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Superior Safety and Ease of Use

Superior Safety and Ease of Use

This Premium CSTD offers Superior Safety and Ease-of-Use

This Premium CSTD offers Superior Safety and Ease-of-Use

for the compounding and administration of hazardous drugs, with clinically substantiated data on elimination of surface contamination with antineoplastic agents[1][1] Clark Bernadette A. and Sessink Paul JM. “Use of a closed system drug-transfer device eliminates surface contamination with antineoplastic agents.” Journal of Oncology Pharmacy Practice 2013and is faster to compound a dose than alternative systemssystems [2].[2] Berdi F, Powell M, Sanz C, et al. “Assessing the efficiency of CSTDs for compounding”. PP&P Journal. 2015; 7(suppl):S4-S10Used by the number one hospital in both Europe and U.S., Equashield® covers more routes of exposure than alternative systems and is substantiated to FDA and defined in FDA’s ONB code cleared labeling as Preventing Microbial Ingress up to 7 days[*][*] Equashield® does not extend the sterility and expiration date of the drug beyond manufacturer recommendations. Please refer to individual drug labeling or USP compounding guidelines for beyond use dating of a drug.

Covers More Routes of Exposure
Encapsulated plunger
No Plunger Contamination
Undetachable Plunger

Covers More Routes of Exposure

Equashield’s proprietary Syringe Unit has an airtight enclosure that encapsulates the syringe barrel, isolates the unique syringe plunger rod and provides the velvet feel in use. Equashield’s unique design it is the only system that prevents syringe plunger contamination by hazardous drugs, which is a major route of exposure during routine drug preparations and IV pushes. Studies in the U.S.[3.4][3] Stephen T Smith et al. “Syringe plunger contamination by hazardous drugs: A comparative study”. Journal of Oncology Pharmacy Practice 2014.[4] Fouzia Berdi et al. “Evaluation of syringes used for compounding hazardous drugs and the contamination risks to healthcare personnel”. Nebraska Methodist Hospital, Omaha, NE. ASHP Midyear clinical meeting 2014. and Europe[5][5]Bertrand Favier et al. “Contamination of syringe plungers during the sampling of cyclophosphamide solutions”. Journal of Oncology Pharmacy Practice 2005.provide substantial scientific evidence for the presence of high levels of drug residuals (Cyclophosphamide) on the exposed plungers and open barrels of regular syringes; which in turn contaminated gloves and other work environment, while in the same studies[3.4][3] Stephen T Smith et al. “Syringe plunger contamination by hazardous drugs: A comparative study”. Journal of Oncology Pharmacy Practice 2014.[4] Fouzia Berdi et al. “Evaluation of syringes used for compounding hazardous drugs and the contamination risks to healthcare personnel”. Nebraska Methodist Hospital, Omaha, NE. ASHP Midyear clinical meeting 2014.no contamination was detected on Equashield® plungers.
Unlike standard syringes, Equashield®can be used safely even beyond its nominal capacity as the encapsulated plunger rod can never be detached from the syringe, preventing the potential for spill.

Be Faster, Prevent Spills
  • Equashield high speed
  • Others tested low speed
Time to compound

Be Faster, Prevent Spills

The connector is factory welded to the Equashield® Syringe Unit saving valuable setup time[2][2] Berdi F, Powell M, Sanz C, et al. “Assessing the efficiency of CSTDs for compounding”. PP&P Journal. 2015; 7(suppl):S4-S10. compared to time spent on opening two packages and assembling a connecter onto an off the shelf syringe.
Additionally, the welded Equashield® Syringe Unit prevents opportunity for luer disconnection and spills..

Nothing In – Nothing Out
Nothing In Nothing Out
Uncontaminated 7 days
Centered Spiking

Nothing In – Nothing Out

The Vial Adaptor’s elastic membrane port has been substantiated for up to 10 connections to the Syringe Unit without leaks or drug residuals on its surfaces[6][6] Migal Analytical Chemistry Laboratory 2009. “Fluorescent Evaluation of Dry Connections in the Equashield, Phaseal and Tevadaptor/Onguard CSTDs”and without transfer of environmental contaminants into the vial[7, 8].[7] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD”[8] Milouda&Migal Laboratories 2014. “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination” The Equashield® system has been substantiated to FDA and defined in FDA cleared labeling as Preventing Microbial Ingress up to 7 days* [*] Equashield® does not extend the sterility and expiration date of the drug beyond manufacturer recommendations. Please refer to individual drug labeling or USP compounding guidelines for beyond use dating of a drug.. This is evident in the extreme tests performed, where the Vial Adaptor’s membranes of the vials containing growth media were inoculated with bacteria and each accessed up to 10 times during 7 days with a total of 770 Syringe Units[7].[7] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD”
The Vial Adaptor is further equipped with a unique telescoping mechanism that guides its spike to the center of the vial stopper and prevents angled spiking, correcting user errors and eliminating any need for space consuming assembly fixtures. Inside the Vial Adaptor there are two internal fluid channels; one for the drug and another for gases with an internal hydrophobic barrier to prevent passage of liquids.

