Trials are needed before new devices are used in routine practice

This blog has highlighted the blindness of professionals and the hypocrisy of regulators in imposing the expensive treatment of ISO accreditation on healthcare without evidence of any efficacy, effectiveness or value.

An analysis published by the BMJ makes interesting reading regarding the lack of trials before medical devices may be used in the EU.  The same trans-national government imposes untested ISO accreditation on its Official Control Laboratories and others.

Trials are needed before new devices are used in routine practice in Europe

Philipp Storz-Pfennig, Mechtild Schmedders, Matthias Dettloff.

BMJ 2013; 346 doi: (Published 18 March 2013). Cite this as: BMJ 2013;346:f1646.

As the EU debates new legislation to regulate medical devices, Philipp Storz-Pfennig, Mechtild Schmedders, and Matthias Dettloff provide examples from Germany to show why the current proposals do not go far enough and call for further assessment after market approval…

Key messages
New medical devices are approved for EU use without evidence of safety and efficacy

In Germany no further assessment is required before devices can be used in hospitals

Examples show that the disproportionate use of new technologies may have harmed patients

If devices are approved without sufficient evidence of safety and efficacy their use should be restricted until evidence from further research studies has been collected.

For what reason should accreditation bodies be exempted from these proposals?

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