FDA Approves Contrast Delivery System with RFID

 

May 9, 2008

May 9, 2008 – The FDA approved Covidien’s contrast delivery system with radio-frequency identification (RFID) technology, integrating the technology to create a system that is designed to enhance patient safety by reducing the risk of medical errors in radiology departments.

Expected to be available summer 2008, the contrast delivery system pairs its unit-dose Ultraject prefilled contrast media syringes with its Optivantage DH power injectors to provide the only RFID-enabled contrast delivery solution available in North America, according to the company. RFID is an automatic identification technology that captures, stores and transmits data between the Ultraject syringe and the Optivantage DH power injector using devices called RFID transponders, or tags.

With this RFID technology, the system creates an intelligent interface between the contrast media syringe and the power injector that enables radiology technologists to better ensure that each patient receives the prescribed drug and drug dose during a procedure, according to the company. The interface allows the injector to physically alter the RFID label on a syringe once it is used, which substantially reduces the probability of life-threatening air injections or air embolisms because the system automatically prevents the injection of contents from a previously used RFID-labeled syringe. Covidien’s system also indicates if the drug in an RFID-labeled syringe is past its expiration date. The system automatically transfers drug and achieved exam protocol information onto a printed label for the patient record, which reduces the need for manual data entry, thereby improving efficiency and accuracy.

As the pioneer in prefilled syringes for contrast imaging, Covidien has helped customers reduce the risk of certain medication-dispensing and mislabeling errors that may occur when clinicians manually fill syringes from bulk packaging. The integration of RFID technology into the Covidien contrast delivery system builds on the Company’s ongoing efforts to address safety-related needs in radiology departments. RFID-labeled syringes strengthen Covidien’s ability to help radiology facilities address Joint Commission on Accreditation of Healthcare Organization (JCAHO) and U.S. Pharmacopoeia 797 standards, which are aimed at ensuring compliance with labeling and unit-dose requirements, as well as the use of aseptic techniques.

For more information: www.covidien.com