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3D Printed Medical Equipment Raises Questions

As with any new tech development, there are many questions patients and consumers are asking. (Image:  FDA  via   wikimedia  /  CC0 1.0)
As with any new tech development, there are many questions patients and consumers are asking. (Image: FDA via wikimedia / CC0 1.0)

The world is transforming at breakneck speed, and technological advances are creating changes that seemed impossible less than a decade ago. 3D printers — printers that create a 3-diminensional object from a digital image — have been researched and worked on for the last 30 years. 3D printing promises a transformed medical future.

The impact of 3D printing today will be gradual, though once society leverages the fullness of the technology, the actual changes will be transformative. 3D printing technology is leading the way for transforming how people are taken care of. One place the field is already seeing change is with medical devices. As of this year, the Federal Drug Administration has approved over 85 applications for 3D printed medical devices.

Mock 3-D printed skull plate (cranioplasty) – the real medical device is used for patients who need a portion of their skull replaced. (Image: FDA via wikimedia / CC0 1.0)

Mock 3D printed skull plate (cranioplasty) — the real medical device is used for patients who need a portion of their skull replaced. (Image: FDA via wikimedia / CC0 1.0)

As with any new tech development, there are many questions patients and consumers are asking. Here are few of the most crucial concerns people have regarding 3D printed medical equipment.

How will designers test this equipment?

Designers must consider the use of the equipment for proper and adequate testing. For instance, with implantable devices — like stents — the device must be customized for each patient. Testing devices created for an individual could prove tricky, but the FDA requires manufacturers to specify varying dimensions for a device that would include all possible sizes.

The Snap-Together RoboHand prosthetic was invented by South African carpenter Richard van As and made available for free on the Internet. Before printing, the hand can be individually sized, and all connecting pieces are also printed. The device can now be printed for less than $100. (Image: FDA via wikimedia / CC0 1.0)

The Snap-Together RoboHand prosthetic was invented by South African carpenter Richard van As and made available for free on the Internet. Before printing, the hand can be individually sized, and all connecting pieces are also printed. The device can now be printed for less than $100. (Image: FDA via wikimedia / CC0 1.0)

For devices that don’t need customization and implantation, testing will be more streamlined, but equally rigorous. According to the FDA, 3D printed medical devices will undergo the same testing as non-3D devices, though testers will consider the building process of the device.

What regulations will the FDA impose?

The FDA first regulates who can create, label, or import any 3D printed medical device. Regulations will be similar to traditionally built-devices. The FDA has created a draft that regulates the manufacture, testing, and distribution of all 3D printed medical devices. There are two main areas of concern regarding them:

  1. Design considerations. The FDA will regulate the creation of the device — which can vary among 3D print designs.
  1. Device testing. What the testing phase should include and the process of implementation will be a crucial consideration during the discussion of regulations for the FDA.

How will designers create equipment for best performance?

Long-term performance is another question many people have regarding 3D printed equipment. The standards are high for the maintenance and creation of 3D printed medical equipment, as with any medical equipment. Printed devices will be tested for the same characteristics as traditionally created equipment, but when testing for performance, the build’s orientation — relative to 3D printing — will be considered.

How will sterilization impact the equipment?

As with any product used in the medical industry, the ability to clean and sterilize the material is crucial — better patient outcomes rely on it. 3D printed medical devices will necessitate the same rigorous cleaning standards, but they will require some flexibility in how it’s done. Radio frequency welding is one popular method of sterilization for medical and pharmaceutical companies.

(Image: via pixabay / CC0 1.0)

Radio frequency welding is one popular method of sterilization for medical and pharmaceutical companies. (Image: Pixabay / CC0 1.0)

Radio frequency welding ensures equipment is safe for medical use with no ill-effects to the sometimes-delicate equipment health care industries use. It’s a direct contrast to chemical-bonding cleaning processes that are standard. Chemical-bonding cleaning techniques are harsh and can damage equipment over time. The reliability of these methods is also a factor for medical industries to consider when using it to sterilize equipment.

Visualize the future for 3D printing in the medical industry

The future of 3D printing for the medical industry is only limited by the imagination. From pills to organs, it looks like the sky is the limit. The FDA recently approved the first-ever 3D printed medicine, SPRITAM, for epilepsy, and some scientists suggest the reproduction of body parts — by manufacturing cells and tissues — isn’t too far in the future.

The implications of 3D printing for the medical industry is exciting, but there’s still much to discover, and it’s still in early stages. Organs developed with 3D printing – customized for the specifics of a patient’s biology — may permanently change health care and improve the lives of millions.

The medical community will have the power of Dr. Frankenstein at their fingertips — remodeling life from digital images — let’s hope they have more wisdom. Thankfully, these parts and devices aren’t from graveyards and won’t need lightening to spark them into action. More importantly, they offer real-world applications throughout the medical field.


Megan Ray Nichols
    This article was written by Megan Ray Nichols. If you enjoyed this article, visit her page Schooled by Science.

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