BIP Central Venous Catheter

Size: px

Start display at page:

Download "BIP Central Venous Catheter"

Adrian Wade
6 years ago
Views:

1 Bactiguard Infection Protection BIP Central Venous Catheter For prevention of healthcare associated infections

2 Bactiguard benefits Reduced healthcare costs Reduced use of antibiotics Save lives Bloodstream infections Catheter related bloodstream infections (CRBSI), also known as Central Line Associated Bloodstream Infections (CLABSI), account for a large proportion of the costs related to healthcare associated infections (HAI) in patients using medical devices, such as central venous catheters (CVC) 1. These infections can lead to serious complications, causing patient suffering as well as increased mortality and healthcare costs. In addition, many of these infections are treated with antibiotics, which increase the risk of emergence and spread of multi-resistant microbes. WHO estimates that antimicrobial resistance is so serious that it threatens the achievements of modern medicine 2. Healthcare Associated infections 1 Other Surgical site 22% 17% Respiratory tract* 32% 15% 14% Urinary tract* Bloodstream* *Bactiguard products available The solution: BIP Central Venous Catheter To address these problems, Bactiguard has developed a central venous catheter, the BIP CVC, with Bactiguard coating that reduces the risk of microbial adhesion and colonization. Bactiguard coated CVCs have been shown to reduce catheterrelated infections in high-risk patients, when compared to uncoated CVCs 3. The Bactiguard Infection Protection (BIP) technology is based on applying a very thin noble metal coating, consisting of gold, palladium and silver, to medical devices. The Bactiguard coating is firmly bound to the surface of the device and reduces the adhesion and growth of microbes. Material BIP CVC is made of polyure thane and coated with the Bactiguard coating. Usage BIP CVC is used to administer drugs and intravenous solutions, sample blood, as well as for blood pressure monitoring. BIP CVC can be used up to 30 days. Environment The Bactiguard coating is environmentally friendly and requires no special procedures for handling, use or disposal. More than 150 million Bactiguard coated urinary catheters have been sold for patient use, with no reported adverse events related to the coating.

The Bactiguard Infection Protection (BIP) technology Preventing infections A few seconds A few hours A few days Medical device surfaces attract bacteria, which develop into a biofilm.

When enough bacteria have developed, they form a biofilm. If they begin to disperse, there is an increased risk of infection.

Coated products demonstrate a reduced bacterial adhesion, which in turn prevents biofilm formation and subsequent infection. A few seconds Bacteria begin to adhere to the surface.

Gold Au Palladium Pd Silver Ag A galvanic effect is created due to the noble metals in the fluids Bacteria Galvanic effect The three noble metals in the Bactiguard coating gold, palladium and silver,

3 The Bactiguard Infection Protection (BIP) technology Preventing infections A few seconds A few hours A few days Medical device surfaces attract bacteria, which develop into a biofilm. Catheter related blood stream infections occur when there is an immune response to bacteria in the blood. Bacteria begin to adhere to the surface. Bacteria begin to multiply. When enough bacteria have developed, they form a biofilm. If they begin to disperse, there is an increased risk of infection. Uncoated surface The noble metals in the Bactiguard coating cause a galvanic effect, which prevents bacteria from adhering to the surface. Coated products demonstrate a reduced bacterial adhesion, which in turn prevents biofilm formation and subsequent infection. A few seconds Bacteria begin to adhere to the surface. A few hours Bactiguard coated catheter surface A few days Less bacteria adhere to the surface of the Bactiguard coated surface, preventing biofilm formation and subsequent infection. Gold Au Palladium Pd Silver Ag A galvanic effect is created due to the noble metals in the fluids Bacteria Galvanic effect The three noble metals in the Bactiguard coating gold, palladium and silver, cause a galvanic effect. This creates a micro current. The current prevents bacteria from adhering to the surface. Bactiguard compared to traditional releasing technologies 4 These technologies depend on release of toxic substances, such as silver ions, attacking the bacteria. Silver Ag Dying bacteria Silver ions are released from the surface, killing bacteria. Can cause tissue damage. 5 to 10 times thicker layer than a surface with Bactiguard coating. Becomes thinner over time due to release.

In Vitro/Ex Vivo Efficacy The reduction of microbial adhesion and colonization to device surfaces has been verified for clinically relevant microbial strains using an in vitro efficacy test.

Less bacteria adhere to the Bactiguard coated surface and for those who adhere, further growth is expected to be suppressed, preventing biofilm formation and subsequent infection.

