Download a PDF of all frequently asked questions, or read on below to learn more.
A1: Irrisept® Antimicrobial Wound Lavage is a single-use, manual, self-contained irrigation device comprised of (1) 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and (1) applicator (Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution. Irrisept is a Class II Medical Device and an unclassified Combination Product. REF # ISEPT-450-USA is packaged 12 single units to a case. Each unit is wrapped in two Central Supply Room (CSR) wraps and sealed in a Tyvek® pouch.
A2: The Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
A3: Irrisept’s bottle design allows users to control the delivery pressure of the solution through manual bottle compression. Grasping the bottle firmly, the user can control the direction and pressure desired to effectively loosen and remove wound debris.
A4: Irrisept can be used for all types of wounds.
Reports for all testing stated above, on file and available upon request through Irrimax Corporation.
A5: 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 debridement1-11:
A6: WARNINGS
CAUTIONS
A7: The solution is aseptically filled in a Blow-Fill-Seal (BFS) bottle. The bottle and applicator are EO-sterilized.
A8: 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.” This caution statement is shown on the Irrisept product back pouch label to define the symbol Rx Only, which is shown on the front pouch label. Irrisept is not available over-the-counter or off-the-shelf through retail vendors.
A9: Labeling on ISEPT-450-USA states: ‘Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.’
A10: Labeling on ISEPT-450-USA states ‘Single patient use only’ along with ‘single use only, do not reuse’ symbol.
A11: Labeling on ISEPT-450-USA states Storage Temperature is between 10°- 30° degrees Celsius (50°- 86° Fahrenheit).
A12: Irrisept maintains a 2-year shelf life from the date of manufacture, which is indicated on the pouch label.
A13: The expiration date is located at the bottom of the ISEPT-450-USA pouch label.
A14: Irrisept may be warmed up to 40 0C (104 0F) and should not exceed 7 days before removal from the temperature-controlled warming cabinet.4 Once removed, Irrisept should be used within 24 hours or discarded.
A15: Each LOT of Irrisept is tested to meet a pH range of 5.0 to 7.0.
A16: 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.13. CHG acts as a preservative to help inhibit microbial growth in the solution.
Customer Service – Please contact the customer service department directly, as needed.
PHONE: 770-807-8445
EMAIL: cs@irrisept.com
FAX: 770-807-8446
Ordering Information – REF # ISEPT-450-USA (sold by the case/12 Irrisept units per case)
Requests can be made through this IRRISEPT® website irrisept.com.
*PLEASE NOTE: Irrisept is a “Rx Only” product and can only be sampled by a licensed healthcare practitioner.
Irrisept is sold through national and regional medical/surgical distributors in the USA.
There is currently no reimbursement code for Irrisept.
IRR024 ISEPT-450-USA FAQs v3.0
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Irrimax®, Irrisept®, Irririnse®, Irriprobe® and Splatterguard® (all regardless of letter case) are registered trademarks of Innovation Technologies, Inc., parent company of Irrimax Corporation.
