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Diagnostic Image Viewers Are Not All Created Equal

Fri, 08/09/2013 - 3:12pm
Pierre Lemire, President and CTO, Calgary Scientific

Innovative new technologies have significantly enhanced the way medical practitioners diagnose patients, review images, seek second opinions, communicate results, and generally approach the care they give. Historically, in order to make an accurate diagnosis or review images, a doctor would need to be at a workstation. If they wanted a second opinion, they would need that person to be at their workstation as well.

Today, a diagnosis is now possible even if the medical professional isn't at their workstation, or even in the hospital at all. In fact, diagnostic images can be securely reviewed over smartphones, tablets, and laptops from any location in the world. The benefits of this flexibility are endless. Medical practitioners can make quicker and more informed decisions to better serve patients and there are opportunities for institutions to realize significant cost savings over older and more limited methodologies. There are many options and they are not all created equal.

Major differences of image-viewing technologies lie in their overall functionality, data security, and the terminology used to describe their intended use. This makes it difficult for the average medical practitioner or institution to distinguish between options—in many cases, it's nearly impossible to compare. Any company can claim their imaging technology is “good enough,” and while inexpensive or free imaging tools may appear to save funds in the short term, there are longer term considerations, including the impact on infrastructure, performance, and data security, as well as knowing if it will perform the way you need it to.

Medical image viewers should be accredited for diagnostic use by the FDA, CE, and/or Health Canada. There are two FDA classes for accreditation. Class I only clears a solution for review, not diagnosis. The process to obtain Class II clearance by the FDA is both lengthy and rigorous. Class II accredited imaging technology has achieved the highest quality standards available and is classified in the same category as PACS. If the image viewer does not have Class II accreditation, then it's not suitable to perform diagnosis.

Achieving Class II clearance is an extensive process that includes steps such as independent laboratory testing to validate the performance characteristics of the device's display against the technical criteria from the American Association of Physicists, as well as clinical validation by board certified radiologists accredited by the American College of Radiology. The solution that is applying for FDA clearance will be tested against a previously validated mobile device and/or PACS workstation. A panel of expert radiologists is used to establish the diagnostic safety and effectiveness of the combined hardware and software system. Each expert has to confirm that their criteria have been satisfied.

Medical practitioners who use an accredited diagnostic image viewer have the added benefit of access logs to track three things:

  1. If the image was viewed on a device that has been cleared for diagnostic use
  2. The image was reviewed in an appropriate amount of time
  3. If a second opinion was obtained

For those medical practitioners that choose to use a non-diagnostic viewer, they need to understand that they're assuming liability if they're ever the subject of a lawsuit. In issuing a clearance, the FDA accepts risk associated with the software on behalf of American practitioners.

For more information, visit www.calgaryscientific.com/useaccredited.

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