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FAQs

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


Q: What is Irrisept?

A: Irrisept is a jet lavage system, containing low concentration chlorhexidine gluconate (CHG*) 0.05% in sterile water for irrigation.

Irrisept is an FDA cleared (K080779), Class II medical device.

Contents are wrapped in two sequential CSR wraps and sealed in Tyvek® header pouch (Model# ISEPT-450-USA).

Irrisept contents include:

(1) Irrisept (one 450 mL bottle containing 0.05% CHG in sterile water, USP (99.95%))

(1) Irriprobe applicator

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

Q: How is using Irrisept different from other irrigation?

A: 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 needed to help remove bacteria, debris and particulate.

Q: Where can I use Irrisept?

A: Irrisept is FDA-cleared for use on wounds. The mechanical action effectively loosens and removes wound debris.

Q: Is Irrisept safe?

A: Irrisept has successfully passed FDA safety testing for:

  • Cytotoxicity
  • Skin Irritation
  • Immune allergic response

Ongoing testing is part of Irrisept’s scientific program. Irrisept has subsequently conducted and successfully completed testing for:

  • Acute Systemic toxicity
  • Neurotoxicity
  • Hemolysis
  • Pharmacokinetics
  • Thoracic Tissue toxicity
  • Chondrocyte toxicity
  • Intraperitoneal Tissue toxicity

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

Q: Does Irrisept have any warnings and/or cautions?

A: Irrisept is contraindicated for patients with a known CHG allergy. Keep away from eyes and ear canals. If there is contact with these areas, rinse out promptly and thoroughly with water or normal saline. Discontinue use immediately if irritation sensitization or allergic reaction occurs. Not for injection. Not made with natural rubber latex. Federal law prohibits this device to sale by or on the order of a licensed physician.

Q: Why does Irrisept packaging state “Use as directed by a physician. Rx Only.”?

A: Irrisept is only available to licensed healthcare professionals. FDA regulations require Irrisept packaging to state: “Federal law restricts this device to sales by or on the order of a license healthcare practitioner.” IrriMax Corporation uses the accepted, abbreviated form of this statement on its’ labeling to conserve space: “Rx Only”. Irrisept is not available over-the-counter or off-the-shelf through retail stores or retail websites.

Q: Can Irrisept be used on children?

A: Irrimax Corporation does not have safety testing data or clinical trial data for neonatal or pediatric patients, under the age of 18.

Q: What applicators are available to use with Irrisept?

A: There are three custom-designed applicators available for use with Irrisept and Irririnse. The Irriprobe applicator is elongated with four parallel ports. The LT Splatterguard tip produces four multi-directional streams and helps decrease splash to the user and the environment.  The Splatterguard produces four parallel streams and helps decrease splash to the user and the environment.

Q: Do I have to use the rinse step?

A: Irrisept’s Instructions for Use require a saline rinse step.

Q: Can Irrisept be re-used?

A: Irrisept is designed as a single-use, disposable system.

Q: What are the storage condition requirements for Irrisept during warehousing and transportation?

A: Irrisept packaging, for warehousing and transportation purposes specifically, is labeled for storage between 10-30 degrees Celsius.

Q: What is the shelf life of Irrisept?

A: Irrisept maintains a 2-year shelf life from the date of sterilization, which is indicated on the expiration label on the unit carton. Report TP-14-001 Summary is on file at Irrimax Corporation.

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

A: The expiration date label is located on the left side panel, of the Irrisept box/unit carton. That expiration date applies to the unit carton and its contents, that date supersedes any other expiration dates on the contents. The Irrisept product maintains a 2-year shelf life, from the date of sterilization. This is indicated as an expiration date on the unit carton label. Please use the unit carton expiration date as the expiration date for entire product. Report TP-14-001 summary is on file at Irrimax Corporation.

Q: Can Irrisept be warmed prior to use?

A: Irrisept may be warmed up to 40°C (104°F) and should not exceed 7 days before removal from the temperature controlled cabinet.  Once removed, Irrisept should be used within 24 hours or discarded.

Q: What is the pH range for Irrisept and Irririnse?

A: Irrisept and Irririnse are tested, as part of the manufacturing and quality requirements of Irrimax Corporation, to confirm that the solutions meet the pH requirements of USP. Each LOT of Irrisept-403 meets a pH of 5.0-7.0 and each LOT of Irririnse meets a pH of 5.0-7.0. Further details and testing data are on file at Irrimax Corporation.

Q: Once Irrisept and Irririnse bottles are opened, seals broken and removed, how long can the product be left open before it should be discarded?

A: Irrimax Corporation regularly performs contamination testing of sealed product. To date, contamination testing of open product in the field, with or without applicators in place, has not been conducted.

Q: Can Irrisept be used in conjunction with negative pressure VAC therapy?

A: Wound cleansing and debridement is regularly performed prior to VAC therapy initiation or in conjunction with VAC therapy dressing changes. VAC therapy is not a debriding tool and is not a substitute for effective forms of debridement.6 When using Irrisept in conjunction with VAC therapy, use Step 1 and Step 2 per the Irrisept instructions for use. Initiate VAC therapy as ordered and follow VAC manufacturer’s directions.

