Laboratories Utilizing Emerging Technologies Print this page

Camera and software technology are evolving at a rapid pace, particularly those related to nuclear cardiology. Often this technology is promoted as offering improved resolution and faster scan times, and several new cameras utilizing novel technology and new reconstruction techniques are now available on the market.

However, the availability of peer reviewed published literature and large scale clinical trials providing validation of these emerging technologies is limited; therefore, it has been a challenge for the related professional organizations to diligently examine and incorporate these new developments into their published guidelines. Since its inception, the ICANL has relied on its sponsoring organizations to first recognize the validity of and update guidelines for any new technology before incorporating it into the accreditation process.

In June 2008, the ICANL began accepting accreditation applications from laboratories utilizing new technologies and other novel imaging approaches that, to date, are not included within the guidelines published by the professional societies. Such laboratories will apply for accreditation via the ICANL Online Accreditation application and undergo further evaluation by way of the new Emerging Technologies Pathway.

Definition of Emerging Technologies

As defined by the ICANL, an "emerging technology" is any new technology which utilizes parameters that fall outside of the currently accepted ICANL Standards; utilization of the new technology must demonstrate the following:

• Clinical validation. The technology must perform, as intended, to produce clinical results that are equal to or better than currently accepted technologies, based on published peer-reviewed data. Includes a clear delineation of the clinical scenario to which it applies (indications/diagnoses) and the method of utilization (procedure).
• Reproducibility. For instrumentation, there must be clearly defined quality control procedures and data to show stability of the device, when used as indicated.

Applying Via the New Emerging Technologies Pathway

Laboratories applying through the new pathway are eligible for accreditation, and will be notified by the Board of Directors of the additional documentation required. The lab will have one year to submit supplementary material and undergo the additional review. Such laboratories are required to provide additional documentation beyond what is included in the current application, including phantom images, acceptable quality control measures, and documentation of training and clinical competency of the technologists. Labs applying through the Emerging Technologies Pathway may potentially incur additional fees.

Quality Assessment Patient Simulator Program

Introduced as part of the Emerging Technologies Pathway is the Quality Assessment Patient Simulator Program. Offered jointly by the ICANL and the Society of Nuclear Medicine (SNM), the Quality Assessment Patient Simulator Program provides provides laboratories with the physiologic phantom required to identify and quantify areas of abnormality and determine the diagnostic significance of these findings. Laboratories applying through the Emerging Technologies Pathway are required to submit the results of the patient simulator program to the ICANL for evaluation and grading, based upon objectives judging defect reproducibility and image quality. Laboratory reporting of images will also be evaluated.

The first module to be made available, the Cardiac SPECT Phantom, is available to test the applicant laboratory’s ability to acquire and process SPECT rest/stress myocardial perfusion studies, identify and quantify areas of perfusion abnormality and determine the diagnostic significance of these findings. The laboratory’s submitted results will be graded by the ICANL using objective criteria. Patient simulators for general nuclear medicine and PET technology are currently under development.