FDA Convenes Advisory Committee to Discuss Whole Slide Imaging

The FDA's Hematology and Pathology Devices Advisory Committee will be convening today and tomorrow to discuss discuss, and make recommendations, about what they describe as "public health issues" related to the use of digital whole slide imaging (WSI) systems that are now being used to replace conventional light microscopy for diagnostic surgical pathology. The meeting will be open to the public. Within the scope of this meeting, digital pathology is defined as the conversion of images that can be observed by conventional light microscopy on histologic glass slides into digital whole slide images via digital scanners. These latter images are then viewed with a computer monitor to render pathologic diagnosis of the lesion of interest. Finally, this process involves digitally archiving and retrieving these images for access at some later time. The committee will not be discussing computer-assisted image analysis or remote real-time microscopy at this time. 

The FDA background briefing for this meeting as a PDF file and downloaded from the FDA web site makes interesting reading for those interested in digital pathology. Below is more detail extracted from this briefing paper about what the FDA hopes to achieve by this meeting. Obviously, the major thrust will be the establishment of a set of principles for evaluating the accuracy and reproducibility of pathologists using this tool including both objective and subjective perspectives.

FDA hopes to gather information about how to evaluate and compare the performance characteristics of both the light microscope‐the reference method‐‐and the digital WSI method.  As background for the panel discussions, there will be presentations to cover the principles of light microscopy and the possible criteria and studies for analyzing the accuracy and reproducibility of the diagnostic performance of pathologists using the light microscope for examination of human tissue specimens, the principles of digital WSI, and the criteria and studies for the evaluation of the diagnostic accuracy and reproducibility of pathologists using digital WI for examination of human tissue specimens.  There will be a discussion of the objective and subjective aspects of reading direct images from a microscope and from a digital screen. 

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