At this year's SIIM annual meeting, Cristine Kao spoke to visitors to Carestream's booth about the need for FDA Clearance for enterprise image viewers. This clearance validates that data integrity is maintained when radiographic images, charts and other data is displayed on specific mobile devices.
Hospitals have been implementing viewers that do not have FDA approval - and this means the image may not be accurately represented and can become a liability issue. DOTmed News reached out to Christine for some additional insight into the problem.
DOTmed News: At SIIM Carestream discussed the need for "FDA clearance for Clinical Reading" on mobile viewers. Why is the FDA clearance important and what does it mean for users?
Cristine Kao: Most PACS vendors have FDA Clearance for Clinical Reading—but it applies to images supplied by the PACS to a PACS workstation. Obtaining FDA Clearance for Clinical Reading on mobile devices involves a process in which the FDA evaluates the display of images on each mobile device submitted by the supplier. This clearance validates that data integrity is maintained through the use of Carestream’s Vue Motion viewer on each specific mobile device. Carestream has FDA clearance for Clinical Reading on 11 mobile devices: Apple iPad AIR, iPhone 6, iPhone 5, iPhone 4S, iPad 4, iPad 3, iPad 2, Galaxy Note 10.1, Galaxy S4, Galaxy S5, and Galaxy S III.
DOTmed News: What problems can occur if an enterprise viewer is does not have this FDA clearance?
CK: If the PACS (or image viewer) supplier does not have FDA Clearance for Clinical Reading on mobile devices, there is no guarantee that data integrity is being maintained as specialists, physicians and others use mobile devices to view images to make diagnostic and treatment decisions. Incomplete or inaccurate display of an image could create liability issues if a condition or illness was misdiagnosed and it was determined that the anatomy was not accurately represented on the mobile device.
DOTmed News: How many PACS suppliers provide FDA clearance for mobile devices?
CK: Many PACS suppliers do not have FDA Clearance for Clinical Reading for mobile image viewing. Carestream is one of the first companies to receive FDA clearance for clinical reading on mobile devices. We believe it’s essential for physicians to access diagnostic-quality images on their mobile devices if they are going to be making diagnostic and treatment decisions.
DOTmed News: What types of functionality does your mobile viewer supply?
CK: Carestream’s Vue Motion is a universal, enterprise-wide viewer that equips referring physicians with “one click” access to DICOM or non-DICOM clinical images such as videos and photos. In addition, it offers access to reports with embedded hyperlinks and bookmarks that allow quick and easy viewing of key images as well as quantitative analysis in the form of tables for vessel analysis or lesion management. Our viewer also equips physicians with access to tools such as 3D/MPR images.
