NIOSH holding Public Meeting on Draft CSTD Protocol

Contact: Nura Sadeghpour, (202) 245.0673

WHAT

Public meeting: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting concerning the draft of a universal closed system drug-transfer device (CSTD) testing protocol entitled, A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. The protocol is still in development but the meeting will allow the public an early opportunity to address the new draft protocol and the proposed list of hazardous drug test surrogates as the protocol is being refined.

WHEN

November 7th, 2016
9:00 a.m. – 3:00 p.m. (ET)

Registration required by October 26^th: please email gpo0@cdc.gov

WHERE

Public meeting: Alice Hamilton Laboratories, Conference Room C, 5555 Ridge Avenue, Cincinnati, OH 45213.

Virtual attendance: Live Meeting and audio conference will be available. Registration is required.  Please contact Deborah Hirst at gpo0@cdc.gov to register by Wednesday, October 26, 2016.

WHO

NIOSH will host a public meeting to give an update of the draft protocol that is still in development. The update will include discussions covering proposed drug surrogates, benefits, and challenges with developing a new universal test protocol, and to allow the public to comment.

BACKGROUND

Closed system drug-transfer devices (CSTDs) used during the compounding and administration of hazardous drugs 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 and (2) 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. On September 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. The draft protocol 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. After significant public comment and several inquiries, on January 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. Since the Federal Register docket for both the draft protocol and the request for information closed on March 8, 2016, NIOSH has done the following:

a. Generated a list of surrogates to test both types of CSTDs.

b. Met individually with CSTD manufacturers who 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. This was in answer to NIOSH’s Request for Information question #12, Are you interested in being a collaborative partner with NIOSH on the development of an air cleaning or filtration technologies CSTD test protocol?

c. Drafted a new universal performance test protocol applicable to both barrier and air-cleaning types of CSTDs, which will be the topic of this public meeting.

NIOSH is the federal agency that conducts research and makes recommendations for preventing work-related injuries, illnesses, and deaths. For more information about NIOSH visit www.cdc.gov/niosh/.