The presented system allows the planning and drilling of multiple minimally invasive canals at the lateral skull base. Further studies are required to reduce the drilling error and evaluate the clinical application of the system.
For multiport image-guided minimally invasive surgery at the lateral skull base a quality management is necessary to avoid the damage of closely spaced critical neurovascular structures. So far there is no standardized method applicable independently from the surgery. Therefore, we adapt a quality management method, the quality gates (QG), which is well established in, for example, the automotive industry and apply it to multiport image-guided minimally invasive surgery. QG divide a process into different sections. Passing between sections can only be achieved if previously defined requirements are fulfilled which secures the process chain. An interdisciplinary team of otosurgeons, computer scientists, and engineers has worked together to define the quality gates and the corresponding criteria that need to be fulfilled before passing each quality gate. In order to evaluate the defined QG and their criteria, the new surgery method was applied with a first prototype at a human skull cadaver model. We show that the QG method can ensure a safe multiport minimally invasive surgical process at the lateral skull base. Therewith, we present an approach towards the standardization of quality assurance of surgical processes.
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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