{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T14:58:02Z","timestamp":1740149882877,"version":"3.37.3"},"reference-count":16,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T00:00:00Z","timestamp":1667520000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T00:00:00Z","timestamp":1667520000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002957","name":"Technische Universit\u00e4t Dresden","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002957","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Oral Maxillofac Surg"],"abstract":"<jats:title>Abstract\n<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>Following the introduction of the Regulation (EU) 2017\/745 by the European Parliament, any bioactive substance or surgical implant introduced into the human body must be documented. The regulation requires any implant to be traced back to the manufacturer. Lot numbers need to be available for every single medical implant. Also, the manufacturer is required by law to provide implants individually packaged and sterilized. Previously, model tray systems (MOS tray) were used for osteosynthesis in oral and maxillofacial surgery, in which the individual implants could not be registered separately. The new regulation made it impossible to use such processes during surgery anymore and a need for a change in the medical practice surged. We examined a possible solution for the new legislation. The aim of this prospective cohort study is to analyze the MOS tray systems to osteosynthesis materials prepackaged in sets. We record and evaluate parameters such as surgical time and documentation time. We perform a short cost analysis of our clinic. The primary aim is to determine how much time is gained or lost by the mandatory increased patient safety. The secondary aim is to describe change in costs.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients that underwent standard surgical procedures in the clinic of oral and maxillofacial surgery of the faculty hospital Carl Gustav Carus in Dresden were included. We chose open reduction and internal fixation (ORIF) of anterior mandibular corpus fractures as well as mandibular advancement by means of bilateral sagittal split osteotomies (BSSO) as standardized procedures. Both of these procedures require two osteosynthesis plates and at least four screws for each plate. MOS trays were compared to prepackaged sterilized sets. The sets include a drill bit, two plates, and eight 5-mm screws.<\/jats:p>\n                <jats:p>A total number of 40 patients were examined. We allocated 20 patients to the ORIF group and the other 20 patients to the BSSO group. Each group was evenly subdivided into a MOS tray group and a prepackaged group. Parameters such as the incision-suture time (IST) as well as the documentation time (DT) by the operating room (OR) staff to complete documentation for the implants are the main focus of investigation.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>For open reduction, the incision-suture time was significantly different in favor of the MOS tray (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05). There was no difference in the BSSO groups. However, we observed a significantly different (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01) documentation time advantage for the prepackaged sets in both the ORIF and BSSO groups. On top of that, we find that by using the prepackaged kits, we are able to reduce sterilization costs by \u20ac11.53 per size-reduced container. Also, there is also a total cut of costs of \u20ac38.90 and \u20ac43.70, respectively, per standardized procedure for implant material.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>By law, a change in the method of approaching surgery is necessary. For standardized procedures, the right choice of implants can lead to a reduction of documentation time and costs for implant material, sterilization, as well as utilizing less instruments. This in turn leads to lower costs for perioperative processing as well as provision of state-of-the-art implant quality implementing higher patient security.