AHCPR, Agency for Healthcare Policy and Research; CDC, Centers for Disease Control and Prevention; CHG, chlorhexidine gluconate; FDA, US Food and Drug Administration; IFU, Instructions for Use; OR, operating room; PSI, pound per square inch; PVP-I, povidone iodine; SAL, sterility assurance level; SHEA, Society for Healthcare Epidemiology of America; USP, US Pharmacopeia; WHO, World Health Organization.
REFERENCES
1. US Food and Drug Administration. 2022 K221504 Trade/Device Name: BD Surgiphor Antimicrobial Irrigation System. https://www.accessdata.fda.gov/cdrh_docs/pdf22/ K221504.pdf. Accessed April 5, 2025. 2. Surgiphor Solution Preservative Effectiveness Report. Orthopor LLC; 2019. 3. Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017 [published correction appears in JAMA Surg. 2017;152(8):803]. JAMA Surg. 2017;152(8):784-791. 4. World Health Organization. Global guidelines for the prevention of surgical site infections. https://www.who.int/publications/i/item/ 9789241550475. Accessed April 5, 2025. 5. Calderwood MS, Anderson DJ, Bratzler DW, et al. Strategies to prevent surgical site infections in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2023;44(5):695-720. 6. Surgiphor Gamma Sterilization Validation Test Report. Orthopor LLC; 2019. 7. United States Pharmacopeia (USP) <797>, Immediate-use CSPs. Rockville, MD; 2022. 8. Barnes S, Spencer M, Graham D, Johnson HB. Surgical wound irrigation: a call for evidence-based standardization of practice. Am J Infect Control. 2014;42(5):525-529. 9. Surgiphor System Mechanical Action Report. Orthopor LLC; 2019. 10. Sidhu, P. Antimicrobial efficacy evaluation of 0.5% PVP-I and Irrisept® by in vitro time-kill assay: 2021. Internal BD report: unpublished.
* Indication for use: BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris and foreign materials, including microorganisms, from wounds.
† PVP-I is an antimicrobial preservative contained within the bottled solution. The BD Surgiphor™ solution is not indicated for use as an antimicrobial at or within the wound site.
‡ At initial time point of 7 days. Product should be used only within 24 hours of opening per IFU.
§ Shown by the in vitro antimicrobial efficacy of the PVP-I preservative in the BD Surgiphor™ solution.
Surgiphor™ Antimicrobial Irrigation System
Product description. Surgiphor™ Antimicrobial Irrigation System is an antimicrobial irrigation system containing 0.5% povidone iodine (PVP-I) in phosphate-buffered saline, potassium iodide and Vitamin E TPGS. PVP-I acts as a preservative to help inhibit microbial growth in the irrigation solution. Indication for use. Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds. Contraindications. Surgiphor™ Antimicrobial Irrigation System should not be used in patients with known allergic reaction to any of the ingredients in the solutions. Surgiphor™ Antimicrobial Irrigation System should also not be combined with other irrigation or antiseptic solutions due to potential reactions and reduction in the effectiveness of the system. Not for use in neonates. Warnings. Do not use or mix with other cleansers, soaps, lotions, or ointments. Do not use for injection or infusion. Do not swallow. Do not use in eyes or ear canals. Discontinue use immediately if irritation or an allergic reaction occurs. Do not use if packaging is damaged or if seal integrity is compromised. Do not reuse Surgiphor™ solution after 24 hours. Precautions. Surgiphor™ solution may cause a temporary irritation and/or burning sensation on exposed skin in very rare cases. Surgiphor™ solution may cause allergic reactions such as rash or skin irritation in patients with iodine allergy. Anaphylaxis with the use of Surgiphor™ solution may occur in patients with severe iodine allergy. Federal law restricts this device to sale by or on the order of a licensed physician. Single patient use only. Not for at-home use.
Please consult product insert for complete indications, contraindications, warnings, precautions, safety information and instructions for use.
