Clinical Studies for Closed-System Transfer Devices: Yes, They Matter

Closed-system transfer devices (CSTDs) are an integral component in reducing occupational exposure to hazardous drugs. The goal of a CSTD is to prohibit drug exposure in the environment during all preparation and administration manipulations. These include injecting or disengaging a syringe into a vial, injecting a syringe into an intravenous (IV) bag, spiking a bag, priming an IV set, administering an IV push dose, and disengaging an IV set from other connections or from a patient. They have also been used to prevent transfer of environmental contents into the vial.

The current definition of a CSTD is descriptive, but does not include measurable performance standards. While standards are being developed, the alternative best measurable standards have come from primary literature evaluations. Just as we use evidence-based literature in our drug evaluations, it should also be used in drug device evaluations. CSTDs have been studied and published in primary, peer-reviewed literature using a variety of methods including wipe sampling, visual assessments, and vapor or smoke tests. The methods behind each of these evaluations need to be carefully considered when also evaluating the effectiveness of a CSTD in preventing drug exposure.

Wipe sampling is used to evaluate surface contamination following drug manipulation. These studies look at preparation and administration areas for contamination, signaling how well the CSTD performs in preventing drug exposure and how well the staff is handling the CSTD in those areas. However, wipe studies do have the limitation of not controlling for outside sources of contamination such as drug residue on the outside of drug vials, if those are not assessed during the wipe test.

Visual assessment of CSTD efficacy has been performed with multiple surrogate markers. One method used is using fluoresceine and ultraviolet light to detect visual fluorescence. In these evaluations, leakage of the CSTD was indicated by visual fluorescence of the fluoresceine. Despite not being a sensitive method of assessment, this is a relatively easy and inexpensive evaluation of a CSTD. A second visual assessment includes smoke or vapor tests. Vapor tests evaluate the ability of the CSTD to retain vapor within the closed system. The results of this type of test can be difficult to quantify and reproduce. A less popular visual assessment method involves the use of radioactive technetium. In these studies, radiation is used to evaluate the level of contamination; however, technetium has a short halflife, which presents challenges to its usefulness and ability to be consistently tested.

The Table lists primary literature evaluating the efficacy of a variety of available CSTDs using many of the methods described above. A variety of methods and surrogate markers have been used to evaluate CSTDs for effectiveness in reducing surface contamination when handling hazardous drugs. When used in combination with other safe handling precautions, they are an integral component to reducing occupational exposure to hazardous drugs. CSTDs need to be treated and evaluated like new drugs by applying the same rigor and methodologies from primary literature studies to fully evaluate their effectiveness.

Danielle A. Griggs, PharmD, MBA, is a PGY-2 health-system pharmacy administration resident at the University of North Carolina Medical Center and a 2016 MS candidate at UNC Eshelman School of Pharmacy.Lindsey B. Amerine, PharmD, MS, BCPS, is assistant director of pharmacy, University of North Carolina Medical Center, and assistant professor of clinical education, UNC Eshelman School of Pharmacy.

References

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