3D Printing: UK Product Safety Issues
The UK's Office for Product Safety and Standards (OPSS) plans to focus on product liability and safety issues relating to 3D printing technology in the coming year, it has told Pinsent Masons, the law firm behind Out-Law.
3D printing, also known as 'additive manufacturing', is a fast-moving area of technology which provides consumers and businesses with a new way to manufacture products. The process involves the design of a 3D object using computer software which is then uploaded to a 3D printer, which prints the desired object by adding successive layers of printed material.
3D printing is often used to create spare parts and customised components for use in other products. It has also been used around the world in the construction of buildings, and to manufacture medical devices and pharmaceuticals. In the UK a Bristol-based company, Open Bionics, has reportedly manufactured "the world's first medically certified 3D-printed bionic arm", opening up further potential medical uses.
The potential for 3D printing has come into focus during the Covid-19 pandemic. A number of UK tech companies, universities and 3D printer owners reportedly used 3D printing to manufacture face shields in response to reports of a shortage in NHS personal protective equipment (PPE).
While these efforts are commendable, the safety risks associated with 3D printed products cannot be overlooked. 3D printed PPE is unlikely to have undergone the required tests to meet EU safety standards, or to carry the necessary 'CE mark'. Currently, there is no sector specific guidance or legislation governing 3D printed products to guide manufacturers and end users.
In its 2019 delivery report (40-page / 3.5MB PDF), the OPSS identified "mechanical hazards" associated with 3D printing, and began to conduct sample testing. It has also recognised the need for "infrastructure that equips the UK for future challenges", including those associated with the growth of 3D printing. It will therefore come as welcome news to many that 3D printing technology will be a priority area for the OPSS in the foreseeable future.
Liability under the existing product safety framework
The UK's regulatory and legislative framework governing product safety and liability for defective products aims to ensure that only safe products are brought to the UK market. It also imposes criminal and civil liabilities on those who manufacture or supply dangerous or defective products.
Under the current framework manufacturers, distributors, importers and retailers of defective 3D printers and printing materials, and of 3D printed products, will be held liable for any resulting injury or damage.
However, there are likely to be grey areas around the attribution and apportionment of liability in respect of these products in practice. For instance, a number of parties may have caused or contributed to the product's defect including the designer or printer of the 3D product; the manufacturer, distributor or importer of the printer; or the party that sold or distributed the 3D printed object. It may be difficult to identify who has caused the loss.
Further difficulties may arise in imposing liability for a defective product which contains a 3D printed replacement part. The addition of a non-standard replacement part may have compromised the safety of the appliance as originally designed, in whole or in part. If the 3D printed component is supplied by the original equipment manufacturer (OEM) or its usual component supplier, then this should not complicate the lines of responsibility. However, if the production of 3D printed components is outsourced, or if the part is provided by a third party vendor, this may obscure the relatively clean lines of liability which exist under the Consumer Protection Act.
More informal, less controlled and less supervised production and supply conditions could also undermine levels of compliance with the General Product Safety Regulations or other applicable product safety regimes.
Regulating for 3D printing risks
We may see the OPSS seek to address these obstacles to imposing liability once it begins to focus on the wide-ranging issues associated with 3D printing. This may include future guidance, standards and sector-specific legislation dealing with the safety of 3D printed products.
Ahead of action by the OPSS manufacturers, distributors and importers of 3D printed products should be encouraged to take steps to develop strategies to mitigate risk and loss. They should consider if they have adequate insurance cover, including any need to purchase recall insurance. They should also consider whether they can negotiate non-liability clauses or caps to limit liability in any contracts that they have with third parties for the supply of 3D printed products.
Given that 3D printing is an emerging technology, some of the safety risks may yet be unknown and these may become apparent in time. Product liability insurers should keep abreast of technological developments relating to 3D printing and their associated risks.
Insurers should also try to have an adequate understanding of the products being made by 3D printers and the implications that arise as a result of defects. For example, the risks associated with a 3D printed part, or replacement part, should be expected to differ radically depending on the intended end use.