ENGLEWOOD, Colo. -- Baxa Corporation introduces the only closed system for handling antineoplastic drugs that has been documented to reduce or eliminate human exposure to toxic hazards in the workplace. The new system, called PhaSeal, is manufactured in Sweden by Carmel Pharma ab, and is distributed in the United States exclusively by Baxa Corporation per an agreement announced in December.
The PhaSeal System consists of a set of disposable containment devices that connect the original drug vial, syringe and IV injection or infusion set together into a completely sealed pathway. The system's double membrane prevents drug leakage and keeps the connections dry. A built-in expansion chamber equalizes system pressure to prevent the release of toxic aerosols and vapors. Because PhaSeal is a closed system, hazardous drugs are contained throughout the entire process of drug transfer, preparation, transport, administration and disposal.
PhaSeal's unique drug containment technology is a new approach to safe drug handling, according to Agneta Ekblad, RN, vice president of oncology solutions for Baxa Corporation. "Traditional thinking relied on containing employees within gowns, masks and gloves in case of drug leakage, which research has shown doesn't fully protect them," she says. "PhaSeal puts the focus on containing hazardous drugs to prevent leakage, so employees don't have to worry so much about their protective gear."
Traditional assumptions about safe drug handling were challenged by studies of U.S. and Canadian drug preparation facilities conducted by the M.D. Anderson Cancer Center and others. These studies confirmed European findings that, despite existing protective measures, there persisted widespread surface contamination with antineoplastic drugs in the workplace and employee exposure to carcinogenic or mutagenic particulates and vapors.
In response, M.D. Anderson decided to evaluate the new PhaSeal closed-system technology based on the record of its successful use in Europe. Studies conducted at M.D. Anderson and other U.S. hospitals demonstrated its efficacy in preventing release of hazardous substances during the drug handling process.
"Our results showed that we can reduce or eliminate human exposure to cancer chemotherapy drugs by using the PhaSeal System," says Roger W. Anderson, Pharm.D., head of the Division of Pharmacy at M.D. Anderson.
These results led M.D. Anderson to become the first U.S. hospital to adopt the PhaSeal System. "We've already implemented the PhaSeal System for all doses prepared and administered in our hospital," Anderson says. "We're convinced it will greatly enhance workplace safety for our employees."
Other major U.S. hospitals now using the PhaSeal System include Dana Farber Cancer Institute, Stanford University Medical Center, and the University of Utah Hospitals and Clinics.
As a leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom; Denmark, and Germany; and distribution partners worldwide.
The PhaSeal System is manufactured in Sweden by Carmel Pharma ab of Goteborg, Sweden. Introduced in Europe in 1994, the PhaSeal System is now used in most Swedish hospitals, with its benefits documented by a significant body of scientific research on the health risks associated with the preparation and administration of cytotoxic drugs.
Source: Baxa Corporation