BRUSSELS, BELGIUM, 9 December 2019 – DITTA, The Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association, welcomes the publication of the international standard IEC 63077 Good refurbishment practices for medical imaging equipment.
IEC 63077 describes and defines the process of refurbishment of used medical imaging equipment and applies to the restoring of used medical imaging equipment to a condition of safety and performance comparable to that of new medical imaging equipment.
Refurbishment extends the life of medical imaging equipment, saves resources and energy, contributes to tackling climate change and to further developing the circular economy.
DITTA Chair Nicole Denjoy says, “The publication of IEC 63077 is the result of more than a decade of dedicated work by DITTA members. This international standard is built on best practices gained from industry experience about refurbishment of medical imaging equipment. IEC 63077 ensures that refurbishment results in equipment meeting the original intended use, performance and safety specifications as defined by the equipment manufacturer.”
By having collected the best practices from across industry and regulatory agencies and documenting the state-of-the-art processes, this standard ensures that all entities adopting it meet these appropriate levels of controls to ensure safety and performance which are the most important aspects to consider for refurbished and new medical imaging equipment.
This standard represents a turning point. From now on, manufacturers can get certified according to an international refurbishment standard. And regulators, authorities and healthcare providers can easily assess the quality and safety of refurbished medical imaging equipment.
DITTA is confident that barriers raised by certain countries to restrict the import, distribution and use of refurbished medical equipment can be reconsidered now, as IEC 63077 allows to distinguish between equipment which has been refurbished in the context of a quality management system and used equipment which is either not refurbished at all or not according to a standardised approach.
Refurbishment of medical imaging equipment accounted for global revenue of approximately 980 million US Dollar in 2017. Approximately 70% of all refurbished medical imaging equipment is sold in the U.S. (46%) and the European Union (24%).
By removing restrictions on the import, distribution and use of medical imaging equipment which is refurbished according to international standards such as IEC 63077, DITTA expects several positive developments: an increase in a Circular Economy business that accounted for approximately 980 million US dollar revenue in 2017, increased access for patients to affordable healthcare and a positive contribution to the environment as it reduces waste generation and saves energy, resources, and raw materials.
DITTA and its associated companies are looking forward to seeing IEC 63077 recognised by regulators and authorities on national, European and global level and are further dedicated to promote the use and market access of medical imaging equipment refurbished according to IEC 63077 as well as to emphasize on the importance to harmonise the refurbishment practices globally.
More information about “Good refurbishment of medical imaging equipment can be found on DITTA website following this link: https://www.globalditta.org/activities/good-refurbishment-practice.html
IEC 63077 is available for purchase at IEC’s website following this link: https://webstore.iec.ch/publication/61821&preview