A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs

March 2016
NIOSH Docket Number 288, CDC-2015-0075

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announced the availability of the following draft document for public comment entitled A Vapor Containment Performance Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs.

The NIOSH definition of a closed system drug-transfer device (CSTD) was first published in the 2004 NIOSH Alert “ Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings(/niosh/docs/2004-165/default.html) ” [DHHS (NIOSH) Publication Number 2004-165]. This definition defined CSTDs as a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system. As of Fall 2015, two CSTD technologies were on the market that may meet this definition, physical barrier and air filtration. In 2012, the U.S. Food and Drug Administration (FDA) began issuing 510(k) clearances under a new product code “ONB code” that was specific to CSTDs. All FDA-cleared CSTD’s that are approved under the ONB code are CSTDs regardless of their technology (physical barrier or air-filtration).

The purpose of the protocol was to test the containment performance of closed system transfer devices (CSTD) of the physical barrier type. During an evaluation of the protocol, registered pharmacists, familiar with the use of CSTDs, tested the protocol’s prescribed compounding and administration tasks using five commercially available CSTDs. They also performed the assigned tasks using a negative control condition without a CSTD. Prescribed tasks were performed in a NIOSH-developed environmental test chamber with 70% isopropyl alcohol (IPA) as the challenge agent. A highly specific gas analyzer, with measurement capabilities specific to IPA and with a low limit of detection (LOD), was used to detect vapor concentrations of escaped IPA during the tasks. The protocol was not intended for CSTDs designed to operate using air-cleaning technologies. This protocol had multiple applications and could be used by manufacturers to evaluate prototype CSTDs, by consumers to compare CSTD products, or by jurisdictions who wished to adopt the protocol for a CSTD performance certification procedure.

A panel consisting of peer reviewers and stakeholders was asked to review and comment on the draft guidance document and protocol. NIOSH reviewed the recommendations of the peer reviewers and stakeholders, then made the final determination regarding document content as well as the decision not to propose a specific pass/fail performance threshold. The protocol has been published for comment in CDC-2015-0075 and Docket Number NIOSH-288 and was posted at www.regulations.govExternal.

NIOSH does not possess enforcement authority and therefore its recommendations, protocols and guidance do not have the force or effect of law. NIOSH is authorized to conduct research and to make recommendations to improve occupational safety and health standards and practices to prevent work-related injury or disease. The draft NIOSH protocol should not be misinterpreted as final NIOSH guidance or be used to endorse any product. This protocol was made public as a draft to solicit comments from the public and should not be cited as if it were a published final agency position.

On January 19, 2016, NIOSH expanded the scope of the docket to include a request for information (RFI) concerning CSTDs using air cleaning or filtration technology. With the additional RFI, NIOSH requested information from the public regarding the feasibility of developing a protocol applicable to CSTDs that use air cleaning or filtration technologies and solicited stakeholders for information on this topic.

To view the notice and related materials, visit http://www.regulations.govExternal and enter CDC-2015-0075 in the search field and click “Search.”

Reference Documents
Page last reviewed: March 9, 2016