4 In Vitro/Ex Vivo Efficacy The reduction of microbial adhesion and colonization to device surfaces has been verified for clinically relevant microbial strains using an in vitro efficacy test. The in vitro test evaluates the adhesion of microorganisms to device surfaces. Example of results (Staphylocuccus aureus) are presented in the figures below 5. Less bacteria adhere to the Bactiguard coated surface and for those who adhere, further growth is expected to be suppressed, preventing biofilm formation and subsequent infection. Staphylocuccus aureus Microbe build-up without Bactiguard coating Microbe build-up with Bactiguard coating Less bacteria adhere to the Bactiguard coated surface Reduction in microbial adhesion to BIP CVC Standard CVC catheter Bactiguard coated CVC catheter CFU/cm % Pseudomonas aeruginosa 76% Coagulase negative Staphylococcus aureus 86% Staphylococcus aureus Average raw data from several batches of BIP CVC

5 TAT* relatively to blood control Clinically proven effective against bloodstream infections In a clinical study of Bactiguard coated central venous catheters it was concluded that the coating significantly reduced the incidence of infections by 52% (graph below). The investigation included 233 hematological oncology patients, 113 received standard uncoated catheters and 120 received Bactiguard coated catheters. Catheter related infection developed in 21% of patients with the standard catheter but in only 10% of the patients with the Bactiguard coated catheters 3. Biocompatible The Bactiguard coating has a strong biocompatibility profile. In ex-vivo experiments (graph below) with human blood, BIP CVC has showed improved blood compatibility properties in terms of lower risk of thrombosis compared to standard CVC. In the same study BIP CVC was also shown to be nonhemolytic compared to other coated CVCs 6. 45,0 40,0 Uncoated 35,0 BIP CVC Number of patient 30 Reduction in catheter related infections 30,0 25,0 20,0 p=0.02, significant Standard CVC catheter Bactiguard coated CVC catheter 15,0 10,0 20 5,0 0,0 Uncoated BIP CVC 10 *TAT= Thrombin Anti-Thrombin complex, depends on activation of coagulation and is used as marker for thrombotic risk Adapted from Vafa Homann et al Catheter-related infection p=0.011 Adapted from Goldschmidt.et al Local catheter infection p=0.232 Catheter-related bacteremia p=0.055 Additionally, in a clinical trial of Bactiguard coated CVC s (table below), data showed no increased risk for trombosis compared to the control group with uncoated CVC 7. Adapted from Goldschmidt H.et al Tissue-friendly and safe technology The Bactiguard solution is unique, tissue friendly and safe for patient use. As opposed to coating technologies, which depend on the release of substances, which kill bacteria, e.g. large amounts of silver ions, chlorhexidine or antibiotics, the Bactiguard coating is neither toxic nor pharmacologic 5. To date, more than 150 million Bactiguard coated urinary catheters have been sold for patient use, with no reported adverse events related to the coating. Frequency of Catheter-Related Thrombosls Examined by Ultrasound Factor Standard Catheter (n = 113) Bactiguard Coated Catheter (n = 120) Visualization of thrombus 3 1 Absence of spontaneous flow 2 0 Total no. of catheter-related thromboses 3 1 Adapted from Table 2, Harter et al. 2002

6 References 1. Klevens RM et al, Public Health Rep Mar-Apr;122(2): Kalra OP et al, J Glob Infect Dis Jan;1(1): Goldschmidt H.et al., Zbl. Bakt.1995; 233: Data on file 5. Data on file 6. Vafa Homann et al. 2015, J. Biomed. Mater. Res. Part B Appl. Biomater 7. Harter et al, Cancer. 94 (1): (2002)

