Background

Regulatory and professional bodies have reported numerous studies that indicate how exposure to antineoplastic and other hazardous drugs in healthcare settings can lead to mild, short-term effects such as skin irritation, as well as severe, long term complications, such as infertility, miscarriage, congenital malformations and abnormalities, leukemia and other types of cancer. Healthcare personnel are in danger of exposure to hazardous drugs and their effects at all contact points, including drug manufacture, transport, distribution, receipt, storage, preparation, administration, and waste handling.The magnitude of exposure has been estimated at over 5.5 million healthcare workers who are potentially being exposed to hazardous drugs in the workplace in the United States alone.

Routes of Exposure

The most commonly identified routes of exposure and contamination have been absorption through direct skin contact, inhalation of vapors, aerosols and dust particles, ingestion, and injection through accidental needle jabs.

It has also been explained that under ambient temperature and pressure conditions, antineoplastic medications often vaporize, causing environmental contamination in healthcare settings. Once vapors, or leaks, settle on work surfaces, they are very difficult to remove, thus presenting high risks of further contamination. For instance, evidence of contamination has been found on floors, carts, countertops, tables and chairs used for administration of hazardous drugs , as well as on Biological Safety Cabinets.

Another recently identified environmental contamination 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

As awareness of these routes of exposure has increased, safety standards have been considerably improved. OSHA, for instance, issued regulatory requirements for controlling occupational exposure to hazardous drugs in 1999, NIOSH published comprehensive guidelines in 2004, and the USP Chapter <797> Pharmaceutical Compounding-Sterile Preparations was established in 2008.

Similarly, professional bodies, such as the American Society of Health System Pharmacists (ASHP, 2006), Oncology Nursing Society (ONS, 2001 and 2003), and Infusion Nurses Society (INS, 2006) published guidelines for the safe handling of hazardous drugs and the use of various Personal Protective Equipment (PPE) such as gowns, gloves, masks, caps and biological safety cabinets, that are now considered to be common practice.

Despite the use of the abovementioned protective measures, studies have still found considerable traces of hazardous drugs in healthcare workers' urine. Consequently, the National Institute for Occupational Safety and Health (NIOSH) has recommended that in addition to the use of the abovementioned PPE, healthcare workers should use an effective Closed System drug Transfer Device (CSTD) in order to minimize exposure to hazardous drugs and 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 concentrations outside the system".

EQUASHIELD^® - An Innovative Closed System drug Transfer Device

EQUASHIELD^® was developed as a result of in-depth research and scrutinization of potential routes of exposure, safety factors, and analysis of the leading transfer devices on the market. The result is a completely airtight and user friendly system, that complies with the strictest aseptic technique requirements and guidelines of 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 air to liquid exchange system 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.

A typical chemotherapy session requires the transfer of a cytotoxin from a vial to a syringe, and then again to the infusion bag. The pressure disparity during drug transfer expels vapors, droplets and aerosols into the work environment, and is considered as one of the main routes of exposure. Maintaining constant equal pressure inside the vial, the EQUASHIELD^® system prevents the escape of vapors and aerosols and provides full aerosol and vapor protection.

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

EQUASHIELD's air chamber is a durable factory sealed sterile air chamber; it places EQUASHIELD^® as the only self contained pressure equalization drug transfer device that provides complete isolation of the vial while maintaining the sterile integrity of the medication. Thus, it is 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.

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

EQUASHIELD's fixed fully shielded needles provide ultimate needle-safe protection against accidental stick injuries.

As EQUASHIELD^® is simple and intuitive to operate, having a very straightforward, short operation sequence, staff will easily learn to use it correctly, it will be implemented effectively, and its benefits will immediately be realized.