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-Ceaning 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.

        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.

              NIOSH

              The National Institute for Occupational Safety and Health (NIOSH) is a key US health protection agency. As part of the Centers for Disease Control and Prevention, NIOSH defines what medical devices qualify as Closed System Drug-Transfer Devices.

                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.

                    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.