Medical Device Recall Artykuł przeglądowy

Abstrakt

Medical devices are crucial for contemporary treatment. Unfortunately, we are witnessing an increasing number of recalls of products which are defective and/or could be a risk to patients’ health. Recall is defined as a measure taken to address problems with a medical device that violate the rules laid down by the regulatory authority. Medical staff may report adverse events which might be attributed to a product damage through the European Medical Agency or the US Food and Drug Administration websites. Recalls are performed voluntarily by manufacturers when they become aware of defects in their devices. After release of a recall, the manufacturer is obliged to reclaim the defective device, correct it or immediately rectify the defect. Given the increasing number of recalls, it is necessary to become familiar with the practical guidelines for managing patients who use recalled devices.