FDA’s 1998 clearance of the first closed system drug-transfer device (CSTD) in the US marked a turning point toward increased safety for hazardous drug (HD) management (note: FDA clears CSTDs for marketing through the 510K process for medical devices). Prior to this, compounding and drug administration personnel had no option but to use devices that were not specifically designed to protect individuals handling HDs. This was particularly risky given that drugs have variations in the physical characteristics of pH, viscosity, vaporization, and reactivity. In addition, there is often a lack of standardized pressurization of vials provided by manufacturers (ie, negative, positive, and neutral), as well as measurable contamination on the vials and packaging of the drugs being handled. Thus, the introduction of CSTDs significantly improved safety for staff handling HDs.
Multiple CSTDs, utilizing different containment mechanisms (eg, mechanical and air cleaning), currently occupy the US market (see FIGURE 1). Given the variety of CSTDs on the market, it can be challenging to establish and compare the effectiveness of the different devices at containing drug and drug vapor and preventing exposure during the compounding and administration processes. While numerous published studies have deployed different testing methodologies, a single recognized testing standard does not currently exist for CSTDs. Such a test would facilitate evaluation of the CSTDs currently available, and also assist in assessing new entrants to the market. Keep in mind that any time the individual components of a device are changed (ie, upgrades to design or materials), the revised device should undergo retesting, as assumptions of performance cannot be applied from previous iterations of a given product. When assessing reviews of these devices, it is important to consider the year the assessment was conducted, while also recognizing that manufacturers can change the materials used to make and assemble medical devices without notification.
NIOSH Efforts at CSTD Evaluation
In August 2015, NIOSH proposed an initial draft test protocol to determine the effectiveness of vial protectors to contain drug and drug vapor using isopropyl alcohol (IPA) as a surrogate marker for chemotherapy. Conducting the test on five CSTDs demonstrated variability in performance, with two products demonstrating particularly strong results. However, NIOSH received criticism as the test did not include air-cleaning devices and used a surrogate with high vapor pressure. In response, NIOSH is creating a revised protocol intended to compare all CSTDs while using a surrogate with less volatility and is asking for public comment. The protocol and posted comments can be accessed at: www.cdc.gov/niosh/docket/review/docket288a/.
It is in pharmacy and nursing’s best interest to provide robust comments for NIOSH consideration, since these devices can significantly impact the safe handling of hazardous medications and are required for cytotoxic drug administration under the proposed USP Chapter <800>.
While vapor is key to assessing a CSTD, it is not the only factor to consider. Ensuring dry connections, preventing accidental disconnections, and preventing bacterial ingress into the sterile product should also be addressed. Because swabbing critical connections with a sterile IPA swab prior to access is a standard of practice for all patient-related devices, dry connections increase safety. Minimizing inadvertent disconnections increases staff confidence in the integrity of the closed system. Minimizing bacterial ingress with a CSTD is an important medication safety consideration.
The test or tests that are developed to evaluate performance must, at a minimum, meet the currently accepted 2004 NIOSH definition for CSTD performance: “A drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system.”
Considerations for Providing Comments
Some potential questions to consider when evaluating the currently proposed NIOSH protocol for CSTDs include:
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