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

Abstract

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. 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. 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." 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.