title: Quality assurance of multiport image-guided minimally invasive surgery at the lateral skull base.
abstract: 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.
authors.affiliation: Chair for Metrology and Quality Management, RWTH Aachen University, Steinbachstr. 19, 52074 Aachen, Germany.
authors.forename: Maria
authors.initials: M
authors.lastname: Nau-Hermes
authors.affiliation: Chair for Metrology and Quality Management, RWTH Aachen University, Steinbachstr. 19, 52074 Aachen, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Schmitt
authors.affiliation: TU Darmstadt, Graphisch-Interaktive Systeme, Fraunhoferstr. 5, 64283 Darmstadt, Germany.
authors.forename: Meike
authors.initials: M
authors.lastname: Becker
authors.affiliation: TU Darmstadt, Graphisch-Interaktive Systeme, Fraunhoferstr. 5, 64283 Darmstadt, Germany.
authors.forename: Wissam
authors.initials: W
authors.lastname: El-Hakimi
authors.affiliation: Hals-Nasen-Ohren-Klinik, Universitätsklinikums Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Hansen
authors.affiliation: Hals-Nasen-Ohren-Klinik, Universitätsklinikums Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Klenzner
authors.affiliation: Hals-Nasen-Ohren-Klinik, Universitätsklinikums Düsseldorf, Moorenstr. 5, 40225 Düsseldorf, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Schipper
mesh_terms: D006801:Humans; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation* / Q000379:methods*; D011785:Quality Assurance, Health Care; D019291:Skull Base / Q000473:pathology / Q000601:surgery*; D025321:Surgery, Computer-Assisted / Q000295:instrumentation* / Q000379:methods*
references.citation: Anesthesiology. 2014 Jun;120(6):1380-9
references.pmid: 24845919
references.citation: Int J Comput Assist Radiol Surg. 2014 Jan;9(1):11-20
references.pmid: 23765213
references.citation: Surg Innov. 2011 Sep;18(3):259-67
references.pmid: 21502203
references.citation: Int J Med Robot. 2010 Sep;6(3):281-90
references.pmid: 20812268
references.citation: Med Image Anal. 2012 Apr;16(3):642-61
references.pmid: 20452269
references.citation: Lancet. 2009 Sep 26;374(9695):1105-12
references.pmid: 19782876
references.citation: Cochrane Database Syst Rev. 2006 Oct 18;(4):CD004788
references.pmid: 17054215
references.citation: Acta Otolaryngol. 2012 Apr;132(4):355-60
references.pmid: 22385333
references.citation: Eur Arch Otorhinolaryngol. 2013 Feb;270(2):477-81
references.pmid: 22460526
references.citation: Lancet. 2009 Sep 26;374(9695):1089-96
references.pmid: 19782874
references.citation: Cochrane Database Syst Rev. 2010 Oct 06;(10):CD001546
references.pmid: 20927725
references.citation: Acta Otolaryngol. 2009 Aug 25;:1-6
references.pmid: 19707904
references.citation: Laryngoscope. 2008 Jun;118(6):1031-9
references.pmid: 18401279
references.citation: Lancet. 2009 Sep 26;374(9695):1097-104
references.pmid: 19782875