2
• A prospective, randomized, controlled clinical trial of 403
central venous catheter insertions in 158 adult patients in
a medical-surgical ICU showed that ARROWg+ard Blue®
catheters were 50% less likely to be colonized at removal
than the control catheters (13.5 compared to 24.1 colonized
catheters per 100 catheters, p=0.005) and were 80% less
likely to produce a bloodstream infection (1.0 compared
to 4.7 infections per 100 catheters; 1.6 compared to 7.6
infections per 1000 catheter days, p=0.03).28
• No adverse effects were seen from the antimicrobial catheter,
and none of the isolates obtained from infected catheters in
either group showed in vitro resistance to chlorhexidine or
silver sulfadiazine.28
• Complete data was obtained for 403 central venous catheters
(195 control catheters and 208 antimicrobial catheters) in
158 patients. Control catheters removed from patients who
were receiving systemic antibiotic therapy occasionally
showed low-level surface activity that was unrelated to the
length of time the catheter had been in place (mean zone of
inhibition ± SD, 1.7 ± 2.8 mm); in contrast, antimicrobial
catheters uniformly showed residual surface activity (mean
zone of inhibition, 5.4 ± 2.2 mm; P < 0.002), which declined
after prolonged periods in situ. Antimicrobial activity was
seen with antimicrobial catheters that had been in place for
as long as 15 days.28
The following clinical study was conducted on the original
formulation 7 Fr. triple-lumen ARROWg+
ard Blue®catheter.
• The ARROWg+
ard Blue®catheter has demonstrated a
signicant decrease in the rate of bacterial colonization
along the catheter in limited animal studies.16
• An independent review of 11 randomized clinical trials on
the ARROWg+
ard Blue®antimicrobial catheters (MEDLINE
search from January 1966 to January 1998) concluded that
central venous catheters impregnated with a combination of
chlorhexidine acetate and silver sulfadiazine are effective
in reducing the incidence of both catheter colonization and
catheter-related bloodstream infections in patients at high
risk for catheter-related infections.43
If the total amount of silver sulfadiazine and chlorhexidine
contained in the antimicrobial surface was released from the
catheter as a single dose, the blood levels of silver, sulfadiazine,
and chlorhexidine that would be found would be less than the
blood levels found after clinical usage of these compounds in
established safe dosages as administered via mucous membranes
and skin.12
The potential exposure of patients to the two agents, silver
sulfadiazine and chlorhexidine, on the antimicrobial surface is
signicantly less than that encountered when these compounds are
used on burn wounds, on cutaneous wounds, or as mucosal irrigants.12
The worldwide reported incident rate due to hypersensitivity
reactions is 0.00023% with a conrmed incident rate of
0.000077%.10
Indications for Use:
The MAC™Multi-Lumen Central Venous Access Device
with ARROWg+
ard Blue®permits venous access and catheter
introduction to the central circulation. It may be inserted into
the jugular, subclavian, or femoral veins. The ARROWg+
ard®
technology is intended to help provide protection against catheter-
related infections. Clinical data have not been collected that
demonstrate the use of the ARROWg+
ard® antimicrobial surface
in decreasing catheter-related infections for this device. It is not
intended to be used as a treatment for existing infections, nor is it
indicated for long-term use.
Contraindications:
The ARROWg+
ard Blue®antimicrobial catheter is contraindicated
for patients with known hypersensitivity to chlorhexidine acetate,
silver sulfadiazine, and/or sulfa drugs.
Hypersensitivity reactions are a concern with antimicrobial
catheters, in that they can be very serious and even life-
threatening. The ARROWg+
ard Blue®antimicrobial catheter was
introduced worldwide in 1990, and six years elapsed before the
rst hypersensitivity reaction was reported in Japan in May 1996.10
To date (August 2003) the ARROWg+
ard Blue®reported incident
rate has been extremely low, at 1 per 503,081 exposures, and
the skin test conrmed rate is even lower, at 1 per 1,446,360
exposures. The vast majority of these episodes (17) have been
endemic to individuals of Japanese extraction living in Japan.
The literature indicates that individuals of Japanese extraction
are known to have had similar hypersensitive reactions following
topical chlorhexidine administration.14,19,25,26,34,35,39,42 Three (3)
incidents have been reported in the UK, two (2) in the USA,
and one (1) in New Zealand. If adverse reactions occur after
catheter placement, remove catheter immediately.
Special Patient Populations:
Controlled studies of the antimicrobial catheter have not been
conducted in pregnant women,32 pediatric or neonatal patients
and patients with known sulfonamide hypersensitivity, erythema
multiforme, Stevens-Johnson syndrome,12 and glucose-6-
phosphate dehydrogenase deciency. The benets of the use of
this catheter should be weighed against any possible risk.
Warnings and Precautions:*
1. Warning: Sterile, Single use: Do not reuse, reprocess
or resterilize. Reuse of device creates a potential risk of
serious injury and/or infection which may lead to death.
2. Warning: Chlorhexidine-containing compounds have
been used as topical disinfectants since the mid-1970’s.
An effective antimicrobial agent, chlorhexidine found
use in many antiseptic skin creams, mouth rinses,
and disinfectants used to prepare the skin for surgical
procedures. In addition, chlorhexidine has been
incorporated into cosmetic products where it reportedly
functions as a cosmetic biocide. In the early 1990’s, the
FDA cleared three types of medical devices containing
chlorhexidine: intravenous catheters, topical antimicrobial
skin dressings, and an implanted surgical mesh.13
Hypersensitivity reactions are a concern with antimicrobial
catheters, in that they can be very serious and even life-
threatening. The ARROWg+
ard Blue®antimicrobial
catheter was introduced worldwide in 1990, and six years
elapsed before the rst hypersensitivity reaction was
reported in Japan in May 1996.10
To date (August 2003) the ARROWg+
ard Blue®reported
incident rate has been extremely low, at 1 per 503,081
exposures, and the skin test conrmed rate is even lower,
at 1 per 1,446,360 exposures. The vast majority of these
episodes (17) have been endemic to individuals of Japanese
extraction living in Japan. The literature indicates that
individuals of Japanese extraction are known to have
had similar hypersensitive reactions following topical
chlorhexidine administration.14,19,25,26,34,35,39,42 Three (3)
incidents have been reported in the UK, two (2) in the USA,
and one (1) in New Zealand. If adverse reactions occur
after catheter placement, remove catheter immediately.
3. Warning: Practitioners must be aware of complications
associated with percutaneous access device introduction
including vessel wall perforation,38 pleural and mediastinal
injuries,1,27 air embolism,7,18,23,30 sheath embolism, thoracic
duct laceration,4 bacteremia, septicemia, thrombosis,5
inadvertent arterial puncture,8 nerve damage, hematoma,
hemorrhage,6 dysrhythmias, and occlusion.
