From the March 2019 issue of HealthCare Business News magazine
Limitations and overcoming hurdles
DP digitally copies but does not replace the glass slide. The equipment, cost, and space for instruments required to produce the glass slide are not eliminated, thus antagonizing the ROI when compared to radiology. The lack of a satisfactory pathology DICOM standard complicates the interoperability of an institution’s DP equipment, and the integration into other software such as HIS and LIS. Efforts from DICOM, the DPA (Digital Pathology Association) and other organizations should soon prove successful in eliminating this barrier.
Another barrier to adoption was the FDA’s former requirement that DP be approved as a Class III or PMA product, thus adding to the expense and difficulty of development and production costs. This clearance standard was more or less appealed to the FDA by a consortium of major manufacturers representing the DPA, and with some guidance the first of the manufacturers was able to achieve de novo clearance (which requires less manufacturer burden) for WSI (whole slide imaging) for clinical diagnosis in August of 2017. There now appears to be a short list of other manufacturers who are pursuing Class II clearance, which is the current requirement for WSI from the FDA, based on predicate devices.
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To summarize the three aforementioned hurdles, the U.S. is most impacted by the FDA and this hurdle has been more or less eliminated (the Class III requirement), with routine clinical trials remaining the only impediment for other interested manufacturers to achieve Class II clearance. Another, the lack of a DICOM standard, will be overcome through perseverance, as it has in the other major imaging disciplines. And in the meantime, with careful planning and diligence, most digital communication issues can be avoided.
The last, and perhaps the biggest obstacle, the ROI, deserves its own paragraph as it remains to be fully proven and will not manifest in the straightforward way that it did in radiology. What appear to be accepted among the vast majority of users are the following findings:
• The workflow of the department, the specimen and the pathologist can be better tracked and directed, and the elimination of paper tracking, routing and monitoring is more efficient.
• There are no longer books of slides traveling the department, as the slides can be immediately stored/archived (still an FDA requirement for 10 years after production) after they are digitally imaged. Lost and broken slides due to transport around and between offices and institutions can be eliminated.