Q: Can you explain the science of CHG?

A: CHG, a cationic bisbiguanide, works by destroying the bacterial cell membrane and precipitating cell contents. The attraction of the cationic CHG molecule to negatively charged bacterial cells results in a rapid rate of bacterial cell death.4

Q: Can chlorhexidine be used for burns?

A: Chlorhexidine has been used extensively in the management of burns.5,7 The World Health Organization (WHO) recommends cleansing burns with chlorhexidine after debridement for burn management.8

Q: Can I mix my own CHG solution?

A: Irrisept is an FDA-cleared product (K080779). Manufactured in an FDA-registered facility, in accordance with Good Manufacturing Practice (GMP) regulations. Irrisept is aseptically filled and manufactured to precise specification, with a critical percentage concentration of CHG in sterile water. Irrimax Corporation holds the rights to US and worldwide patents that provide broad protection for the use of CHG concentrations of 1% or less. For more information, please contact the Irrisept Clinical Team.

CUSTOMER SERVICE AND ORDERING

Q: How do I obtain a sample of Irrisept?

A: Requesting a sample is easy.

    • Visit our website www.irrisept.com and submit an online request
    • Email directly to a Customer Service representative: cs@irrisept.com
    • Call a Customer Service representative directly at 770.807.8445
  • *PLEASE NOTE: Irrisept is an “Rx Only” product and can only be sampled by a licensed healthcare practitioner.

Q: How is Irrisept packaged?

A: Irrisept is currently offered in sterile Tyvek tray packaging. Irrisept contents include Step 1 (Irrisept, 450mL, 0.05% CHG in sterile water, USP- (99.95%)), Step 2 (Irririnse, 450mL, sodium chloride, USP) and three custom applicator tips.

Q: How do I order Irrisept?

A: We have contracted with National US distributors and Group Purchasing Organizations, in addition to smaller regional distributors, to make ordering Irrisept easily accessible.

    • Contact our Customer Service department directly at 770.807.8445 or email cs@irrisept.com to help identify the smoothest path to facilitating your order.
    • Or – contact your local National Distributor and see if their local warehouse is already stocking the product in your area and order through your regular process.
  • You can also reach out to your Irrisept Sales Representative for assistance in placing your initial order or helping you work with your preferred distributor to get started.

Q: Which distributors handle Irrisept?

A: Irrisept can be ordered through these major distributors:

    • Cardinal
    • Owens & Minor
    • McKesson
    • Henry Schein
    • Medline
    • AmerisourceBergen
    • Mohawk
    • Buffalo Hospital Supply
    • Claflin Company
  • LeeSar

Q: Is Irrisept on contract with any Group Purchasing Organizations (GPOs)?

A: Irrisept is under contract with:

    • Vizient (formerly Novation and MedAssets)
  • Premier Healthcare Alliance.

Q: Is there a reimbursement code for Irrisept?

A: No, a reimbursement code is not currently available.

References

1. Biocompatibility compliance tests completed per FDA’s Blue Book Memorandum G95-1 and ISO 10093-1, Biological Evaluation of Medical Devices, on file at IrriMax Corporation.

2. Study: Systemic Toxicity in Mice; GLP Study Number T0626_504. NAMSA. Report on file at Irrimax Corporation.

3. Study: Neurological Toxicology with local effects after implantation assessment of Irrisept in a chronic rabbit dorsal; GLP Study number 265-01. NAMSA. Report on file at Irrimax Corporation.

4. CDC MMWR (2002). Guideline for hand hygiene in health-care settings: Recommendations of the healthcare infection control practices advisory committee and the HICPAC/SHEA/APIC/IDSA hand hygiene task force. 51:RR-16.

5. Denton, G. (2001). Chlorhexidine. In: Block, S. ed. Disinfection, sterilization, and preservation. 5th ed. Lippincott Williams & Wilkins; Philadelphia, PA. 321-336.

6. V.A.C. therapy: Clinical guidelines a reference source for clinicians (2012). Retrieved 9/11/2013 from http://www.kci1.com/cs/Satellite?blobcol=urldata​&blobheadername1=Content-type&blobheadername2=Content-​disposition&blobheadername3=MDT Type​&blobheadervalue1=application%2Fpdf​&blobheadervalue2=inline%3B+​filename%3D913%252F210%252F2-​B-128f_Clinical%2BGuidelines-WEB.pdf&blobheadervalue3=​abinary%3B+charset%3DUTF-8&blobkey=​id&blobtable=MungoBlobs&blobwhere​=1226674964720&​amp;ssbinary=true)

7. WHO (2007). Management of burns. Retrieved from http://www.who.int/surgery/pubilcations/Burns management.pdf

8. Platt, J. & Bucknall, R.A. (1984). An experimental evaluation of antiseptic wound irrigation. Journal of Hospital Infection. 5:181-188.

IRR024 REV 08

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