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Bardex™ I.C. Foley Catheter with the Bactiguard^® Coating

Designed to lower the occurence of CAUTI

Overview
CAUTI Challenges
Clinical Evidence
Cost Savings

Developed to lower the occurrence of CAUTI and reduce adherence of UTI pathogens.

The Bardex™ I.C. Foley Catheter has a coating that combines the Bactiguard^® Coating with the Bard™ Hydrogel Coating. These coatings are applied to the inside and the outside of the catheter. Bardex™ I.C. Foley Catheters are used for transurethral and suprapubic use. The Bactiguard^® Coating requires no special procedures for handling, use, or disposal.

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Galvanic effect

The Bactiguard^® Coating is based on a very thin noble metal alloy coating, consisting of gold, silver, and palladium. When in contact with fluids, the noble metals create a galvanic effect.

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Reduction of microbial adhesion

The galvanic effect creates a micro current that reduces microbial adhesion to the catheter material, which decreases the risk for biofilm formation leading to infection.

In vitro test

The reduction of microbial adhesion and colonization to device surfaces has been verified for clinically relevant microbial strains using an in vitro test. It evaluates the adhesion of gram-positive and gram-negative bacteria and fungi to device surfaces.¹

Scanning electron microscopy

The reduction of microbial colonization has been observed by scanning electron microscopy (SEM). The pictures show the colonization of E. Coli on an uncoated surface versus on a Bactiguard® Coated surface. Less bacteria colonized on the Bactiguard^® Coated surface.

Interested in learning how Bardex™ I.C. Foley Catheters could benefit your patients?

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Data on File. Rep-18299.

Foley catheters are intended for use in the drainage and/or collection and/or measurement of urine. Cautions: Latex Foley catheters contain natural rubber latex which may cause allergic reactions.

Federal (U.S.A.) law restricts these devices to sale by or on the order of a physician.

Warnings: On catheter, do not use ointments or lubricants having a petrolatum base. They will damage the catheter and may cause balloon to burst.

After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.

Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.

BD, Bard and Bardex are trademarks of Becton, Dickinson and Company or its affiliates. Bactiguard®* is a registered trademark of Bactiguard AB. *The Foley catheters included in the Bardex™ I.C. System contain Bactiguard®* noble alloy coating which is licensed from BactiGuard AB.

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Catheter associated urinary tract infection (CAUTI)

CAUTIs occur when germs, usually bacteria, enter the urinary tract through a Foley catheter and cause an infection. Catheters are susceptible to the accumulation of bacteria, which can lead to biofilm formation on the surface. Microbes in biofilms are more resistant to antibiotics due the extracellular polymeric substance that protects the cells.

In 2012, CMS implemented CAUTI reporting requirements in acute care hospitals.¹ For every CAUTI, there are 7 hospital onset UTIs (HOUTIs).²

UTI-positive urine cultures are significantly linked to hospital onset bacteremia and fungemia (HOB) diagnoses. An HOB is a bloodstream infection that is diagnosed on or after day 4 of a patient’s hospital admission.³

Patients with HOBs have:

FAQs: NHSN CAUTI Definition & Rebaseline - Centers for Disease Control, Centers for Disease Control, www.cdc.gov/nhsn/pdfs/rebaseline/faq-cauti-rebaseline.pdf. Accessed 26 Dec. 2023.
Data on file. BD Urology and Critical Care, Covington, GA. [Kelly T, Ai C, Jung M, Yu K. (2024) Catheter-Associated Urinary Tract Infections (CAUTIs) and Non- CAUTI Hospital-onset Urinary Tract Infections: Relative Burden, Cost, Outcomes and Related Hospital-Onset Bacteremia and Fungemia Infections. (Unpublished manuscript)]
Yu KC, Jung M, Ai C. Characteristics, costs, and outcomes associated with central-line-associated bloodstream infection and hospital-onset bacteremia and fungemia in US hospitals [published online ahead of print, 2023 Jul 10]. Infect Control Hosp Epidemiol. 2023;1-7.

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The efficacy of Bardex™ I.C. Foley Catheters and the Bactiguard^® Coating have been evaluated in more than 30 studies published in peer reviewed journals. The studies below are examples that comply with latest CAUTI definition, measuring only symptomatic infections for patients catheterized longer than 2 days.

