Focus on Patient Safety - « Implantable medical devices (IMDs) »

Context

A review of care-related serious adverse events associated with medical devices (MDs) reported by healthcare professionals indicated that many of these events are associated solely with implantable medical devices (IMDs).

Objectives 

By sharing feedback from professionals, this Focus on patient safety aims to draw attention to the incidence of care-related serious adverse events that could have been prevented, on one hand, by implementing IMD-related regulations and, on the other, by complying with clinical IMD implantation, use and monitoring guidelines.

So it doesn’t happen again 

Based on the review of reported care-related serious adverse events, the main causes detected are:

• failures in IMD circuit management, at all stages (from IMD order to use) ;
• but also a lack of awareness of IMDs among healthcare professionals whether at the time of fitting, use or monitoring.

Main key messages to prevent these events: 

• implement IMD-related regulations applicable to all healthcare organisations, that is to say : 
  • complete real-time IMD traceability in the healthcare organisation’s information system, at each stage and by each healthcare professional involved (using the unique device identification [UDI]), 
  • implement an IMD circuit quality management system in the healthcare organisation. 
• always comply with best final pre-implantation verification practice in the team, in order to fit the right implant, at the right time, in the right patient.