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Staff writer Tanya Lewis published in the journal Life: 09/03/30 am 09: 22 EDT when Kaiba Gionfriddo was only a few months old
The printing device saved his life.
Kaba was born with a rare disease called the trachea obronacia alacia, which means that his trachea is weak and will collapse and prevent the air from flowing to his lungs.
Researchers at the University of Michigan seek approval from the United States. S.
Food and Drug Administration 3D-
They implanted printed trachea splints around the baby's airway to help him breathe.
Thanks to 3D printing technology, which can produce objects of any shape from computer models, including medical devices customized for patients, these stories are becoming more and more common.
To keep up, the FDA is now working on how to evaluate medical devices made using 3D printers.
The skull of another patient was replaced by 75% in 3D.
Customized printed implant for his head.
FDA also has 3D
Printing equipment such as a spinal fusion device and a hip Cup, part of a hip impact, mounted on a hip socket. [
7 Cool uses of 3D printing in medicine]
FDA is currently treating 3D
fda spokesman said printing equipment is the same as traditional medical equipment.
'We evaluate all equipment, including any equipment that uses 3D printing technology, to ensure safety and effectiveness, and to identify appropriate benefits and risks, regardless of the manufacturing technology used, spokesman Susan Lane told Life Science in an email.
She added, 'In some cases, we may ask the manufacturer to provide us with additional data based on the complexity of the device.
'In order for the new device to be approved by the FDA, its creator must demonstrate that the device is equivalent to the same-purpose device that has been sold, or that the device must go through a pre-market approval process.
Anyone, not just a medical device company, can submit a piece of equipment for approval.
But because 3D-
Printed Products use different manufacturing methods than traditional medical devices, and they may require additional or different forms of testing.
Two FDA laboratories are working on the impact of 3D printing on the way medical devices will be produced in the future.
FDA's functional performance and equipment use computers in the laboratory
Modeling methods to determine how adjustments to the design of medical products affect their safety and performance in a variety of patient populations.
Understanding the effects of these adjustments helps the FDA to evaluate devices tailored to individual patients or groups.
The focus of the FDA Solid Mechanics Laboratory is on how different printing methods affect the strength and durability of materials used in manufacturing equipment.
The lab's findings 'will help us to develop standards and set parameters for scale, materials and other key aspects that contribute to product safety and innovation, FDA scientists wrote in a recent blog post.
3D printing makes it easier to customize the device according to the specific anatomy of the patient.
For example, custom dental equipment, hearing aid earplugs and surgical instruments can be created using medical imaging.
Laine said the FDA reviews each device as a separate submission, but the manufacturer does not have to get approval for patients with each device being adjusted.
President Barack Obama launched a national effort in August 2012 at companies, universities and non-profit organizations to support the new 'additive manufacturing '(3D printing)
Technology known as the National Institute of Additive Manufacturing Innovation (NAMII).
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Original article about life science.