AAOS: American Academy of Orthopaedic Surgeons; ICM: International Consensus Meeting for Musculoskeletal Infection
** Covers all concentrations of PVP-I used for irrigation in the past 50 years.
Compounded Irrigation Products May Introduce Additional Risk
Surgical wound irrigation solutions are often mixed on the back table of ORs. The FDA,7 the Joint Commission8 and the USP 7979 discourage manual compounding because of the numerous risks involved with manual preparation.
Unintended implications of manual compounding:
Potential risks:
Non-sterile formulations
Per USP 797, all components used must be evaluated for use in sterile drug preparation.9 Components labeled with "not for pharmaceutical use," "not for injectable use," or an equivalent label must not be used for irrigation. Since compounded or mixed products are not FDA-approved,7 they pose a high risk of contamination.
Bacterial contamination
Bacterial contamination may occur through re-use of skin antiseptic bottles.9
Medical errors
Unless the container in the sterile field is labeled as a multiuse container, it should be discarded after a single use.10 Unless immediately used, unlabeled containers are required to be discarded safely, as per the USP 7979 and the NPSG guidelines.8
Inconsistent application of aseptic technique
Inconsistencies rising from different practitioners' variations can result in contact with non-sterile surfaces, introduction of particulate matter or mix-ups with other CSPs.9
Non-sterile and non-standard irrigation solutions
Non-compliance with local and international standards like USP 797, to prepare and administer wound irrigation solutions using sterile components and aseptic technique results in non-standard solutions.11
Non-standard irrigation concentrations
Variations in manual measuring and mixing can result in non-standard irrigation concentrations.11
Lower effectiveness
Inconsistent irrigation pressure (being too much, or too low) arising from variations in the operators' selection of irrigation device and application pressure.12
Align Your Irrigation Approach with Current Best Practice Guidance
- Use of dilute PVP-I for wound irrigation†
Use dilute PVP-I solution and not antibiotics for wound irrigation: WHO,13 CDC14 and SHEA15
- Label the container to avoid errors and ensure patient safety
Label solutions in various procedural settings both on and off the sterile field: Joint Commission7, USP Standards9
- Apply adequate pressure when irrigating
Within the recommended range of 4 to 15 PSI by AHRQ12
- Align with USP standards for sterile preparations9
- Compound using no more than three sterile packages
- Bear a label listing names and amounts of ingredients
- Use within 4 hours
- Discard if not used within recommended time
- Demonstrate competence in following standard operating procedures for compatibility testing
†PVP-I is an antimicrobial preservative contained within the bottled solution.
Choosing an Irrigation Product: Questions to Ask
When evaluating irrigation products, consider:
- Does the solution align with current guideline recommendations?
- Is the product supplied sterile?
- Is dilution or compounding required before use?
- How is sterility maintained throughout preparation and delivery?
- Does the delivery method support consistent application?
- Can the product help standardize practice across surgical teams?
- Is the solution cleared by the FDA for intraoperative irrigation?
Evaluating preparation, delivery and sterility together can help facilities make more informed irrigation decisions while supporting consistency, efficiency and patient safety.