An Introduction to MABs
MABs (Monoclonal Antibodies) are proteins engineered to recognize and bind to specific targets, such as antigens on the surface of cells. They are highly selective in their action, allowing them to precisely target and address disease-related molecules.1
MABs are pivotal in modern medicine, providing effective treatments for various conditions such as cancer, autoimmune diseases, inflammatory disorders, and infectious diseases. Their versatility and effectiveness have made them a cornerstone of numerous therapeutic approaches.2 However, their classification as hazardous drugs by the national institute for occupational safety and health (NIOSH) underscores the potential occupational risks they pose to healthcare workers involved in their preparation and administration.3
Occupational Risks of Handling MABs
The risks associated with MABs stem from four primary exposure mechanisms:
- Dermal Contact: Accidental spills during preparation or administration can lead to skin absorption.
- Mucosal Absorption: Handling MABs without adequate safety protocols can lead to mucosal exposure, such as through splashes to the eyes or mouth.
- Inhalation of Vapors: Aerosolized particles or vapors from hazardous drugs can be inadvertently inhaled by healthcare workers.
- Oral Ingestion: Contamination of surfaces or improper hand hygiene can result in accidental ingestion of hazardous substances.4
Certain monoclonal antibodies, particularly those conjugated with cytotoxic agents or radioisotopes, present heightened risks.5,6 Examples include brentuximab vedotin, gemtuzumab ozogamicin, inotuzumab ozogamicin, trastuzumab deruxtecan, and trastuzumab emtansine—all of which are listed as hazardous drugs by NIOSH3 and as products medicinal hazardous (HMPs) by ETUI (the European trade union institution).7 Chronic exposure, even at low levels, could potentially result in health complications. Over the years associations have been made between the therapeutic use of MABs and the increased risk of developing malignancies such as lymphoma. In addition, some literature categorizes MABs as “substances with developmental toxicity.”8
Despite their widespread use, the long-term effects of low-dose exposure to these hazardous agents on healthcare professionals remain uncertain.2 Adopting the precautionary principle can prioritize measures to minimize occupational exposure to these agents whenever possible.9
The Role of CSTDs in Ensuring Safety
Closed System Drug-Transfer Devices (CSTDs) provide an essential layer of protection when preparing and administering hazardous medicinal products. These devices are specifically designed to prevent contamination and reduce risks of exposure. CSTDs create a closed system that ensures vapors and fluids remain contained during drug preparation and administration. This containment minimizes the risk of accidental exposure for healthcare workers by reducing the chance of leaks or spills. CSTDs act as a shield not only for healthcare workers but also for the environment and patients, ensuring that hazardous substances are handled responsibly and safely.10
When to Use CSTDs for Handling MABs
Guidelines from institutions like the National Institute for Occupational Safety and Health (NIOSH) recommend CSTDs when handling MABs classified as hazardous.3 While some MABs may have lower toxicity profiles, healthcare organizations should carefully assess the risks based on available medical literature and regulatory guidance to determine when CSTDs are necessary. For instance, a hospital or clinic handling trastuzumab emtansine would benefit significantly from CSTD implementation due to its cytotoxic properties.
Choose EQUASHIELD’s CSTD
EQUASHIELD’s CSTDs set the standard in safety and usability, providing healthcare institutions with advanced solutions for hazardous drug handling.
Innovative Design Features
/ Closed Back Syringe: EQUASHIELD’s syringe unit is fully closed, preventing vapor release and accidental plunger disconnection, which could result in spills or exposure.
/ Leak-Proof Membranes: These protect against accidental needle sticks while maintaining sterile conditions, reducing the risk of infections or injuries.
/ Full Volume Use: FDA-cleared syringes enable safe usage up to their maximal volume, reducing the number of syringes needed and minimizing waste. This feature improves workflow efficiency, particularly in high-demand environments
/ User-Friendly Design: The ergonomic design of EQUASHIELD’s CSTDs reduces the learning curve, promoting quick adoption by healthcare staff and enhancing operational efficiency. This user-focused approach ensures that safety measures are seamlessly integrated into daily practices.11
The Advantages of Using EQUASHIELD’S CSTD when handling MABs
/ Healthcare Worker Safety: By minimizing exposure to hazardous substances, EQUASHIELD CSTDs protect personnel from potential health risks associated with handling MABs. The closed design prevents vapors from escaping and reduces the likelihood of leaks or spills, ensuring a safer working environment.
/ Environmental Safety: The use of CSTDs reduces contamination in preparation and administration areas, creating safer workspaces for healthcare teams.11
/ Compliance: EQUASHIELD CSTDs support adherence to regulatory recommendations, such as the National Institute for Occupational Safety and Health (NIOSH) recommendation to use CSTDs when handling MABs classified as hazardous.3 Compliance with these guidelines not only enhances worker safety but also reduces liability for healthcare institutions.
/ Patient Safety: By preventing microbial contamination and maintaining sanitary conditions, CSTDs enhance the safety and efficacy of administered treatments. This is particularly crucial in oncology settings, where even minor contamination could have significant implications for immunocompromised patients. 11
EQUASHIELD Implementation
EQUASHIELD’s Customer Experience provides full support for healthcare facilities adopting their Closed System Transfer Devices (CSTDs). Their expert clinical team offers in-person consultations, hands-on training, setup assistance, and ongoing resources to ensure a smooth transition and optimal device use.
Conclusion
The safe handling of monoclonal antibodies is essential to protecting healthcare workers, patients, and the environment. EQUASHIELD’s CSTDs offers a robust approach to minimizing risks associated with hazardous medicinal products while enhancing compliance and safety standards. For any handling procedures, healthcare professionals are strongly advised to follow the manufacturer’s instructions and institutional guidelines. By investing in advanced protective measures, healthcare institutions can ensure a safer and more efficient working environment, ultimately improving outcomes for all stakeholders.
