ICU Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for its ChemoLock needlefree closed system transfer device (CSTD).
The CSTD is approved 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.
ICU Medical CEO Dr George Lopez said the company designed ChemoLock as an intuitive needlefree system to keep pharmacy and nursing staffs and their patients safe from exposure to hazardous drugs.
"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," Dr Lopez added.
ChemoLock, a mechanically and microbiologically closed needlefree system, is safe, intuitive, and easy to use during every step of the hazardous drug handling process.
It is designed in accordance with OSHA, NIOSH, ASHP, ISOPP, ONS, APHON and USP safe-handling guidelines.
The ChemoLock system comprises of easy to use needlefree components that connect with an audible click, cannot be deactivated, and help prevent both needlestick injuries and the exposure cytotoxic medications.
By remaining completely closed throughout the entire safe handling process, — including preparation, transportation, administration, and disposal — the ChemoLock system ensures safety as well as the sterility of the prepared medication.