Global harmonization of regulations for medical devices

26 July 2006

Lübeck, Germany. The 10th annual GHTF (Global Harmonization Task Force1 ) Conference was held in Lübeck from June 28–30, attended by over 400 participants from 33 countries.

Under the motto "Design for Patient Safety in a Global Regulatory Model", representatives from government, regulatory agencies, industry, and users met in panels, workshops and plenary sessions to discuss the next steps towards globally harmonized regulatory requirements for medical devices.

The event was organized by the European Commission in Brussels, which currently chairs the GHTF. EUROM, the European Federation of Precision Mechanics and Optical Industries, hosted the event with the medical technology industry. Dräger Medical was the cooperation partner.

In her opening speech, Georgette Lalis, current chair of the GHTF,
Director of the European Commission, Directorate F — Consumer Goods, Brussels, Belgium, briefly introduced the global regulatory model that is made up of GHTF guidelines. These guidelines outline requirements that must be met both before (premarket) and after a medical product is put on the market. Another main focus is the establishment of quality systems for medical device manufacturers, regulatory auditing, and verification criteria for the clinical claims for medical devices.

In his videotaped message, Günter Verheugen, Vice President of the
European Commission, underscored the special economic importance of medical technology and the need for worldwide harmonization of approval regulations. The idea of being able to introduce products all over the world as soon as they have been tested once, stated Verheugen, connects the GHTF not only to the guiding principles of the European Union, but also to the Hanseatic League, whose special significance for the hosting city of Lübeck, was well known.

Dietrich Austermann, Minister of Science, Economics, and Transportation from Schleswig-Holstein, Germany, also discussed this regional and historical relationship. He emphasized the economic importance of medical technology for the entire region and thanked the participants for making it possible to hold the international conference in Lübeck.

In his opening speech, Dr. Jeffrey B. Cooper, Director, Biomedical
Engineering, Department of Biomedical Engineering, Massachusetts
General Hospital, Boston, USA, noted that patient safety must always be at the forefront in the use of medical devices.

Cooper remarked that although there may be differences of opinion on individual topics, the shared vision was to improve patient safety with the help of globally uniform regulations for the approval of medical devices and corresponding standards. In times when the use of information technology (IT) is becoming more prevalent in hospitals, the windows for errors widen, and present challenges for aiming at safe, secure technology so patients come to no harm.

Cooper outlined the demands that in the future would implement methods to detect medical device defects prior to clinical use. In his opinion, simulations and tests under extreme conditions could be helpful when testing.

Stefan Dräger, CEO of Drägerwerk AG, characterized standardization as an ethical imperative, because it helps all countries to use dwindling healthcare resources more wisely. Dräger pointed out that countries aligning themselves with these global standards would have to manage higher costs. The GHTF and Dräger share the same vision.

"Technology for Life" is the guiding principle that unites them. The goal, Stefan Dräger said, was to contribute to the improvement of quality of life while achieving economic sustainability, for the benefit of individuals and the society in which we live.

In a panel discussion entitled "GHTF quo vadis?", Dr Wolfgang Reim, President & CEO of Dräger Medical AG & Co. KG, addressed three issues to be considered. First, whatever the countries agree upon must also be implemented in those countries. As an example, he cited STED (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices), which governs the globally uniform approval of medical devices. If this model were actually put into "business operation", innovations could probably benefit patients more quickly. Secondly, stronger efforts must be made to include countries such as China, Russia, India, Mexico, and others in the harmonization work. Reim described the most challenging aspect of the future as being the regulated marriage between IT and medical technology that will speed medical innovations to the market and help more patients.

The 11th GHTH conference will be held in September, 2007 in
Washington DC, USA.

Further information

GHTF website: www.ghtf.org/

Download 5-page summary of the Lübeck meeting from the GHTF website: www.ghtf.org/sg4/inventorysg4/sg4-n76.pdf


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