Study Shows ChemoLock™ and ChemoClave™ CSTDs Prevent the Escape of HDs, Passing Latest NIOSH Test

Study results presented at the ASHP Midyear Clinical Meeting by Baystate Health and UCHealth-Northern Colorado researchers show ChemoLock and ChemoClave both restrict drug mass from escaping the system using NIOSH test protocol.

San Clemente, Calif. December 5, 2018 – ICU Medical, Inc., (NASDAQ: ICUI) presented the results of a new study at the 2018 American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting and Exhibition in Anaheim showing that the company’s ChemoLock and ChemoClave closed system transfer devices (CSTDs) prevent the escape of hazardous drug or vapor concentrations outside the system, passing the latest National Institute for Occupational Safety and Health (NIOSH) test protocol for CSTDs.

Plum 360 The study was performed by Andrew Szkiladz, PharmD, BCPS, BCOP, Baystate Health, Springfield, Massachusetts, and Shawn Hegner, PharmD, UCHealth-Northern Colorado, Loveland, Colorado — and presented during the ASHP Midyear professional poster presentations.

In the study, Evaluation of Two Closed System Transfer Devices based on the Proposed National Institute for Occupational Safety and Health Performance Test Protocol, researchers evaluated both ChemoLock and ChemoClave, with a barrier type vial adapter or an air-cleaning vial adapter, to determine their ability to contain propylene glycol during simulated compounding and administration tasks.

NIOSH drafted — and has since updated — a universal protocol to be used in the evaluation of CSTDs to aid the clinical community in device selection. The current protocol to evaluate CSTDs for their ability to function as a closed system that restricts drug mass (vapor or liquid) from crossing the system boundary and escaping into the environment is NIOSH Docket Number 288-A, CDC-2016-0090. This protocol includes new surrogates, one of them being propylene glycol.

When evaluating both ChemoLock and ChemoClave, researchers reported no detectable propylene glycol during simulated compounding and administrative tasks, demonstrating that the two CSTDs effectively met the current NIOSH test protocol. Results also verify ChemoLock and ChemoClave’s ability to reduce the risk of hazardous drug exposure to healthcare workers during compounding and administration, especially when compared to a needle and syringe.

ChemoLock is the first needlefree CSTD to receive FDA 510(k) clearance for both pharmacy compounding (ONB) and patient administration applications. The CSTD provides passive safety with a novel technology that is easy to use and cannot be deactivated, thus reducing the risk of exposure to healthcare workers involved in the hazardous drug handling process.

ChemoClave is the world's first needlefree closed system and closed system transfer device for the safe handling of hazardous drugs. It provides passive safety with a needlefree luer-based technology that is easy to use, cannot be deactivated and does not require added components at the bedside, thus reducing the risk of exposure to healthcare workers involved in the hazardous drug handling process.

Media Contact:
ICU Medical, Inc.
Tom McCall, Corporate Vice President and General Manager
(949)366-4368
tmccall@icumed.com

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