Diagnostic Quality Viewer Doesn't Mean Cleared to Diagnose

September 24, 2013

Not all diagnostic image viewers are the same. Know what questions to ask before making a purchasing decision.

One of the hardest decisions medical institutions make is deciding what technology to implement. This decision impacts all aspects of healthcare, from the level of service provided to patients to the cost and risk incurred by the medical practitioner. And diagnostic image viewing technology is no different – there are many options, and they are not all created equal.In the past, in order to make an accurate diagnosis, a medical practitioner would need to be at his or her workstation. If the provider wanted a second or third opinion, another medical practitioner would also need to be at his or her workstation. With incredible technological advances, a diagnosis is now possible even if the medical practitioner isn't at the workstation or even at the hospital. Diagnostic images can be reviewed over smart phones, tablets, and laptops from any location in the world.These 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. Yet, any treatment decision or treatment adjustment a medical practitioner makes upon viewing an image could be considered a diagnosis.Radiologists, in particular, are wide open for malpractice claims. In fact, half of all radiologists will be sued by the time they are 60 years old. And diagnostic errors are the most common type of medical mistake – it’s estimated that they cost the healthcare system $38.8 billion in malpractice claims. Radiologists would not want to increase their risk further by using technology that is not accredited.Image viewing technologies vary greatly in terms of functionality and capabilities. The average medical practitioner will have a difficult time distinguishing between the options.  This is further confused by the fact that there is no governing institution that oversees diagnostic image viewing technology to verify whether it is of high enough quality to perform a diagnosis. This means there are several options on the market that can claim to be for diagnostic use without the proper accreditations.Healthcare organizations should look for a few standards when deciding which diagnostic medical image viewer on which they're going to rely. Due to stringent regulations, the first step should be accreditations. Diagnostic medical image viewers should be cleared for diagnostic use by the FDA, CE, and Health Canada. This certification proves the technology is of sufficient quality to perform a diagnosis. Accreditation is binary; the technology is either cleared or it's not. If the image viewer hasn't been cleared, then it's not good enough to perform a diagnosis.A few questions hospital decision makers and medical practitioners can ask are:1. Does the technology have the appropriate FDA, CE mark, or Health Canada clearances?2. Does the technology have MPR and 3D viewing?3. Does the solution work with key modalities, including CT, MR, CR, DX, ES, KO, MG, NM, OP, OT, PT, SC, US, XA?4. Is the technology FDA-cleared for both web and mobile use or only one?5. Is the technology FDA-cleared for use on all device types? Pierre Lemire is President and CTO of Calgary Scientific. He directs engineering, is a chief contributor in the product vision for PureWeb, and manages the Calgary Scientific patent portfolio.