in the abstract.

20. Discussion Points
In Rochester Medical study, “A Prospective Indwelling Urinary Catheter”, the same researchers compared a Rochester Medical (ROCM) 100% Silicone uncoated catheter to a Rochester Nitrofurazone-impregnated infection control catheter (non-IC). Infection rates for this trial studied 344 patients (14 infections in 170 catheters – all silicone vs. 9 infections out of 174 patients-Release NF) to calculate the infection rate.
An objective look at these two studies indicates that 100% silicone catheter material by itself may provide the greater or equal benefit in reducing CAUTI than an IC coating on a Latex Foley Catheter. Comparing the two studies, the Std. Silicone Foley had an infection rate of 8.2% vs. the Bard Latex IC Catheter which had a 15.4% infection rate.

21. “Silicone Solution” Summary
Silicone is non-toxic and eliminates latex allergies in patients
Reduces urethritis or inflammation
Reduces urethral stricture
Reduces encrustation
Reduces UTI

22. “Silicone Solution” Summary
Better flow rate and drainage vs. latex
Reduced incidence of non-deflators
Dr. Maki Abstracts, Belgium Study, and the Bard Labeling Claim Change all add up to the advantage of Silicone vs. Bard’s Latex catheter and the Bardex IC.
Dr.xxxxx, given the above summary information, can we proceed with a trial of the Dover 100% Silicone Foley Catheter and Tray at your facility?
(For a Bard IC Foley Threat) Given the substantial cost advantage of the Dover line vs. the Bard Latex IC Line, is there any other reason why you wouldn’t use the Dover 100% Silicone Foley Catheter?
(For a Bard Lubricath Conversion)Given the cost neutral scenario of Dover 100% Silicone vs. Bard Lubricath combined with the advantages of Dover Silicone, can we proceed with a conversion/trial of the Dover line at your facility?