Equashield

Hazardous drugs, such as chemotherapy antineoplastic agents, present an occupational hazard to those who handle them. Occupational exposure to hazardous drugs can lead to both acute and chronic effects, ranging from skin irritation to more serious reproductive complications and even some forms of cancer.

The Centers for Disease Control and Prevention’s (CDC’s) National Institute for Occupational Safety and Health (NIOSH), the US Pharmacopeia (USP) Chapter <797>, the recently added USP Chapter <800>, the American Society of Health-System Pharmacists (ASHP), the International Society of Oncology Pharmacy Practitioners (ISOPP) and the Oncology Nursing Society (ONS) have all recognized and made recommendations to take additional measures based on the potential health risks associated with occupational exposure to hazardous drugs.

While the dangers are often invisible to the naked eye, common practice when handling hazardous drugs creates multiple routes of exposure that can lead to contamination of the environment despite the use of standard personal protective equipment (PPE), Biological Safety Cabinets and associated handling procedures. Since hazardous drugs have adhesive characteristics, traces can often be carried out of the workspace, and are often found on unlikely surfaces such as keyboards, doorknobs and elevator buttons, outside of the designated areas for drug compounding and administration.

NIOSH defines closed system transfer devices (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,” and the FDA recently created the ONB category that clears devices as “closed antineoplastic and hazardous drug reconstitution and transfer system.”

CSTDs, which typically encapsulate the syringe and vial into one closed system, provide a vital layer of protection against hazardous drug exposure. In fact, studies have shown that using a CSTD has significantly reduced the levels of surface contamination in labs, pharmacies and hospitals.¹

However, not every CSTD provides the same level of protection, and not every CSTD is equally effective at closing off the major routes of exposure.

Equashield’s closed systems are among the only CSTDs in the world cleared under the FDA’s ONB code, confirming that they meet the requirements of a truly closed system.

Equashield’s first- and second-generation systems are also the first to be substantiated to FDA and defined in FDA-cleared labeling as preventing microbial ingress up to 7 days.

Equashield’s system was created with a simplified, elegant design that provides ease of use, and covers more routes of exposure to hazardous drugs.

One of the major routes of exposure, the syringe plunger, is uniquely covered by Equashield’s system. Studies show that a typical standard syringe plunger is contaminated many times after a drug transfer when it is drawn back out.

When pharmacists use standard syringes, and even when they use standard syringes that are found in other closed systems, they can be exposed to hazardous drugs due to plunger contamination, and they risk major spills, as these plastic syringes can be pulled out of the barrel completely.

Equashield’s flagship CSTD, EQUASHIELD^® II, introduced in late 2013, uses a metal plunger instead of a standard plastic plunger. The metal rod runs through the center of the barrel, and is fully encapsulated and sealed in. This design prevents plunger contamination and it cannot be removed from the barrel, so it also prevents potential spills.

The metal rod plunger cannot come in contact with the inner walls of the barrel, and therefore remains uncontaminated by the barrel sides. In this way, Equashield’s CSTD is the only CSTD to cover this major route of exposure by minimizing plunger contamination to undetectable levels.²

Equashield developed its fully encapsulated syringe system with an internal, self-contained pressure equalizer and sterile air chamber found within the syringe barrel. This feature allows for a more streamlined design that is intuitive for those using it in the compounding, transferring and administration of hazardous drugs.

Equashield’s CSTD design also innovates with its connection mechanism. Whether connecting the syringe to a vial adapter, infusion bag or infusion tubing, each Equashield adapter and syringe are designed for safe and easy connections made in one smooth motion.

Committed to protecting healthcare professionals, Equashield’s devices are qualified to the highest industry standards. Equashield’s CSTD is simple, with an elegant design and ease of use, which make it the CSTD of choice by hundreds of healthcare facilities in North America, Europe, Asia-Pacific and the Middle East.

Equashield is a privately held medical device company with more than 140 employees. With offices located in Port Washington, N.Y., and its manufacturing facilities located internationally, the company has a growing global footprint, and is committed to continuing to protect healthcare professionals from exposure to hazardous drugs.

References

1. ncbi.nlm.nih.gov/​pubmed/​19965949.
2. http://opp.sagepub.com/content/early/​2014/​03/​05/​1078155214526428.full.pdf+html.

This corporate profile was reviewed and approved by Equashield .