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Lack of FDA Regulations on 3D Medical Printing Could be Putting Patients at Risk

October 7, 2015  ·  By HM&M

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The emersion of 3D medical printing has created quite the frenzy due to the stories of lives saved or improved because of the technology. Medical professionals, the media, and even the general public are mystified and entranced by the possibilities, the lives that could be enhanced, and the money that could be saved. But is it really all it is cracked up to be? Or is 3D medical printing a super storm of medical malpractice lawsuits waiting to happen?

What is 3D Medical Printing?

Three-dimensional printing, more commonly called 3D printing, works a lot like regular printing in the respect that it must have a template or format from which to create the printed item. But, unlike typical printers, the ink (or solution) adheres to itself in droplets, creating a three-dimensional item. In medical printing, the most commonly used solutions are comprised of powders or cells.

This technology can be used to make virtually anything. In the context of 3D medical printing, it is used to make medical devices. While this technology is not yet advanced enough to extend to the manufacturing of large, complex, vascular organs, such as the heart, kidney, or lungs, it has been used to make everything from prosthetic limbs to dental implants.

The Hidden Problem in 3D Printing

It might sound simple enough—3D printing—but there is a lot going on beyond the eyes of the public, namely the lack of regulations surrounding this fast-evolving technology. One prime example is the 3D creation of a working handgun and magazine clips. Though not related to the medical field, it brings to light just how loose current regulations are on 3D printing. And, much like a gun has the potential to end lives, 3D medical printing can and does have the potential to cause death or personal injury. Yet, the FDA currently regulates 3D printing much like any other medical device, with little to no respect to the complexities of 3D printing, and virtually no idea of how to move forward with better regulatory standards.

The Difficulty in Setting Regulatory Standards

Any number of things could go wrong with 3D medical printing; the code needed to print a device could be infected with a virus, the solution used to make a device could become contaminated, or the product could be altered to a point that it no longer works as effectively as it should, among others. But how do you begin to regulate such a complex device, particularly when it is typically used to create individualized products that are tailor-made to each patient? And where should the lines be when it comes to accountability for when something goes wrong?

If the solution is contaminated, is it the fault of the hospital for not storing it correctly? Or is it the fault of the supplier, who maybe failed to ship it properly? Or was it simply a matter of a failed device or a medical error made by the surgeon? If a virus happens, is the hospital responsible for implementing it? Or is it the code writer? Or is it the printer manufacturer?

All of these questions must be answered before 3D medical printing becomes mainstream. If they are not, the public may be at serious risk, and it may be unclear of whom, exactly, is to blame. As a result, there may be many victims and families that are left with very little ammunition when it comes to obtaining fair compensation for their personal injury or wrongful death lawsuits.

Injured by a Medical Mistake? Seek Qualified Legal Help

Clearly, medical malpractice suits—regardless of their nature—are complex. But victims do deserve fair compensation when they are injured or killed by a medical mistake. This is why it is essential that victims and their families seek qualified legal representation as soon as possible.

We understand just how deeply medical mistakes can affect the lives of victims and their loved ones. With the use of state-of-the-art technology and the expertise of medical specialists, our legal team provides your case with the kind of aggressive representation it deserves. For a free consultation with one of our Chicago medical malpractice attorneys.


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