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New Cardiac Image Phantom and Test Standard is now industry approved.
A new phantom and image quality standard has been developed by a joint working group of the Society for Cardiac Angiography and Interventions (SCA&I) and National Electrical Manufacturers Association (NEMA). The design has been approved as NEMA Standard XR 21-2000 "Characteristics of and Test Procedures for a Phantom to Benchmark Cardiac Fluoroscopic and Photographic Performance". Clarté Imaging was an active member of this group and was instrumental in the evaluation of the phantom and associated test protocol.
The Phantom is a device used to test systems under conditions simulating normal clinical use for fluoroscopically-guided invasive and interventional procedures. The Phantom is constructed of Plexiglas with iodine and aluminum test objects. This material has x-ray absorption and scatter properties similar to human soft tissue. Configuring the Phantom simulates the entire range of patient sizes and imaging projection angles.
Phantom and Training Program Now Available
The consistency of the tests performed using the NEMA XR-21 Standard Fluoro Benchmarking Phantom is dependent on the skill and training of the observer. As stated in the NEMA XR-21 Standard, all testers should receive formal training before being allowed to work independently. The FDA has reached a similar conclusion in conjunction with their Mammography regulations (MQSA).
Clarté Imaging is a recognized leader in cardiac image quality and system performance assessments. The company has been involved in the development of NEMA XR-21 phantom, developed a comprehensive test protocol, and maintains a database of tested laboratories. The Society for Cardiac Angiography and Interventions (SCA&I) has adopted this phantom for standardized benchmark testing of Cardiac Cath Labs imaging systems and has sanctioned Clarté Imaging to be a provider of formal training in the use of the phantom.
Training includes set-up and testing one or two imaging planes utilizing the Fluoro Benchmark Phantom. Each person in the class will receive hands-on training in the use of the phantom, test protocol, data collection, and future-reporting procedure of collected data. A list of those trained at each site will be sent to the SCA&I to establish that the person is qualified to send future data test results to the Society for input to the Society registry. Includes initial data collection of demographic data and test results for each plane tested for submission to the SCA&I Registry. In addition, the Institution will receive a formal test results report(s), thereby establishing a benchmark for trend analysis.
For additional information, or purchase XR-21 Phantom and/or to set up a training session, please contact Marv Alley toll free at 866-620-7828 or email marv@clarteimaging.com.
A performance benchmark for all cardiac cath labs is soon to be released.
Clarté Imaging to do Cardiac X-ray Image Quality StudyClarté Imaging Solutions, Inc. announces that they are using the NEMA XR-21 2000 Standard for a Fluoro Benchmarking Phantom to evaluate the performance of the adult cardiac catheterization laboratories fluoroscopic imaging system(s) in a benchmark study. The phantom and testing protocol have been designed to provide clinically relevant information to meet the needs of the catheterization laboratory. The goal of the study is to assess the image quality and radiation dose for each laboratory tested and to collect that data from twenty or more sites for a total of approximately forty imaging planes. There will be a mix of all X-ray manufacturers equipment. The benchmark study is intended to produce a registry of cath lab image quality and radiation exposure measurements, which will enable evaluation and comparison of lab equipment performance. The SCA&I Laboratory Performance Standards Committee will ultimately maintain the registry.
The Study’s goal is to collect data that will enable each lab to compare image quality and radiation dose to:
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trends of a single lab over time;
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other labs in the same institution; and
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labs in other institutions.
Application of this testing system should eventually result in:
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early recognition of deteriorating acquisition & display equipment;
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improved image quality;
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reduced radiation exposure to the patient and angiographer; and
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standardized image quality for labs involved in multicenter studies.
Things to Remember:
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Testing to this Standard can satisfy JCAHO quality assurance compliance for the Cardiac Cath Lab.
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Improved image quality leads to quicker diagnosis, increased patient throughput, and physician satisfaction.
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Don't you want lower operational costs, better profitability and the bonus of JCAHO compliance?
Links to Sites of Interest
American College of Cardiology
Medical Conferences & Meetings -- Cardiology
The Society for Cardiac Angiography & Interventions
The Society of Invasive Cardiovascular Professionals