Background: Technological advancements have made 3D printing more accessible and affordable for both individuals and institutions. Despite significant efforts by the International Medical Device Regulators Forum to standardize 3D printing regulations for medical use, challenges remain. We conducted a survey to gather insights from physician end-users on their opinions regarding the regulation of 3D printing in medicine. Additionally, since FDA guidance is often adopted internationally, this survey aimed to capture the demographics of physician end-users globally and provide a snapshot of the current use of 3D printing in clinical practice and research.
Methods: After developing and validating a 26-question survey, we emailed it to the corresponding authors of all PubMed-indexed publications on 3D printing in medicine. Participants received an introductory email explaining the survey's purpose and an invitation to participate. Only responses from participants who declared themselves to be physicians were accepted. The survey was open for responses from April 5th to May 3rd, 2022, with weekly reminders sent until the response period closed. Responses with at least 80% survey completion were accepted for analysis.
Results: Out of 951 surveys sent, we received 114 responses (11.9%) with an average completion rate of 89%. Most respondents were from Europe (35.5%) and North America (30.9%), followed by Australia and New Zealand (9.1%). The majority were affiliated with academic institutions (83.9%) and were primarily surgeons (49.1%). The most common application of 3D printing was surgical planning (74.1%), followed by medical education (61.6%). Nearly 50% of respondents used open-source segmentation software without FDA approval. Most had access to an onsite printer (82.2%) and specially trained staff to assist with segmentation (53.4%).
Conclusions: The integration of 3D printing technologies into clinical practice will continue to grow. This paper presents the largest survey of physicians practicing 3D printing to date. Given the underrepresentation of this key demographic within regulatory bodies, the opinions and positions of physician respondents reported here should be considered in the development and application of new guidelines and regulations in the field.
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