Just 2 CSTD Products Pass NIOSH’s 2015 Vapor Containment Performance Protocol

The American Society of Health-System Pharmacists and National Institute for Occupational Safety and Health (NIOSH) define hazardous drugs as those that contain 1 of the following properties: carcinogenicity, genotoxicity, organ toxicity at low doses, reproductive toxicity, teratogenicity, and toxicity profiles similar to those of drugs that have already been deemed hazardous. In 2015, NIOSH proposed a protocol for the compounding and administration of hazardous drugs.

Researchers in a study determined that using closed-system transfer devices (CSTDs) while compounding hazardous drugs is the best way to prevent both the contamination by a drug and the exposure of hazardous materials to the compounding site. There are a variety of CSTDs now on the market, but there have not been any regulations or standards for a product to be considered such. The lack of standards prompted NIOSH to find a method to test the efficacy of a CSTD and create a standard for vapor containment, allowing health care providers to stay informed about the safest products available. When applied, just 2 of 6 products were found to meet adequate vapor containment standards, according to study results published by the Journal of Oncology Pharmacy Practice.

Protective equipment, such as CSTDs, is crucial when working with hazardous drugs, as exposure can have serious health risks that increase with the frequency of exposure, according to the study findings.

Although the data show that use of safety materials, includ- ing gloves, goggles, and gowns, reduces the risk of exposure to hazardous drugs, contamination was found on surfaces throughout the compounding site from aerosolized vapors of drug, increasing the risk of skin contact with the hazardous materials, according to the study results.

In the study, researchers used isopropyl alcohol 70% as the challenging agent, as it is both easy to detect and safe to use. Isopropyl alcohol also has a high vapor pressure that puts the vapor containment abilities of a CSTD to the test. The following CSTDs were evaluated in the study: ChemoClave, ChemoLock, Equashield, OnGuard with Tevadaptor, PhaSeal, and SmartSite VialShield.

The study began with dose preparation for each CSTD, as outlined in task 1 of NIOSH’s protocol. The researchers evaluated the amount of vapor released from 4 samples of isopropyl alcohol, which were transferred from 1 bag adapter, 2 syringe adapters, and 2 vial adapters during preparation, they said.

The second task involved injecting the isopropyl alcohol into the Y site of an intravenous tube to stimulate the administration of chemotherapy. This task evaluated the vapor containment of 1 bag adapter, 1 intravenous port adapter, 2 syringe adapters, and 2 vial adapters. Vapor release was measured after each stimulated step of administering and preparing the isopropyl alcohol, according to the researchers.

Just 2 of the brands tested were determined to function as a true closed system during both tasks: EquaShield and PhaSeal. These CSTDs are the optimal choices for preparing and administering chemotherapy, according to the findings. ChemoLock proved only to be adequate for task 2, while the other brands failed both tasks.

Health care providers should keep these results in mind when choosing a CSTD product to ensure that hazardous drugs are compounded and administered in the safest way possible, according to the researchers.

Reference

Forshay CM, Streeter SO, Salch SA, Eckel SF. Application of 2015 proposed NIOSH vapor containment performance protocol for closed system transfer devices used during pharmacy compounding and administration of hazardous drugs [published online July 24, 2018]. J Oncol Pharm Pract. 2018. doi: 10.1177/1078155218787256.