3D technology has been touted as a groundbreaking development in the way complex surgery is performed. 3D technology has been used in facial reconstructive surgery; to assist surgeons in the navigation of complex heart surgery; and in the production of artificial vertebra implanted into a child as part of treatment for bone cancer. Now, 3D technology is being used in the production of custom-made prosthetics and orthopaedic devices. Insurers might like to consider the supply chain that takes a proposal from the drawing board to the human body, via a 3D printer.
So how does it work? In short, the process of printing a 3D object involves the creation of a 3D design file of the object to be printed using 3D modelling software, or a 3D scanner. Software is used to divide the design file into layers. The object, which will often be comprised of hundreds or thousands of layers, is then printed layer by layer.
The real appeal of 3D technology is that it allows products to be tailor made to the specification of the individual patient. However, whilst 3D technology undoubtedly has the potential to benefit thousands of patients, what happens when something goes wrong? For example, imagine that a 3D printed prosthetic, tailor made to the specifications of an individual patient on a hospital owned 3D printer fails. Who is to blame?
A number of parties could potentially be exposed should the patient decide to bring a product liability claim under the provisions of the Consumer Protection Act 1987, including:
- the hospital (as the owner of the printer)
- the supplier of the materials used in the printing process
- the developer/ licensor of the 3D modelling software
- the operator of the 3D printer.
An added complexity is that the numerous processes involved in creating a 3D printed product, make it difficult to trace the precise stage at which any error occurred.
It is also worth taking into account that, under the current UK Medical Devices Regulations, the regulatory burden on manufacturers of custom-made devices is relatively low. Although manufacturers are obliged to adhere to a number of requirements, such devices are not required to be CE marked.
Insurers should be aware that the potentially complex chain of parties involved in the production process, and the relatively low regulatory burden for custom-made products, may muddy the waters for claimants seeking to prove the elements of a claim, but might, conversely increase insurers’ exposure to liability. It may therefore be prudent to consider from the outset including disclaimers within user information, and provision for apportionment of responsibility in contracts which cover the production process.