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What Makes a Wound Irrigation
Solution Terminally Sterile?

When it comes to surgical wound care, terminal sterility isn’t just a preference, it’s a necessity. In clinical settings where maintaining a contamination-free environment is paramount, utilization of a terminally sterile wound irrigation solution constitutes a fundamental requirement to uphold aseptic standards and safeguard patient outcomes.

But what does it really mean for a wound irrigation solution to be terminally sterile? And how can healthcare professionals ensure they’re using a product that meets the highest standards?

Let’s take a deep dive into the science of sterility, FDA classifications, and how BD® Surgiphor™ Antimicrobial Irrigation System is setting the standard in sterile wound irrigation.

Understanding Sterility: More Than Just a Label

While antiseptics have antimicrobial activity, they can become contaminated during or after manufacture. Antiseptics cannot achieve sterility themselves without the process of sterilization.1

The FDA1 and the CDC2 report that commonly used antiseptics, (such as alcohol, chlorhexidine, benzalkonium chloride, and povidone-iodine) have been linked to3:

Organisms implicated in the outbreaks included Bacillus cereus, Burkholderia cepacia, Pseudomonas aeruginosa, Achromobacter xylosoxidans, Ralstonia pickettii, Serratia marcescens, and Mycobacterium abscessus.1
 

Sterility is measured by how likely a single device might still carry a microorganism. The FDA requires that implantable and injectable devices have a sterility assurance level (SAL) of 10-6 unless the device is only intended for intact skin contact1. This requirement helps ensure patient safety during procedures.

Here’s how different SALs compare:

Many antiseptics and wound irrigation products on the market are aseptically processed, meaning they are manufactured in a sterile environment but not subject to terminal sterilization. Aseptically processed solutions can still allow for contamination, especially if the product is diluted or repackaged after opening. Aseptic processing cannot assure sterility in the same way as terminal sterilization and is dependent on processes and techniques which can fail, resulting in contamination.


Intrinsic vs. Extrinsic Contamination

Contamination can occur in two ways:

  • Intrinsic contamination: happens during the manufacturing process where the antiseptic solution or container is contaminated with viable microbes even before the end-user opens the device/drug1,3
  • Extrinsic contamination: the antiseptic solution or container is contaminated during use. Microbes may enter the product after opening.

What do the guidelines and standards recommend for a sterile antiseptic solution?

On the topic of Formulation:

  • AAOS: Use sterile dilute povidone-iodine5
  • FDA: Do not dilute antiseptic products after opening them.1
  • SHEA: Use dilute povidone-iodine, making sure sterility is maintained6


On the topic of Preparation:

  • USP <797>: Use products labeled as “sterile”7
  • FDA: Compounded drugs are not FDA-approved8

Healthcare practitioners should consider the use of PVP-I to minimize the risk of transferring viable microorganisms to the patient, and to comply with current standards and guidelines.

AAOS: American Academy of Orthopaedic Surgeons; FDA: Food and Drug Administration; USP: United States Pharmacopoeia; SHEA: Society for Healthcare Epidemiology of America.

How Surgiphor™ Antimicrobial Irrigation System Meets the Standard

The Surgiphor™ Antimicrobial Irrigation System is the only ready-to-use, terminally sterile, surgical wound irrigation system cleared by the FDA that aligns with the WHO,9 SHEA,10 AAOS11 and CDC12 guidelines to use dilute PVP-I for intraoperative wound irrigation.

  • Pre-mixed and pre-labeled, reducing risks associated with solution variability and medical errors7,12
  • Aligns with USP standards for aseptic process, consistent mixing and sterile solution7


By choosing terminally sterile solutions like the Surgiphor™ Antimicrobial Irrigation System, healthcare professionals can better protect their patients and uphold the highest standards of care.

Remember: Always check the label. Not all wound irrigation solutions are created equal.

WHO: World Health Organization; SHEA: The Society for Healthcare Epidemiology of America; AAOS: American Academy of Orthopaedic Surgeons; CDC: Centers for Disease Control and Prevention

Get in touch with a BD representative

References

1. Food and Drug Administration. 2016. Accessed on September 26, 2024, at https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-requests-label-changes-and-single-use-packaging-some-over-counter 2. Centers for Disease Control and Prevention. 2020. Accessed on September 26, 2024, at https://wwwnc.cdc.gov/eid/article/26/9/19-1746_article. 3. Weber DJ, et al. Antimicrob Agents Chemother. 2007;51(12):4217-4224. doi:10.1128/AAC.00138-07 4. American Pharmaceutical Review. 2023. Accessed on September 26, 2024, at https://www.americanpharmaceuticalreview.com/Featured-Articles/598935-Process-Validation-and-Sterility-Assurance-Relations-and-Requirements/. 5. American Academy of Orthopaedic Surgeons (AAOS). Intraoperative Risk Factors. In Surgical Risk ReductionToolkit. Accessed on September 6, 2022, at https://www.aaos.org/quality/quality-programs/quality-toolkits/intraoperative-irrigation/. 6. American Pharmaceutical Review. 2023. Accessed on September 26, 2024, at https://www.americanpharmaceuticalreview.com/Featured-Articles/598935-Process-Validation-and-Sterility-Assurance-Relations-and-Requirements/. 7. United States Pharmacopoeia (USP) <797>, Immediate-use CSPs. Rockville, MD; 2019. 8. Rutala WA, et al. Am J Infect Control. 2023;51(11S):A13-A21. doi:10.1016/j.ajic.2023.01.004. 9. World Health Organization. 2018 Global guidelines for the prevention of surgical site infection. Accessed September, 2022, at https://apps.who.int/iris/handle/10665/277399. 10. Calderwood MS, et al. Infect Control Hosp Epidemiol. 2023;44(5):695-720. doi:10.1017/ice.2023.67. 11. Berrios-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. doi: 10.1001/jamasurg.2017.0904.. 12. 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. doi:10.1016/j.ajic.2014.01.012.

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.

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