Overregulation Revisited

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The Atchabahian and Boublik1 quotes from USP 797, “Pharmaceutical Compounding – Sterile Preparations” in the United States Pharmacopeia National Formulary, only apply to compounded sterile preparations and are not applicable to simple intravenous (IV) and arterial line setups. Morey’s2 statement, “Currently, arterial line setups must be used within an hour of preparation, preventing health care providers from having a setup ready for the patient. According to the USP 797 guidelines, ‘sterile contents of commercially manufactured products’ such as an arterial line setup that are created in ‘room air quality worse than ISO [International Organization for Standardization] Class 5’ are considered ‘contaminated or at high risk to become contaminated’ if they are not used within 1 hour” is incorrect.
USP 797 only refers to pharmaceutical compounding of sterile preparations. Because commercially prepared arterial line flush solutions and IV solutions are not compounded, these preparations are not subject to time limits between spiking and use. The important distinction here is that the simple spiking of a sterile, commercially prepared solution should not be confused with compounding. A personal communication from USP chief liaison officer for chapter 797, Rick Schnatz, PharmD, verified that USP 797 refers solely to compounded preparations and not the simple spiking of manufactured sterile products.
If we were to accept the notion that an IV or arterial line flush bag becomes contaminated 1 hour after spiking, then we must accept that time-dependent contamination would also continue after the IV or arterial line has been attached to a patient. By that reasoning, all IV and arterial line setups should be replaced every hour.
This simple, and unfortunately common misunderstanding of USP 797, may have led and could lead to unnecessary, costly, and burdensome overregulation by well-intended hospital administrators unless it is stopped. As an example at our institution, the administration proposed a more than $1 million facilities modification to create an ISO class 5 clean room in the operating area. This room was to be dedicated solely to spiking IV bags and arterial line setups. After several meetings and email exchanges, reason eventually prevailed. An overzealous and misguided administration can needlessly increase operational expense while simultaneously decreasing operational efficiency with no benefit to patient care.
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