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BD Surgiphor™ Irrigation instruments BD Surgiphor™ Sterile Wound Irrigation System

SKU:

910110

GTIN:

00382909101102

BD® Surgiphor™ Antimicrobial Irrigation System

Surgiphor™ Antimicrobial Irrigation System is a ready-to-use aqueous PVP-I lavage solution used to mechanically loosen and remove debris and foreign materials, including microorganisms from wounds. PVP-I, a well-known antiseptic agent, serves as a preservative within the solution providing a broad-spectrum antimicrobial effect against gram-positive and gram-negative bacteria and yeast to reduce the risk of unwanted microbial growth in the solution after the bottle is opened.¹

Efficacy

Provides 99.99% antimicrobial reduction with PVP-I preservative in the solution.‡,1
Consistency

Pre-mixed and pre-labeled bottles are ready-to-use reducing variability to support surgical outcomes.
Guidelines

Aligns with recommendations from CDC2 , WHO3 , and SHEA4 to use dilute PVP-I for surgical wound irrigation.
Sterility

Terminal sterilization of the container and wound irrigation solution provides a validated sterility assurance level (SAL) of 10-6

Efficacy

Provides 99.99% antimicrobial reduction with PVP-I preservative in the solution.‡,1
Consistency

Pre-mixed and pre-labeled bottles are ready-to-use reducing variability to support surgical outcomes.
Guidelines

Aligns with recommendations from CDC2 , WHO3 , and SHEA4 to use dilute PVP-I for surgical wound irrigation.
Sterility

Terminal sterilization of the container and wound irrigation solution provides a validated sterility assurance level (SAL) of 10-6

false

CDC, Centers for Disease Control and Prevention; FDA, US Food and Drug Administration; IFU, Instructions for Use; OR, operating room; PVP-I, povidone iodine; SAL, sterility assurance level; SHEA, Society for Healthcare Epidemiology of America; USP, US Pharmacopeia; WHO, World Health Organization.

REFERENCES
1. Surgiphor Solution Preservative Effectiveness Report. Orthopor LLC; 2019.
2. 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.
3. World Health Organization. Global guidelines for the prevention of surgical site infections. https://www.who.int/publications/i/item/ 9789241550475. Accessed April 5, 2025.
4. 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.

* Indication for use: BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris and foreign materials, including microorganisms, from wounds.
‡ At initial time point of 7 days. Product should be used only within 24 hours of opening per IFU.

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

GTIN - Case

50382909101107

GTIN - Each

00382909101102

Packaging

Case Quantity

Product Basic Specification

Bottle Type

Surgiphor™ 450 mL compressible plastic bottle with terminally sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS.

GTIN

GTIN - Case	50382909101107	8
GTIN - Each	00382909101102	1

Packaging

Case Quantity

Product Basic Specification

Bottle Type

Surgiphor™ 450 mL compressible plastic bottle with terminally sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, Vitamin E TPGS.

false

BD products

true

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BD Surgiphor™ Antimicrobial Irrigation System & Overview

Surgiphor™ Antimicrobial Irrigation System is the first and only terminally sterile, ready-to-use aqueous PVP-I lavage system. It is used to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

The Surgiphor™Antimicrobial Irrigation System includes a 450 mL compressible bottle with terminally sterile 0.5% PVP-I formulation with 0.9% saline, Potassium Iodide, Phosphate Buffer, and Vitamin E TPGS.

Surgiphor™ Antimicrobial Irrigation System is an intraoperative irrigation system intended to loosen and remove debris, and foreign materials, including microorganisms, from wounds.

Benefits of the Surgiphor™ Antimicrobial Irrigation System include:

● A terminally sterilized solution with a sterility assurance level of 10^-6, giving our customers the confidence that the product they are using has a one in a million chance of containing a single viable microorganism¹^,²

● It reduces the risk of unwanted microbial growth in the solution after the bottle is opened, due to its broad-spectrum antimicrobial effect against gram-positive and gram-negative bacteria and yeast.¹

● Provides 99.99% reduction of bacteria with PVP-I as a preservative in the solution³

● The concave bottle design prevents rolling and enables users to generate and control pressure of the solution facilitating mechanical debridement.

Wound Irrigation Basics

1. Remove bottle and cap from tray using aseptic technique.

2. Screw the cap on to the bottle and fully tighten, cap will puncture the seal as it is tightened.

3. Invert the bottle, compress the bottle and direct the fluid into the wound to irrigate the entirety of the wound area.

4. Immediately after irrigation remove Surgiphor™ solution from the wound, and rinse thoroughly with sterile saline solution.

5. Remove excess saline from the wound area.

6. If the wound requires additional irrigation, the remaining Surgiphor™ solution may be used until the solution has been exhausted, for up to 24 hours after puncturing the seal. After 24 hours, dispose of unused solution and device.

The use of liquids in a surgical field to improve visualization and remove debris from the surgical field and deeper tissues. Intraoperative techniques during surgery are commonly used to^4.

● Reduce contamination by removing particles and bacteria

● Remove nonviable tissue

● Expose healthy tissue

Solutions commonly used for intraoperative irrigation can include the following:

● Normal Saline: This is non-toxic to tissues and similar in tonicity to physiologic fluids, making it the most commonly used method.

● Sterile Water: Sterile water is non-toxic to tissues but is hypotonic and may cause cell lysis.

● Potable Water: This method is used in austere environments where sterile water or saline isn’t available.

● Antimicrobial Solutions: These would include dilute PVP-I, dilute CHG, and antibiotics with saline

Irrigation solutions that require manual mixing are prone to inconsistency, and every variation in preparation can lead to increased risk. In addition, irrigation products which are not specifically labeled as “sterile” may increase the risk of compromising in sterility. Consider the following when selecting a solution:

Sterility: Use a terminally sterile antiseptic solution to minimize the risk of transferring viable microorganisms to the patient.
Ease of use: Pre-mixed, ready-to-use solutions can save time and reduce variability in the OR.
Guideline alignment: Ensure the solution aligns with current standards and guidelines.
Shelf life and usage window: Consider how long the solution remains effective after opening.

Sterile Irrigation

A terminally sterile solution is one that has undergone sterilization in its final, sealed container. This process ensures that the product is free from viable microorganisms before it is opened. Terminal sterilization is typically validated to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, meaning there is only a one in a million chance that a single microorganism remains in the product. The FDA requires that implantable and injectable devices have this level of sterility.^2,5

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