ICU Medical, Inc. ICUI today announced that its ChemoLock^™ needlefree closed system transfer
device (CSTD) is the first and only CSTD to receive United States Food and
Drug Administration (FDA) 510(k) clearance for pharmacy applications (product
code ONB), as well as patient administration applications (product code FPA)
that adhere to current guidance standards, which were updated in 2008.
"We designed ChemoLock as an intuitive needlefree system to keep pharmacy and
nursing staffs and their patients safe from exposure to hazardous drugs,"
explained ICU Medical CEO Dr. George Lopez. "By preventing the transfer of
environmental contaminants into the system and blocking the escape of drug or
vapor concentrations outside the system, ChemoLock will keep clinicians and
patients safe from exposure to a wide range of hazardous drugs—including those
used in chemotherapy—while maintaining the sterility of the drugs themselves."
The ChemoLock system consists of easy to use needlefree components that
connect with an audible click, cannot be deactivated, and will passively aid
in preventing both needlestick injuries and the exposure cytotoxic
medications. No complex assembly is required prior to usage and the system
remains completely closed throughout the entire safe handling
process—including preparation, transportation, administration, and
disposal—assuring both patient and caregiver safety as well as the sterility
of the prepared medication.
"ChemoLock is a mechanically and microbiologically closed needlefree system
that is safe, intuitive, and easy to use during every step of the hazardous
drug handling process, helping assure compliance with OSHA, NIOSH, ASHP,
ISOPP, ONS, APHON and USP <797> safe-handling guidelines," explained Robert
Houde, RPh, Director of ICU Medical's Oncology Division. "It offers
significant advantages over competitive products on the market, and is a
perfect complement to our current product line, which includes the
ChemoClave^® CSTD and Closed System product line and the Diana™ hazardous drug
compounding system. No other company can offer customers the range of safe
handling solutions that we do."
Currently in limited market release and in clinical use at several early
adopter hospitals throughout the United States and Europe, ChemoLock will be
formally introduced and available later this year, and will be featured at the
American Association of Hospital Pharmacists' (ASHP) midyear meeting and
exposition in Orlando, FL in December.
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