Glossary

Simplivia is dedicated to developing and manufacturing high-quality medical solutions for drug delivery to ensure the safety of healthcare professionals. The following terms will help you get to know our innovative closed system solutions. Simplivia. Where healthcare and simplicity click.

Air-Cleaning Technology

There are a range of CSTDs on the market today that are based on one of two technologies – physical barrier and air cleaning. Air-cleaning CSTDs rely on air cleaning technology to prevent leakage of hazardous drug vapors. Both types of CSTDs can be used to reduce the risk of occupational exposure to hazardous drugs.

    American Society of Health-System Pharmacists (ASHP)

    The American Society of Health-System Pharmacists (ASHP) is a professional organization representing pharmacists serving as patient care providers in hospitals, health systems, ambulatory clinics, and other healthcare settings. ASHP has over 60,000 members, including pharmacists, student pharmacists, and pharmacy technicians. For more than 80 years, ASHP has led efforts to improve medication use and boost patient safety.

      Closed System Transfer Device (CSTD)

      NIOSH, the National Institute for Occupational Safety and Health, is a top US health protection agency. As part of the Centers for Disease Control and Prevention, NIOSH defines a Closed System Drug-Transfer Device (CSTD) as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of the hazardous drug or vapor concentrations outside the system.”

      There are two CSTD design types covered by the NIOSH definition: CSTDs that operate using air-cleaning technology, and CSTDs that use a physical barrier. Both CSTD types can be used to prevent hazardous drug release into the environment.

        Drug Leak

        A drug leak in the context of chemotherapy drugs refers to the unintended release or spillage of these drugs. This can occur during the handling, storage, or transportation of the drugs, and it can pose a serious health hazard to anyone who comes into contact with the leaked drugs.

        To prevent drug leaks and minimize the risk of exposure to hazardous drugs, healthcare facilities often use closed system drug-transfer devices (CSTDs) like Simplivia’s Chemfort™. These devices are specifically designed to prevent the release of drugs into the environment, and they are used to transfer chemotherapy drugs from one container to another.

        The use of CSTDs is an important part of safely handling and administering chemotherapy drugs, and it can help to prevent drug leaks and protect the health and safety of healthcare workers and patients.

          Effects of Hazardous Drug Mishandling

          The effects of hazardous drugs mishandling can be severe. In Europe, 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. In addition, 17,185 miscarriages occur every year as a result of occupational exposure.

          Safe handling during hazardous drug administration is essential for healthcare professionals, particularly for pharmacists, nurses and veterinarians. In combination with using personal protective equipment (PPE), best practices and other controls, Simplivia’s Chemfort™ CSTD product portfolio provides safety when handling and administering cytotoxic medications.

            Hazardous Drugs

            Hazardous drugs are medications that have the potential to cause harm to the people who handle them, either through inhalation, ingestion, absorption, or injection. These drugs are often used in healthcare settings, and they can be dangerous if not handled properly.

            One type of hazardous drug is chemotherapy drugs, which are used to treat cancer. These drugs are highly toxic and can cause serious side effects in the people who take them. As such, they must be handled with extreme care to minimize the risk of exposure to healthcare workers and others who may come into contact with them.

            Proper handling of chemotherapy drugs involves wearing personal protective equipment (PPE), such as gloves, masks, and gowns, to prevent contact with the skin or inhalation of the drugs. Preparation and administration of these drugs should be done using closed system drug-transfer devices (CSTDs) like Simplivia’s Chemfort™. In addition, these drugs must be stored and transported in special containers to prevent spills or leaks.

            Overall, it is important to take appropriate precautions when handling hazardous drugs, including chemotherapy drugs, to protect the health and safety of those who come into contact with them.

              Hazardous Drug Exposure

              Certain drugs, such as chemotherapy drugs used in oncology, antibiotics, and monoclonal antibodies, can put medical staff at risk of skin irritation, reproductive issues, cytotoxicity, and cancer if not handled properly. According to the Centers for Disease Control and Prevention (CDC), around 8 million healthcare workers in the United States alone are at risk of such exposure to these hazardous drugs.

                Hazardous Drugs USP<800>

                USP is an independent, scientific nonprofit organization dedicated to ensuring the supply of safe, high-quality medicines. USP is committed to strengthening the world’s supply chain so that the medicines people require to ensure health are available when needed and work as expected.

                In particular, USP <800>, also known as USP General Chapter <800>, outlines standards, requirements, and responsibilities for safe handling of hazardous drugs to reduce the risk of exposure for healthcare professionals, patients, and the environment. This includes facility and engineering controls, deactivation, decontaminating and cleaning, spill control, and documentation.

