Current industry practices on closed system drug-transfer devices for parenteral drug products

Abstract

USP<800> and NIOSH provide guidance on the use of Closed System Drug-Transfer Devices for hazardous drug in the healthcare setting. However, CSTDs are used by clinical sites irrespective of drug hazard status. In this paper, previous publications that describe evaluation and CSTD risk assessment strategies are presented. In addition, a pharmaceutical industry survey was performed to describe the current strategies for evaluation of CSTDs and how these devices are managed for clinical studies. Finally, recommendations are proposed to mitigate risks associated with CSTDs. These recommendations incorporate: testing considerations, risk assessments, and communication.