Checking the Safety of Closed System Transfer Devices

The Nov. 7 meeting allows NIOSH personnel to give an update of new protocol developments.

NIOSH 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 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 for public review; it was developed by NIOSH to evaluate how effectively the physical barrier-type CSTDs prevent hazardous drugs from escaping 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.

This article originally appeared in the November 2016 issue of Occupational Health & Safety.

About the Author

Jerry Laws is Editor of Occupational Health & Safety magazine, which is owned by 1105 Media Inc.

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