Abstract. Principles of uncertainty evaluation for measurement processes and capability studies for production processes are established in many producing enterprises to ensure capable processes. Together with further quality management methods this allows to estimate and minimize the risk of producing defective parts and of taking wrong decisions about the part's conformity with its specification. This understanding is also desirable for a completely different field, for medical surgery. To quantify the risk of minimally invasive surgery for an individual patient, principles of metrology and production engineering are transferred to the medical domain and are exemplarily applied to minimally invasive surgery at the inner ear. It is shown how the main influencing factors, the uncertainty of the imaging and image processing and the uncertainty of the navigation process of the surgical instrument can be estimated with methods from production metrology. Furthermore, it is shown how these factors contribute to quantifying the patient's risk of a specific surgery by contributing to a therapeutic risk indicator (TRI).Abstract. Les principes et méthodes pour estimer l'incertitude de mesure et l'aptitude de procès de manufacture ont été établis dans beaucoup d'entreprises pour obtenir des procès capables. En combinaison avec d'autres méthodes de gestion de qualité, le risque de fabriquer des pièces endommagées et de prendre une décision non-fondée concernant la qualité d'une pièce peut être réduit. Ce concept est aussi souhaitable pour un autre domaine : les opérations chirurgicales mini-invasives. Les principes de métrologie et de technique de production sont transférés dans le domaine médical pour quantifier le risque d'une opération mini-invasive pour un patient, par exemple d'une opération mini-invasive de l'oreille interne. Ce travail montre comment les facteurs principaux, l'incertitude d'imagerie et l'incertitude de naviguer les instruments chirurgicaux, peuvent être estimés avec les principes de métrologie manufactures. En plus, cela montre comment ces facteurs contribuent à quantifier le risque d'une opération mini-invasive et à l'index thérapeutique de risque (TRI).
Principles of uncertainty evaluation for measurement processes and capability studies for production processes have been known for several years and are established in many producing enterprises where they ensure capable and controlled processes. The ability to quantify the processes risk is also desirable for a completely different field, for medical surgery. Especially for new and minimally invasive surgery it is very important to estimate and state the risk of the surgical intervention for the individual patient. To achieve this, principles of metrology and production engineering are transferred to the medical domain and are exemplarily applied for minimally invasive surgery at the inner ear. The contribution shows how the individual patients risk can be expressed analogous to the calculation of capability indices (ISO 22514-1) and how the patients risk for this intervention is directly affected by uncertainty contributions along the surgical process chain.
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