The use of medical device is constantly growing and constitutes a valid aid to ailing people because of remarkable technological advances. The regulations on their circulation in Italy and Europe are inspired by the principle of free circulaion: it is sufficient for a device to have the CE logo for it to be freely commercialized in all European countries. These regulation that favors commerce also expose the sick to the risk of harm from defective devices that have not been suitably checked prior to commercial release. this paper reports a case of a defective MitraClip Delivery System, discusses other episodes of similar device malfunctioning and analyzed the European legislation on medical devices. In the author's opinion, a careful "control" policy for devices, an adequate care in device manufacturing, an appropriate evaluation of pre-and post-marketing and suitable measures for the patient's safety are needed.
Monaldi Archives for chest disease
Vacchiano G.
2018-01-01
Abstract
The use of medical device is constantly growing and constitutes a valid aid to ailing people because of remarkable technological advances. The regulations on their circulation in Italy and Europe are inspired by the principle of free circulaion: it is sufficient for a device to have the CE logo for it to be freely commercialized in all European countries. These regulation that favors commerce also expose the sick to the risk of harm from defective devices that have not been suitably checked prior to commercial release. this paper reports a case of a defective MitraClip Delivery System, discusses other episodes of similar device malfunctioning and analyzed the European legislation on medical devices. In the author's opinion, a careful "control" policy for devices, an adequate care in device manufacturing, an appropriate evaluation of pre-and post-marketing and suitable measures for the patient's safety are needed.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
