Tubes, pumps and cannulas: For a long time, the test rules for medical devices were comparatively lax.
Bild: Picture Alliance
After numerous scandals about medical devices, the EU sets stricter standards. Doctors and clinics warn. You see innovation and supply in danger, others sentiment.
SThey measure vital signs, enable difficult operations, ensure a tolerable everyday life or survival: medical products such as ventilators, stents, surgical instruments or nursing beds and plasters. Indispensable devices, then, and yet there were always scandals – about cable breaks and electric shocks in implanted defibrillators, tissue damage due to metal abrasion from prostheses or stents, after the use of which more strokes occurred. French manufacturer PIP has even criminally used inferior industrial silicone in tens of thousands of breast implants, possibly with fatal consequences for some women.
Previous EU rules were quite lax. The necessary CE markings are not issued by authorities, but by notified bodies: companies that are accredited for this. But they sometimes worked sloppy, journalists from the British Medical Journal received positive feedback on problematic documents for invented products. One reason: the test centers did not have to employ medical experts, and they are interested in orders. They also did not have to inspect the production unannounced.