In issuing guidelines on repairing endoscopes, the aim of the European Society of Gastrointestinal Endoscopy (ESGE) Guidelines Committee is to draw the attention of those who manage endoscopy units to the quality control requirements involved in having endoscopes repaired. Information on endoscope repair is important not only for medical doctors, nurses and assistants, but also for medical engineers and ± even more so ± for hospital administrators.The aim of these ESGE guidelines is to draw the attention of endoscope users to both the technical and the legal implications relating to endoscope repair. The sources of spare parts and the exact repair procedures used should be clearly stated in the repair contract. If second-hand spare parts are used, traceability and hygiene issues should be taken into consideration.For the ESGE, it is clear that repair services can be provided both by endoscope manufacturers and by other repair service providers (known as ªthird partiesº), as long as they follow the same quality control processes and guarantees as those followed in endoscopy units.The intention in these guidelines is to provide users of medical endoscopes with information about the appropriate selection of service providers, including information on how to reduce user liability relative to compliance with the Medical Device Directive (MDD) during the lifespan of endoscopic equipment and devices.The Medical Device Directive (MDD) regulates the requirements for the design, manufacture and sale of new medical devices and equipment very precisely. A clear sign for the user that the equipment or device complies with MDD regulations is the CE mark. A reference to the original manufacturer is also provided by the identification label on each product. The basic aim of these measures is to ensure the safety of users, patients, and others, as well as to ensure compliance with technological standards. Before the first use of any new endoscope, the MDD requires proof that these requirements have been met, based on both clinical and nonclinical testing procedures. The original manufacturer maintains a master configuration file, which documents the design configuration, manufacturing configuration, and test results. This ensures seamless configuration control.After the product has been sold, the liability and responsibility for ensuring safe usage of the product is transferred to the user. The degree of user liability is likely to depend on the contract between the user's organization and the selected service provider. The transfer of liability, and all associated risk, depends on the person or organization undertaking the service and on the way in which maintenance and repair work is carried out. If a failure in use occurs after maintenance or repair and this failure leads to serious injury to a patient or user, there is a greater likelihood that the user and service provider may be held legally responsible for any injuries caused, if the endoscope was not repaired in accordance with the manufacturer's instructions and operatin...

One of the main limitations of additive manufacturing (AM) technologies consists in the relatively low build rate. Low productivity discourages companies from investing in AM machines, thus limiting the market of additive technologies. Machine manufacturers have introduced new solutions to their designs to increase the build rate, some of them are described in this paper. However, design improvements are not the only method to accelerate the process. The paper specifies factors that influence the build rate in the laser powder bed fusion process and provides an analytical assessment and comparison of the significance of how they affect its productivity. The influence that a change in selected parameters has on the process and the influence of multi-laser systems on its productivity are analysed in terms of the melted material quality. The processes from which the data for analysis were obtained were carried out on an SLM 280 machine with single- and dual-laser versions as well as on an SLM 500 with four lasers. Two types of samples, solid and thin-walled, both of the same volume, were tested. The data under analysis were the process times for both geometries, manufactured with different sets of parameters from the adopted range. Processing times were analysed to determine the main effects and interaction effects for extreme values of a given parameter. The height of the melted powder layer had the greatest influence on the build rate, which turned out to be greater even than the application of a two-laser system.