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.

LEARN MORE

Designing for Healthcare

HaloGUARD^TM 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.

HaloGUARD^TM 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.

HaloGUARD^TM 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. HaloGUARD^TM prevents contamination of the dressing by inhibiting microbial growth and colonization of the dressing.

HaloGUARD^TM 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.
HaloGUARD^TM 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, HaloGUARD^TM 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!

HaloGUARD^TM 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

HaloGUARD^TM

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

HaloGUARD^TM

Competing Brand

DESIGN FEATURES

HaloGUARD^TM 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 HaloGUARD^TM vs. BioPatch

HaloGUARD^TM 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 HaloGUARD^TM 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.

Summary of ISO 10993 Testing Completed

Wound Healing Study Day 7 Evaluation Data Summary

Wound Healing Study Day 14 Evaluation Data Summary

Wound Healing Study Day 21 Evaluation Data Summary

Wound Healing Study Day 28 Evaluation Data Summary

Microbial Simulated Use Challenge Results (Day 7)

To place your HaloGuard order today
call us directly at 1-888-828-6286.

Click Here to Email us

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