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New "Imaging Bulk Package" For Use With Power Injectors
August 14, 2014
An ISOVUE (iopamidol) Imaging Bulk Package (IBP) from Bracco was just approved by the US Food and Drug Administration (FDA) and should be available later this year. This is a new dosage form designation, designed and labeled for multi-patient use in the CT suite in conjunction with an automated contrast injection system or a contrast management system approved or cleared for use with this new presentation. It can also be used with a syringe-based CT injection system and transfer set designed for multi-patient use. 

Additionally, the ISOVUE MULTIPACK PBP (Pharmacy Bulk Package) has been renamed ISOVUE PBP. The PBP product should never be used in radiology for any purpose and should be limited to preparation of syringes in an ISO Class 5 environment in the pharmacy. The PBP product is NOT approved for use in automated contrast injection systems. 

The introduction of the IBP product was apparently in response to the sterility issues we discussed in our newsletter (www.ismp.org/sc?id=400) with using PBPs of contrast for multiple patients in radiology. With the IBP product, FDA required testing for sterility and chemical compatibility in simulated in-use studies with transfer sets, transfer syringes, and contrast injectors. But keep in mind, sterility is still a concern in radiology if the IBP products are not used exactly as described in the package insert. Other manufacturers besides Bracco may have similar IBP products available in the future.
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