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.
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
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.
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
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.
GHTH conference will be held in September, 2007 in
Washington DC, USA.
Download 5-page summary of the Lübeck meeting from the GHTF website: