Regulatory Focus™ > News Articles > FDA Meeting to Focus on Interoperability Standards for Medical Imaging

FDA Meeting to Focus on Interoperability Standards for Medical Imaging

Posted 26 March 2013 | By Alexander Gaffney, RAC

An upcoming meeting co-sponsored by the International Color Consortium (ICC) and the US Food and Drug Administration (FDA) seeks to address questions regarding the interoperability of medical imaging devices, of which an increasing number are using color imaging instead of black-and-white.


The use of color in medical imaging is a relatively new phenomenon, and FDA explained in a Federal Register posting that a "variety of hardware and software platforms … rely on medical and non-medical devices to implement medical imaging product solutions for color surgery."

With so many devices involved in the imaging process, regulators said they are concerned that devices might pose interoperability problems.

The devices are, even without the addition of color, often complex. Medical imaging systems are frequently in FDA's Class II recall notice list, often for reasons including images being incorrectly oriented, the systems recalling the wrong image from memory, or other general image display problems.

Add in another variable-color-and these problems have the potential to become even more complicated, FDA said, particularly given the large number of devices involved in medical imaging.

FDA noted that clinical photography, ophthalmic photography, digital microscopy, digital histopathology, endoscopy, laparoscopy, telemedicine, handheld mobile displays, display devices, and color measurement all stand to be affected by the adoption of color imaging.

Need for New Technical Framework and Guidelines

What is needed, then, is a technical framework-standards, if you will-for color management between devices along the entire imaging lifecycle (imaging, processing, storage, transfer and display).

"Due to the increasing use of color images and the need for integrated electronic health records, this issue is of current relevance for device manufacturers, users, and regulators. In addition, topics might include color methods for handheld display devices, system approaches for color consistency, and inter-vendor interoperability," FDA explained.

FDA added that the workshop might consider recommending the creation of a "technical special interest group," potentially under the auspices of the ICC, to establish best-practice guidelines for the industry.

The 8-9 May 2013 workshop will include seven sessions:

  1. general landscape of color use in medical imaging
  2. whole-slide imagers and digital microscopy/histopathology
  3. endoscopy and laparoscopy
  4. other medical imaging modalities
  5. standards and professional organization
  6. recommendations
  7. color in telemedicine
  8. color in mobile displays

Regulatory Focus newsletters

All the biggest regulatory news and happenings.