FDA Must Oversee Medical 3D Printing

3D printing is becoming increasingly more popular in the medical field. 3D printed models help surgeons prepare for surgeries and customized prosthetics and implants are becoming more accessible. As 3D printing continues to be used in healthcare, regulatory guidelines are becoming increasingly more involved. Since 3D printing can be so different depending on the category within medicine it is serving, it will take time before the regulations become all encompassing.

How is 3D printing used in healthcare?

“To date, most FDA-reviewed products developed via 3D printing have been medical devices such as orthopedic implants; more than 100 have been reviewed.3 Such a manufacturing approach offers several clinical advantages.”

Since the 3D printing process involves stacking material layer by layer, more complex geometries can be achieved as opposed to other more traditional style manufacturing processes that involve carving out of an existing form. Another benefit of 3D printing that is particularly helpful in medicine is the ability to create a device or part at once, whereas other manufacturing processes typically require several parts to be developed separately.

“Because this type of manufacturing does not rely on molds or multiple pieces of specialized equipment and designs can rapidly be modified, 3D printing can also be used for creating patient-matched products based on the patient’s anatomy. Examples include joint replacements, cranial implants, and dental restorations.5 While some large-scale manufacturers are creating and marketing these products, this level of customization is also being used at the site of patient care in what is called point-of-care manufacturing. This on-demand creation of 3D-printed medical products is based on a patient’s imaging data. Medical devices that are printed at the point of care include patient-matched anatomical models, prosthetics, and surgical guides, which are tools that help guide surgeons on where to cut during an operation. The number of U.S. hospitals with a centralized 3D printing facility has grown rapidly in the past decade, from just three in 2010 to more than 100 by 2019. As the technology evolves, this point-of-care model may become even more widespread.”

What does 3D printing regulations look like?

The FDA (Food and Drug Administration) is responsible for reviewing and regulating medical 3D printed parts. The regulation process is not exactly straightforward because. What product is being made, the intended use of the product and the potential risks that exist for the patient are three key factors that look different depending on the medical 3D printing technology at hand. It is common that the FDA is having to develop regulations and guidelines at a case by case basis.

“FDA classifies devices based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I devices are low risk and include products such as bandages and handheld surgical instruments. Class II devices are considered moderate risk and include items such as infusion pumps, while Class III devices, which are considered high risk, include products that are life-supporting or life-sustaining, substantially important in preventing impairment of human health, or present an unreasonable risk of illness or injury. A pacemaker is an example of a Class III device.”

 

If you’re interested in learning more about the FDA regulations on medical 3D printing, for example learning about some of the challenges the FDA faces and how its crucial to find the balance of innovation and safety, make sure you read the full article here.

Categories: Innovation