Journal Article

CONTAINMENT OF A NEW ADMINISTRATION SYSTEM FOR HAZARDOUS DRUGS

Smith, Elana Slutsky, Alon, Asaf

2024

Overview

Clinicians are regularly exposed to hazardous drugs (HDs). Existing protective equipment may be more effective during drug preparation than administration. USP 800 now requires the use of Closed System Transfer Devices (CSTDs) during HD administration. A new closed administration system for minimizing exposure of healthcare professionals to HDs was recently marketed. The objective was to evaluate the efficacy of the ChemfortTM CADM system in preventing HD release during administration. Containment was assessed upon the first and final (10th) connection cycle at both beginning and end of shelf-life (four different test groups). The principles of the NIOSH 2015 containment performance draft protocol! were followed: isopropanol (IPA) is the drug surrogate; acceptance criterion is <1.0 ppm IPA vapor concentration inside a closed chamber. Three tasks were developed to mimic administration and subsequent disconnection of three different combinations of CADM components. The Bag Adaptor Ghemfort™ Port is the required partner of each of the other three CADM components: Closed Adaptor Spike Port (task 1); Closed Y-inline Set (task 2); and Closed Secondary IV Set (task 3). In each task, a 500 ml IV bag containing 70% IPA was connected in series with the tested components and placed inside a closed chamber, which was sealed and connected to a Fourier-transform infrared spectroscopy gas analyzer in a closed circuit. Inside the chamber, administration was simulated, and IPA levels were monitored during the task and for at least 30 minutes afterwards. Each task was repeated four times per test group. The relevant result for each repetition was the highest increase in IPA vapor concentration reached over the course of the task, relative to the average background levels before commencement of that task. IPA concentrations observed for all components in all test groups were well below the acceptance criterion of 1.0 ppm. CSTDs are well-adopted in pharmacy, but less during administration. USP 800 requires use of CSTDs for administration. A new closed administration system was evaluated according to a NIOSH methodology. Results show that CADM prevents the escape of hazardous aerosols and vapors and that new administration systems could potentially raise the safety standard for clinicians to that already adopted in pharmacies.

• Publisher: Oncology Nursing Society
• Subject: Oncology