Four top organizations in Geneva unite for world health

When standards development organizations (SDOs) prepare their publications, they need to ensure that they meet stakeholders’ needs, that stakeholders be involved, that they respond to innovation in fast-moving technologies, and that they find a way to helping to reduce the “health divide” between industrialized countries and industrializing ones. These were the main conclusions from the “World Standardization Cooperation’s High-Level Workshop on International Standards for Medical Technologies” hosted in Geneva, Switzerland, by the World Health Organization on 26 and 27 February. The workshop addressed the intersection where standards and health meet and brought together the world’s top three organizations devoted to preparing international standards.

IEC President Sei-ichi Takayanagi, speaking to the opening session, said, “Every single element that goes into a piece of medical equipment… every single piece of equipment that goes into a hospital or clinic… every single hospital that serves a community: ultimately, each of these are aimed at one type of individual – the patient…. So our role as standardizers is fundamental.”

The aim of the workshop was:

• to review current approaches and projects that are underway in international standardization;
• to highlight the main trends in this sector;
• to examine how to address present and future challenges; and
• to provide input on priorities, programmes and approaches for developing standards and conformity assessment efforts that respond to market and society needs.

While the end goal of medicine is to ensure the health of the patient, the road leading to this runs in part via the equipment that is used to examine, diagnose and treat. This equipment is built to standards for safety and performance and these standards come from the IEC, ISO, the International Organization for Standardization, and the International Telecommunication Union (ITU).

Because of the increasing complexity of medical equipment and systems, the three standards organizations recognize the need to co-ordinate their efforts in this field. The WHO workshop provided a forum to begin to explore how this co-ordination could best take place.

About 130 people from around the world attended the event, which consisted of six sessions covering:

• overall vision (main emerging needs and challenges to be addressed);
• links between regulators and standards developers;
• standards development practices;
• new technologies and standards;
• development dimension (issues related to industrializing countries); and
• wrap-up (summary of each session: issues and proposed action plan).

In concluding remarks, ISO Secretary-General Alan Bryden pointed to five lines of action that he said need to be pursued:

• sharing priorities and essential principles by the Global Harmonization Task Force, the World Health Organization and the World Standardization Co-operation (WSC);
• the achievements and programmes of the WSC presented in a very visible way so as to enable the best and most effective use of its standardization system;
• increased collaboration by the WSC and other SDOs;
• explanation and promotion of the complementarity between regulators and standardizers;
• encouraging participation by all players.

The workshop was hosted by the World Health Organization (WHO) in partnership with four organizations having relevant interests in the medical technologies field: the Global Harmonization Task Force; the Association for the Advancement of Medical Instrumentation; the European Medical Technology Industry Association; and Japan Federation of Medical Devices Associations.

WSC
In 2002 the IEC, ISO and the ITU created the World Standardization Cooperation to present a united front on issues common to the three organizations. The WHO workshop offers the second real test of the WSC’s effectiveness (the first involved the WSIS declaration in December 2003).