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10006-022-01126-2","type":"journal-article","created":{"date-parts":[[2022,11,4]],"date-time":"2022-11-04T15:03:15Z","timestamp":1667574195000},"page":"179-184","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Cost minimization analysis of indication-specific osteosynthesis material in oral and maxillofacial surgery"],"prefix":"10.1007","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9324-9574","authenticated-orcid":false,"given":"Adrian","family":"Franke","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhard","family":"Weiland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michaela","family":"Bu\u010dkova","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian","family":"Br\u00e4uer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G\u00fcnter","family":"Lauer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henry","family":"Leonhardt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2022,11,4]]},"reference":[{"key":"1126_CR1","unstructured":"Official Journal of the European Union, L117 (2017) Regulation (EU) 2017\/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001\/83\/EC, Regulation (EC) No 178\/2002 and Regulation (EC) No 1223\/2009 and repealing Council Directives 90\/385\/EEC and 93\/42\/EEC (Text with EEA relevance.). EUR-Lex. http:\/\/data.europa.eu\/eli\/reg\/2017\/745\/oj. Accessed 5 May 2017"},{"key":"1126_CR2","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjps.2006.01.012","author":"TST Adams","year":"2007","unstructured":"Adams TST, Crook T, Cadier MAM (2007) A late complication following the insertion of hydrogel breast implants. J Plast Reconstr Aesthetic Surg JPRAS. https:\/\/doi.org\/10.1016\/j.bjps.2006.01.012","journal-title":"J Plast Reconstr Aesthetic Surg JPRAS"},{"key":"1126_CR3","unstructured":"Gerlach FM, Wille E, Greiner W et al (2014) Needs-based health care: opportunities for rural regions and selected health care sectors. ADVISORY COUNCIL on the Assessment of Developments in the Health Care System. https:\/\/www.svr-gesundheit.de\/fileadmin\/Gutachten\/Gutachten_2014\/Kurzfassung_engl_2014.pdf. Accessed June 2014"},{"key":"1126_CR4","doi-asserted-by":"publisher","DOI":"10.1007\/s10006-020-00917-9","author":"SA-H Elsayed","year":"2021","unstructured":"Elsayed SA-H, Elsayed EH, Altaweel AA (2021) Stabilization of anterior mandibular fracture using different osteosynthesis devices: perioperative clinical notes. Oral Maxillofac Surg. https:\/\/doi.org\/10.1007\/s10006-020-00917-9","journal-title":"Oral Maxillofac Surg"},{"key":"1126_CR5","doi-asserted-by":"publisher","DOI":"10.1016\/j.joms.2019.01.0018","author":"M Tiwari","year":"2019","unstructured":"Tiwari M, Meshram V, Lambade P et al (2019) Titanium lag screw versus miniplate fixation in the treatment of anterior mandibular fractures. J Oral Maxillofac Surg. https:\/\/doi.org\/10.1016\/j.joms.2019.01.0018","journal-title":"J Oral Maxillofac Surg"},{"key":"1126_CR6","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijom.2016.05.015","author":"K Andersen","year":"2016","unstructured":"Andersen K, Thastum M, N\u00f8rholt SE et al (2016) Relative blood loss and operative time can predict length of stay following orthognathic surgery. Int J Oral Maxillofac Surg. https:\/\/doi.org\/10.1016\/j.ijom.2016.05.015","journal-title":"Int J Oral Maxillofac Surg"},{"key":"1126_CR7","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjoms.2020.08.124","author":"CM Bowe","year":"2021","unstructured":"Bowe CM, Gurney B, Sloane J et al (2021) Operative time, length of stay and reoperation rates for orthognathic surgery. Br J Oral Maxillofac Surg. https:\/\/doi.org\/10.1016\/j.bjoms.2020.08.124","journal-title":"Br J Oral Maxillofac Surg"},{"key":"1126_CR8","doi-asserted-by":"publisher","unstructured":"Garg M, Cascarini L, Coombes DM et al (2010) Multicentre study of operating time and inpatient stay for orthognathic surgery. Br J Oral Maxillofac Surg. https:\/\/doi.org\/10.1016\/j.bjoms.2009.08.035","DOI":"10.1016\/j.bjoms.2009.08.035"},{"key":"1126_CR9","doi-asserted-by":"publisher","DOI":"10.1097\/iop.0000000000001531","author":"AJ Chen","year":"2020","unstructured":"Chen AJ, Baxter SL, Gali HE et al (2020) Evaluation of electronic health record implementation in an academic oculoplastics practice. Ophthal Plast Reconstr Surg. https:\/\/doi.org\/10.1097\/iop.0000000000001531","journal-title":"Ophthal Plast Reconstr Surg"},{"key":"1126_CR10","doi-asserted-by":"publisher","DOI":"10.1001\/jamaophthalmol.2013.8196","author":"DS