European product safety, liability and single-use devices in a medical context

A few European initiatives to improve product safety in a medical environment can be mentioned. Controls on the safety of medical devices for example has been improved by the introduction of the directives on medical devices. The producer has to follow certain procedures before his products can be placed on the market. It seems that also hospitals sterilisin single-use devices for reuse are subject to these directives. In an innovative field like medicine, the regulator cannot possibly regulate everything. An important effort therefore has to be made by professional groups and other private-law organisations. The European regulatory initiatives are only the first steps towards total quality management. However, even the best quality-rules cannot guarantee absolute safety. The increased number of (technical) quality rules make it easier for victims to prove a fault: the standard of care has been made more transparant. Even if the directive on product liability is applied, the quality-rules that refer to products can be used to evaluate a defect. Producers give technical instructions for safe use of their products. They are even obliged to do so by the directives on medical devices. Courts are not bound by these instructions to evaluate the product's defect in case the directive on product liability is applied. The primary duty of the producer is to produce safe products. If this is not possible, adequate information has to be provided.