According to the National Institute for Occupational Safety and Health (NIOSH), a CSTD is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapors outside of the system1. These devices serve as a critical tool to prevent exposure to hazardous drugs, which can cause serious health effects in healthcare workers. The use of CSTDs has been mandated in several countries worldwide, including the United States, due to the high incidence of hazardous drug exposure among healthcare workers. The EU and the UK strongly recommend their use and are moving towards mandatory regulation.
Hazardous drugs, or hazardous medicinal products such as chemotherapy agents, antiviral medications, and immunosuppressive drugs pose significant health risks to medical personnel who handle them. These risks include skin irritation, allergic reactions, reproductive issues, and even the development of cancer.2 To minimize exposure to hazardous drugs and ensure the long-term health and safety of medical personnel, it is essential to implement best practices and safety measures.
The FDA ONB code ensures rigorous evaluation and regulation of CSTD for safety and efficacy. It standardizes device classification, streamlines oversight, supports compliance, and enhances healthcare worker safety in handling hazardous drugs. EQUASHIELD® is cleared under FDA 510(k) clearance: K221513 Product Code: ONB Classification Name: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System.
The CE Mark plays a critical role in ensuring that medical devices, including Closed System Transfer Devices (CSTD), meet the required health, safety, and environmental protection standards within the European Economic Area (EEA). By achieving CE Mark certification, CSTD demonstrate compliance with relevant directives and regulations, such as the European Medical Device Regulation (MDR). EQUASHIELD® is certified the CE mark under the Medical Device Regulation 2017/745.
The CMR guidelines prioritize worker safety by minimizing exposure to carcinogenic, mutagenic, or reprotoxic substances. They advocate for strict controls, like CSTD, to contain and reduce contamination risks.
Luer systems such as those with an additional valve on the market today are leaky systems as shown by independent and peer reviewed studies. Although they are needle free, they still may leak and are less effective when used with HDs.
Membrane based systems are typically better at leakage prevention. Testing data consistently highlights EQUASHIELD® as a top performer among membrane-based solutions, effectively preventing microbial ingress.5
Filter Based Systems use either a charcoal and/or 0.2 micron filter to equalize pressure with the environment. Filter based technologies aren’t mechanically closed or air tight.
Balloon Based Technologies build a pressure equalization chamber in the external dome/bladder/balloon. These systems add an additional step to compounding.
Full Encapsulation Technology is defined as a no external balloons or environment to equalize pressure. The closed back dual needle encapsulated design achieves built in pressure equalization requiring no additional steps.
Syringe barrel contamination compromises the integrity of the medication and the safety of the patient.
Fully encapsulated Syringe Units prevent the exposure to syringe barrel contamination.
Vapor escape in healthcare settings can result in the inhalation of aerosolized drugs and environmental contamination, posing significant health risks to medical personnel who handle them. These risks include skin irritation, allergic reactions, reproductive issues, and even the development of cancer.
EQUASHIELD® Syringe Units maintain a closed pressure equalization that prevent the escape of vapors and aerosols during compounding and administration.
Plunger Rod Contamination exposes healthcare workers to hazardous drugs upon coming into contact with the contaminated plunger rod during handling.
The closed back protects from plunger rod contamination and from the back of the syringe. Significant contamination levels were detected on syringe plungers of CSTD competitors whereas all EQUASHIELD® syringes remained uncontaminated.6
Accidental disconnections and needle stick injuries pose significant risks in oncology healthcare and cleanroom environments, potentially leading to hazardous spills and direct exposure to dangerous substances.
The connector is permanently bonded onto the syringe body housing the shielded needles to prevent the risk of accidental needle sticks. This, combined with locking connectors prevents accidental disconnects in preparation and administration.
Most CSTDs utilize standard syringes and limit the fill volume to three-quarters when handling hazardous drugs (as recommended by OSHA and ASHP). This precaution is in place to prevent plunger disconnection. This restriction results in increased waste, added workload, longer administration times, and higher overall costs.
Designed with ergonomic features like comfortable grips and contours that naturally fit in healthcare providers hand. Simple sliding motion to lock.
Holding it in your hands feels solid and secure, offering reliability unlike other solutions. Its design ensures it stays firmly connected, making accidental disconnection virtually impossible.
Low strain vs high strain means lower potential for repetitive stress injury. Fewer steps to compound and administer minimizes repetitive motions and risk for developing joint pain or carpal tunnel syndrome.
EQUASHIELD® requires 12 steps to compound, the fewest of CSTD competitors.8 EQUASHIELD® has lowest average time for administering compared to other CSTD solutions.9
Built in pressure equalization means fewer steps to compound compared to balloon CSTDs.
Unique locking mechanism with red-to-red markings for fail proof connections. Locking mechnasim prevents accidental disconnects.
EQUASHIELD is engineered to be the safest and most closed option on the market. A leader in pharmacy in the US, its proprietary design makes it faster and more user-friendly compared to other CSTDs.10
With decades of clinical experience, the EQUASHIELD mission is to protect healthcare teams from hazardous drugs. We understand your needs and speak your language in order to ensure seamless integration. Let’s talk!
