This piece was originally published in the October 2018 issue of electroindustry.
Lisa Spellman, AStd, DICOM General Secretary, MITA
Digital Imaging and Communications in Medicine (DICOM®) standardizes the communication of medical imaging information. First published in the 1980s, it is maintained by a collaborative committee of industry and medical professional societies. DICOM maintains active liaisons with several standards developing organizations.
Even though DICOM has been deployed globally, it is a consensus Standard that is largely voluntarily adopted based on its utility and not as a result of a legal or regulatory mandate. In the United States, DICOM is recognized by the Food and Drug Administration (FDA) as a consensus Standard. It is similarly recognized in most European Union nations and Japan.
Adoption of voluntary consensus Standards is a smart move for vendors and end users. Vendors can decrease R&D time, allowing resources to be directed toward innovations and market completion features. The adoption of medical device products can streamline premarket review, provide clearer regulatory expectations, and facilitate market entry.
According to the FDA, “Consensus standards provide a consensus approach to certain aspects of the evaluation of device safety and effectiveness, such as testing methods, pass/fail performance criteria, and processes to address areas, such as risk management and usability. The use of consensus standards can also promote international harmonization.”
For clinical end users, requesting a voluntary consensus Standard such as DICOM in RFPs helps to promote interoperability between clinical systems.
To learn more, visit www.dicomstandard.org.