770-807-8445   |   cs@irrisept.com
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Frequently Asked Questions

(US Product Labeling)

Download a PDF of all frequently asked questions, or read on below to learn more.

Q1: What is Irrisept®?

A1: 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. 

Q2: What are Irrisept’s indications for use in the USA?

A2: The Irrisept® Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.

Q3: How does the device create pressure for irrigation?

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.

Q4: Where can I use Irrisept?

A4: Irrisept can be used for all types of wounds.

Q5: Is Irrisept safe to use on wounds?

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 debridement3:
  • Cytotoxicity
  • Sensitization
  • Irritation
  • Acute Systemic Toxicity
  • Material Mediated Pyrogens
Reports for all testing stated above, on file and available upon request through Irrimax Corporation.

Q6: What are the risks and safety information associated with Irrisept?

A6: 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).

Q7: Is Irrisept sterile?

A7: 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.

Q8: Why does Irrisept packaging state “Rx Only.”?

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.” 

Q9: Do I have to rinse with saline?

A9: Labeling on all Irrisept products state: ‘Wait for approximately one minute, rinse with normal saline for irrigation. Discard any unused solution.’

Q10: Can Irrisept be used on more than one patient?

A10: Labeling on all Irrisept products state ‘Single patient use only’ along with ‘single use only, do not reuse’ symbol.

Q11: What are the storage condition requirements for Irrisept?

A11: Labeling on all Irrisept products state Storage Temperature is between 10°- 30° degrees Celsius (50°- 86° Fahrenheit).

Q12: What is the shelf life of Irrisept?

A12: Irrisept maintains a 3-year shelf life from the date of manufacture, which is indicated on the pouch label.

Q13: Where can I find the expiration date on the Irrisept product?

A13: The expiration date may be located at the top of the Irrisept product pouch label or on a sticker on the pouch or box

Q14: Can Irrisept be warmed?

A14: 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.14

Q15: What is the pH range for Irrisept?

A15: Each LOT of Irrisept is tested to meet a pH range of 5.0 to 7.0.

Q16: What is CHG?

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.15 CHG acts as a preservative to help inhibit microbial growth in the bottled solution.

CUSTOMER SERVICE AND ORDERING INFORMATION

Customer Service – Please contact the customer service department directly, as needed.

PHONE: 770-807-8445

EMAIL: cs@irrisept.com

FAX: 770-788-1079

Ordering Information –

REF # ISEPT-450-USA (sold by the case/12 Irrisept units per case)

REF # ISEPT-150-USA (sold by the case/15 Irrisept units per case)

REF # ISEPT-150N-USA (sold by the case/15 Irrisept units per case)

REF # ISEPT-150RP-USA (sold by the case/12 Irrisept units per case)

Sample Product

Requests can be made through this IRRISEPT® website www.irrisept.com.

*PLEASE NOTE: Irrisept is a “Rx Only” product and can only be sampled by a licensed healthcare practitioner.

DISTRIBUTION

Irrisept is sold through national and regional medical/surgical distributors in the USA.

REIMBURSEMENT

There is currently no reimbursement code for Irrisept.

References

3. Biocompatibility Matrix. Data on file at Irrimax Corp. Lawrenceville, GA.

14. TR 17-017 Irrisept Temperature Excursion Test

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

 

 

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Continuing Education

Irrisept offers Continuing Education. Please speak with an Irrisept Representative to get more details about the program.

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Irrisept®, Irriprobe® and Splatterguard® (all regardless of letter case) are registered trademarks of Innovation Technologies, Inc., parent company of Irrimax Corporation.