For safety reasons, many medical devices are only suitable for single use before disposal. However, due to recent technological progress, up to 16% of those currently labelled “single-use” could be safely reprocessed, allowing significant cost savings and wider application of these (some life-saving) devices. When this reprocessing occurs in a controlled environment, with high quality standards, thorough research has shown that it presents no increased risk to patients’ welfare. In confirmation of this, reprocessors are able to secure sizeable coverage from insurance companies against liability claims arising from the reprocessing of medical devices. In the thirteen years since the reforms in Germany, it is worth mentioning that not one claim has arisen in this context, however it is important to have this insurance in place.
On July 24, 2007, the European Council adopted the revision of the Medical Devices Directives 90/385/EEC, 93/42/EEC and 98/8/EC, accepting all amendments proposed by the European Parliament at first reading. Yet the amendments again failed to mitigate the risks of the unregulated reprocessing of medical devices. The Commission has therefore been requested by the European Parliament to submit a report within the next three years, based on an assessment of the current practices and their real costs as well as existing national regulations and market studies, serving as a basis for proposals on a future regulation in Europe. For this purpose, the European Commission has recently started a public consultation on the reprocessing of medical devices and as a next step will set up an Experts Group which is going to analyze the status quo of the reprocessing industry, the potential harm to human health, national regulatory approaches as well as the impact of reprocessing on international trade.
Coming back to the aspect of labelling, more and more countries worldwide accept that labelling a device “single-use” does not automatically mean that the device cannot be safely reprocessed – it simply means that the manufacturer cannot or will not accept liability for the function of the device beyond its first use. This concern of the manufacturers is understandable, from both a legal and commercial standpoint. However, if reprocessing can be shown to be safe, and the reprocessors themselves are able to assume clear liability (as is the case in Germany and other countries), then there is no safety or economic reason to prohibit this practice.
In spite of this, in some European countries it is prohibited to reprocess any medical device which the manufacturer has chosen to label “single-use”, or else there is no legislation in place to ensure that this is done safely. Not only does this prevent those countries from enjoying the cost savings and improved patient treatment that reprocessing can provide, it can actually drive hospitals and clinics to reprocess their devices without any regulation or monitoring at all, which has been shown actually to increase the risk to patients. It seems absurd, therefore, that under these regimes, professional reprocessors are prohibited from offering their high quality services – while illegal reprocessing, which has been shown to create risks, carries on unchecked.
It is EAMDR’s position that this situation is causing unnecessary costs, risks, and waste generation to the European medical sector. A harmonised European legislation would allow validated reprocessing services to be extended across Europe, providing savings and improved healthcare to the citizens of all Member States. EAMDR therefore calls upon the national governmental authorities and the European Commission to analyse how a European regulation as outlined on the EAMDR Websites can be implemented at national and European level. EAMDR will demonstrate during the consultation process that professional reprocessing means interlinking patient safety and cost effectiveness. EAMDR believes that the development of consistent EU legislation will enhance patient safety whilst paving the way for significant cost savings in the health sector as well as securing ecological improvements throughout Europe. Only binding quality standards and validated procedures offer convincing solutions since label categories do not serve as an appropriate link for regulation.