NIOSH Sets Nov. 7 Meeting on Closed System Transfer Device Protocol
NIOSH has drafted a new universal performance test protocol applicable to both types of CSTDs. The meeting allows agency personnel to give an update of new protocol developments.
NIOSH announced it will hold a public meeting Nov. 7 on a universal closed system drug-transfer device testing protocol, "A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs," giving the public and stakeholders the opportunity to comment on the protocol, the proposed list of surrogates, and to respond to NIOSH's questions regarding the protocol.
The meeting will take place from 9 a.m. to 3 p.m. Eastern Time, or until after the last public commenter has spoken, at the Alice Hamilton Laboratories, Conference Room C, 5555 Ridge Ave., in Cincinnati. Virtual attendance using LiveMeeting and audio conference will be available. Electronic or written comments must be received by Dec. 7, 2016, and may be submitted via www.regulations.gov (identified by CDC-2016-0090 and Docket Number NIOSH 288-A).
The announcement says closed system drug-transfer devices (CSTDs) are generally available in two design types. One 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, while the other uses air cleaning or filtration technologies to prevent those problems. On Sept. 8, 2015, NIOSH released the draft test protocol, "A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs," for public review; it was developed by NIOSH to evaluate how containment effective the physical barrier-type CSTDs were as an indicator of how protective they would be at preventing hazardous drug escape from the closed system.
On Jan. 19, 2016, NIOSH published a Request for Information for the development of a test protocol to evaluate the performance of CSTDs that adopt air-cleaning or filtration technologies, and since then NIOSH has generated a list of surrogates to test both types of CSTDs; has met with CSTD manufacturers that requested informal meetings to discuss the current draft protocol and/or items NIOSH should consider in developing a new performance test protocol for air-cleaning CSTDs; and has drafted a new universal performance test protocol applicable to both types of CSTDs. The meeting allows agency personnel to give an update of new protocol developments.
Requests to provide oral comments at the meeting should be submitted by telephone (513-841-41410), fax (513-841-4506), or emailed to DHirst@cdc.gov with "Request to Speak" in the subject line. Requests to speak should contain the name, address, telephone number, and relevant business affiliations of the speaker, and the approximate time requested for oral comments. Requests must be received by Oct. 21.