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DOI: 10.1055/s-2004-825837
ESGE Guidelines for Quality Control in Servicing and Repairing Endoscopes
Publikationsverlauf
Publikationsdatum:
28. September 2004 (online)
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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 ”third parties”), 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 operating standards.
Users need to ensure that they follow an appropriate strategy for maintaining and repairing the equipment. Options for maintenance and repair services include choosing either:
The original manufacturer of the endoscope An in-house biomedical engineering department An independent service provider A managed service provider.
Usually, the original manufacturer is the primary source for maintenance and repair services. However, not all manufacturers carry out repair and maintenance of their devices. Whoever is carrying out the maintenance and repair activity, the written service documentation provided by the manufacturer should always be used. If any organization other than the original manufacturer undertakes repair or maintenance work, the organization concerned should ensure that the work and inspection is carried out in accordance with the latest manufacturer’s instructions and specifications, and according to defined standards.
The most important issues to be considered as selection criteria for any service provider are in the four core areas:
General competence Workmanship Parts and materials Verification, inspection, and risk management.
However, in addition, the following criteria are important elements that should also be taken into account when choosing a service provider:
A clear analysis and understanding of the relationship between apparent financial savings and increased liability risks, and calculation of total ownership costs relative to repair frequency The frequency with which maintenance and repairs are likely to be needed and the time required to respond to endoscope malfunction Uptime requirements Requirements for loan equipment Requirements for a mobile service.
It is advisable for the owner of the endoscopic equipment to always make a clear contractual agreement with the chosen service provider. This agreement should clearly describe the level of service to be provided to the owner organization, and it is recommended that it should include:
Reference to the original manufacturer’s written instructions Information on availability, source, and traceability of spare parts Notification of any changes in parts, procedures, tests performed, etc., including the use of parts and methods other than those specified by and originating from the original manufacturer Details of the training and qualifications of the technicians and inspectors Details on the way in which requirements for adequate record-keeping regarding traceability are ensured Regulations on the use of subcontractors employed by the service provider.
A repair organization that complies with both the comprehensive legal and quality aspects as well as with specific customer requirements will be able to respond positively to the following questions.
J- F. Rey, M. D.
Institut Arnault Tzanck
Avenue du Dr Maurice Donat · F-06700 Saint-Laurent du Var · France
Fax: +33-493075158
eMail: jean-francois.rey@wandadoo.fr