Evaluation of real-world hazardous drug wipe test data to assess surface contamination following the use of a closed system transfer device.

Introduction/Rationale for Study: This retrospective, observational analysis evaluated real-world hazardous drug (HD) surface wipe test data collected from U.S. healthcare facilities following implementation of a closed-system transfer device (CSTD).

Methods

Wipe test submissions collected between 2018 and 2022 were analyzed to characterize the frequency, magnitude, and distribution of HD contamination across hospital systems, care locations, and drug analytes under routine clinical practice conditions. Although pre-implementation (baseline) wipe data were not available, this analysis reflects real-world effectiveness of CSTD use in minimizing detectable HD surface contamination within participating facilities.

Results

Among 5531 wipe samples analyzed, 4.45% demonstrated measurable contamination, with the majority originating from two hospital systems. Higher contamination frequencies were observed in patient administration rooms and infusion areas compared with other locations, with 5-fluorouracil demonstrating higher contamination frequency relative to other analytes.

Conclusion

An independent statistical analysis corroborated the initial Sponsor findings, confirming that using the CSTD significantly minimizes contamination and the potential for HD exposure risks. Variability in contamination across facilities and locations highlights the need for standardized cleaning protocols and clear standards for acceptable limits in hazardous drug handling. Overall, these data provide insight into HD contamination patterns observed during routine clinical use of a CSTD and support continued optimization of handling practices, along with prospective studies employing standardized wipe protocols and pre/post implementation designs.