B. Braun’s OnGuard® CSTD Qualifies as an Effective Barrier for Vapor Release Based on the NIOSH Draft Universal Protocol
BETHLEHEM, Pa., Jan. 08, 2019 (GLOBE NEWSWIRE) -- B. Braun Medical Inc. announced today that OnGuard® Closed System Transfer Device (CSTD) demonstrated effective barrier performance under the National Institute for Occupational Safety and Health (NIOSH) Draft Protocol for CSTD used during pharmacy compounding and the administration of hazardous drugs.
NIOSH, the United States’ federal agency responsible for preventing work-related injury and illness, issued a universal draft protocol in September 2016 to evaluate the performance of CSTDs. They listed nine proposed surrogates to be replicated for the evaluation of vapor containment for all CSTD types on the market – both physical barrier and air cleaning.
BSTL (Biopharma Stability Testing Laboratory LTD), an independent testing lab in the UK, replicated the NIOSH environmental test chamber using one of the nine proposed surrogates with four different CSTDs. The results demonstrated that OnGuard tested well below the limit of quantitation (LOQ) of 0.71 parts per billion, therefore indicating air-cleaning technology as an effective CSTD physical barrier in preventing the release of hazardous drug vapor†. The entire study was published in the PLOS ONE Journal and can be found here.
“We are pleased that OnGuard is a market leader in NIOSH-recognized CSTD air-cleaning technology,” said Steve Weber, Director of Marketing of IV and Vascular Access Systems at B. Braun. “Health care worker safety is as important as patient safety. OnGuard CSTD is designed to provide easy-to-use protection for nurses, pharmacists, and administrators while working with hazardous drugs,” Weber said.
OnGuard’s 0.2-micron filter allows for pressure equalization and prevents microbial ingress, while its charcoal drug-binding matrix is designed to ensure drug vapors cannot escape from this unique vial adaptor. Its audible click-to-lock linear connection – which is made with a push action rather than a twist motion – is designed to eliminate pre-priming or pre-activating the vial adaptor. Most compounding product needs are achieved with just three stock keeping units (SKUs), which helps reduce waste, helps make implementations easier, and helps reduce confusion.
The linear membrane-to-membrane connection is designed for a dry disconnect to prevent accidental worker and patient exposure to hazardous drugs during compounding and administration. Its smooth septum is designed for easy swabbability and disinfection.
Effective December 2019, USP <800> has more than 100 requirements for the handling of hazardous drugs that will significantly impact healthcare institutions.
“With USP <800> on the horizon, pre-planning for compliance is paramount,” said Weber. “Implementing these new requirements will take coordination and efficiency across the board.”
B. Braun has created an online resource to help healthcare providers with this preparation. The Readyfor800.com website provides expert insights, interactive resources, and a detailed requirement checklist for healthcare institutions that want to get a solid start on planning and implementing the new protocols.
“Additionally, OnGuard is a viable solution to help healthcare facilities comply with USP <800> requirements and reduce exposure to hazardous drugs for healthcare workers and patients,” Weber said.
OnGuard® manufactured by TEVA Pharmaceutical Industries Inc. Distributed by B. Braun Medical Inc.
About B. Braun
B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include ostomy and wound care, dialysis, nutrition, pharmacy admixture and compounding. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap® and CAPS®.
Globally, the B. Braun Group of Companies employs more than 61,000 employees in 64 countries. Guided by its Sharing Expertise® philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit www.BBraunUSA.com.
† Wilkinson, A-S., Allwood, MC., Morris, CP., Wallace, A., Finnis, R., Kaminska, E., Hemingway, M. (2018). Performance testing protocol for closed-system transfer devices used during pharmacy compounding and administration of hazardous drugs, PLOS ONE 13(10), 1-15.
Contact: Allison Longenhagen
B. Braun Medical Inc.
Upcoming Life Sciences Events
- March 2019
- Singapore: Phar-East 2019
- Porto: 3rd Annual Biosimilars & Biologics 2019
- Vienna: RESI Vienna 2019