                  Monoclonal Antibodies

                  Antibodies are made by the body to help fight disease. When bacteria and viruses enter the body, the body makes antibodies designed to fight each specific pathogen. Monoclonal antibodies (mAbs) are usually produced produced in rodents even if they are "humanized" or "fully human." Some mAbs are made using human genes that form antibodies in E coli. Produced in large quantities in bioreactors, they are concentrated and can then be administered to patients either by injection or infusion.

                    Occupational Safety

                    In Europe, healthcare professionals, including 7.3 million nurses, are exposed to carcinogenic, mutagenic and reprotoxic hazardous drugs every year. 2200 new cases of leukemia are diagnosed year each as a result of occupational exposure to hazardous drugs. And 17,185 Miscarriages occur every year as a result of occupational exposure to hazardous drugs.

                    Exposure to toxic drugs as droplets or vapor can occur through inhalation, skin contact, unintentional hand-to-mouth ingestion or accidental needle stick and sharps injuries. In wards, and especially oncology wards, unintentional exposure to hazardous drugs poses a risk not only to nurses, but also to other hospital personnel, patients and their families, and the environment.

                    Studies show that nurses who handle antineoplastic drugs are exposed to the active ingredients. A recent study showed that 61% of wipe tests in hospital settings were positive for antineoplastics, with the highest concentrations on toilet floors, an IV pump, and a waste bin cover.

                    Occupational safety from hazardous drug exposure starts with Simplivia's Closed System Drug-transfer Device (CSTD).

                      Personal Protective Equipment (PPE)

                      When handling hazardous drugs, healthcare professionals should use personal protective equipment (PPE) in combination with closed system drug-transfer devices (CSTDs). PPE can include face and eye protection, gloves, gowns, and shoe covers. These items should not be reused even when using CSTDs. NIOSH guidelines recommend the use of PPE when engineering controls are not sufficient to reduce the risk of hazardous drug exposure. Guidelines and training should be kept current as the most up-to-date regulations may require changes in PPE.

                        Safe Medication Administration

                        Healthcare professionals must ensure that they ensure safe medication administration when working with hazardous drugs. Appropriate PPE and closed system drug-transfer devices (CSTDs) should be used when

                        • Spiking and unspiking at the bedside
                        • Connecting and disconnecting syringes and tubing
                        • Improper priming of IV tubing
                        • Wearing improper of no PPE
                        • Handling waste and excreta

                        Failure to ensure safe medication administration has been shown to result in a range of potential risks, ranging from nausea and skin rashes all the way to infertility and miscarriages, birth defects and even cancer.

                          Sterile Medication Transfer Device

                          A sterile medication transfer device (SMTD) is a specialized piece of equipment that is used to transfer chemotherapy drugs from one container to another in a safe and sterile manner. SMTDs are typically used when administering chemotherapy drugs to patients, and they are designed to prevent the drugs from coming into contact with the external environment.

                          SMTDs are typically made of plastic or other non-permeable materials, and they have special seals and valves that prevent the drugs from leaking out. They also have filters that prevent vapor from escaping, which helps to prevent inhaling of the drugs.

                          In addition to their safety features, SMTDs are also sterile, which means that they have been treated to eliminate any microorganisms that could potentially contaminate the drugs. This is an important consideration when administering chemotherapy drugs, as these drugs can be highly toxic and any contamination could pose a serious health hazard.

                          Overall, sterile medication transfer devices like Simplivia’s Chemfort™ CSTD are an essential part of safely administering chemotherapy drugs, and they help to prevent drug leaks and protect the health and safety of healthcare workers and patients.

                            Vial Adaptor

                            Simplivia offers a range of innovative, user-friendly Vial Adaptors which connect to standard vials. The Vial Adaptors are sized to match all standard vial neck sizes (20 mm, 28 mm or 32 mm and a 13 mm convertor, which connects to the 20 mm Vial Adaptor). Our Vial Adaptors are mounted on the drug vial to allow drug transfer in a closed system. The process is designed to be brilliantly simple to make drug preparation and compounding easy.

                            Our Chemfort™ Syringe Adaptor / Syringe Adaptor Lock connects with minimal effort to a Simplivia Vial Adaptor, allowing safe drug transfer from the drug vial to the syringe and then to another container. For repeated use, up to 10 Syringe Adaptor to Vial Adaptor connections and disconnections, the Vial Adaptor’s protective cap can be used for safe, cost-effective vial storage.