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BD Surgiphor™ Antimicrobial Irrigation System
Ready-to-use and terminally sterile.
Every bottle. Every time.
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Control what you can in the OR with the next generation of surgical wound irrigation
The Operating Room is a dynamic environment where every second matters. Your choice of wound irrigation can make a difference for surgeries. The new BD Surgiphor™ Antimicrobial Irrigation System is the only pre-mixed, terminally sterile dilute povidone-iodine (PVP-I) wound irrigation system. It is ready to use, enabling you to directly deliver a dilute PVP-I lavage to mechanically loosen and remove debris and foreign materials, including microorganisms from wounds during surgery. Using the BD Surgiphor™ System, you can reduce variability in wound irrigation processes, standardize wound irrigation practice and formulation for your patients, and align with current guidelines from the CDC1, WHO2, and the American Academy of Orthopaedic Surgeons (AAOS)3 to use dilute PVP-I for surgical wound irrigation.
The BD Surgiphor™ Antimicrobial Irrigation System is a 450 mL bottle designed with multiple innovations to help you make sterility standard.
Click on each hot spot to see how it can enable you to improve control, confidence and quality assurance in the OR.
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AAOS: American Academy of Orthopaedic Surgeons. CDC: Centers for Disease Control and Prevention. USP: United States Pharmacopeial Convention. WHO: World Health Organization.
**PVP-I is an antimicrobial preservative contained within the bottled solution. The Surgiphor solution is not indicated for use as an antimicrobial at or within the wound site.
†Sterility assurance level in accordance with ISO 11137. *At initial time point of 7 days. Product should be used only within 24 hours of opening per IFU. ^Preservative solution with 0.5% PVP-I tested against Candida albicans (ATCC #10231), Pseudomonas aeruginosa (ATCC #9027), Aspergillus brasiliensis (ATCC #16404), Escherichia coli (ATCC #8739) and Staphylococcus aureus (ATCC #6538). **Against USP <51> organisms for up to 28 days.8 Once opened, the product should not be used on the patient after 24 hours. #Shown by the in-vitro antimicrobial efficacy of the PVP-I preservative in the BD Surgiphor™ 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.
References:
- Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. JAMA Surg. 2017;152(8):784-791. doi: 10.1001/jamasurg.2017.0904
- World Health Organization (WHO). Global Guidelines for the Prevention of Surgical Site Infection, 2nd edition. Geneva: World Health Organization; 2018. Accessed on September 6, 2022, at https://apps.who.int/iris/rest/bitstreams/1168437/retrieve.
- American Academy of Orthopaedic Surgeons (AAOS). Intraoperative Risk Factors. In Surgical Risk Reduction Toolkit. Accessed on September 6, 2022, at https://www.aaos.org/quality/quality-programs/quality-toolkits/prevention-of-surgical-site-infection/.
- Surgiphor Gamma Sterilization Validation Test Report. Orthopor LLC; 2019.
- Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST67:2019. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. Arlington: AAMI; 2019.
- 3National Patient Safety Goals® Effective January 2023 for the Hospital Program. The Joint Commission website. http://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2023/npsg_chapter_hap_jan2023.pdf. Published January 2023. Accessed January 26, 2023.
- Surgiphor System Mechanical Action Report. Orthopor LLC; 2019.
- Surgiphor Solution Preservative Effectiveness Report. Orthopor LLC; 2019.
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AAOS: American Academy of Orthopaedic Surgeons; CDC: Centers for Disease Control and Prevention; USP: United States Pharmacopeial Convention; WHO: World Health Organization
**PVP-I is an antimicrobial preservative contained within the bottled solution. The Surgiphor solution is not indicated for use as an antimicrobial at or within the wound site.
†Sterility assurance level in accordance with ISO 11137. *At initial time point of 7 days. Product should be used only within 24 hours of opening per IFU. ^Preservative solution with 0.5% PVP-I tested against Candida albicans (ATCC #10231), Pseudomonas aeruginosa (ATCC #9027), Aspergillus brasiliensis (ATCC #16404), Escherichia coli (ATCC #8739) and Staphylococcus aureus (ATCC #6538). **Against USP <51> organisms for up to 28 days.8 Once opened, the product should not be used on the patient after 24 hours. #Shown by the in-vitro antimicrobial efficacy of the PVP-I preservative in the BD Surgiphor™ 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.
