[Safety monitoring of disposable medical products].
In 1988 medical devices have become a part of the German AMG. According to this law safety monitoring similar to the one with drugs should be introduced. In the United States the so called medical device report regulation is responsible for safety monitoring. They have demonstrated that the risks of these instrument cannot be neglected. Therefore medical organisations or technical supervising institutions in Germany should take care of safety monitoring with medical devices, because otherwise supranational organisations, which are already present in different countries, or European community authorities will become responsible after the introduction of the free European market in 1992.
Müller
H
H
Klinik für Anaesth. und Intensivmedizin Städt. Krankenhaus Kemperhof, Koblenz.
D002408:Catheters, Indwelling; D004209:Disposable Equipment; D004869:Equipment Safety; D006801:Humans; D013677:Medical Laboratory Science / Q000295:instrumentation*; D013594:Syringes
Sicherheitsmonitoring für medizinische Einmalartikel.