February 12, 2019
ROSSLYN, Va.—The National Electrical Manufacturers Association (NEMA) published NEMA/MITA RMD P1-2019 Considerations for Remanufacturing of Medical Imaging Devices. This new white paper outlines a framework for establishing the distinction between servicing and remanufacturing activities for medical imaging devices. Further, this white paper recommends that organizations adopt appropriate quality management systems to define the nature and scope of the activities they are undertaking to ensure servicing and remanufacturing activities are properly performed, documented, and regulated.
"We hope this white paper will serve as a resource for the U.S. Food and Drug Administration and the broader stakeholder community as it moves forward with future guidance on this issue," said Dennis Durmis, Chair of MITA's Board of Directors. "It is important that a sound process and clear definitions are in place to ensure that servicing activities are clearly distinguished from remanufacturing and all stakeholders understand the differences."
This white paper is useful for hospitals, physicians, medical imaging device manufacturers, and medical imaging device servicers.
NEMA/MITA RMD P1-2019 is available as an electronic download at no cost on the NEMA website.