Critical Characteristics of CSTDs: How They May Evolve in the Future

Healthcare professionals must sometimes deliver patient treatments that include hazardous drugs such as monoclonal antibodies and chemotherapy medications. These drugs can save patients' lives, but can also affect the health status of others through skin contact, inhalation, accidental hand-to-mouth ingestion, or sharps injuries. Leaks of these drugs, when handling for compounding, reconstitution, or administration, put patients and healthcare professionals, patient families and friends, and the environment in the healthcare facility or patients' homes at risk through potential exposure.

According to the CDC¹ approximately eight million healthcare professionals in the United States face the danger of exposure to hazardous drugs in the workplace. These at-risk professionals include nursing and pharmacy personnel, operating room staff, physicians, surgeons, environmental services professionals, those employed in research laboratories, care workers in veterinary clinics, and those in shipping and receiving areas. Closed-system drug-transfer devices (CSTDs) offer a safe way to work with hazardous drugs.

Closed-system drug-transfer devices (CSTDs) use one of two general design concepts² to prevent the accidental release of hazardous drugs into the work environment. These design concepts utilize either a physical barrier to prevent the release of contaminants, hazardous drugs, or vapor concentrations into the surrounding environment or air-cleaning technology to protect against environmental contamination.

A CSTD provides enhanced protection to healthcare workers against exposure to potentially harmful substances such as chemotherapy drugs during compounding and administration. CSTDs have evolved since their early introduction in the 1990s, and those available from manufacturers such as Simplivia include a variety of innovative characteristics³.

The primary purpose of a CSTD is to contain spills, sprays, fumes, and vapors produced by hazardous drugs during compounding and administration. Approaches to ensure containment include one or more of these systems:

• Filtration
• Sealed expansion chamber
• Sealed diaphragm
• Compartmentalization

Simplivia's Chemfort™ CSTD system demonstrated superior performance when tested. They prevent exposure when manipulating drugs that vaporize by adjusting in response to varying atmospheric pressures or altitudes¹¹.

Some of the protective CSTD design features used include:

• One-way engagement
• Reverse spinning function
• Pre-bonded devices
• A break-away feature resulting in spinning

For convenience and as a cost-control measure, Simplivia's Chemfort™ Syringe Adaptor and Syringe Adaptor Lock seamlessly interface with all standard Luer lock syringes. The Chemfort™ Bag Adaptor SP/LL and Chemfort™ IV Safety Set connect distally to any luer lock connection and fit any spike port¹¹.

There are multiple interface types offered in Simplivia's CSTDs:

Device-to-Vial Interface
Hazardous drugs come in vials of a variety of sizes and depths. Therefore, to minimize spiking errors related to the varying thicknesses and shapes of vial stoppers, there is a simple, consistent attachment of the CSTD vial spike to a drug vial.

Device-to-Device Interface
CSTDs may achieve a device-to-device interface using a needle-safe membrane-to-membrane design. It can create a common fluid pathway without needles.
The other option for device-to-device transfer is a membrane-to-membrane design that employs one or multiple needles to facilitate the transfer of drugs and vapors.

User-to-Device Interface
A CSTD system should not be any more labor intensive than using a needle, syringe, and open-ended IV lines. Factors affecting the user's interface with the CSTD system include:

• Easily removed manufacturers' wrapping
• Number of components, number of steps needed for compounding, and the number of steps required for administration
• Connecting vial adapters to vials with simplicity
• Minimal manipulation of device components required, including minimal use of twisting or bending at the wrist
• Easy reconstituting of powders and transfer of fluid between the device components
• Confirm system engagement by visual and tactile means

An excellent example of minimal preparation steps is Simplivia’s Chemfort™ product family. No preparation steps are needed before working with Simplivia's innovative CSTD system¹¹.

The ability of a CSTD system to integrate with other IV delivery systems increases the ease of using it. Be sure to include nursing in the evaluation process when considering one CSTD system over another. Nursing staff must understand the safety benefits they'll gain by using the CSTD.

Some difficulties identified with current CSTDs that offer direction for manufacturers to improve their products in the future⁴ include:

• Syringes should not disengage from the CSTD device accidentally or purposely during the compounding or administration process.
• Pressures between vial lots and different drug manufacturers should automatically equalize to prevent exposure.
• CSTDs must adjust to match the size of the CSTD spike with the neck diameters and the overall depth of the vial.
• The tightness of the seal in a device-to-device interface should eliminate spills, spray, and vapor leakage and facilitate transfers without contaminating the membranes' outer surfaces.
• Design points that allow circumvention (purposely or accidentally) of safety protocols during compounding and administration of hazardous drugs should be modified from existing designs.
• Surface contamination is a recurring hazard when compounding, transferring, or administering chemotherapy medications. Next-generation CSTD devices must address surface contamination hazards.

Moving forward, manufacturing goals⁶ should encourage the development of CSTDs that accommodate more types of drug compounding and transfers.

A wide variety of adverse health conditions may result from occupational exposure to hazardous drugs while compounding and administering them. Protecting healthcare professionals against these negative consequences is the motivation behind CSTDs like Simpliva’s Chemfort™ CSTD⁷.

Simpliva’s Chemfort™ Closed System Drug-Transfer Device holds clearance through the Food and Drug Administration (FDA)⁸ under the ONB product code⁹ and is CE-approved. In addition, leading journals and reputable conferences¹⁰ have peer-reviewed and acknowledged the quality performance of our Chemfort™ CSTD.

You can review Simpliva's products on our website. Questions? Check our FAQ section¹¹ here, or you can contact us with a direct message through our contact page.