Sanders","year":"2014","unstructured":"Sanders DS, Read-Brown S, Tu DC et al (2014) Impact of an electronic health record operating room management system in ophthalmology on documentation time, surgical volume, and staffing. JAMA Ophthalmol. https:\/\/doi.org\/10.1001\/jamaophthalmol.2013.8196","journal-title":"JAMA Ophthalmol"},{"key":"1126_CR11","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjoto.2020.102764","author":"S Gidumal","year":"2021","unstructured":"Gidumal S, Gray M, Oh S et al (2021) Utilization fraction of rhinoplasty instrument sets: model for efficient use of surgical instruments. Am J Otolaryngol. https:\/\/doi.org\/10.1016\/j.amjoto.2020.102764","journal-title":"Am J Otolaryngol"},{"key":"1126_CR12","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.19866","author":"S Hermena","year":"2021","unstructured":"Hermena S, Solari F, Whitham R et al (2021) Rationalization of orthopaedic surgical instrument trays: three years\u2019 experience of a practical approach to cut down unnecessary costs. Cureus. https:\/\/doi.org\/10.7759\/cureus.19866","journal-title":"Cureus"},{"key":"1126_CR13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpurol.2019.01.013","author":"K Nast","year":"2019","unstructured":"Nast K, Swords KA (2019) Decreasing operating room costs via reduction of surgical instruments. J Pediatr Urol. https:\/\/doi.org\/10.1016\/j.jpurol.2019.01.013","journal-title":"J Pediatr Urol"},{"key":"1126_CR14","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajog.2016.06.019","author":"MM Van Meter","year":"2016","unstructured":"Van Meter MM, Adam RA (2016) Costs associated with instrument sterilization in gynecologic surgery. Am J Obstet Gynecol. https:\/\/doi.org\/10.1016\/j.ajog.2016.06.019","journal-title":"Am J Obstet Gynecol"},{"key":"1126_CR15","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2021.01.041","author":"JH Lonner","year":"2021","unstructured":"Lonner JH, Goh GS, Sommer K et al (2021) Minimizing surgical instrument burden increases operating room efficiency and reduces perioperative costs in total joint arthroplasty. J Arthroplasty. https:\/\/doi.org\/10.1016\/j.arth.2021.01.041","journal-title":"J Arthroplasty"},{"key":"1126_CR16","doi-asserted-by":"publisher","DOI":"10.2319\/012014-56.1","author":"N El-Wassefy","year":"2015","unstructured":"El-Wassefy N, El-Fallal A, Taha M (2015) Effect of different sterilization modes on the surface morphology, ion release, and bone reaction of retrieved micro-implants. Angle Orthod. https:\/\/doi.org\/10.2319\/012014-56.1","journal-title":"Angle Orthod"}],"container-title":["Oral and Maxillofacial Surgery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10006-022-01126-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10006-022-01126-2\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10006-022-01126-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,3,6]],"date-time":"2024-03-06T03:03:08Z","timestamp":1709694188000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10006-022-01126-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,4]]},"references-count":16,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,3]]}},"alternative-id":["1126"],"URL":"https:\/\/doi.org\/10.1007\/s10006-022-01126-2","relation":{},"ISSN":["1865-1569"],"issn-type":[{"type":"electronic","value":"1865-1569"}],"subject":[],"published":{"date-parts":[[2022,11,4]]},"assertion":[{"value":"24 August 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"23 October 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 November 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was performed in line with the principles of the Declaration of Helsinki. The Ethics and Institutional Review Board of the University Hospital Carl Gustav Carus at the Technical University of Dresden (Institutional Review Board number IRB00001473) registered at the Office for Human Research Protections (IORG0001076) approved of the study (Internal Ethics Committee ID number: EK 117032017). Informed consent was obtained from all individual participants included in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors affirm that human research participants provided informed consent for publication of the collected data. No images or other material was used that can be traced back to the participants.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}