NEN:Standards facilitate new developments

In recent years, Europe has seen several large-scale livestock epidemics. The diagnosis of foot-and-mouth disease in a cow in England, in the summer of 2007, therefore understandably generated a major scare. The source of the disease was extraordinary: the animal had a variation of a virus that was being multiplied in a nearby laboratory with the aim of developing medicines to combat the disease. The incident underlined the need for sound agreements on the safety of biomedical laboratories. Particularly also in view of the increasing number of laboratories operating in the market today, especially in the new member countries of the European Union and in China. The safety conditions in those facilities often leave much to be desired.

NEN held the secretariat of the committee that, in 2007, set up a CEN Workshop Agreement. The CWA, Laboratory bio risk management standard can be used as basis for a bio-safety certificate. In air quality, particulate matter is a much-debated issue nowadays. Take for instance the reporting in the media on building projects that are being stopped due to their effect on air quality. Research has shown that use of the European reference method for the determination of PM10 by different parties yields different measurement results. Following this, the Netherlands decided to develop a technical agreement to improve the comparability of particulate matter measurements. By specifying requirements for equipment, filters, and conditioning procedures the comparability of measurement results should be enhanced. Medical devices

The European Directives on Medical Devices and Active Implants provide companies with an important framework of requirements for their products. The recent revision of the Directives will have implications for quite a number of standards. Approximately 750 nationally implemented European standards have been put up as ‘technical specification’ within the scope of the old Directives.

In November 2007, the Policy Committee on Medical Technology held a brainstorming session on the possible implications. A number of follow-up sessions will be held in 2008. Urgency is felt, as the member states are required to adopt the new rules and regulations in their national legislation before 1 December 2008. Companies will then have until 21 March 2010 to come into compliance with those requirements. Telemedicine provides new opportunities formedical care. It enables, for example, remote communication between doctors and patients with the use of video streams. The patient will thus not need to leave home, and the doctor can work more efficiently. To make telemedicine work, however, clear agreements need to be set. In 2007 a NEN standards committee started work on this, which resulted in the establishment of a Netherlands Technical Agreement Health informatics - Telemedicine that was handed over to the permanent government commission of the Ministry of Public Health, Welfare and Sports at the end of December 2007. The document outlines, among other things, what exactly is to be understood by telemedicine. It also describes various quality aspects. 2007 also saw the publication of the NTA Safety Management System for Hospitals and Hospital Care Institutions. The NTA is an initiative of three important umbrella organizations in the healthcare sector: the Dutch Hospital Association, the Order of Medical Specialists and the Dutch Nursing Association, and comprises the basic requirements for a safety management system aimed at increasing patient safety in hospitals. In 2008 revision of this NTA based on user experiences will be taken up.