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Why Terminal Sterility Matters

5 Common Misconceptions About Sterile Solutions in the OR

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Surgery Blog Post

In the world of surgery, maintaining sterility is critical to patient safety and successful surgical outcomes. Sterile solutions are essential for maintaining high safety standards in surgical environments. This article explores the importance of terminally sterile solutions for procedures where the risk of introducing viable microorganisms must be minimized to ensure patient safety.

Importance of Terminal Sterility in the OR

There are many potential risks in the operating room (O.R.). One of the greater risks is a surgical site infection or SSI–a common type of hospital associated infection (HAI) that can place patients and facilities at risk. Surgical wound irrigation is commonly utilized in the O.R. to clean and debride surgical wounds. Antiseptics cannot achieve sterility themselves without the process of sterilization.1

The FDA and the CDC report that commonly used antiseptics, (such as alcohol, chlorhexidine, benzalkonium chloride, and povidone-iodine) have been linked to peritonitis, bacteremia, and septic arthritis, caused by organisms like Bacillus cereus and Pseudomonas aeruginosa.1,2,4

Utilizing terminally sterile antiseptic solutions is essential to minimizing risks and complies with current healthcare standards and guidelines.3

5 Common Misconceptions

  1. Antiseptics Are Self-Sterilizing: Contrary to popular belief, antiseptics can become contaminated and do not inherently possess self-sterilizing properties.1
  2. Aseptic Processing = Sterility: Aseptic processing is not equivalent to terminal sterilization and may fail, resulting in contamination.5
  3. All Antiseptics Are Sterile: Not all antiseptic products are sterile; it is crucial to check labels for sterility indications.1
  4. Diluting Antiseptics Is Safe: Diluting antiseptics after opening can introduce contaminants and should be avoided.1
  5. Sterility Assurance Is Guaranteed: Sterility assurance levels (SAL) indicate the probability of viable microbes; only terminally sterile products meet the highest standards.1

Ensuring Best Practices

Healthcare professionals should adhere to best practices by selecting terminally sterile products and avoiding practices that compromise sterility, such as diluting solutions post-opening.1 Regular training and updates on sterility standards are essential for maintaining a safe surgical environment.

Contact Us for More Information

For further details on sterile solutions and best practices in the OR, please fill out the form below. Our team is ready to assist you with any questions or additional information you might need.


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. United States Pharmacopoeia (USP) <797>, Immediate-use CSPs. Rockville, MD; 2019.
  4. Weber DJ, et al. Antimicrob Agents Chemother. 2007;51(12):4217-4224. doi:10.1128/AAC.00138-07
  5. 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/.

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