Idea to Implementation: Knowing the Unknown — Regulatory and Legal Issues Related to Pre-surgical Applications Using 3D Printing

Hui Jenny Chen, MD and Michelle Gabriel, MS, MBA
(This blog is adapted from our A Roadmap from Idea to Implementation: 3D Printing for Pre-Surgical Application: Operational Management for 3D Printing in Surgery)

There are many active discussions in professional societies and across legal forums, but current regulatory, policy, and legal guidelines are very incomplete or non-existent for medical applications of 3D printing, ranging from medical device manufacture to pre-surgical applications. As more healthcare providers and legal experts are getting involved in the field, the final details on regulatory and legal issues for the production process will slowly but surely unfold. In fact, several major law firms are now leading the way in establishing a subspecialty related to medical 3D printing as can be seen in several recent publications. [45,46]

Because 3D printing pre-surgical applications are very new, healthcare and service providers can only speculate on potential regulatory and legal issues based on similar scenarios with applications of other new technologies. Therefore, it is foreseeable that regulatory issues may need to be carefully considered every step along the way, from design to production. For example, in the medical imaging post-processing (for example, segmentation and DICOM to STL conversion), there is currently no established software standard. Although a few popular software systems such as Mimics (Materialise, Belgium) and Osirix (Pixmeo, Switzerland) are FDA-approved, it is still debatable if FDA-approved software must be used. Many current users default to FDA-approved software, fearing pending regulatory ruling that could make their new workflow obsolete, but in reality, there is no evidence that using non-FDA-approved software would necessarily produce lower quality products. It is also unclear how extensively the FDA should be involved in software development intended for pre-surgical 3D printing applications. For example, although it is commonly accepted that FDA approval is needed when software is used for diagnostic and treatment purposes, multiple software selections are often involved in the process. Some argue that the CAD component of the workflow need not be FDA-approved, but others will argue that every single design step will ultimately affect the quality of the final printout. Very recently, during the draft of this book, Food and Drug Administration published a new draft laying out a framework to discuss developing more specific guidelines for the industry, signifying the importance of staying up to date on the regulatory rules related to this new technology. [59]

Additionally, the associated ownership, patent, and liability issues associated with digital design are also increasingly gaining attention. [46, 54] The intensity of the debate on whether a 3D digital file can be patented was demonstrated in a recent case involving Align Technology Inc. (California, U.S.A.) and ClearCorrect (Texas, U.S.A.). [54] As another hypothetical example, if a color-coded congenital heart model is proven effective in pre-surgical planning for pediatric congenital heart disease, should and can the color-coding process be patented? Also, if there is an unexpected corruption of 3D Printing digital file for an implant which subsequently causes harm in patients, who should be liable for the mistake and to what degree? Similar questions need to soon be addressed by lawmakers and the legal community.

In the manufacturing process itself, safety guidelines for managing 3D printing material, operating 3D printers, and post-print processing must be followed to OSHA standards. We will cover material management in a different post. For patient care, more stringent requirements need to be met as the 3D printed product is used in close proximity and sometimes direct contact with the patient. Currently, only a handful of materials are FDA-approved and can be sterilized sufficiently to be within the operating field. An even smaller number of materials can be used for implant production. [47]Full understanding of the toxicity and biocompatibility of the 3D printing material used will be critical in compliance with future regulations in pre-surgical applications.

Regulatory concerns have significantly increased the complexity of many 3D printing applications. A 3D printed surgical guide is one such example. A Patient Specific Instrument (PSI), or 3D printed surgical guide can be produced on an in-house 3D printing center within 24 hours. However, due to regulatory concerns, many healthcare providers choose to use outside medical device vendors with regulatory approval. This significantly increases the turn around time to up to weeks, markedly decreasing the appeal of using a patient-specific instrument (PSI).

Idea to Implementation: Organization and Staffing of A Multidisciplinary 3D Printing Team