Single Motion Connectors

Single Motion Connectors

Just a single straight motion is required to connect and disconnect any Equashield® components.
The large flow channels in all system components enable fast transfers with just a little force.

10 Dry Connections & Needle safe
Dry Connectors
Needle Safe
Safety Lock

10 Dry Connections & Needle safe

As the user connects the Syringe Unit to the Adaptor, membranes of both connection components are pressed and locked together. The locking mechanism then descends back into the Syringe Unit causing both membranes to be pierced by stationary internal needles. The needles are never exposed and remain fully shielded inside the housing and beyond reach at all times, preventing needle stick injuries.
During disconnection, the needles wipe against the resealing membranes, preventing any contact between the drug and outer surface of the membranes, leaving the contact area dry and drug residual free.
10 repeated activations of Equashield® connectors were substantiated to be free of leaks or drug residuals on external surfaces[6][6] Migal Analytical Chemistry Laboratory 2009. “Fluorescent Evaluation of Dry Connections in the Equashield, Phaseal and Tevadaptor/Onguard CSTDs” and for the prevention of the transfer of environmental contaminants into the system[7, 8].[7] Nelson Laboratories (Salt Lake City, UT) 2013/14. “A 7 Days Microbial Ingress Test of Single Use Vials Utilizing the Equashield® CSTD”[8] Milouda&Migal Laboratories 2014. “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination”
The Equashield® system has been substantiated to FDA and defined in FDA cleared labeling as Preventing Microbial Ingress up to 7 days*. [*] Equashield® does not extend the sterility and expiration date of the drug beyond manufacturer recommendations. Please refer to individual drug labeling or USP compounding guidelines for beyond use dating of a drug.

Closed Pressure Equalization Prevents the Escape of Vapors
Pressure Equalization
Internal Equalization

Closed Pressure Equalization Prevents the Escape of Vapors

One of the main routes of contamination is caused by expulsion of vapors, droplets and aerosols into the work environment caused by typical pressure variation during drug transfer. Filter based venting systems are unable to prevent the escape of toxic vapors out of the container. Equashield® constantly maintains equalized pressure inside the fully closed system, preventing the escape of vapors and aerosols out of the system[9, 10].[9] Migal Analytical Chemistry Laboratory 2009. “Comparative Study of Vapor Containment Efficiency of Hazardous Drug Transfer Devices”.[10] Milouda&Migal Laboratories 2014. “Evaluation of Equashield Close System Compatibility in Prevention of Environmental Contamination Alcohol vapor detection”
The encapsulated dual chamber Syringe Unit offers a standard chamber in the front of the syringe for drug in addition to a factory sealed sterile air chamber in the back of the syringe. Two needles for air-to-liquid exchange, communicate with each chamber respectively. As the syringe 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 replaced by an equivalent volume of air from the air chamber into the vial. During reconstitution of drug powder the process is reversed; the short liquid needle injects liquid into the powder vial, while the long air needle offsets the overpressure by transferring air from the vial into the air chamber in the back of the syringe.
No setup is needed as the pressure is automatically equalized with any manipulation of the system. Both air bubbles and drug can be ejected back into the vial at any time during the drug withdrawal process.

Dry Disconnection
Clean Surface

Dry Disconnection

During disconnection, retracting needles wipe against the resealing membranes, preventing any contact between the drug and the outer membrane surface, leaving the contact area dry and free of residues.

Adaptors for All

Adaptors for All

A large variety of Equashield Adaptors, Connectors and Tubing sets are available for almost any possible transfer of drugs from any size vial into any volume of IV Bag and IV pushes. Additionally connectors are available for primary and secondary tubing sets, Foley catheters and other complex procedures. Ultimately, all Equashield Adaptors share a common closed mechanism of connection and disconnection, a single smooth motion.
Recognizing that there are variations amongst various IV Bag manufacturers and that no one IV port fits all bags, only Equashield® produces two Spike Adaptors; for regular ports and for bags with larger ports. These port designs prevent the opportunity of accidental spike disconnection from IV bag reducing opportunity for leaks and spills.

More

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.