Israel Mandates Closed System Drug Transfer Use
GOTHENBURG, SWEDEN (December 15, 2010) – Israel becomes the first country in the world to make the use of closed systems for the preparation and administration of hazardous drugs mandatory.
Carmel Pharma welcome the Israeli Ministry of Health’s decision to make closed systems a mandatory addition to the protective equipment requirements in all Israeli medical institutions that prepare and administer cytotoxic drugs. ’It’s a decision that will continue to improve the welfare of Israeli heathcare workers by providing them with a safer working environment’, says Dan Pitulia, CEO. of Carmel Pharma, the manufacturer of the PhaSeal closed-system drug transfer device.
We will continue to monitor this and sincerely hope that other countries will follow this excellent initiative.
The Israeli Ministry of Health ruling stipulates that closed systems must be available in any place where cytotoxic drugs are prepared and administered; and as the first line of defence against hazardous drug contamination, healthcare workers must work with closed systems.
The ruling was made in relation to scientific studies proving that cytotoxic drug contamination can be found in preparation and administration areas, and that a closed system drug transfer device is able to minimize this contamination by mechanically controlling the transfer of the cytotoxic drugs.
The definitions used by the Ministry of Health regarding a closed system closely mirrors that of the American based National Institute of Occupational Health and Safety.
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 hazardous drug vapour concentrations outside the system. The International Society of Oncology Pharmacy Practioners uses a similar definition, but includes the terms airtight and leakproof.
Carmel Pharma is the manufacturer of the PhaSeal System, today’s only clinically proven closed-system drug transfer device (CSTD) for the safe handling of hazardous drugs. Supported by more than 15 years of experience focused solely on the development of PhaSeal, Carmel Pharma offers a level of trust, quality and confidence that is unparalleled in the safe handling industry. Carmel Pharma was founded in Gothenburg, Sweden in 1994 and has played an active role in the Swedish medical market ever since. In October of 1999, the company expanded its safe handling initiatives to the U.S. market with the formation of Carmel Pharma, Inc., which operates a corporate office and distribution facility out of Columbus, OH. The exclusive U.S. distributor of PhaSeal since 2006, Carmel Pharma has more than 200 shareholders, the main ones being Investor Investment Europe Ltd and Priveq Investment. Today, the PhaSeal System is trusted by and implemented in more than 2000 cancer facilities, infusion centers and private practices across 30+ countries, including M.D. Anderson and Texas Children’s in Houston, TX; City of Hope in Duarte, CA; Dana Farber Cancer Institute in Boston, MA; and SwedishAmerican Hospital in Rockford, IL, just to name a few.