Randomized multicenter study, India – 2021

Kai-Larsen et al conducted a multicenter study with 1000 urology, general surgery and intensive care patients, catheterized for more than 2 days. There was a reduction in the occurrence of CAUTI by 69% in the group with a Bactiguard^® Coated Foley Catheter, compared with the standard catheter group. CAUTI / 1000 catheter days; 6.5 vs. 20.8.¹

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Cardiac surgery patients, Spain – 2015

Hidalgo Fabrellas et al performed a randomized study on 116 post-op cardiology patients in Spain with a 4 day mean catheterization time, and found a 38% reduction in the occurrence of CAUTI. The use of Bactiguard^® Coated Foley Catheters was shown to be cost effective.²

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Multicenter study, USA – 2014

Lederer et al conducted a multicenter surveillance study in the USA, including 853 patients at 7 hospitals, catheterized for an average of 8 days. The Bactiguard^® Coated Bardex™ I.C. Foley Catheter reduced the occurrence of CAUTI by 58% after it’s introduction.³

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Burn unit patients, USA – 2002

Newton et al studied the effect of Bactiguard^® Coated Bardex™ I.C. Foley Catheters on 1,757 patients in a burn unit in Georgia. Results demonstrated a 39% reduction in the occurrence of CAUTI per 1,000 catheter days with Bactiguard^® Coated Bardex™ I.C. Foley Catheters.⁴

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Kai-Larsen Y, Grass S, Mody B, et al. Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial. Antimicrob Resist Infect Control. 2021;10(1):40.
Hidalgo Fabrellas et al. Enferm Intensiva. 2015; 26(2):54–62.
Lederer JW, Jarvis WR, Thomas L, Ritter J. Multicenter cohort study to assess the impact of a silver-alloy and hydrogel-coated urinary catheter on symptomatic catheter-associated urinary tract infections. J Wound Ostomy Continence Nurs. 2014;41(5):473-480.
Newton T, Still JM, Law E. A comparison of the effect of early insertion of standard latex and silver-impregnated latex Foley catheters on urinary tract infections in burn patients. Infect Control Hosp Epidemiol. 2002;23(4):217-218.

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Health economic benefits

According to a report prepared for the Agency for Healthcare Research and Quality, the estimated cost for a CAUTI is $13,793.³ The Bactiguard^® Coating has been found to reduce the risk of CAUTI by 32% to 71.2% compared to standard catheters.^1,2,4,5,6

A number of studies have estimated a net economic benefit when utilizing the Bactiguard® Coated Foley catheter.^4,5,6 Similarly, a decision model that contemplated the reduction in symptomatic UTI and bacteremia estimated a cost savings with silver alloy-coated catheters compared to standard catheters.⁸

Urinary pathogens are likely the primary source of 12.7% of non-CLABSI hospital-onset bacteremia and fungemia (HOB).⁸ Non-CLABSI HOB contributes an additional $25,207 incremental cost in patients without an ICU stay and substantially more in patients with an ICU stay.⁸

Kai-Larsen Y, Grass S, Mody B, et al. Foley catheter with noble metal alloy coating for preventing catheter-associated urinary tract infections: a large, multi-center clinical trial. Antimicrob Resist Infect Control. 2021;10(1):40.
Hidalgo Fabrellas et al. Enferm Intensiva. 2015; 26(2):54–62.
Bysshe T, Gao Y, Heaney-Huls K, et al. Estimating the Additional Hospital Inpatient Cost and Mortality Associated With Selected Hospital-Acquired Conditions. Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Publication No. 18-0011-EF. November 2017.
Karchmer TB, Giannetta ET, Muto CA, Strain BA, Farr BM. A randomized crossover study of silver-coated urinary catheters in hospitalized patients. Arch Intern Med. 2000;160(21):3294-3298.
Rupp ME, Fitzgerald T, Marion N, et al. Effect of silver-coated urinary catheters: efficacy, cost-effectiveness, and antimicrobial resistance. Am J Infect Control. 2004;32(8):445-450.
Seymour C. Audit of catheter-associated UTI using silver alloy-coated Foley catheters. Br J Nurs. 2006;15(11):598-603.
Saint S, Veenstra DL, Sullivan SD, Chenoweth C, Fendrick AM. The potential clinical and economic benefits of silver alloy urinary catheters in preventing urinary tract infection. Arch Intern Med. 2000;160(17):2670-2675.
Yu KC, Jung M, Ai C. Characteristics, costs, and outcomes associated with central-line-associated bloodstream infection and hospital-onset bacteremia and fungemia in US hospitals [published online ahead of print, 2023 Jul 10]. Infect Control Hosp Epidemiol. 2023;1-7.

Foley catheters are intended for use in the drainage and/or collection and/or measurement of urine. Cautions: Latex Foley catheters contain natural rubber latex which may cause allergic reactions.

Federal (U.S.A.) law restricts these devices to sale by or on the order of a physician.

Warnings: On catheter, do not use ointments or lubricants having a petrolatum base. They will damage the catheter and may cause balloon to burst.

After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.

Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use.

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