The National Electrical Manufacturers Association (NEMA) and the Medical Imaging and Technology Alliance (MITA) are looking to set the record straight on servicing and remanufacturing activities for medical imaging devices.
The organizations have authored a new white paper intended for hospitals, physicians, medical imaging device manufacturers, and medical imaging device servicers, titled "Considerations for Remanufacturing of Medical Imaging Devices." The white paper recommends that organizations adopt quality management systems that define the nature and scope of those functions to ensure that service and remanufacturing 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, in a statement. "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."