The Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) has issued an endorsement of the NEMA/MITA 1-2015 Good Refurbishment Practices for Medical Imaging Equipment.

The association stated that the standard builds on years of work by DITTA members and lays out quality management and process requirements for refurbishing of medical imaging equipment.

The standard — which MITA, a division of NEMA, adapted from the European Coordination Committee of the Radiological, Electromedical, and Healthcare IT Industry (COCIR) Medical Electrical Equipment: Good Refurbishment Practices (GRP) and published in February — is intended as a reference guide for regulators, customers, refurbishers and manufacturers.
“This standard is built on best practices gained from industry experience for refurbishment performed over decades. It ensures that refurbishment results in equipment meeting the intended use, performance and safety specifications as defined by the original manufacturer, and will lead to improved patient access to advanced health care,” said Satoshi Kimura, DITTA chair, in a statement.

The FDA has also shown a renewed interest in the refurbished medical market through a docket it opened last month entitled Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers in order to establish new and clearer definitions of refurbishment terms and the challenges associated with these devices.

"Refurbished systems are an effective way for health care providers to upgrade their equipment while maintaining quality and being budget-conscious," said MITA Executive Director Patrick Hope, in a statement. "Understandably, regulators and customers need to be certain that all refurbished equipment is high-quality, safe, and effective. This standard outlines industry best practices that, if followed, will result in refurbished equipment that is just as safe and effective as brand new."

NEMA/MITA 1-2015 is free to download on the NEMA website. And the FDA docket is open for public comment until May 3.

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