The Medical Imaging & Technology Alliance (MITA) has released a new whitepaper outlining key considerations for servicers and remanufacturers of medical imaging equipment.
The revised paper, “Considerations for Remanufacturing of Medical Imaging Devices” is updated from a version released in February and, again, requests that the FDA clarify the distinction between servicing and remanufacturing. It also offers descriptions to differentiate the two, along with additional resources and best practices for medical imaging device servicers.
“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,” said Dennis Durmis, chair of the MITA Board of Directors and head of Americas Region, Bayer Healthcare, in a statement.
Currently, the FDA does not regulate third-party device servicers, and, as the statement points out, there are no mandated controls to distinguish servicing from remanufacturing. The FDA does, however, regulate remanufacturing, but has no safeguards to avoid uncontrolled and unregulated remanufacturing. According to MITA, this is a risk to the safety of patients and those who use medical imaging devices.
“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 concluded.
The full white paper is available for free here.