A standardization strategy for facilitating the worldwide deployment of innovative medical technologies to enhance public health and foster international trade was the successful output of the World Standards Cooperation (WSC) workshop bringing together some 130 experts representing the major players in this sector.
"Over the past two days we have witnessed major global actors in the field of medical technologies demonstrate their willingness to contribute and collaborate on the development of standards for this sector," said ISO Secretary-General Alan Bryden in his closing remarks. "Participants cited numerous success stories of how International Standards help contribute to the efficiency and dissemination of medical technologies. More importantly, however, we reached consensus on the need for globally relevant solutions for this innovate rapidly changing sector."
The workshop, which took place in Geneva, Switzerland on 26 and 27 February, was organized by WSC (World Standards Cooperation), the coordination entity between IEC (International Electrotechnical Commission), ISO (International Organization for Standardization), and ITU-T (International Telecommunication Union's standardization sector). It was held under the patronage of the WHO (World Health Organization) and in partnership with four organizations having relevant interests in the medical technologies sector: GHTF (the Global Harmonization Task Force), AAMI (Association for the Advancement of Medical Instrumentation) Eucomed (The European Medical Technology Industry Association), JFMDA (the Japan Federation of Medical Devices Associations).
President of IEC, Mr. Sei-ichi Takayanagi (left), Director of ITU-T (centre), Mr. Houlin Zhao and ISO Vice-President (policy) Dr. Torsten Bahke (right) at the opening of the WSC high-level workshop at the World Health Organization in Geneva
In the opening address, Mr. Houlin Zhao, Director of ITU-T, welcomed participants and commented on the importance of having a workshop at a time when the medical community becomes increasingly reliant on new and converging technologies. Mr. Zhao pointed out the importance of international standardization for the evolving world market that will lead to a harmonized system capable of supporting worldwide free trade in optimal and equitable terms. He said, "For this reason, the three organizations are committed to promoting and harmonizing the international standardization system, strengthening cooperation among themselves and with all partners concerned. WSC is an initiative that aims to strengthen, and promote the voluntary consensus based International Standards system of ISO, IEC and ITU."
Mr. Sei-ichi Takayanagi, President of IEC said, "Individually and as a group, IEC, ISO and ITU respond to market needs and to society's needs by providing the basic standards. The WHO responds to an essential human need in finding ways to bring health to the people of the world...I believe this [workshop] is a very important and good thing to do not just because of the topic but also because it increases collaboration among the four organizations."
Dr. Torsten Bahke, ISO Vice-President (policy) further clarified the stakes: "International standards are a key element for getting access to global markets. Historically, ISO, IEC and ITU address different sectors of technologies. However, within a global market emerging technologies and innovation are going to force the organizations to adjust. The political and economic developments of the past years ask for a close cooperation which will lead to synergies in the committee work. The spirit of WSC shall serve all stakeholders worldwide - industry, the business community, governments and other international organisations, users, including consumers."
At the workshop sessions, participants exchanged experiences from their own technical committees, organizations and countries in five sessions related to: Vision, Links between Regulators and standards developers, Standards development practices, New technologies and standards and the Development dimension.
Presentations and discussion panels provided an overview of the state-of-the-art in a variety of medical technology fields, highlighting the links with standardization activities and the importance of the international standardization system for this sector.
- In this respect, participants at the workshop made a number of important recommendations, such as:
- Calling for closer cooperation between ISO, IEC, ITU-T and WHO as well as other standards developing organizations (SDOs);
- Simplifying and speeding up the standards development process;
- Ensuring standards are responsive and relevant to the current market needs;
- Relying on the use of electronic tools such as videoconferencing and e-balloting;
- Meeting the needs of all stakeholders (regulators, medical community and industry) through their involvement in the standards developing process;
- Increasing the participation of developing countries;
- Focusing on the development of horizontal standards (i.e. risk management, quality management and biological safety), and,
- Increasing transparency and mutual feedback among the parties concerned.
ISO Secretary-General Alan Bryden summed up: "We are going to pursue these directions for actions, starting with consolidating collaboration on priorities setting and relations of standards with essential health and safety principles between the WSC members, the Global Harmonization Task Force for Medical Devices and the World Health Organization. We will present and increase the visibility of our achievements and programmes, as well as enable the optimal and effective use of the system to the worldwide community of stakeholders. In addition to the existing collaboration between IEC, ISO and ITU-T, we will expand partnerships with other standards developing organizations (SDOs) in order to improve coordination and avoid duplication of the work that already exists. Finally, we will highlight and promote the complementarities between regulations and standards, as well as encourage the participation of all stakeholders having relevant interests in the medical technologies sector."