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. 2023 Dec;27(4):661-673.
doi: 10.1007/s10006-022-01109-3. Epub 2022 Aug 22.

A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany

Alexander-N Zeller #  1 , Elisabeth Goetze #  2 , Daniel G E Thiem  3 , Alexander K Bartella  4 , Lukas Seifert  5 , Fabian M Beiglboeck  6   7 , Juliane Kröplin  8 , Jürgen Hoffmann  9 , Andreas Pabst  10
Affiliations

A survey regarding the organizational aspects and quality systems of in-house 3D printing in oral and maxillofacial surgery in Germany

Alexander-N Zeller et al. Oral Maxillofac Surg. 2023 Dec.

Abstract

Purpose: The aim of the study was to get a cross-sectional overview of the current status of specific organizational procedures, quality control systems, and standard operating procedures for the use of three-dimensional (3D) printing to assist in-house workflow using additive manufacturing in oral and maxillofacial surgery (OMFS) in Germany.

Methods: An online questionnaire including dynamic components containing 16-29 questions regarding specific organizational aspects, process workflows, quality controls, documentation, and the respective backgrounds in 3D printing was sent to OMF surgeons in university and non-university hospitals as well as private practices with and without inpatient treatment facilities. Participants were recruited from a former study population regarding 3D printing; all participants owned a 3D printer and were registered with the German Association of Oral and Maxillofacial Surgery.

Results: Sixty-seven participants answered the questionnaires. Of those, 20 participants ran a 3D printer in-unit. Quality assurance measures were performed by 13 participants and underlying processes by 8 participants, respectively. Standard operating procedures regarding computer-aided design and manufacturing, post-processing, use, or storage of printed goods were non-existent in most printing units. Data segmentation as well as computer-aided design and manufacturing were conducted by a medical doctor in most cases (n = 19, n = 18, n = 8, respectively). Most participants (n = 8) stated that "medical device regulations did not have any influence yet, but an adaptation of the processes is planned for the future."

Conclusion: The findings demonstrated significant differences in 3D printing management in OMFS, especially concerning process workflows, quality control, and documentation. Considering the ever-increasing regulations for medical devices, there might be a necessity for standardized 3D printing recommendations and regulations in OMFS.

Keywords: 3D printing; Documentation; In-house manufacture; Organization; Process; Quality control; Workflow.

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