European medical devices Journal

Information Literacy Weblog: March 2012

If you read the review of the Federal Ministry of Health for the reprocessing of medical devices (see elsewhere in this issue of the MPJ), you might be satisfied in principle with the safety of medical devices. Or is this just a deceptive calm. That was close! What was the nature of the drug Thalidomide and the foods of rotten meat scandal, there has not been the medical products sector. As long as no scandal, as long as no public outcry, as long as no strong commercial pressure. One could from the mistakes of others (areas) learn and prevent. Prevention is better than cure. Or wait in the medical field to a "rotten meat scandal"? The article in the magazine "Der Spiegel" of 5 Mai 2008 (19/2008) "Dangerous Schnarchnasigkeit" should build up enough pressure. If you technically can also expose some of the articles, so hopefully he will fulfill the purpose that now represent the public, politicians and other players in this area more in their focus and act. So far, the nature of many drug makers and opinion-dominated consciousness in the political sphere. One can have the impression that the medical nature is subordinated to the drug being in many cases. Thank the magazine "Der Spiegel" - for waking, less for many statements that do not stand up to a professional suspension but this drink with law. The European Commission adopted on 8 May 2008 consultation called to determine in conjunction with the applicable European medical device legislation deficits to seek solutions and take action. Here the critics who have reported in this mirror post to word, the opportunity to make constructive proposals. But before you return before your own door.

In principle, the mirror article on problem areas, towards real and potential weaknesses of the medical system. Despite the obvious to a person skilled shortcomings of the report he also has a good, it also leads to the questions and problems that exist in Germany with regard to understanding and processes in the field of medical devices. There are shortcomings, as well as in other areas. But it lacks many players on the knowledge of the content and the structure of the European and German Medical Devices, Instruments and its application, the differences for drug law and the will or the ability to accept the Europeanization of the medical system. This reflects a certain aversion to the EU with many. The Spiegel article criticizes in particular the Federal Institute for Drugs (BfArM) for its failure regarding the safety of medical devices and the associated risk management. Experts (see the editorial in this issue of the MPJ) are cited. The blame is shifted from one location to another, with certain places are not mentioned, although it would have to be involved with what some is not aware. But also highlights the contribution that the medical devices sector is equivalent to the area of ​​pharmaceuticals in its relevance. The article gives a good description of status quo and an opportunity to respond to these deficits.


The German Medical Products Law is based on European law. This law was discussed in the EU, involving all stakeholders and political institutions. Germany is (founding) member of the EU. The federal government has agreed to the EC directives. The German Bundestag and the Bundesrat, thus the authorities responsible for monitoring federal states, the Medical Products Law (law and regulations) given legal force. They have therefore the responsibility and duties in connection with the implementation and application of European law over with. This responsibility is towards the German people and the German institutions as well as to the residents of the other Contracting States of the European Economic Area. There are instruments for application and correction of this right. The affected districts and sites should know this and be able to apply. It is also possible to inform the EU Commission to defects decision to provide materials and make suggestions for improvement. The European Commission has called for a consultation and published to a questionnaire. Deadline is the 2nd July 2008 (see elsewhere in this issue of the MPJ)., The results of the EU Commission will publish on its website, unless the sender does not prohibit this

2005-04-04 22:03:48 by -

Not a lap band survivor here, but

It still has a lot of dangers and complications. Here's an online article (5 years old):
FDA panel refuses to endorse obesity 'Lap-Band'
The Lap-Band device
June 19, 2000
Web posted at: 8:45 PM EDT (0045 GMT)
WASHINGTON (CNN) -- A government advisory committee refused to give its seal of approval Monday to a weight-control device that's been used in Europe for seven years - - but has run into medical difficulties during its U.S. trials.
By a 6-4 vote, the Food and Drug Administration advisory committee concluded there was insufficient data to determine whether the device, called Lap-Band, was safe and effective

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The medical devices vigilance system: European Commission guidelines
Book (Department of Health)

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