Closed drug transfer systems are defined as drug transfer devices that prohibit the transfer of environmental contaminants into the system and release the hazardous vapor concentrations outside the system. The system is used to transfer hazardous drugs from one receptacle to another without being exposed to outside environment and to the person who is working on it. For example, for preparing and administering chemotherapy drugs containing hazardous antineoplastic agents, there is a need to transfer drug from vial to syringe and then from syringe to IV infusion bag. During each transfer there is a possibility for exposure to the hazardous drugs. To prevent such exposure, closed drug transfer systems are used as these exposures may lead to serious health complications from skin irritation to birth defects and even some type of cancers. One of the studies demonstrates that nurses working with cytotoxic drugs on regular basis have found a statistically higher rate of spontaneous abortion.
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The market for closed drug transfer systems is growing at faster pace driven by the regulatory and industry efforts to design the procedures and standards for protecting workers and patients from incidental and accidental exposure to cytotoxics. Various government regulatories such as American Society of Health System Pharmacists, The Oncology Nursing Society and The Occupational Safety and Health Administration among many others have set up a list of guidelines for safer handling of hazardous drugs leading to the increased use of the closed drug transfer systems. On the basis of the available closed drug transfer systems, the market for closed drug transfer system is segmented into five segments namely: PhaSeal, AquaShield, OnGuard, SmartSite, ChemoClave.
All of the above mentioned closed drug transfer systems are approved by Food and Drug Association (FDA) and are used extensively. One of the trials conducted at the Yamada Red Cross Hospital, Japan using PhaSeal to detect the concentration of cyclophosphamide in pharmacist’s urine samples demonstrated that the mean amount of cyclosphosphamide in the samples was 3.6 ng in 24 hours in comparison to 47.4 ng in 24 hours before the installation of PhaSeal. The major restraint which the market is facing is the bio-hazardous waste generated by the closed drug transfer systems as this waste could lead to serious infections. Among all the available closed drug transfer systems, ChemoClave is considered as the most efficient system on the basis of exposure percentage, cost-effectiveness and amount of bio-hazardous waste generation.
North America leads the closed drug transfer system market followed by Europe majorly due to strict government safety regulations driving the demand for these systems and presence of high awareness about these products. The available reimbursement policies in U.S., Europe and Japan are an additional factor leading to increased use of these systems. Market of Asia-Pacific is driven by the growing awareness about the healthcare products in emerging countries such as India and China and strict government guidelines for preparing anti-cancer drugs in Japan. Additionally, new products innovations is also helping the market to grow as currently there is no 100% safe closed drug transfer system available in the market.
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Companies whose products are approved by the U.S. FDA in the closed drug transfer systems market include B.Braun Medical, Inc., Becton, Dickinson and Company, iCU Medical, Inc., EquaShield Medical and Carefusion Corporation.