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

"Technology for Life" is the guiding principle that unites them. The goal, Stefan Drger 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 Drger 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 Lbeck meeting from the GHTF website: www.ghtf.org/sg4/inventorysg4/sg4-n76.pdf

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