Letter to the Editor:

USP-797 Guidelines Raise Concerns

To the Editors:

As a member of the anesthesia community I want to make sure that the APSF is aware of the following matter that could affect timely care of acutely injured patients and could potentially increase medical waste and cost.

CMS appears to be supporting USP guidelines regarding the compounding of sterile medications (USP 797) that was written in 2007, raising concerns that setting up an IV bag or pressure line or cardiopulmonary bypass machine more than an hour in advance of a procedure increases infectious risk. Agreeing with an "hour rule" would be like saying that OR instruments used in a case are no longer sterile after an hour of surgery or that any IV bag connected to a patient for more than an hour poses an added infectious risk. Clinical, pharmaceutical, and perfusion data on cardiopulmonary machine priming indicate that this practice does not increase infectious risk, even up to 7 days. The Joint Commission has no problem with up to 96 hours as long as medication drip stability is not compromised. Infectious disease specialists have no issue with it so long as federal regulations are not violated (based on a recent meeting I attended).

Some centers keep operating rooms ready to go for trauma, cardiac, and obstetric emergency cases. A room that is immediately ready includes intravenous fluids and pressure transducers that are spiked and flushed. In addition, basic vasoactive drips are generally prepared, spiked, and ready to go, loaded onto tested infusion pumps, as well a cell saver machine. All of these should be dated and timed. I believe that there is enough medical and perfusion-related evidence to categorically state that an IV or drip prepared under sterile conditions remains sterile for up to 7 days. In addition, the evidence also points out that if a bag is contaminated, then it is contaminated even after a minute of being prepared. Most of the solutions that we prepare for a trauma case, such as normal saline or lactated ringers, do not support bacterial growth unlike a propofol or TPN drip. Would 24, 48 or 96 hours be OK as evidence indicates it would? Those of us who work in large centers know often enough of critically injured patients, cath lab complications, unstable aortic dissection cases, or acutely bleeding patients who arrive in the OR with little or no prior notice. To have to begin setting up a room for such a case detracts and delays critical patient care. These issues are even more evident later in the day or at night when faced with limited personnel who may already be involved in other cases.

All these comments are my personal beliefs and in no way represent the institution in which I work and practice.


Enrique Pantin, MD
Newark, NJ