The Italian Court of Cassation, with sentence no. 2149 of 3.11.2021 (filed on 19.01.2022), confirmed the conviction of a manufacturer of medical devices for the personal injuries that a clamp had caused to the patient shattering during a surgery.
In this judgment, the Court clarified the various obligations of the manufacturer, specifying that “the devices must be designed and manufactured in such a way that their use does not compromise the clinical status and safety of patients, nor the safety and health of users and eventually of third parties when they are used under the conditions and for the intended purposes (…) “.
It also specified that, in order to guarantee the safety of the products, the manufacturer must adopt solutions that take into account technological progress, eliminating or reducing risks as far as possible.
And precisely this last aspect had led to the manufacturer’s condemnation on appeal, as the expert in charge at first instance had found that the crushing of the clamp had been caused by an impurity of the material that could have been detected through special checks (radiographic or wave sound).
The Italian Court of Cassation confirmed the conviction of the manufacturer, responsible for the structural defects presented by medical devices likely to cause damage during use, even after years and after various uses.