7 Order information Product range BIP Central Venous Catheter Article number Size (Fr/Ch) Lumen Gauge (G) Length (cm) Introducer needle 1 Lumen EU-CVN BIP 4 18G 16 Straight EU-CVN BIP 4 18G 20 Straight EU-CVN BIP 5 16G 16 Straight EU-CVN BIP 5 16G 20 Straight EU-CVN BIP 7 14G 16 Straight EU-CVN BIP 7 14G 20 Straight EU-CVN Y-BIP 5 16G 16 Y-valve EU-CVN Y-BIP 5 16G 20 Y-valve EU-CVN Y-BIP 7 14G 16 Y-valve EU-CVN Y-BIP 7 14G 20 Y-valve 2 Lumen EU-CVN BIP 4 22/22G 6 Straight EU-CVN BIP 4 22/22G 10 Straight EU-CVN BIP 4 22/22G 16 Straight EU-CVN BIP 5 18/18G 10 Straight EU-CVN BIP 5 18/18G 16 Straight EU-CVN BIP 5 18/18G 20 Straight EU-CVN BIP 7 16/16G 16 Straight EU-CVN BIP 7 16/16G 20 Straight EU-CVN BIP 7 16/16G 30 Straight EU-CVN BIP 8,5 13/13G 16 Straight EU-CVN BIP 8,5 13/13G 20 Straight EU-CVN BIP 8,5 13/13G 30 Straight EU-CVN Y-BIP 5 18/18G 10 Y-valve EU-CVN Y-BIP 5 18/18G 16 Y-valve EU-CVN Y-BIP 5 18/18G 20 Y-valve EU-CVN Y-BIP 7 16/16G 16 Y-valve EU-CVN Y-BIP 7 16/16G 20 Y-valve EU-CVN Y-BIP 7 16/16G 30 Y-valve EU-CVN Y-BIP 8,5 13/13G 16 Y-valve EU-CVN Y-BIP 8,5 13/13G 20 Y-valve EU-CVN Y-BIP 8,5 13/13G 30 Y-valve 3 Lumen EU-CVN BIP 5,5 20/22/22G 8 Straight EU-CVN BIP 5,5 20/22/22G 13 Straight EU-CVN BIP 5,5 20/22/22G 30 Straight EU-CVN BIP 7 16/18/18G 10 Straight EU-CVN BIP 7 16/18/18G 16 Straight EU-CVN BIP 7 16/18/18G 20 Straight EU-CVN BIP 7 16/18/18G 30 Straight EU-CVN BIP 7 14/18/18G 10 Straight EU-CVN BIP 7 14/18/18G 16 Straight EU-CVN BIP 7 14/18/18G 20 Straight EU-CVN BIP 7 14/18/18G 30 Straight Article number Contents BIP CVC-kit: Size (Fr/Ch) Central venous catheter J-guidewire (Nitinol), sized to catheter Introducer needle (Y-shape* or Straight) Dilator, size appropriate to catheter Scalpel with protective cover Luer-Lock syringe 5 ml The products are CE marked according to Medical Device Directive 93/42/EEC Lumen Gauge (G) Length (cm) EU-CVN BIP 8,5 14/18/18G 16 Straight EU-CVN BIP 8,5 14/18/18G 20 Straight EU-CVN BIP 8,5 14/18/18G 30 Straight EU-CVN Y-BIP 7 16/18/18G 10 Y-valve EU-CVN Y-BIP 7 16/18/18G 16 Y-valve EU-CVN Y-BIP 7 16/18/18G 20 Y-valve EU-CVN Y-BIP 7 16/18/18G 30 Y-valve EU-CVN Y-BIP 7 14/18/18G 10 Y-valve EU-CVN Y-BIP 7 14/18/18G 16 Y-valve EU-CVN Y-BIP 7 14/18/18G 20 Y-valve EU-CVN Y-BIP 7 14/18/18G 30 Y-valve EU-CVN Y-BIP 8,5 14/18/18G 16 Y-valve EU-CVN Y-BIP 8,5 14/18/18G 20 Y-valve EU-CVN Y-BIP 8,5 14/18/18G 30 Y-valve 4 Lumen EU-CVN BIP 8,5 14/16/18/18G 16 Straight EU-CVN BIP 8,5 14/16/18/18G 20 Straight EU-CVN BIP 8,5 14/16/18/18G 30 Straight EU-CVN Y-BIP 8,5 14/16/18/18G 16 Y-valve EU-CVN Y-BIP 8,5 14/16/18/18G 20 Y-valve EU-CVN Y-BIP 8,5 14/16/18/18G 30 Y-valve Guidewire advancer, for one hand use Suture wings and staples Clamp for extension tube Cannula holder Sterilization and storage; see packaging. Department pack = 10 pcs. Transport pack = pcs. Size department pack W H D: mm Introducer needle * Y-Valve needle allows for easy guidewire insertion while minimizing air embolism and backflow of blood

8 Phone +46 (0) Fax +46 (0) Visit: Alfred Nobels Allé Tullinge Sweden Mail: Box 15, Tullinge Sweden RMH021-C Phone +46 (0) Fax +46 (0)

multicath & multistar

Paediatric catheters multicath & multistar Breakthrough in antimicrobial technology Rifampicin-Miconazole supersaturated Vs have demonstrated the potential to prevent catheter-associated colonization,