Name
#51 Organizational Aspects, Quality Systems, and Challenges of In-House 3D Printing in Oral and Maxillofacial Surgery: Implications for War-Related Reconstruction
Speakers
Content Presented on Behalf of
International Delegates
Services/Agencies represented
International/Non-US Delegate
Session Type
Posters
Room#/Location
Prince Georges Exhibit Hall A/B
Focus Areas/Topics
Clinical Care, Medical Technology
Learning Outcomes
1. Understand the Role of 3D Printing in OMFS: Describe how 3D printing and patientspecific
surgical guides improve surgical outcomes in oral and maxillofacial surgery,
particularly for reconstructing war-related injuries.
2. Identify Regulatory Challenges: Explain the regulatory landscape surrounding the
use of in-house 3D-printed devices, including the implications of the Medical Device
Regulations (MDR) on surgical practices for war-related injuries.
3. Develop Quality Assurance Strategies: Outline key recommendations for
implementing standardized quality systems and documentation processes to enhance
the safety and efficacy of in-house 3D printing practices in OMFS, specifically in the
context of treating war-related injuries.
surgical guides improve surgical outcomes in oral and maxillofacial surgery,
particularly for reconstructing war-related injuries.
2. Identify Regulatory Challenges: Explain the regulatory landscape surrounding the
use of in-house 3D-printed devices, including the implications of the Medical Device
Regulations (MDR) on surgical practices for war-related injuries.
3. Develop Quality Assurance Strategies: Outline key recommendations for
implementing standardized quality systems and documentation processes to enhance
the safety and efficacy of in-house 3D printing practices in OMFS, specifically in the
context of treating war-related injuries.
Session Currently Live
Description
Microvascular free flaps (MFFs) represent the gold standard for reconstructing warrelated
injuries in the head and neck within Oral and Maxillofacial Surgery (OMFS).
Specifically, in bony reconstructions of the midface or mandible using fibula or iliac
crest free flaps, the advent of digital planning and the intraoperative use of 3D-printed,
patient-specific surgical guides have transformed surgical practices. These guides,
which can be digitally designed and produced in-house via additive manufacturing
(AM), facilitate reduced surgery times and enhance surgical precision, offering
significant benefits for both surgeons and patients. However, the intraoperative
application of in-house 3D-printed devices is increasingly regulated, posing challenges
for compliance within the European Union. This study aimed to gather specific data on
the implementation of 3D printing and in-house AM in OMFS across Germany, with the
goal of developing tailored recommendations for effective in-house 3D printing
practices.
An online questionnaire, featuring dynamic components and consisting of 16 to 29
questions, was distributed to OMF surgeons in university and non-university hospitals,
military medical facilities, and private practices, both those with and without inpatient
treatment capabilities. Participants were recruited from a previous study on 3D printing,
ensuring that all respondents owned a 3D printer and were registered with the German
Association of Oral and Maxillofacial Surgery.
The study collected responses from 67 participants after an initial recruitment yielded
only 5 out of 92. Participants were from university hospitals, non-university hospitals,
and private practices. Among them, 75% of university hospitals owned 3D printers.
Most frequently, participants performed dental implant procedures, using between 20
to 100 CAM products annually. In traumatology, many conducted over 150 procedures
but used few CAM products. For orthognathic surgery, 50-100 procedures were
common, often with corresponding CAM product usage. Participants employed various
3D printing technologies, primarily SLA and FLDM, with autoclaving as the main
sterilization method. Many reported no immediate impact from new Medical Device
Regulations (MDR) but indicated plans for future adaptations. Most 3D data were
generated from radiologic sources, using a mix of certified and non-certified CAD
software. Quality assurance measures were conducted in 65% of units, though
standardized operating procedures (SOPs) were largely absent. Quality control
processes varied, with some participants performing regular checks and documenting
results. Most focused on verifying the fit and integrity of printed goods during surgery.
CAD data were mostly archived centrally, with segmentation and CAD processes
primarily carried out by medical doctors. Over half of participants found owning a 3D
printer economically beneficial, rating its financial impact positively, though many did
not conduct formal evaluations.The findings reveal considerable disparities in 3D printing management within OMFS,
particularly regarding workflow processes, quality control, and documentation. Given
the increasing regulatory demands for medical devices, there is an urgent need for
standardized recommendations and regulations for 3D printing in OMFS, especially in
the context of reconstructing war-related injuries. Key recommendations include: (1)
ensuring products are not used in other facilities, (2) implementing appropriate quality
systems, (3) documenting reasons for bypassing commercial products, (4) providing
information about usage to the relevant authorities, (5) maintaining a publicly
accessible declaration of origin, identification, and conformity with MDR, (6) keeping
records of manufacturing sites, processes, and performance data, (7) ensuring all
products are produced according to predefined requirements, and (8) evaluating
clinical use and addressing potential issues. These measures are crucial for ensuring
patient safety and maintaining the viability of in-house 3D printing in OMFS.