Closed System Transfer Device for Hazardous Drugs
Closed System Transfer Device ( CSTD ) came into existence short time after 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.
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.
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 was established in 2008 with focus on Pharmaceutical Compounding of Sterile Preparations. Introduced in 2016 the USP800 chapter was a major evolution mile stone in regulating the handling of hazardous drugs and mandating the use of Closed System Transfer Device for administration of hazardous drugs. 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 Closed System Transfer Device, 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”.
The EQUASHIELD® Closed System Transfer Device 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 Closed System Transfer Devices on the market. The result is a completely airtight, leakproof and user friendly Closed System Transfer Device that complies with the strictest aseptic technique requirements and guidelines set forth by NIOSH and OSHA. EQUASHIELD’s CSTD 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. 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® Closed System Transfer Device prevents the escape of vapors and aerosols providing full protection against these harms. EQUASHIELD’s CSTD design also relies on the proven concept of tight seal double membranes to keep connectors and residual free despite multiple entries.