Variant Creutzfeldt-Jakob disease (vCJD) is a transmissible form of spongiform encephalopathy believed to be contracted from the consumption of bovine spongiform encephalopathy (BSE) infected beef products. To date over 100 individuals have developed this incurable disease. There have been no documented cases of iatrogenic infection, but there is a theoretical risk that surgical procedures could transmit the disease. This review describes the background of the disease and assesses the possible risks of transmission through endoscopic procedures. The risk of transmission by endoscopy is small and probably negligible if suitable procedures are followed. The greatest potential danger arises from healthy individuals who are incubating the disease. Pathological prions (PrP(sc)) may be found in lymphatic tissue of these individuals (particularly tonsils), but smaller amounts have been identified in the appendix and Peyer's patches. These prions are resistant to all forms of conventional sterilization. There is a theoretical risk that biopsy forceps and the operating channel of endoscopes could become contaminated. This review gives recommendations as to how these small risks can be minimized. They include the employment of single-use forceps for biopsies taken from the terminal ileum, greater attention to the maintenance of endoscopic equipment and accessories, more rigorous manual cleaning of endoscopic equipment and the use of well designed, disposable cleaning brushes for the operating channel of the endoscope.
The MST appeared adequate to cover a large part of routine endoscopy reports, and could thus be used as a tool for standardization of endoscopic reports in clinical practice. The latter could be significantly improved by the use of a structured and standardized terminology for the production of endoscopic reports.
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...
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