Background: The United States Pharmacopeia Convention (USP) is the organization that sets standards for drugs, supplements, and food ingredients, and is responsible for creating the current standards under which medication... [ view full abstract ]
Background:
The United States Pharmacopeia Convention (USP) is the organization that sets standards for drugs, supplements, and food ingredients, and is responsible for creating the current standards under which medication compounding is monitored. Unfortunately, hospital administrators often quote USP Chapter 797 as the standard for managing commercially prepared IV bags after they have been spiked (attached to a sterile IV administration set), misunderstanding the difference between spiking and compounding. Since USP 797 only refers to pharmaceutical compounding of sterile preparations, commercially prepared arterial line flush solutions and IV solutions are not by definition compounded preparations and therefore they are not subject to USP time-limits between compounding and use.
The objective of our study was to determine:
if spiking IV bags under the ordinary conditions found in a busy anesthesia workroom could result in microbial contamination of the IV solution.
if simple storage of a spiked IV bag in that same workroom would eventually result in microbial contamination of the IV solution.
if excess cost is associated with treating spiked saline solutions as sterile compounds.
Methods:
Twenty-five bags of normal saline were spiked at our institution by our anesthesia technologists. The technologists had no knowledge that these bags were to be used for a study, and they were prepared in their usual fashion in a non-sterile environment without masks, but using clean gloves and sterile IV tubing. Samples were collected within one hour of spiking, and again after 1, 2, 5 and 9 days. Twenty milliliters of saline were collected from each of five bags selected at random at each time period. Each 20 ml sample was then divided equally between two blood culture vials. The vials were brought to our hospital microbiology lab to be monitored for five days for growth of bacteria and fungi. Each IV bag was discarded after sampling.
Results:
At day zero, one, two, five, and nine, no growth of bacteria or fungi was observed in any sample after five days of incubation under standard blood culture conditions.
Conclusion:
We learned the following:
That under the present anesthesia workroom non-sterile, blinded conditions in which our saline bags were spiked, no growth of bacteria or fungi occurred at zero, one, two, five, or nine days after spiking. This demonstrates that there is no need to change existing protocols that assume the maintenance of sterility for at least 24 hours., Hospital resources should not be wasted on a misinterpretation of USP recommendations
The cost savings achieved by this educational effort was calculated to be approximately $500,000 per year in labor, in addition to a one-time cost avoidance of three million dollars to build a level 5 clean room dedicated to the IV bag spiking as proposed by our hospital and pharmacy administrators. Additional costs for sterile clothing and cleaning should also be factored in. Additional intangible costs of employee job dissatisfaction, employee replacement and the treatment of repetitive motion injuries would probably be substantial.
The misunderstanding of regulations can be very costly.
