Insufficient Quality Assurance of 3D-Printed Patient-Specific Medical Devices May Harm Patients

January 28, 2021 | Evaluations & Guidance


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Patient-specific 3D-printed medical devices created without appropriate clinical verification of the design, quality control of the manufacturing process, and validation of the end product may not accurately represent patient anatomy or perform as intended. 3D printing technology is now being used to create patient-specific devices such as implants (orthopedic, maxillofacial, and dental), anatomical models for surgical planning, surgical guides for orthopedic procedures, and prostheses.

To design these devices, specialized expertise and dedicated software are used to transform Digital Imaging and Communications in Medicine (DICOM) 3D patient imaging data into a digital model of what is to be printed. Clinical knowledge and engineering expertise are necessary to identify the target anatomy and create a printable design. Manufacturing the 3D-printed device involves identifying suitable...

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