A new system to help reduce the risk of life-threatening medical errors in computed tomography (CT) procedures has been approved by the FDA. Covidien's (St. Louis) contrast delivery system integrates radio frequency identification (RFID) technology to provide a set of checks and balances to prevent human error.

RFID technology is not new. In fact it's virtually everywhere from pet identification tags to toll-booth cards that allow you sail through.

"This is a new foray to bring RFID to the radiology suite. RFID allows us to build on our current risk-reduction platform," Brian Straeb, vice president of marketing in the U.S. for Covidien's Imaging Solutions business, told Medical Device Daily. "What we'll be doing is adding RFID technology as the next step in our commitment to helping customers and patients address safety concerns."

Covidien's contrast delivery system combines its Ultraject prefilled contrast media syringes with its Optivantage DH power injectors to provide the only RFID-enabled contrast delivery solution available in North America. The RFID automatically captures, stores and transmits data between the Ultraject syringe and the Optivantage DH power injector using RFID transponders, or tags.

Covidien had some technical assistance from semiconductor giant Texas Instruments (Dallas). "It's a supply agreement; they are not sharing in the financial piece, though," Straeb said.

Some of the safety issues surrounding contrast delivery include accidental use of a used syringe, the risk of injecting air into a patient and use of an incorrect substance.

Covidien's RFID tag changes after an injection is made so it's not possible for a used syringe to be reused. It automatically rejects it.

"This creates an intelligent interface to allow the radiologist to make sure the correct contrast media is in the syringe," Straeb said. "RFID also prevents use of expired contrast media."

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. Straeb said it will be further modified at some point to allow for data transfer directly to electronic medical records.

"It allows the technologist to spend less time filling empty syringes and putting it into the injector and to spend more time with patients," he said. "This allows us to improve the accuracy. Typically when a patient receives an injection, the technologist has to record that information. But the RFID technology communicates that data to the injector and prints out a label to put on the patients record."

Covidien has been providing prefilled syringes for contrast imaging for a number of years, reducing the risk of medication-dispensing and mislabeling errors that may occur when clinicians manually fill syringes from bulk packaging.

Straeb said RFID-labeled syringes strengthen the company'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.

"There have been events in which patients were injected with cleaning fluid. Contrast media in a syringe that's not labeled can easily be mistaken for something else," he said. "We're talking about reducing confusion. Mislabeling of lookalike products can be catastrophic. JCAHO encourages the use of prefilled, pre-labeled products where possible."

Covidien's RFID technology is currently available only with the company's prefilled syringes and injectors. Details on cost were not yet available.

Straeb said the company expects to start shipping the RFID-enabled system during the late summer.