References:
- Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. JAMA Surg. 2017;152(8):784-791. doi: 10.1001/jamasurg.2017.0904
- World Health Organization (WHO). Global Guidelines for the Prevention of Surgical Site Infection, 2nd edition. Geneva: World Health Organization; 2018. Accessed on September 6, 2022, at https://apps.who.int/iris/rest/bitstreams/1168437/retrieve.
- American Academy of Orthopaedic Surgeons (AAOS). Intraoperative Risk Factors. In Surgical Risk Reduction Toolkit. Accessed on September 6, 2022, at https://www.aaos.org/quality/quality-programs/quality-toolkits/prevention-of-surgical-site-infection/.
- Surgiphor Gamma Sterilization Validation Test Report. Orthopor LLC; 2019.
- Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST67:2019. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. Arlington: AAMI; 2019.
- 3National Patient Safety Goals® Effective January 2023 for the Hospital Program. The Joint Commission website. http://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2023/npsg_chapter_hap_jan2023.pdf. Published January 2023. Accessed January 26, 2023.
- Surgiphor System Mechanical Action Report. Orthopor LLC; 2019.
- Surgiphor Solution Preservative Effectiveness Report. Orthopor LLC; 2019.
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AAOS: American Academy of Orthopaedic Surgeons; CDC: Centers for Disease Control and Prevention; USP: United States Pharmacopeial Convention; WHO: World Health Organization
**PVP-I is an antimicrobial preservative contained within the bottled solution. The Surgiphor solution is not indicated for use as an antimicrobial at or within the wound site.
†Sterility assurance level in accordance with ISO 11137. *At initial time point of 7 days. Product should be used only within 24 hours of opening per IFU. ^Preservative solution with 0.5% PVP-I tested against Candida albicans (ATCC #10231), Pseudomonas aeruginosa (ATCC #9027), Aspergillus brasiliensis (ATCC #16404), Escherichia coli (ATCC #8739) and Staphylococcus aureus (ATCC #6538). **Against USP <51> organisms for up to 28 days.8 Once opened, the product should not be used on the patient after 24 hours. #Shown by the in-vitro antimicrobial efficacy of the PVP-I preservative in the BD Surgiphor™ 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.
References:
- Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection. JAMA Surg. 2017;152(8):784-791. doi: 10.1001/jamasurg.2017.0904
- World Health Organization (WHO). Global Guidelines for the Prevention of Surgical Site Infection, 2nd edition. Geneva: World Health Organization; 2018. Accessed on September 6, 2022, at https://apps.who.int/iris/rest/bitstreams/1168437/retrieve.
- American Academy of Orthopaedic Surgeons (AAOS). Intraoperative Risk Factors. In Surgical Risk Reduction Toolkit. Accessed on September 6, 2022, at https://www.aaos.org/quality/quality-programs/quality-toolkits/prevention-of-surgical-site-infection/.
- Surgiphor Gamma Sterilization Validation Test Report. Orthopor LLC; 2019.
- Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST67:2019. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. Arlington: AAMI; 2019.
- 3National Patient Safety Goals® Effective January 2023 for the Hospital Program. The Joint Commission website. http://www.jointcommission.org/-/media/tjc/documents/standards/national-patient-safety-goals/2023/npsg_chapter_hap_jan2023.pdf. Published January 2023. Accessed January 26, 2023.
- Surgiphor System Mechanical Action Report. Orthopor LLC; 2019.
- Surgiphor Solution Preservative Effectiveness Report. Orthopor LLC; 2019.
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.
Intraoperative techniques during surgery are commonly used to4.
● Reduce contamination by removing particles and bacteria
● Remove nonviable tissue
● Expose healthy tissue
Solutions 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 Irrigations: These would include dilute PVP-I, dilute CHG, and antibiotics with saline
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- Surgiphor Gamma Sterilization Validation Test Report. Orthopor LLC; 2019.
- Association for the Advancement of Medical Instrumentation (AAMI). ANSI/AAMI ST67:2019. Sterilization of health care products—Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”. Arlington: AAMI; 2019.
- Surgiphor System Mechanical Action Report. Orthopor LLC; 2019.
- American Academy of Orthopaedic Surgeons (AAOS). Intraoperative Risk Factors. In Surgical Risk Reduction Toolkit. Accessed on September 6, 2022, at https://www.aaos.org/quality/quality-programs/quality-toolkits/prevention-of-surgical-site-infection/.
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.
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