Analysis of the French health ministry's national registerof incidents involving medical devices in anaesthesia and intensivecare

Abstract

This study details all incidents involving medical devices used in anaesthesia and intensive care reported to the relevant authorities in France in 1998. There were 1004 reports during that year. Incidents were classified as serious (harmful to patients) in 11% of cases; death resulted in 2% of cases. Equipment for ventilation and infusion, and monitors of all kinds, accounted for most of the reports, representing 37%, 30% and 12%, respectively, of all reports. The leading causes of failure varied according to the category of device. User errors, quality control problems during production of the device and design faults were the three main causes. The problems identified during the study period enabled the faulty medical devices to be improved in 12-44% of cases. We conclude that post-marketing vigilance is a useful way of improving the quality of medical devices.

The investigation and analysis of critical incidents and adverse events in healthcare

“…Reports can provide information not only on what happened, but also how and why. 107,108 Historically, there has been more of an emphasis on pharmacodynamics where drugs are concerned and on design features where medical devices are concerned, but there are examples of publications where the human factors involved in generating adverse outcomes have also been given attention. Where the regulatory agency is less focused on drugs and technology, there may be even greater scope for learning on both the underlying and the direct causes of incident reports.…”

Critical incident reporting: Why should we bother?

“…[9] The UK National Patient Safety Agency (NPSA), established in 2001, set up a Reporting and Learning System[10] (RLS) to collect and learn from adverse incidents and near misses reported throughout the National Health Service in England and Wales. Various pertinent publications,[1112] including an Australian manual for the management of critical situations in anesthesia[8] are available for reference, but huge lacunae still persist. This warrants, further work on appreciating methodology to learn from incidents, wider propagation of such ideas, and measuring impact on standards, quality, research, and patient outcomes.…”

Enquête sur la perception de la matériovigilance par les médecins dans les services hospitaliers publics français de médecine physique et de réadaptation

“…Les autres pays européens ont mis en place des systèmes indépendants mais relativement proches [13]. Il n'est cependant pas simple d'harmoniser 19 pays avec des cultures et des expériences différentes (sans parler de la langue) [14].…”

“…Il n'est cependant pas simple d'harmoniser 19 pays avec des cultures et des expériences différentes (sans parler de la langue) [14]. À défaut d'exploitation commune des déclarations d'incidents, la coordination européenne repose actuellement en partie sur les fabricants qui sont tenus par la réglementation et par leur garantie d'assurance qualité de signaler à leurs clients les risques liés à leurs produits [13]. L'autorité compétente de chaque pays doit aussi informer les autres états membres ainsi que la commission européenne des faits marquants [14].…”