Good refurbishment practice

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.

  • Chair: Mr Michael Schmit, GE Healthcare
  • Vice Chair: Ms Patricia Gehrlein, Siemens Healthineers
  • Secretary: Mr Susumu Uchiyama, JIRA


Mission

  • Build awareness and knowledge of the Good Refurbishment Practice and the international standard IEC 63077 amongst relevant stakeholders globally
  • Remove market barriers for medical imaging equipment that are refurbished according to IEC 63077
  • Drive for global harmonization of terminology and requirements


Goals

  • DITTA promotes the use of and market access for refurbished medical imaging equipment according to IEC 63077 and emphasizes on the importance to harmonize the refurbishment practices globally.
  • DITTA does not want refurbished medical imaging equipment which is refurbished to IEC 63077 to be considered used medical imaging equipment.
  • DITTA wants governments to distinguish between used medical equipment and refurbished medical equipment.
  • DITTA wants refurbished medical imaging equipment refurbished according to IEC 63077 allowed to be imported and distributed for diagnostic and treatment purposes.

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

  • The Good Refurbishment Practices (GRP) have been developed by DITTA and its member associations COCIR (EU), JIRA (Japan) and MITA (USA) filling a need in the global healthcare market for safe and effective refurbished medical imaging equipment
  • DITTA has triggered the idea to have an international standard on “Good Refurbishment Practices” and is further dedicated to promoting the use and market access of refurbished medical imaging equipment as well as to emphasize on the importance to harmonize the refurbishment practices globally.
  • With the support of DITTA, the US medical imaging and technology alliance MITA managed to develop and publish the NEMA/MITA 1-2015 standard on “Good refurbishment practices for medical imaging equipment” in February 2016. (Link to NEMA/MITA 1-2015)
  • DITTA (via MITA) collaborated with ANSI (American National Standards Institute) to file a request to the International Electrotechnical Commission (IEC) to publish the content of NEMA/MITA 1-2015 standard as an IEC PAS.
  • In 2016, IEC published IEC PAS 63077 on “Good refurbishment practices for medical imaging equipment” – content wise identical to NEMA/MITA 1-2015.
  • In 2018 and 2019, IEC SC62B WG53 has been finalizing the standard by developing it from a Publicly Available Specification (PAS) to an international standard 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.

  1. Environment: Refurbishment in the medical imaging equipment industry also makes a positive contribution to the environment as it reduces waste generation and saves energy, resources, and raw materials. It is therefore considered a “Circular Economy” business. DITTA estimates that around 30 MWh can be saved for each ton of refurbished medical imaging equipment. In the context of waste prevention, DITTA estimates that in 2012 around 16,400 tons of used medical equipment were prevented from becoming waste; instead they were considered for refurbishment and repair. In addition, refurbishment of medical imaging equipment saves resources and ensures their supply, including scarce raw materials that are needed for the manufacturing of some unique properties of medical equipment. 
  2. Economy: Refurbishment of medical imaging equipment is an established practice in the medical imaging equipment industry since more than two decades: it accounted for global revenue of approximately 980 million US Dollar in 2017. Approximately 70% of all refurbished medical imaging equipment are sold in the U.S. (46%) and the European Union (24%).
  3. Patients, hospitals and society: Refurbished medical imaging equipment makes a positive contribution to increased access to affordable and high-quality healthcare as they can be offered at a lower price than the comparable new ones. In current times of constrained budgets, refurbished medical imaging equipment helps hospitals and medical centers with budget restrictions to purchase high-quality equipment and replace their used equipment. The cost savings in comparison to a new medical imaging equipment vary depending on the product and its configurability, the refurbisher and the country. By replacing used, outdated equipment with refurbished medical imaging equipment, the overall quality of healthcare for patients can be improved, e.g. by providing better diagnosis, which allows for better therapy and increasing chance of survival.


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.

The brochure is available for download in EnglishSpanishChineseJapanese and French.

Presentations of the DITTA GRP working group
October 2019 / KUALA LUMPUR, MALAYSIA: Presentation at the International Medical Device Conference

  • Title of the presentation: IEC PAS 63077 "Good Refurbishment Practice of Medical Imaging Equipment" & Regulations for refurbished medical devices in the USA, EU, Japan and ASEAN countries
  • Presenter: Patricia Gehrlein

November 2018 / MEXICO-CITY, MEXICO: Presentation at the Second International Week of Regulatory Science

  • Title of the presentation: IEC PAS 63077: Good Refurbishment Practices for Medical Imaging Equipment
  • Presenter: Patricia Gehrlein

April 2018 / SHANGHAI, CHINA: Presentation at the 4th IEC International Medical Equipment Standards Forum, Medical Device Standards in the Digitalized Era

  • Title of the presentation: “Good refurbishment practices of medical imaging equipment: past developments, status quo and way forward to an international standard”
  • Presenter: Patricia Gehrlein