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Irrisept Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device. Irrisept contains 0.05% chlorhexidine gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP). The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the bottled solution. Irrisept is a Class II Medical Device and an unclassified Combination Product.

CHG is chlorhexidine gluconate. It is a cationic bisbiguanide salt. CHG works by destroying the bacterial cell membrane and precipitating cell contents. The attraction of the positively charged CHG molecule to negatively charged bacterial cell wall causes disruption of the cell membrane and subsequent cellular death.² CHG acts as a preservative to help inhibit microbial growth in the bottled solution.

The Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds.

Irrisept’s bottle design allows you to control the delivery pressure of the solution through manual bottle compression. Grasping the bottle firmly, you can control the direction and pressure desired to effectively loosen and remove wound debris.

Irrisept can be used for all types of wounds.

Irrisept meets biocompatibility guidelines for ≤ 24 hours contact with breached or compromised surfaces following the ISO standard 10993-1. The following testing supports biocompatibility of Irrisept for the intended use of wound cleansing and debridement³:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Material Mediated Pyrogens

Reports for all testing stated above are on file and available upon request through Irrimax Corporation.

WARNINGS

• Do not use this product if the patient is allergic to chlorhexidine gluconate.
• Discontinue use immediately if irritation, sensitization, or allergic reaction occurs.

CAUTIONS

• Do not use unless solution is clear and bottle twist seal is intact.
• When using this product keep away from eyes and ear canals. If solution inadvertently contacts these areas, rinse out promptly and thoroughly with water and/or normal saline.
• Not for injection.
• Single patient use only.
• Irrisept is intended for use in adults by healthcare professionals only.
• Irrisept solution meets biocompatibility guidelines for ≤ 24 hours contact with breached or compromised surfaces (ISO 10993-1).

Irrisept is a prescription device. FDA regulations require that prescription devices have the following statement “Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.” 

ISEPT-450-USA and ISEPT-150-USA are manufactured using aseptic processing per ISO13408 Aseptic Processing of Healthcare Products. The bottle, applicator, and packaging are EO-sterilized.

ISEPT-150N-USA and ISEPT-150RP-USA are also manufactured using aseptic processing per ISO13408 Aseptic Processing of Healthcare Products.

Labeling on all Irrisept products states: “Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.”

Labeling on all Irrisept products states: “Single patient use only” along with “single use only, do not reuse” symbol.

Labeling on all Irrisept products state storage temperature is between 10°–30° degrees Celsius (50°–86° Fahrenheit).

Irrisept maintains a 3-year shelf life from the date of manufacture, which is indicated on the product packaging or IFU insert.

The expiration date may be located at the top of the Irrisept product pouch label or on a sticker on the pouch or box.

If desired, the Irrisept Antimicrobial Wound Lavage device may be warmed in its packaging up to 40°C (104°F) by placing it in a temperature warming cabinet prior to use. Note: Prior to warming, store the device as per the device labeling.⁴

Each LOT of Irrisept is tested to meet a pH range of 5.0 to 7.0.

1. (2022). KTK Summary. Doc. 537161 V5 Evaluation of CHG as a preservative in the solution

2. Biocompatability Matrix. Data on file at Irrimax Corp. Lawrenceville, GA.

3. TR 17-017 Irrisept Temperature Excursion Test

4. McDonnell, G. & Russell, A.D. (1999). Antiseptics and Disinfectants; Activity, Action and Resistance. Clin Micro Rev, 12(1), 147-179. doi.org/10.1128/cmr.12.1.147