National Institute Safety and Health (NIOSH)The National Institute for Occupational Safety and Health (NIOSH) is a key federal agency of the United States. NIOSH is part of the Centers for Disease Control and Prevention (CDC).
Regarding the prevention of exposure to hazardous drugs in healthcare settings, the NIOSH definition of a closed system is: "Closed System Drug-transfer Device” - 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. According to NIOSH “CSTDs are generally available in two design types:1. One that uses a physical barrier to block the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway and2. One that uses air cleaning or filtration technologies to prevent the unintended release of drug into the surrounding environment or the intake of environmental contaminants into the sterile drug pathway.”NIOSH decided to develop a single test protocol applicable to both barrier and air-cleaning types of CSTDs.Chemfort™ meets the NIOSH definition that was issued and shows excellent performance according to the current NIOSH draft protocol.
Are CSTDs Required by NIOSH Regulations? NIOSH provides an evidence-based recommendation that healthcare professionals use a CSTD at all stages of the hazardous drug-handling chain from compounding through to administration. While not legally mandated, NISOH recommends that CSTDs be used as part of a comprehensive hazardous drug safety program together with additional engineering controls.
How Does the NIOSH Performance Test Protocol Compare CSTDs? The NIOSH Test Protocol provides standardized, objective testing to evaluate how effectively a CSTD prevents both the escape of hazardous drug vapors/aerosols (containment) and the ingress of environmental contaminants (protection). The test is conducted using surrogate compounds. The NIOSH Test Protocol is the only US federally recognized standardized method for evaluating how “closed” a system truly is.
Related Materials NIOSH ALERT - Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care SettingsDownload PDFA Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous DrugsDownload PDF