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FDA Lifts Warning Label on Contrast Imaging Agent: Will Use with Ultrasound Increase?

Posted by Leslie Patton on Thu, Nov 3, 2011 @ 15:11 PM

header left newThe American Society of Echocardiography (ASE) has worked diligently since 2008 to raise awareness about the safety of contrast agents used in ultrasound. They have established thorough training programs, supplemented with videos, guidelines and coding information. Earlier this year the FDA held a multi-committee hearing to gather public opinion from groups including Cardiovascular and Renal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (DSaRM). The purpose was to review the safety requirements of contrast agents and hear feedback from other healthcare professionals in regard to its use.

Since its inception contrast agents have been used for clinical echocardiography studies to use a bubble effect to measure blood flow and look for defects in the heart where Doppler alone is not sensitive enough to highlight abnormalities. Knowing that ultrasound is a safe modality and produces less ionizing radiation than other imaging devices such as CT or nuclear imaging, "Dr. Barry Goldberg, radiologist for The American College of Radiology (ACR) and the American Institute of Ultrasound in Medicine (AIUM), expressed the desire of these groups to expand the approved uses of ultrasound contrast agents to include multiple other indications, such as vascular imaging, liver perfusion, and breast imaging..."

Concurring with what Dr. Goldberg expressed was Dr. Paul Grayburn of The International Contrast Ultrasound Society (ICUS), who also asked the FDA "to reconsider its current labeling and lift the black box warning." The decision was made in October to lift the warning label, confirming its value in patient safety and benefits to ultrasound scans, which will hopefully now open the door to more clinicians utilizing contrast agents.

Intersocietal Commission for Accreditation of Echocardiography Laboratories (ICAEL) has also released new guidelines in reference to contrast agents and ultrasound which state:

Equipment standards have also been enhanced, in Part IV, the section on equipment (1.1 on page 33), states:

"Ultrasound instruments utilized for stress echocardiographic studies must include, at a minimum,hardware and software to perform: 

A) Two-dimensional (2-D) imaging. The system should include harmonic capabilities and instrument settings to enable optimization of ultrasound contrast agents."

Regardless if you are conducting echo, stress echo, or general imaging ultrasound exams, United Medical Instruments, Inc. inventories a diverse selection of ultrasound systems to meet your needs, please contact us to learn which system will be best for your practice.

Topics: UMI Blog