Simplivia Blog

In Europe, 12.7 million healthcare professionals, including 7.3 million nurses, are exposed to carcinogenic, mutagenic and reprotoxic hazardous drugs every year. 2,200 new cases of leukemia are diagnosed year each as a result of occupational exposure to hazardous drugs, while 17,185 miscarriages occur every year as a result of this workplace exposure.

Healthcare professionals such as pharmacists, oncology nurses and veterinarians need to protect themselves when they work or come into contact with hazardous drugs. They also need to protect patients and the workplace environment.

Closed-system drug-transfer devices (CSTDs) help healthcare professional reduce the risk of this occupational exposure to hazardous drugs¹. CSTDs are designed to reduce exposure to cytotoxic or antineoplastic drugs, including chemotherapy medications, antibiotics and biologics such as monoclonal antibodies (mAbs).

Working with a CSTD requires medical professionals to understand how these innovative systems works. Consider some common questions about CSTDs.

NISOH is a key US research agency and part of the Centers for Disease Control and Prevention (CDC). NISOH is focused on the study of worker safety and health. The NIOSH definition of a "Closed System Drug-transfer Device” is “A drug transfer device that … - mechanically prohibits the transfer of environmental contaminants into the system - and the escape of hazardous drug or vapor concentrations outside the system”. The US Food and Drug Administration (FDA) additionally defines CSTDs as Class II medical devices that reconstitute and transfer hazardous drugs in a controlled healthcare setting². A wide range of CSTD designs, including Simplivia’s Chemfort^®, meet these guidelines.

As awareness has increased around the risks to healthcare professionals of working with hazardous drugs, regulations and guidelines have been developed around the world for the safe handling of antineoplastic materials. For example, The American Society for Health-System Pharmacists (ASHP) release its initial guidance on hazardous drugs (HDs) in 1983. The ASHP Guidelines on Handling Hazardous Drugs followed in 2006, which aligned with the 2004 NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

Today, required standards exist for healthcare professionals to reduce exposure to hazardous drugs where they are compounded and administered, and where hazardous drug residue may be encountered, including outside of hospitals and clinics. Specifically, the 2016, the United States Pharmacopeial Convention (USP) released USP <800>, a new general chapter that defined many of NIOSH’s guidelines as enforceable requirements for healthcare professionals who handle hazardous drugs.

Hazardous drugs must be handled, prepared, dispensed, and stored under conditions that ensure worker and patient safety and prevent environmental contamination. Spaces designated for handling hazardous drugs must have signs prominently displayed at the entrance to the area³. Only authorized personnel should have access to these areas. Safe handling areas are not allowed near breakrooms or refreshments to reduce the risk of exposure to healthcare personnel, patients and visitors.

Safe handling of hazardous drugs is vital to ensure the health of hospital personnel, such as pharmacists, nurses, and others who could come into contact with these materials⁶. A closed-system drug-transfer device's purpose is to contain the hazardous drugs and reduce the risk of exposure.

Most hazardous drugs, especially those used in oncology cases, require reconstitution, dilution, and transfer to IV bags for administration, or are given directly through syringe injection⁶. While these drugs can treat cancer effectively, they are cytotoxic, making them a serious risk to those who handle, prepare, and administer them to patients.

When compounding sterile and nonsterile hazardous drugs, the PPE required for workers includes gowns, covers for the head, hair, and shoes, and two pairs of chemotherapy gloves. These precautions, combined with a CSTD, provide your staff with the best level of protection available.

Possible routes of occupational exposure to hazardous drugs can include⁴:

• Needle stick and sharps injury
• Inhalation and skin contact
• Unintentional hand-to-mouth ingestion

These exposure vectors are compounded by:

• Wearing improper or no PPE
• Spiking and unspiking at the bedside
• improper priming of IV tubing
• Connecting and disconnecting syringes and tubing
  

Pharmacists, nurses and veterinarians work with hazardous drugs daily. This puts them at risk of exposure. Simplivia’s CSTDs and Closed Administration solutions are designed to provide a complete, vial-to-vein solution for healthcare staff safety.

Since safety is the primary goal of CSTDs, including prevention of environmental contamination, their use is necessary for administering antineoplastic drugs when the dosage form allows it⁵. A closed-system drug transfer device (CSTD) is the only contamination control device available when administering hazardous drugs¹. This requirement, required by USP<800>, means that if a particular drug is available in a route or a dosage compatible with a CSTD, then the use of the CSTD is compulsory³.

Any workers who come in contact with hazardous drugs, from delivery of packaged vials to infusion into a patient's vein, can benefit from using a CSTD system. It's estimated that eight million workers in the United States are at risk of exposure to hazardous drugs or waste, such as contaminated packaging, used needles, escaped vapor or contaminated dust at their worksites. These workers do not just include nursing and pharmacy personnel – rather, they extend to operating room workers, physicians, physical therapists, veterinary professionals, laundry workers, maintenance workers, waste handlers, and shipping and receiving personnel.

Exposure comes from handling drug vials, cleaning spills, or touching contaminated surfaces when they compound, administer, or dispose of hazardous drugs. They also risk exposure by hand-to-mouth ingestion, inhalation, injection by a sharp needle or blade, or absorption through the skin, mucous membranes in the eyes, nose, or mouth⁶.

In recent years, the use of biologics, such as monoclonal antibodies (mAbs), has been increasing. Since these drugs are bioengineered to target specific cells directly, they represent a powerful weapon in the fight against cancer.
Simplivia CSTDs have a proven track record of delivering the highest safety and efficacy for healthcare staff worldwide. Simplivia's Chemfort^® CSTD features an intuitive design and peer-reviewed performance.

The Chemfort^® system is compatible with all known hazardous drugs. The Chemfort^® portfolio has been proven to stand up to even the most aggressive chemotherapy solvents under rigorous testing protocols².

The Chemfort^® vial adaptor easily clicks into place, eliminating worker fatigue. The adaptor is also available in several standard vial dimensions, avoiding mismatches between the vial size and the adaptor. Chemfort^®'s simplicity and ease of use also reduce the need for force when piercing vials.

Drug sterility is never a concern with Chemfort^®'s patented Toxi-Guard^® air-cleaning technology. The air-cleaning activated charcoal membrane prevents any leakage of hazardous drug vapors, aerosols, or liquids. It also blocks environmental contaminants from entering the fluid path, ensuring sterility.

At Simplivia, our goal is to keep healthcare workers safe and empower them to provide the best care possible to their patients. Whether considering a CSTD system for pharmacy, nursing, or veterinary use, Simplivia's Chemfort^® system provides the protection you need. Explore our website or contact us to learn more about our products.