Reporting Adverse Medical Device Events Is an Obligation and Not a “Fashion”

Excerpt

We thank George et al. for their interest in our recent publication of a case series of patients that developed acute pancreatitis after the insertion of intragastric balloons [1]. Reporting adverse medical device events (AMDEs) is an important aspect that is overlooked by the medical community; a recent paper by Gagliardi et al. [2] demonstrated that practitioners perceived reporting AMDEs as unnecessary, not possible, or futile. The aim of reporting such AMDEs includes increasing awareness among healthcare practitioners, healthcare regulators, and industry, as well as patients about potential AMDEs. This is in an attempt to optimize the selection of cases, and hopefully mitigate these risks either through smarter designs of devices, or patient selection, or a combination thereof. At least practitioners and patients would have more details and a better-informed decision about interventions that are offered. …