There are a variety of situations where the initial draft protocol is still an appropriate evaluation tool. Response: While the initial draft protocol (CDC–2015–0075, Docket Number NIOSH–288, September 8, 2015) is not an appropriate evaluation tool for air-cleaning CSTDs, it is a robust test protocol applicable to barrier-type CSTDs. Q1: In what situations can the initial Draft CSTD protocol be used? The draft unified protocol, meeting announcement, and submitted public comments can be found at. NIOSH also held a public meeting at NIOSH facilities in Cincinnati, Ohio, on Novemto discuss the draft unified protocol. 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. Īs 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. The original request for comments can be found in this document: Federal Register Notice 2016-00827. Īfter 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 draft plus submitted public comments can be found at. The protocol was posted for public comment at (CDC-2015-0075) and NIOSH Docket Number 288. jurisdictions who wished to adopt the protocol for a CSTD performance certification procedure.manufacturers to evaluate prototype CSTDs,.This protocol had several potential applications including that it could be used by: 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. They also tested a negative control condition without a CSTD. 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. NIOSH scientists developed this protocol with input from registered pharmacists experienced with CSTD use. 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 closed system transfer devices (CSTDs), but it was not designed to test air-cleaning type CSTDs. Check back for more on this continuing NIOSH research project and other relevant CSTD information. This is a unified test protocol for both air-cleaning and barrier type CSTDs. Also provided is an update on the research status of the most-recent NIOSH draft CSTD test protocol. The following is information on NIOSH CSTD research activities and includes links to early draft protocols, other associated documents, and public comments. They should be used as part of a hazardous drug safety program and used in conjunction with other engineering controls. CSTDs should not be the only means of worker protection. While all CSTDs may not be equally protective, research shows that CSTD use can reduce hazardous drug contamination. NIOSH recommends healthcare workers use a CSTD throughout the hazardous drug-handling chain, from pharmaceutical compounding to patient dose administration. When appropriately designed and used, CSTDs offer enhanced protection against potentially hazardous exposures to healthcare workers during the compounding and administration of hazardous drugs. 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. 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”. CSTD bag or infusion adapter attached to an IV bag.
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