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Safe. Simple. Closed

Background

Regulatory and professional bodies have performed numerous studies that outline the significant level of exposure that exists to healthcare workers handling antineoplastic agents and other hazardous drugs. While some of the risks are mild with short-term effects such as skin irritation, other risks are more severe and have long term complications, such as infertility, miscarriage, congenital malformations or abnormalities and cancers including leukemia. Healthcare personnel are in danger of being exposed to hazardous drugs at all contact points including drug manufacture, transport, distribution, receipt, storage, preparation, administration, and during disposal. The magnitude of exposure has been estimated to be over 8 million healthcare workers who are potentially being exposed to hazardous drugs in the workplace in the United States alone.

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 needle sticks. 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 settles on work surfaces. These modes of indirect contamination are difficult to detect and are hard to remove, presenting a higher risk of 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.

Safety Standards

With increase in levels of awareness of the routes of exposure, safety standards have been considerably improved. OSHA, for instance, issued regulatory requirements for controlling occupational exposure to hazardous drugs in 1999. Whereas NIOSH published comprehensive guidelines in 2004 and USP Chapter <797> was established in 2008 with focus on Pharmaceutical Compounding of Sterile Preparations.

Similarly, professional bodies such as the American Society of Health System Pharmacists (ASHP), Oncology Nursing Society (ONS), and Infusion Nurses Society (INS) published guidelines for the safe handling of hazardous drugs between 2001 and 2006. Some of the recommendations included advocating the use of various Personal Protective Equipment (PPE) such as gowns, gloves, masks, caps and use of biological safety cabinets to compound drug, practices now considered to be standard.

Despite the use of then recommended protective measures, trace levels of hazardous drugs were found in healthcare workers urine in studies evaluating the effectiveness of safety measures.

Consequently, the National Institute for Occupational Safety and Health (NIOSH) has recommended that in addition to the use of the above mentioned PPE, healthcare workers should use an effective Closed System Transfer Device (CSTD) in order to minimize exposure to hazardous drugs and limit their 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".

EQUASHIELD® - An Innovative Closed System Transfer Device for the safe handling of hazardous drugs

EQUASHIELD® was developed as a result of years of in-depth research through including assessment of potential routes of exposure, safety factors, and analysis of leading transfer devices on the market. The result is a completely airtight, leakproof and user friendly system that complies with the strictest aseptic technique requirements and guidelines set forth by NIOSH and OSHA.

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 communicat es 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.

A typical chemotherapy session requires the transfer of a cytotoxic drugs from a vial to a syringe, and then to the infusion bag. The typical pressure disparity during drug transfer expels vapors, droplets and aerosols into the work environment, one of the main routes of exposure. Maintaining constant pressure equalization inside the vial, the EQUASHIELD® system prevents the escape of vapors and aerosols providing full protection against these harms.

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

Back of EQUASHIELD's Syringe Unit consists of a durable factory sealed sterile air chamber; making EQUASHIELD® the only self-contained pressure equalization drug transfer device on the market, providing complete isolation of the vial while maintaining the sterile integrity of the medication. This unique feature makes Equashield® the only system to fully comply with NIOSH's definition of a closed system (NIOSH 2004): it mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system from all possible routes of exposure.

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 in 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.

EQUASHIELD's fixed fully shielded needles provide the ultimate protection from accidental needle stick injuries. Equashield provides a wide portfolio of compounding and administration products, designed to reduce the risk from accidental needle sticks during use. Due to EQUASHIELD’s simple and intuitive design, the closed system transfer device offers a shorting learning curve making staff training a breeze. Intuitive connections and elimination of several time consuming steps make this product ideal for both pharmacy and nursing.