10. Insufficient quality assurance of 3D-printed patient-specific devices

If a 3D-printed, patient-specific device is created without appropriate clinical verification of the design, quality control of the manufacturing process and validation of the end product, the resulting object may not accurately represent important patient anatomy or may not perform as intended, according to ECRI. The use of an improperly-created, 3D-printed device could lead to procedure delays, surgical complications, infection or patient injury.

Because the physicians who will use the patient-specific 3D-printed devices play a key role in the design process, they bear increased responsibility for verifying that quality assurance measures have been followed. ECRI recommends that healthcare facilities establish a written acceptance policy that specifies the need to approve the object design and the quality of the finished device before a 3D-printed, patient-specific medical device is accepted for clinical use.

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