Equashield

At Equashield, “we strive to provide superior and innovative solutions for the protection of health care workers throughout the world.” A key way we do this is by the design and sale of our flagship EQUASHIELD^® II Closed System Transfer Device (CSTD).

In a few short years, Equashield has grown to supply its state-of-the-art CSTD, with peer-reviewed studies on safety and efficacy, to more than 500 customers across four continents, and is used in some of the biggest and most reputable cancer centers around the world. The company employs more than 200 individuals globally for the design, manufacture and sale of the 2016 Red Dot Award and the Medical Design Excellence Award–winning CSTD system.

Routes of Exposure

Exposure to hazardous drugs can occur via direct and indirect contact. Most common routes of direct exposure include absorption through direct skin contact, ingestion, inhalation of vapors/aerosols/dust particles and injection through accidental needlesticks. Leaks, aerosols or spills are typically caused by needles or by luer-based needleless connectors. Indirect exposure is caused by touch contamination from aerosolized antineoplastic medications that often settle on work surfaces. These modes of indirect contamination are difficult to detect and are hard to remove, presenting a higher risk for exposure. Evidence of contamination has been found on floors, carts, countertops, tables and chairs used for administration of hazardous drugs in addition to Biological Safety Cabinets.

Another recently identified route of exposure is the open barrel of standard syringe plungers that comes into contact with the hazardous drug during aspiration of medication and remains exposed to the environment once the medication is discharged from the syringe.¹

Safety Standards

The National Institute for Occupational Safety and Health (NIOSH) has recommended that in addition to the use of personal protective equipment (PPE), health care workers should use an effective CSTD to minimize exposure to hazardous drugs and limit adverse effects. An effective CSTD, as defined by NIOSH, is a system that “mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor outside the system.”

Additionally, NIOSH realized that there are several types of CSTDs available on the market today, and there is no one test standard that can assess the closeness claimed by each CSTD manufacturer. In 2015, NIOSH introduced a draft testing protocol for assessment of CSTDs under its Vapor Containment Protocol for public comment. Based on third-party testing, EQUASHIELD II repeatedly had vapor release below the test’s lowest detection levels, as proposed in the draft protocol. Most of the systems on the market had higher levels of vapor release.²

2018 brings the implementation of U.S. Pharmacopeial Convention (USP) Chapter <800> with its focus on Hazardous Drugs - Handling in Healthcare Setting. USP <800> requires CSTD use in Nursing, because nurses remain vulnerable to hazardous drug exposure.³

Equashield: An Innovative CSTD for the Safe Handling of Hazardous Drugs

EQUASHIELD’s Syringe Unit has two chambers: the proximal liquid chamber and the distal air chamber that is located at the end of the piston. A dual-needle system for the air-to-liquid exchange communicates with each chamber, respectively. As the piston moves, one chamber’s volume increases, while the other chamber’s volume decreases by precisely the same amount. Consequently, any displacement of liquid from the vial is supplanted by an equivalent amount of air that is added to or subtracted from the vial, respectively.

EQUASHIELD’s design also relies on the proven concept of tight-seal double membranes to keep connectors and residual free despite multiple entries.

Plunger and open-barrel contamination is a recent and growing concern. The possibility of syringe plunger contamination during routine drug preparations and IV pushes at hospitals is evident by several recently conducted studies. These studies indicate that high levels of drug residuals on the open syringe plungers and cylinders of standard syringes exist. These residuals in turn contaminate gloves, gowns and other work environment. Unlike other devices that use standard syringes with open cylinders and plungers, EQUASHIELD’s distinctive double-jacket syringe enclosure makes it the only CSTD to address this issue and eliminate the possibility of exposure through the back of the syringe.

Importance of Clinical Evidence

When it comes to making a decision on implementing a new drug within a hospital’s formulary, typically the evaluation team looks at clinical data on safety and efficacy. Why should a medical device selection be any different? At Equashield, our CSTD is bound by peer-reviewed studies on device safety and efficacy as seen by Contamination Reduction studies post-implementation and the contamination elimination study from the back of the plunger rod.^1,4 Additionally, there are independent studies that have evaluated Equashield’s ability to:

• contain vapor as compared with other CSTDs, as tested per NIOSH’s proposed vapor containment protocol²;
• maintain leak-free membrane connection as compared with other CSTDs using 5-fluorouracil⁵; and
• save time by requiring the least number of steps and time to compound a dose of chemotherapy among the devices tested.⁶

References

1. Smith ST, Szlaczky MC. Syringe plunger contamination by hazardous drugs: a comparative study. J Oncol Pharm Pract. 2014;20(5):381-385.
2. Massoomi F. Assessment of testing method for closed system transfer devices across vapor release. www.regulations.gov. Comment ID: CDC-2015-0075-0027. February 18, 2016.
3. USP Compounding Compendium. Chapter <800> Hazardous Drugs – Handling in Healthcare Setting.
4. Clark BA, Sessink PJ. Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents. J Oncol Pharm Pract. 2013;19(2):99-104.
5. Massoomi F. Assessment of closed system transfer devices 5-FU drug leakage. www.regulations.gov. Comment ID: CDC-2015-0075-0027. February 17, 2016.
6. Fouzia B, Powell MF, Sanz C, et al. Assessing the efficiency of CSTDs for compounding. Pharmacy Purchasing & Products. 2015;12(7).

This corporate profile was reviewed and approved by Equashield.

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