Drs. Parwani, Hassell, Glassy and Pantanowitz have an excellent editorial entitled “Regulatory barriers surrounding the use of whole slide imaging in the United States of America” in the most recent edition of the Journal of Pathology Informatics (J Pathol Inform 2014;5:38). I think their summary below sums up very nicely the time for FDA to act is now. The past nearly decade and a half has left pathologists and patients in murky waters regarding the safe, appropriate use of this technology which we as practioners and manufacturers alike have strived for patient safety first and foremost.
I have not had a lot of faith in this process going back 5 years (see: Minnesota is in the middle – Part 2).
The question that no one seems to asking is not what is the risk of using the technology, but what are the risks in not using the technology for patient care?
The authors state:
“All of this is relevant to whole slide imaging because it is clear that the FDA does not have the authority to regulate laboratories. However, it appears that they are attempting to do so through regulating WSI manufacturers, creating a long and bumpy road ahead for labs who would like to use WSI for clinical diagnostic work. Even though laboratories are not regulated by the FDA, they must abide by other governing regulatory bodies such as CLIA and the College of American Pathologists (CAP) accreditation programs, not to mention the individual medical licensing of the physician. As such, although the FDA’s decision to regulate WSI as a class III device will certainly impact the ability of manufacturers to ‘market’ their WSI systems, this should not and does not impact a laboratory’s ability to use these devices according to its own medical and professional obligations.
In summary, it is clear that WSI is a key enabler of improved patient care and provides pathologists with the ability to share cases with experts. These WSI devices are reliable, provide portability, ease of sharing, and retrieval of archival digital images. Even more powerful is the ability to couple these images with computer-aided image analysis tools. WSI has proven benefits for remote consultation, as it is easier to move an image than it is to move a pathologist or patients’ glass slides. While pathologists in other countries have already received approval to use WSI for routine diagnostic use, regulatory barriers in the United States of America are preventing patients from reaping similar benefits from this promising and ground-breaking technology. There is an immediate need to overcome regulatory barriers and guide WSI device manufacturers, allowing pathologists to be equipped to utilize WSI and further develop this technology. Some specific actions by the FDA may be to reconsider the class III designation and/or issue reasoned and reachable guidance to the vendors as to the kind of studies that are needed to meet the requirements for approval. The authors of this editorial call for urgent resolution and clarification to the murky regulations currently hampering WSI before the digital pathology candle burns out.”
Anil V Parwani1, Lewis Hassell2, Eric Glassy3, Liron Pantanowitz1
1 Department of Pathology, Division of Pathology Informatics, UPMC Shadyside Hospital, Pittsburgh, PA 15232, USA
2 Department of Pathology, University of Oklahama, Oklahoma City, OK, USA
3 Affliated Pathologists Medical Group, Torrance, CA, USA
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