Washington, DC, September 25, 2019 --(PR.com
)-- The Medical Imaging & Technology Alliance (MITA) today 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 2019, calls on the U.S. Food and Drug Administration (FDA) to clarify the distinction between servicing and remanufacturing and offers detailed descriptions of the types of activities that would constitute either. It 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,” said Dennis Durmis, Head of Americas Region, Bayer Healthcare and Chair of the MITA Board of Directors.
The updated white paper released today includes additional examples of remanufacturing and highlights resources available to entities engaged in medical imaging device servicing activities. 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.
Third-party medical device servicers are not currently regulated by the FDA, and no mandated controls are in place to determine if their servicing activities constitute remanufacturing. While the FDA does regulate remanufacturing activities, it has few safeguards in place to ensure that servicing activities do not cross over to become uncontrolled and unregulated remanufacturing. This lack of oversight poses an increased risk to public health and the safety of patients and device users.
“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.
To view the updated white paper, click here
The Medical Imaging & Technology Alliance (MITA), a division of NEMA, is the collective voice of medical imaging equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for advanced medical imaging technology. For more information, visit www.medicalimaging.org. Follow MITA on Twitter @MITAToday.