Validating the efficacy of this practice is not easily tested at the individual patient level because the rates of failures are often low. Because of this, we need to understand that the traditional evidence-based approach cannot be the sole source of information for advancing patient safety. Many of the improvements in medicine, particularly anesthesia practices and aviation safety, were not built on evidence that certain practices reduced the frequency of errors or crashes. It relied on the widespread implementation of hundreds of small changes in procedures, equipment, training and organization that aggregated to establish a strong safety culture and amazingly effective practices. These changes made sense; were usually based on sound principles, technician theory, or experience; and addressed real-life problems, but few were subjected to controlled experiments. The one-hour timeframe was one of those small changes targeted at preventing contamination.
How do organizations meet this rule? Logistically, it has some challenges but they can be overcome with staff training and understanding why the rule is in place. Many facilities are outsourcing activities such as drawing up syringes for cases or mixing products together. Reputable compounding pharmacies are able to perform many of these activities and those that specialize in preparing sterile products should have the facilities to ensure longer shelf life dating.
Note: Thank you to Eric Kastango, who served on the USP Sterile Compounding Committee, for providing some of the information referenced in this response.
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