News | May 13, 2008

FDA Approves Covidien System With RFID To Reduce Life-Threatening Errors

medical

Covidien (NYSE: COV, BSX: COV) recently announced that the U.S. Food and Drug Administration (FDA) has approved Covidien Imaging Solutions' contrast delivery system with radio-frequency identification (RFID) technology. The components integrate novel RFID technology to create a system that is designed to enhance patient safety by reducing the risk of medical errors in radiology departments.

Covidien's contrast delivery system combines 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. 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.

"Covidien's new, innovative system has the potential to reduce medical errors and increase efficiency in CT imaging," said Steve Hanley, President of Covidien Imaging Solutions. "We expect this technology to be the platform for future innovation."

With 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. 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. Additionally, 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.

"Risk reduction is one of the key challenges facing the radiology community," Hanley added. "Our new delivery system underscores Covidien's commitment to helping our customers address safety-related concerns."

Covidien expects its contrast delivery system with RFID technology to be available in the summer of 2008.

About Covidien
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2007 revenue of nearly $9 billion, Covidien has more than 42,000 employees worldwide in 57 countries, and its products are sold in over 130 countries. Please visit www.covidien.com to learn more about our business.

SOURCE: Covidien