COOK Medical Spectrum Gebrauchsanweisung Seite 4

ENGLISH
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To distend great vessels and to prevent inadvertent air aspiration during catheter insertion,
patient should be placed in Trendelenburg position.
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Development of a hypersensitivity reaction should be followed by removal of the catheter and
appropriate treatment at the discretion of the attending physician.
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In rare cases, hepatotoxicity, systemic lupus erythematosus and exacerbation of porphyria have
been associated with the systemic use of minocycline and/or rifampin.
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
catheter's antimicrobial efficacy.
CLINICAL STUDIES
A prospective, randomized, multicenter clinical study was conducted in which 817 patients were
enrolled to receive either a 7.0 French triple-lumen Cook Spectrum Minocycline/Rifampin Impregnated
Catheter or a 7.0 French triple-lumen chlorhexidine gluconate and silver sulfadiazine (CG/SS) coated
catheter, with at least 350 patients available for follow-up in each study arm. The patient characteristics
(age, sex, underlying disease, degree of immunosuppression, therapeutic interventions, site of
insertion, duration of catheterization and reason for catheter removal) were comparable in the two
groups. Results from the clinical study showed a statistically significant decrease in the incidence of
bacterial colonization of the Spectrum catheter (7.9% as compared to 22.8% for the CG/SS catheter,
p<0.001), and a statistically significant decrease in the incidence of catheter-related bacteremia in
patients receiving the Spectrum catheter (0.3% as compared to 3.4% for the control catheter, p<0.002).
The antimicrobial durability of the Spectrum catheter against Staphylococcus epidermidis lasted for at
least 21 days after catheter insertion in patients (zone of inhibition ≥25 mm). Examination by
high-performance liquid chromatography showed that the Spectrum catheter contained 11.08 mg
(554 µg/cm) and 10.50 mg (525 µg/cm) per catheter of minocycline and rifampin, respectively. More-
over, there were no detectable changes in antibiotic susceptibilities of bacteria cultured from the
Spectrum Catheter and from adjacent skin.
PRODUCT RECOMMENDATIONS
Catheter Size and Puncture Site
Preliminary reports indicate that catheter size can influence clotting; larger diameter catheters tend to
promote clots. As reported by Amplatz and others
material than to size of catheter. The angle of the catheter tip to the vessel wall should be checked
carefully. Blackshear reviewed the medical literature of catheter perforations, which have confirming
x-rays, and found that an incident angle of the catheter to the vessel wall greater than 40 degrees was
more likely to perforate.
Another critical factor that can cause a catastrophic event is the choice of puncture site. Findings by
Tocino and Watanabe indicate that the left subclavian and left jugular veins should be avoided when
practical. Eighty percent of the perforations or erosions were found when these vessels were used. In
addition, they have observed that the tip curve of a wedged catheter can be detected with lateral view
x-ray. 4
The above discussion is meant to be a guide for catheter size and puncture site. As more data become
available, other causal factors may become evident, but present information suggests that:
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2 , clot formation has less relation to type of catheter
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