Cook Medical G44015 – TRAY, SPECTRUM TRIPLE LUMEN, EACH

Cook Spectrum Central Venous Catheter Tray Double Lumen – Minocycline/Rifampin Impregnated

To combat CRBSIs, we impregnate our polyurethane catheters with the clinically proven combination of minocycline and rifampin. More than 21 peer-reviewed articles and meta-analyses recognize Spectrum as superior — its evidence of protection no other process or technology can match. Furthermore, over 10 years of clinical use and a study of more than 500,000 catheter days show no evidence of bacterial resistance.1 Cook Spectrum catheters give your patients the best protection possible against CRBSI and may also provide significant economic benefits for your hospital.

Designed for treatment of critically ill patients and suggested for:

• Continuous or intermittent drug infusions
• Central venous blood pressure monitoring (CVP)
• Acute hyperalimentation
• Blood sampling
• Delivery of whole blood or blood products
• Simultaneous, separate infusion of drugs

The activity of the antimcrobial agents, minocycline and rifampin, is localized at the internal and external catheter surface and is not intended for treatment of systemic infections. The device is a short-term use catheter.

Standard Trays – Polyurethane

Included Componenets

• Cook Spectrum Central Venous Catheter
• Disposable Safety Scalpel
• CLC-2000 Injection Caps
• EchoTip Echogenic Introducer Needle
• ChloraPrep One-Step Large Fenestrated Drape w/Clear Window
• Pre-filled Sodium Chloride Syringe
• Sharps Needle Holder Cup
• Curved Needle with Suture and Needle Holder
• Straight and Curved Safe-T-J Double Flexible Tipped Wire Guide
• Dilator(s)
• Disposable Syringe
• 25-Gage Needle
• 22-Gage Needle
• TFE Catheter Introducer Needle
• Straight Needle with Suture (Optional)

Each year in the United States tens of thousands of patients will contract a catheter-related bloodstream infection (CRBSI). The consequences associated with this type of infection are significant:

• 12% – 25% mortality rate

• U.S. $11,9712 – $56,0001 average cost per line infection

• U.S. $296 million – $2.3 billion in annual expenses

The Right Combination Minocycline+rifampin is the most rigorously studied and synergistic combination of antibiotics available on a catheter for reducing CRBSIs through two distinct mechanisms of action. Unlike most antibiotics, this combination has the ability to penetrate the biofilm that forms on all indwelling catheters. Unmatched Evidence Two decades of evidence, including more than 21 peer-reviewed studies and four meta-analyses, confirm minocycline+rifampin catheters are the most effective tool available to provide broad-spectrum protection against grampositive, gram-negative and fungal infections3,4 in both short- and long-term use. Its evidence of protection no other process or technology can match. No Eviden ce of Resistance More than 10 years of clinical use has shown no evidence that M+R catheters lead to bacterial resistance, and a seven-year study of over 500,000 catheter days confirms these results.1 A separate study indicates that a facility using M+R catheters may have shown a decrease in vancomycin usage. Worth Switching In a challenging clinical environment, a hospital that switches to M+R catheters may expect to see a decrease in CRBSI rates, attributable mortality and CRBSI-related costs. Even high-performing hospitals can switch to Spectrum to drive incremental improvement in CRBSI rates and may still achieve substantial reductions in mortality and expenses.

Technical Specifications

Standard Catheter Lengths Available for Pediatric Use

Triple-Lumen Information

Suggested Lumen Utilization: Triple-Lumen

• #1 Distal exit port (endhole) — whole blood or blood product delivery and sampling; any situation requiring more flow rate; CVP monitoring; medication delivery. It is strongly recommended that this lumen be used for all blood sampling.
• #2 Middle exit port — medication delivery; acute hyperalimentation.
• #3 Proximal exit port — medication delivery; acute hyperalimentation

More Technical Features

The Right Combination

Minocycline+rifampin is proven to be the most synergistic combination of antibiotics in reducing infections through two distinct pathways, and has the ability to penetrate the biofi lm that forms on all indwelling catheters.

Coated catheters [that can maintain an in vitro zone of inhibition] of = 15 mm were highly predictive of in vivo effi cacy.

Unmatched Evidence

In vitro studies show that our M+R catheters maintain an effective zone of inhibition for up to 21 days – longer than any other catheters. Over two decades of evidence, including more than 21 peer-reviewed studies and meta-analyses, prove M+Rs ability to prevent bloodstream infections.

Decreased Resistance

More than 10 years of clinical use has shown no evidence that M+R catheters lead to bacterial resistance, and a seven year study of over 500,000 catheter days confirms these results.9 Data indicate that facilities using M+R catheters have a decreased need for systemic antibiotic use.

M/R CVC use is not associated with long term increased staphylococcal resistance to tetracyclines and rifampin; however, it represents a crucial strategy to significantly decrease CRBSI in critically ill cancer patients.

Precautions

• The catheter is intended for use by physicians trained and experienced in the placement of central venous catheters using percutaneous entry (Seldinger) technique. Standard Seldinger technique for placement of percutaneous vascular access sheaths, catheters and wire guides should be employed during the placement of a central venous catheter.
• Do not re-sterilize catheter.
• Do not cut, trim or modify catheter or components prior to placement or intraoperatively.
• Patient movement can cause catheter tip displacement. Use should be limited to controlled hospital situations. Catheters placed from either a jugular or subclavian vein have demonstrated forward tip movement of 1-3 cm with neck and shoulder motion.
• Catheter should not be used for long-term indwelling applications.
• If lumen flow is impeded, do not force injection or withdrawal of fluids. Notify attending physician immediately.
• Catheter should not be used for chronic hyperalimentation.
• Select puncture site and length of catheter needed by assessing patient anatomy and condition.
• Use of ECG, ultrasound and/or fluoroscopy is suggested for accurate catheter placement.
• Left subclavian and left jugular veins should be used only when other sites are not available.
• Controlled clinical trials of the Cook Spectrum and Spectrum Glide central venous catheters in pregnant women, pediatric and neonatal populations have not been conducted. The benefits of the use of the Cook Spectrum and Spectrum Glide central venous catheters should be weighed against possible risks.
• Prior to insertion, the Cook Spectrum or Spectrum Glide catheter shaft should not be wiped with or immersed in ethyl alcohol, isopropyl alcohol, or other alcohols, acetone or other non-polar solvents. These solvents may remove the antimicrobial from the catheter and reduce the catheters antimicrobial efficacy.

How Supplied

Supplied sterilized by ethylene oxide gas in peel-open packages. Intended for one-time use. Sterile if package is unopened or undamaged. Do not use the product if there is doubt as to whether the product is sterile. Store in a dark, dry, cool place. Avoid extended exposure to light. Upon removal from package, inspect the product to ensure no damage has occurred.