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The Intego PET Infusion System (Medrad, Inc., Indianola, PA) is an automatic injector for 18F-FDG and has been recently approved by the FDA. Does use of the Intego™ PET Infusion System meet the requir
USP <797> is not applicable to the administration aspect of the Intego™ PET Infusion System; however, the insertion of two needles (one for venting purpose and the other for drawing dose) into the multidose 18F-FDG vial should be carried out in an ISO Class 8 or cleaner air environment if administrations take place beyond 1 hour. If all administrations are completed within 1 hour of puncture of the 18F-FDG vial, the immediate-use exemption may apply.
The Intego™ PET Infusion System (Fig. 1) is a computer-operated device for the dispensing and injection of 18F-FDG doses to patient. On June 17, 2008, Medrad received 510(k) clearance from the FDA. Please click here for more information about the Intego™ PET Infusion System.
The Intego™ PET Infusion System was recently introduced at the 2008 annual meeting of the SNM. The Intego™ PET Infusion System has a port to house a shielded multidose vial of 18F-FDG supplied by either a commercial or in-house PET drug production facility.
A source administration set (SAS) consisting of a dual-needle cartridge, a connector port, tubing, and a bag of physiological saline is connected to the multidose vial of 18F-FDG via a needle penetration (only one penetration during the entire use period of the multidose vial) of the rubber septum. Each patient dose is automatically measured and calibrated inside a shielded cart, which can be easily moved from room to room and positioned between the imaging technologist and patient during the injection procedure.
A patient administration set (PAS), which is attached to the connector port of the SAS, is changed for each patient administration.
There is much similarity with the Ultra-TechneKow® DTE 99mTc generator (Covidien, St. Louis, MO), in which a “multidose” vial of normal saline is placed onto the new generator with one needle puncture and it remains there for the duration of use. Based on this similarity, as well as the impracticality of hoisting it into a biosafety cabinet, the dual-needle punctures of the 18F-FDG multidose vial being loaded onto the infusion system should be in an ISO Class 8 or cleaner air environment. Once the 18F-FDG multidose vial is firmly in place, the infusion system could be taken from room to room or, of course, used within 1 hour per the immediate-use provision in USP <797>.