The Medical Imaging & Technology Alliance (MITA) has announced the publication of a revised white paper, titled “Considerations for Remanufacturing of Medical Imaging Devices.” The paper, updated from an earlier version released in February, calls on the U.S. FDA to clarify the distinction between servicing and remanufacturing and offers detailed descriptions of the types of activities that would constitute either.
The white paper also recommends that organizations adopt appropriate quality management systems to define the nature and scope of the activities they are undertaking in order to ensure servicing and remanufacturing activities are properly performed, documented, and regulated.
“By updating this white paper, we hope to create a resource for involved parties to ensure that third-party device servicing activities are done in a manner that protects patient health and safety and are clearly distinguished from remanufacturing,” says Dennis Durmis, head of Americas region, Bayer Healthcare and chair of the MITA Board of Directors.
The updated white paper released includes additional examples of remanufacturing and highlights resources available to entities engaged in medical imaging device servicing activities, according to MITA officials. The inventory of resources reflects the MITA perspective on best practices and includes citations of the relevant FDA regulations and guidance documents concerning device servicing and remanufacturing as well as a reference list for international and NEMA/MITA Standards on the subject, officials for the association add.
“As the FDA moves forward with future guidance on third-party device servicing, we look forward to working with the agency and the broader stakeholder community to improve the current remanufacturing regulatory framework,” Durmis concludes.
What are your thoughts on this potentially divisive white paper? Share them in the comments section.
