New advancements in 3D printing are exciting, and hospitals are eager to provide patients with new cutting-edge solutions to their medical issues. In fact, as 3D printing becomes commercially available, hospitals are using them to create 3D models of patients to help physicians practice surgery or other procedures. 3D printing is also being used to create temporary tools such as templates surgeons affix to the bone during surgery or drill guides. Hospitals are using other 3D printed devices such as splints, hip prosthetics, stents, spinal cages and artificial bone structures.
While this new technology can be exciting, risk managers warn that hospitals could be opening themselves up to liabilities only previously held by medical manufacturing companies. When hospitals create their own medical devices, they assume the risk of failure. Most medical manufacturing companies are required to test their products for long-term wear and tear. If the hospital is printing these devices on premises, without quality tests, they could be held responsible should one fail after use.
Nurses, doctors, and other medical staff are also at risk of medical malpractice lawsuits because there is a serious knowledge gap in the methods of manufacturing, materials used and installation process in the manufacture of these new medical devices. Medical malpractice attorneys also cite tort liability as a concern when 3D printing is used in hospitals. If failure or injury is caused by a 3D printed medical device, who is at fault? Would the manufacturer of the 3D printer be held accountable? Or the software designer responsible for coding the program that created the device? Would the court hold the individual medical professional responsible for the device failure? There is currently no legal precedence for these issues, which is why risk managers are so concerned.
If you are a hospital insistent on using 3D printers for medical treatment and surgeries, consider using the same safeguards you would usually use when offering a patient a new medical device. Explain how new the item is and the risks associated with using such a new device. Explain there is no liability precedence currently set for this product.