DITTA, The Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association, is expressing support for a recent industry standard on refurbishment of medical imaging equipment it says will increase patients’ access to healthcare and contribute to the circular economy.
Published in February 2016 by the Medical Imaging & Technology Alliance (MITA), a division of National Electrical Manufacturers Association (NEMA), standard NEMA/MITA 1-2015 Good Refurbishment Practices for Medical Imaging Equipment outlines basic requirements for a refurbishment process for medical electrical equipment that will not change the equipment’s original intended use, safety profile, or performance.
“Refurbished systems are an effective way for healthcare providers to upgrade their equipment while maintaining quality and being budget-conscious,” MITA Executive Director Patrick Hope said when the standard was first issued. “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.”
The document includes terms and definitions to establish common understanding, as well as general and specific requirements concerning the refurbishment process and guidelines on topics such as risk-based selection of equipment, hardware and software safety updates, and record keeping, among others. Refurbishment is necessary to address “the high demand for affordable and reliable products” by both small regional hospitals and leading medical institutions, the document says, and such criteria will ensure such equipment’s safety and effectiveness.
“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 healthcare,” says DITTA Chair Satoshi Kimura.
NEMA/MITA 1-2015 is available for free download from the NEMA website.