Medical 3D printing (or ‘additive manufacturing’) which creates bespoke anatomical models such as for use in planning complex surgery, not surprisingly raises issues in medico-legal risk and medical indemnity insurance.
As with any innovative technique, medical indemnity insurers must strike a balance between not accepting unknown risks, and not impeding medical progress – which have the potential of reducing risk through improved patient outcomes.
Medical practitioners wishing to apply 3D printing techniques in a clinical setting should seek advice from their medical indemnity insurer. While healthcare using 3D printing may not be specifically excluded from standard indemnity policies, product liability is generally not included. Even if 3D printing is used only in the public sphere, doctors should ascertain their insurer’s position at the outset (in case of any future conflict with their employer hospital).
The additional complexity presented by 3D printing in a medical negligence context is that errors can occur at various levels – for instance with the CT scanner, the software, the printing, and/or the human operator. In the event of claim, not only would causation be complicated but also the apportionment of liability – which may prove a particular challenge if there is no product liability insurance to cover human error in creating a defective product. Difficulties will also arise from the lack of any established standard of care in relation to such novel treatment (a least in Australia), and the dearth of evidence available. Issues such as peer review and practitioners’ training and ‘qualifications’ in 3D printing may be called into question, noting that the use of medical 3D printing is currently unregulated (Australian regulatory guidelines for medical devices, including ‘custom made devices’, are currently under review by the Therapeutics and Goods Administration).
As always, patient consent and privacy are paramount, as is adequate medical record keeping (which may include 3D models created from the patient images). Finally, for doctors contemplating 3D printing in their own practices, there are also occupational health and safety considerations with plastic being modeled in an enclosed space.
This publication is general in nature and is not comprehensive or constitute legal or medical advice. You should seek legal, medical or other professional advice before relying on any content, and practice proper clinical decision making with regard to individual circumstances. Persons implementing any recommendations contained in this publication must exercise their own independent skill or judgment or seek appropriate professional advice relevant to their own particular practice. Compliance with any recommendations will not in any way guarantee discharge of the duty of care owed to patients and others coming into contact with the health professional or practice. Tego Insurance Pty Ltd is not responsible to you or anyone else for any loss suffered in connection with the use of this information.
Eric is the CEO of Tego, an insurance agency offering specialist indemnity insurance solutions for the healthcare and life sciences sectors. His qualifications include a bachelor’s degree in business and law, a master’s degree from UNSW in law and management and an MBA from the AGSM.