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Hoe voorkom je dat medische hulpmiddelen een gezondheidsrisico vormen (en)

Met dank overgenomen van Europees Parlement (EP), gepubliceerd op maandag 21 oktober 2013.

Medical devices are in need of a health check following recent scandals with breast and hip implants across Europe. New rules requiring stricter safety checks are to be voted on by MEPs on Tuesday 22 October during this week's plenary. MEPs also called for stricter rules on informed consent on DNA testing.

This article was originally published on 26 September and has been republished because of the plenary vote on Tuesday 22 October.

Need to change the system

The proposal aims to give member states more control over the organisations that check the medical devices before they are allowed on the market. "Patient safety will be substantially improved in Europe," said Dagmar Roth-Behrendt, who wrote the draft resolution on medical devices. "In the recent past, too many dangerous medical devices such as hip implants have been introduced into the bodies of thousands of patients in Europe. We dramatically needed to change the system."

The German member of the S&D group added that they had also introduced the possibility of a review of clinical data by medical specialists, for example when there had been a series on incidents with medical devices.

Stricter rules for DNA testing

A separate proposal dealt with improving the safety of in-vitro diagnostic medical devices, which are used for diagnostics outside the human body. They include tests for blood sugar levels, pregnancy, HIV or DNA, used in laboratories or self-tests, bought over the counter or online.

The public health committee insisted on stricter rules for informed consent and genetic counselling. Peter Liese, who wrote the draft report on in-vitro diagnostic medical devices, said: “Genetic tests should only be done after appropriate information has been given as they might have dramatic consequences for insurances, for employees, or psychological risks. To get this information you need to reflect first."

Committee members also called for all clinical studies to be checked by an ethics committee, an independent body made up of healthcare professionals as well as laypeople.

REF. : 20130923STO20631

Updated: ( 21-10-2013 - 11:57)

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