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Closed System Drug-Transfer Device (CSTD) should be used throughout the hazardous drug-handling chain, from pharmaceutical compounding to patient dose administration.
NIOSH defines a Closed System Drug-Transfer Device (CSTD) as "a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system" 1. Currently, CSTDs generally follow one of two design concepts, using either a physical barrier or an air-cleaning technology to prevent the escape of hazardous drugs into the work environment. When appropriately designed and used, CSTDs offer enhanced protection against potentially hazardous exposures to healthcare workers during the compounding and administration of hazardous drugs.
NIOSH recommends healthcare workers use a CSTD throughout the hazardous drug-handling chain, from pharmaceutical compounding to patient dose administration.2 CSTDs should not be the only means of worker protection. They should be used as part of a hazardous drug safety program and used in conjunction with other engineering controls.1
As CSTD designs and available models changed, NIOSH and its industry partners realized the need for an independent testing method for CSTD performance.
While CSTD performance standards are available that apply to sterile practice and patient protection, no CSTD performance standards are available for drug containment.3 To address this gap, NIOSH researchers are developing a test protocol that evaluates a CSTD''s containment of hazardous drugs.
The following is information on NIOSH CSTD research activities and includes links to early draft protocols, other associated documents, and public comments. Also provided is an update on the research status of the most-recent NIOSH draft CSTD test protocol. This is a unified test protocol for both air-cleaning and barrier type CSTDs. Check back for more on this continuing NIOSH research project and other relevant CSTD information.
NIOSH published a public comment draft protocol entitled, "A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs." The draft protocol tested the containment performance of the physical-barrier type of CSTDs, but it was not designed to test air-cleaning type CSTDs.
NIOSH scientists developed this protocol with input from registered pharmacists experienced with CSTD use. The pharmacists performed the protocol''s prescribed compounding and administration tasks for five commercially available CSTDs with 70% isopropyl alcohol (IPA) as the challenge agent. They also tested a negative control condition without a CSTD. The tests were conducted in an environmental test chamber, and a gas analyzer was used to detect vapor concentrations of escaped IPA during the tasks.
This protocol had several potential applications including that it could be used by:
The protocol was posted for public comment at (CDC-2015-0075) and NIOSH Docket Number 288. The original draft plus submitted public comments can be found at https://
After receiving public comments following the original draft protocol, NIOSH sought stakeholder input to develop a performance test protocol for CSTDs that use air-cleaning technology. The original request for comments can be found in this document: Federal Register Notice 2016-00827.
As the public submitted comments on the development of an air-cleaning type CSTD test protocol, NIOSH began investigating a unified CSTD test protocol which could be used to evaluate both air-cleaning and barrier-type CSTDs. NIOSH published an early draft of a unified test protocol, "A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs," in September 2016 and requested public comment.
NIOSH also held a public meeting at NIOSH facilities in Cincinnati, Ohio, on November 7, 2016 to discuss the draft unified protocol. The draft unified protocol, meeting announcement, and submitted public comments can be found at https://
Q2: Recently, I have seen claims about CSTDs that have already “passed” the Unified CSTD test protocol applicable to both barrier and air-cleaning types of CSTDs. Is that possible?
Response: NIOSH has been continuing to evaluate several key components of the unified test protocol for both barrier-type and air-cleaning CSTDs. NIOSH is evaluating propylene glycol methyl ether (PGME) as a potential surrogate for testing both with and without the presence of a volatile diluent. Regarding sampling and analytical methods, NIOSH is investigating the use of Fourier-transform infrared spectroscopy (FTIR) (Date of update 05/19/21).
The next-generation closed-system drug-transfer Device (CSTD) from BD that advances hazardous drug protection
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Optimized with you, for you
The BD PhaSeal™ System pioneered the category of closed-system drug-transfer devices (CSTDs) to help protect the pharmacists and clinicians who prepare and administer hazardous drugs. Twenty years later, we turned to healthcare professionals like you for feedback and guidance to optimize its every component. The result is the BD PhaSeal™ Optima System—a next-generation, user-tested CSTD solution that advances hazardous drug safety.
Design innovations in every component
Every component of the BD PhaSeal™ Optima System is designed with no inlets or air exchange for airtight hazardous drug transfers. Click on each hot spot below to see how we have also optimized ease of use, ergonomics and performance.
* Within an ISO Class V environment following aseptic technique
^ The ability to prevent microbial ingress for up to 168 hours should not be interpreted as modifying, extending or superseding a manufacturer's labeling recommendations for the storage and expiration dating of the drug vial. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.
Designed to address your economic concerns
The BD PhaSeal™ Optima System replaces the push-turn-push connection mechanism of the BD PhaSeal™ System with a one-step straight-push mechanism, making it easier for pharmacists and clinicians to use.
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