Same Functionality,
improved performance,
10X increase in effectiveness
in reducing microbial contamination

Single-use protective disc with CHG to
reduce microbial impact on the site dressing
on patients with IV and other catheters.
Improved absorbency, better wound
healing, and superior disc design over
market-leading product.
Halo Guard Disk

Designing for Healthcare

HaloGUARDTM Protective Disc with CHG (Chlorhexidine Gluconate) has demonstrated in-vitro antimicrobial efficacy against a broad range of organisms known to cause Catheter Related Blood Stream Infections (CRBSI's).

Blood stream infections associated with IV catheters and similar are a common cause of death in US hospitals. The Center for Disease Control (CDC) has recommended the use of 0.5% Chlorhexidine Gluconate on skin at the catheter exit site for the prevention of catheter-related blood stream infections.

HaloGUARDTM is a sterile, single-use disposable disc infused with the antimicrobial agent chlorhexidine gluconate (CHG) to reduce contamination of the dressing by inhibiting microbial growth and colonization of the dressing.

HaloGUARDTM is intended to cover and protect insertion sites on adult patients. Common applications include IV catheters, central venous lines, suction catheters, epidural catheters, PICCs, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices. HaloGUARDTM prevents contamination of the dressing by inhibiting microbial growth and colonization of the dressing.

HaloGUARDTM has undergone applicable in vitro, biocompatibility, sterility, and performance testing for safety and effectiveness.

Same Functionality as the Competition

Vascular insertion sites
Preventing contamination of the wound dressing for 7 days (168 hours)
Biocompatible circular foam disc with center hole and radial slit for ease of placement
Chlorhexidine gluconate (CHG) Antimicrobial agent consistent with CDC and DOQI guidelines
Incorporation/infusion through soaking foam in CHG solution
Broad-spectrum of antimicrobial agent
5 log CFU/ml reduction of 8 different target pathogens
Pyrogen and latex free
Multiple product sizes
Sterility assurance level: 10-6
Film adhesive: Pressure sensitive acrylic

Improved Performance

We asked clinical professionals how to improve discs currently used for this.
HaloGUARDTM was designed on the basis of the feedback:

  • Beveled edges to reduce potential for catheter kinking and securement
  • Softer material to reduce skin irritation/abrasion
  • Higher absorbency of foam (38% higher than market-leading product)
  • Performed tests of In-Vitro Cytotoxicity, irritation and skin sensitization, and chemical characterization
  • Better in-vivo wound healing results (by day 21, HaloGUARDTM compared to BioPatch showed a 63% reduction in observed signs of infection; a 15% smaller wound circumference; 20% less eschar formation and 50% greater re-epithelialization)
Contact us for clinical study, FDA clearance summaries and more details!

HaloGUARDTM Protective Disc with CHG (Chlorhexidine Gluconate) has demonstrated in-vitro antimicrobial efficacy against a broad range of organisms known to cause Catheter Related Blood Stream Infections (CRBSI's)

VIEW FOCUS GROUP RESULTS

Same Great Device.....

Description
HaloGUARDTM
Compare our product
Competing Brand
Competing brand
PATIENT ANATOMICAL SITE FOR USE OF DEVICE
Vascular insertion sites of other devices (i.e. catheters, etc.) outside the body
MODE OF OPERATION
Antimicrobial foam disc with antimicrobial agent CHG to protect device related vascular insertion sites
GEOMETRY OF DEVICE
Circular foam disc with center hole and radial slit
TEMPERATURE REQUIREMENTS: 15 to 30°C (59 to 86°F)
ANTIMICROBIAL AGENT: Chlorhexidine gluconate (CHG)
FUNCTION/PURPOSE OF ANTIMICROBIAL AGENT
Prevents contamination of the dressing by inhibiting microbial growth and
colonization of the dressing
PHARMACOLOGY OF ANTIMICROBIAL AGENT
CHG provides antiseptic and antimicrobial effect with rapid bactericidal action.
CHG has a positive charge that reacts with the negatively charged microbial
cell surface and destroys the integrity of the cell membrane.
ANTIMICROBIAL AGENT APPLICATION METHOD TO MEDICAL DEVICE
Incorporation/infusion through soaking foam in CHG solution
SPECTRUM OF ACTIVITY OF ANTIMICROBIAL AGENT
Broad spectrum (works against a wide range of gram-positive and
gram-negative bacteria, yeast and mold) antimicrobial agent
TARGET PATHOGENS
• Staphylococcus aureus (MRSA)
• Pseudomonas aeruginosa
• Staphylococcus epidermidis (MRSE)
• Candida albicans
• Vancomycin-Resistant Enterococci (VRE)
• Candida tropicalis
• Enterobacter cloacae
• Klebsiella pneumoniae
AVERAGE CHG CONCENTRATION
Industry standard concentration across sizes
PRODUCT SIZE CONFIGURATIONS
• 1 inch (2.5 cm) disc, 4.0 mm center hole with radial slit
• 1 inch (2.5 cm) disc, 7.0 mm center hole with radial slit
• 0.75 inch (1.9 cm) disc, 1.5 mm center hole with radial slit
PYROGEN & LATEX FREE
SINGLE USE & DISPOSABLE
STERILITY ASSURANCE LEVEL (SAL): 10-6
FILM ADHESIVE: Pressure-sensitive acrylic

....with better features

HaloGUARDTM
Competing Brand
DESIGN FEATURES
HaloGUARDTM Protective Disc with CHG is a chlorhexidine gluconate (CHG) infused sterile hydrophilic absorptive foam dressing (disc)
BIOPATCH Protective Disc with CHG is a hydrophilic polyurethane absorptive foam with chlorhexidine gluconate (CHG)
DEVICE MATERIALS
Medical grade hydrophilic polyurethane foam impregnated with chlorhexidine gluconate (CHG) with a polyether polyurethane film with print
Polyurethane foam impregnated with chlorhexidine gluconate with a nylon reinforced urethane film with print
ABSORBENCY
11 times its own weight in fluid
8 times its own weight in fluid
STERILIZATION METHOD
E-beam Radiation
Ethylene Oxide
MICROBIAL REDUCTION
5 log reduction or greater
4 log reduction
PRODUCT EDGE FINISH
Pinched (beveled)
Straight
PACKAGING
LLDPE film and aluminum foil laminate, non-breathable (suitable for E-beam)
Tyvek/lid is spun bound polyolefin with an adhesive coating, breathable (suitable for ethylene oxide)
MEM ELUTION CYTOTOXICITY
Moderately cytotoxic
Severely cytotoxic

Summary of ISO 10993 Biocompatabilty Testing and Wound Healing Studies for HaloGUARDTM vs. BioPatch

HaloGUARDTM was evaluated according to recommended ISO biocompatibility tests for safety and compared with the predicate BioPatch. Upon completion of the testing FDA requested further in-vivo testing designed to evaluate the effect both HaloGUARDTM and BioPatch may have on wound healing. This test is not the standard required for this type of device, but was asked for by FDA due to the presence of MDR's related to patch devices and wounds.
To place your HaloGuard order today
call us directly at 1-888-828-6286.
or
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Product Code Product Description Units/carton Cartons/Case
Hg00751510 Protective Disc with CHG,
¾ inch disc, 1.5 mm hole
10 4
Hg01710 Protective Disc with CHG,
1 inch disc, 7mm hole
10 4
Hg01410 Protective Disc with CHG,
1 inch disc, 4mm hole
10 4
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