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EQUASHIELD'S SYRINGE UNIT FDA CLEARED FOR FULL-VOLUME USE


News provided by

Equashield LLC

Oct 03, 2023, 09:36 ET

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The recent clearance reconfirms the freedom to utilize the entire volume of EQUASHIELD's Syringe Unit, leading to enhanced cost savings and safety with handling of hazardous drugs. 

PORT WASHINGTON, N.Y., Oct. 3, 2023 /PRNewswire/ -- EQUASHIELD®, a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs, is thrilled to announce that its EQUASHIELD® Syringe Unit has received FDA clearance for full-volume use: "The system's closed Syringe Unit prevents intended and unintended syringe plunger detachment and can be used safely up to its maximal nominal volume with hazardous drugs" 1. 

Equashield's Syringe Unit Filled to Full Volume
Equashield's Syringe Unit Filled to Full Volume

EQUASHIELD'S SYRINGE UNIT FDA CLEARED FOR FULL-VOLUME USE

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EQUASHIELD's unique CSTD Syringe Unit features an integrated barrier type pressure equalization system, a leak-preventing dry disconnection mechanism, and an encapsulated closed back syringe with a metal plunger rod to mitigate hazardous drug contamination, preventing vapor escape and plunger contamination. This achievement represents a significant stride within the industry, raising the standard for safety, efficiency, and cost-effectiveness. EQUASHIELD's comprehensive CSTD portfolio encompasses closed-back syringes and adaptors for a wide range of hazardous drug preparation and administration processes, establishing it as the most used CSTD in the USA for five consecutive years. 

When working with hazardous drugs, conventional syringes are limited to 3/4 of the volume (OSHA, ASHP) to prevent loss of the plunger2,3. The EQUASHIELD® Syringe Unit is uniquely designed with a closed-back structure and a fixed connector, preventing plunger detachment. With this feature EQUASHIELD® Syringe Unit eliminates more routes of hazardous drug exposure than alternative systems, providing enhanced safety while also enabling them to use the most accurate syringe size for compounding and administration procedures4.

"Many facilities adhere to guidelines that limit the fill volume of standard syringes to three-quarters when handling hazardous drugs to mitigate the risk of plunger separation." explains Jason Dutcher from EQUASHIELD®. "Our syringe unit's encapsulated plunger cannot be detached from the barrel, which allows safe utilization of the entire syringe volume. This critical design aspect leads to reduced cost, strain, waste, and time spent by using fewer syringes in compounding and dose administration, while also preventing vapor escape and plunger contamination." 

The EQUASHIELD® Syringe Unit's FDA clearance for full-volume use solidifies its position as an industry leader. It is the safe, efficient, and cost-effective solution for medication compounding and administration needs.

EQUASHIELD® is dedicated to enhancing safety standards in the healthcare industry. This FDA clearance, joining previous innovative FDA cleared closed system transfer devices in EQUASHIELD's portfolio, marks a significant milestone in the company's journey and underscores its unwavering commitment to delivering superior, safety-focused solutions. 

About EQUASHIELD® 

EQUASHIELD ® is a leading provider of manual and automated solutions for the compounding and administration of hazardous drugs. EQUASHIELD's product suite includes the EQUASHIELD® Closed System Transfer Device (CSTD), and EQUASHIELD® Pro, the first ever closed system-enabled Automated Pharmacy Compounding System. EQUASHIELD's CSTD is clinically proven to protect healthcare professionals from hazardous drug exposure. It covers more routes of exposure than alternative systems and has passed the proposed 2015 alcohol vapor containment protocol from NIOSH, confirming that it can contain the harshest vapors and emissions. Studies have shown EQUASHIELD's CSTD as faster to deploy and easier to use than competing systems. Used by thousands of hospitals and clinics around the world, EQUASHIELD is CE marked and FDA cleared for preventing microbial ingress for up to seven days. 

For more information, please visit www.equashield.com. 

Media Contact: [email protected]

SOURCE Equashield LLC

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