About the DITTA GRP working group
The DITTA Good Refurbishment Practice (GRP) Working Group (WG) is existing since February 2012. The objective of this WG is to promote medical imaging equipment refurbished by Original Equipment Manufacturers (OEM), enabling market access where refurbished medical equipment is not used or banned by law to be imported and sold. Activities are focusing on the promotion of the concept of GRP and the international standard IEC 63077 “Good refurbishment practice of medical imaging equipment”. Since 2017 the DITTA GRP WG is coordinated by the JIRA office.
Refurbishment of medical imaging equipment
Refurbishment of medical imaging equipment is an established practice in the medical imaging equipment industry and has been for more than two decades. It is applied to medical imaging equipment for professional use in all healthcare segments, including Magnetic Resonance, Computed Tomography, Molecular Imaging, X-ray Products and Ultrasound. This imaging equipment is required for diagnostic imaging and image guided therapy in clinics as well as medical centers, and are used, for example, for mammography screening, diagnostic and interventional radiology, neuroradiology, cardiology, and surgery.
From “Good Refurbishment practices” to IEC 63077
IEC 63077 ED1 Good refurbishment practice of 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 without significantly changing the equipment’s performance, safety specification and/or intended use as in its original registration.
IEC 63077 ED1 has been published by the International Electrotechnical Commission in November 2019. The standardization document is available for purchase via the IEC website. (Link to IEC website)
Benefits of refurbished medical imaging equipment
Refurbishment of medical imaging equipment has benefits for the environment, the economy as well as patients, hospitals and society.
DITTA (2019) Refurbished Medical Imaging Devices. Dossier for the for the Government of the Socialist Republic of Vietnam
This dossier on “Refurbished Medical Imaging Devices” has been prepared on the occasion of a roundtable discussion on “Good Refurbishment Practice & Import of Refurbished Medical Imaging Devices to Vietnam” “Practice sharing on management and application of refurbished medical imaging devices
Roundtable discussion: How to enable the import and distribution of refurbished medical imaging devices to Vietnam” with DITTA in Hanoi in April 2019.
DITTA (2015) Refurbishment of medical devices: Contribution to Circular Economy
In 2015, DITTA published a brochure highlighting the contribution of refurbishment of medical imaging equipment to the circular economy and sustainability.
Presentations of the DITTA GRP working group
October 2019 / KUALA LUMPUR, MALAYSIA: Presentation at the International Medical Device Conference
November 2018 / MEXICO-CITY, MEXICO: Presentation at the Second International Week of Regulatory Science
April 2018 / SHANGHAI, CHINA: Presentation at the 4th IEC International Medical Equipment Standards Forum, Medical Device Standards in the Digitalized Era