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Published Tuesday, May 16, 2017

The healthcare industry's use of 3D printing is gaining traction and garnering attention, particularly in hospitals, medical and dental surgery centers, and rehabilitation facilities. These devices — which include, among others, surgical instruments, implants (such as prosthetic hip joints), external prosthesis (including hands or ears) and even pharmaceuticals — offer important opportunities for innovative treatment, but the 3D printing technology involves various liability risk exposures.

In the 3D printing process, a manufacturer creates digital files and component range criteria from a computer-aided design (CAD) drawing or Magnetic Resonance Image (MRI). These configurations are then printed through a computerized, additive manufacturing process. In this process, successive layers of material are deposited until a solid object is created.

Similar to traditional product innovation pathways, the FDA regulates a manufacturer of 3D-printed devices for their safety and effectiveness. In some cases, exemptions are available for custom-created devices. Physicians and hospital technicians must ensure that the end medical device product, for instance, is sterile and is produced specifically for the patient with appropriate materials. This process raises potential liability concerns for both the manufacturer and the facility.

A 3D-printed medical device offers considerable advantages, including customization and immediacy of results. For example, if a patient lost part of his skull, surgeons can produce a specifically tailored cranial plate designed for the patient's anatomy without delay. And, if a patient required a nose prosthetic, 3D printers could create a prosthesis modeled after the damaged nose, optimally leading to a more rapid recovery. However, if the device is not "manufactured" properly, negative consequences may ensue resulting in patient bodily injury.

Consider this scenario: A physician designs a silicone spinal device to be created using a hospital's onsite 3D-printer technology. Once printed, a surgery technician handles the device and brings it to the physician, who then implants this device into a patient. Years later, the silicone dissolves and the patient is injured. Who is liable for this injury? Did it occur due to design error? Were there deficiencies in the product materials or in the fabrication of the product? Did the physician possess the knowledge, training, skills and credentials to safely manufacture the implant? Did the hospital technician receive adequate training on how to handle the device? Was the device contaminated after its creation? Was the supplier's silicone compromised in any manner?

According to FDA regulations, a manufacturer means, "any person who designs, manufactures, fabricates, assembles or processes a finished device." Under this definition, a hospital or similar facility may be deemed a "manufacturer" when creating medical devices through 3D printing. Therefore, the entity must comply with FDA regulations regarding their safety and effectiveness for its intended use.

While a healthcare facility may not wish to assume the responsibilities associated with current good manufacturing practices (cGMP), the FDA is authorized to regulate and inspect a range of activities at hospital and research centers, the innovators of 3D-manufactured devices, as well as healthcare facilities, and, therefore, should consider implementation of the following strategies:

  • Be aware of any and all 3D-printed products brought into the healthcare facility. Facilities should establish and implement procedures, programs and protocols to identify these products and determine those physicians who are credentialed and have the associated staff privileges to utilize those products.
     
  • Develop and ensure device innovator-backed training for any facility, staff member or qualified physicians who will manufacture or use 3D-printed products. Training for those who work with a 3D-printed instrument, implant or prosthetic should be conducted in a structured and organized manner, including an introduction to the device, training on its uses, learning how it is handled and kept sterile, and training on disposal, if necessary.
     
  • Document receipt of the 3D-printed product. Facilities should create and instill a tracking, tracing and recall program in order to remain in contact with patients who receive the 3D-printed device. If you discover a year later that the silicone used to make a 3D-printed device lacks shelf life, measures calling for device innovator and patient notification, as well as follow up, should be deployed. Additionally, any adverse event report received from the patient also should be included in the notification plan and addressed immediately.
     
  • Ensure patient informed consent. Patients must be apprised of who designed their 3D-printed devices, the entity that manufactured the devices and if the device has been FDA-approved. Patients should be informed of the right to refuse treatment with the device. For example, a customized 3D-printed prosthesis is not typically FDA-approved for the end product, as such approval relates to the safety of the materials used in the fabrication and validation of the manufacturing process in order to ensure that the device can perform as intended. The FDA produced Draft Guidance in May of 2016 regarding the Technical Considerations for Additive Manufactured Devices and is still evaluating further procedural guidelines.
     
  • Construct adequate contractual protections and risk financing for the entities supplying the 3D-printing manufacturing tools, and the owner/operators of these tools and the end product. If a physician is creating the product onsite, the healthcare facility must ensure adequate risk transfer or financing for both the hospital facility and physicians involved.
      

The revolution created by 3D printing of medical devices is here to stay, and in the future, it is expected to even construct living body parts. In fact, in the March 2016 issue of the scientific journal, Nature Biotechnology, a Wake Forest University Institute for Regenerative Medicine study team describes its cutting edge research into "bioprinting" technology — growing customized organs and tissues from an individual's own cells.

The global expansion of healthcare access and emphasis on wellness coupled with longer life expectancy, consumer driven healthcare and demand for immediacy of care will continue to fuel rapid patient product customization and innovation. Allied Market Research's November 2016 report projects that the global 3D-printed medical device market will sharply grow to $2.36 billion by 2020, up from $579 million in 2014.

As the healthcare industry's use of 3D-printing technology grows, product liability remains a vulnerable area for all stakeholders in its development and use based upon questions surrounding U.S. and global regulatory oversight and the substantial risk of new causes of action that may arise surrounding its use. Following the risk control measures outlined in this article can help to mitigate some of this risk. My colleagues and I provide further detail on 3D printing risks in this edition of Life Sciences POV, Three-dimensional Printing: Key Regulatory and Risk Issues.

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