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.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2022

    June 2022

    Featuring:

    • SAFETY CULTURE
      Corporate Safety Culture Is Workplace Culture
    • HEAT STRESS
      Keeping Workers Safe from Heat-Related Illnesses & Injuries
    • EMPLOYEE HEALTH SCREENING
      Should Employers Consider Oral Fluid Drug Testing?
    • PPE FOR WOMEN
      Addressing Physical Differences
    View This Issue