Experimental surgery

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Operating scene in the experimental operating room in Tübingen

An experimental operating room is a facility in which operating room technology, medical, building and textile technology are further developed, demonstrated and trained in terms of an efficient and safe system. In this “experimental operating room”, a complete system in various functional states can not only be explained and trained, but also repaired and maintained, without endangering patients and without interrupting operations. Research and development of new products and the simulation and optimization of work processes are also the aim of the system.

The world's first and currently only “experimental operating room” was established in 2006 at the Tübingen University Hospital and financed with additional funds from the state of Baden-Württemberg . Over 80 industrial companies from medical, building and textile technology as well as architects and planners built a complete operating theater wing. In addition to training rooms, essential functional areas of a hospital are fully functional in the "experimental operating room":

In the fully equipped operating wing, research and development is carried out without endangering the patient, as no operations on patients or animal experiments are necessary. The main focal points in the "experimental operating room" are usability and user-oriented design , hygiene , technology development, system integration, staff training, further training and qualification, hospital planning, construction and certification.

Usability and user-centered design

Usability test in the experimental operating room in Tübingen

In close collaboration with academia, industry and medical users "OP experimental" are in medical products and operating concepts in accordance with the international standards EN 62366 and EN 60601-1-6 and the requirements of usability engineering develops, designs and its terms usability evaluated . Furthermore, user requirements and user goals can be collected and discussed in the "experimental operating room" under realistic conditions. With the "UseProb" method developed at the "Experimental OP", usability problems and medical devices are evaluated with regard to their risk, with special consideration given to patient safety as part of risk management according to ISO 14971 . These usability studies are a prerequisite for admission to the clinical tests according to DIN ISO 14155 and MEDDEV 2.7.1. They are based on the amendment to the Medical Devices Act in 2009.

hygiene

In the experimental operating room, the interaction between devices and the specialized air conditioning technology (TAV) can be examined and tested under realistic conditions . Together with the developers from the industry, hygienically safe and reprocessable medical products can be developed, as well as practice-oriented reprocessing instructions according to the Medical Device Operator Ordinance (MPBetreibV). Existing products are assessed with regard to their hygienic suitability and further developed together with the manufacturer.

Technology development

Coexistence test in the experimental operating room in Tübingen

Different companies use the "experimental operating room" as a laboratory for research and development of new technologies and services that are used for the planning, construction and operation of health facilities. The experimental OR enables the viewing angle to be expanded from the sole product development to the requirements, processes and work tasks in the hospital. Products can be developed and evaluated in an integrated manner taking into account the hospital system, the influencing technology and the requirements of the user. Here are u. a. In addition to product testing for system capability within the OR, testing of medical products and devices in terms of their preparation, ergonomics, workflows and efficiency is possible in this laboratory (e.g. coexistence tests according to ANSI C63.18-1997 , IT systems according to ISO 80001 , ventilation systems according to DIN 1946-4 ). Unique in the world, developers in the role of a doctor or a nurse can retrace all processes and work steps within a simulation and carry them out themselves and thus develop user-oriented products.

Personnel training, further education and qualification

The close interlinking of theory and practice can be experienced live in the experimental operating room, supported by the most modern didactic concepts and technology. The "Experimental OP" is suitable, among other things. a. for the training of

Hospital planning, construction and certification

The findings from research, development and testing in the "Experimental OP" in Tübingen are transferred from the "Innovative Hospital" industry cluster to the planning, implementation and operation of hospitals worldwide.

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