3D Imaging in Healthcare

Sarah Normile, Andrea RitchieChristina Sniecikowski, Mona Wissa

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Overview: Effects of technology on healthcare and how some solutions that have been explored recently by medical professionals can save lives and enhance the quality of life of many patients.

Critical questions needs to be resolved before this incredible technology makes a greater impact in the field of medicine regarding material, cost, liability, FDA approval, and other ethical concerns.

3D Imaging in Healthcare

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Learning Objectives:● What is 3D printing?● How can the Healthcare field benefit from 3D printing?● Current successful procedures and future goals● What are the challenges for 3D printing?● Who is responsible for the design of the 3D “blueprints”?● Who is liable if something goes wrong?● Ethical concerns● How does a product get FDA approval?

3D Imaging in Healthcare

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● 3D printing “is a method of building objects layer-by-microscopic layer, fusing each cross-section of molecules until a complete object is formed” (Pellet, 2013, para. 2).

● Digital directions (gathered from an MRI or CT, for example) are used to layer-by-layer print and fuse specific materials creating a three-dimensional complex object (Hayhurst, 2014).

What is 3D Printing?

Image (Diana, 2014)

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● 3D printing can be used by healthcare professionals for surgical planning and reconstruction.

● Bio printers, using a “bio-ink” made of living cell mixtures can build a 3D structure of cells, layer-by-layer, to form human tissue and eventually human organs for replacements (Thompson, 2012).

● 3D printed materials are used for supportive care that more precisely fit the patient’s size and needs (e.g. leg braces and dental retainers) (Miller, 2014).

How can Healthcare Benefit from 3D Printing?

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Current Achievements in 3D Printing

● Supportive devices such as crutches

● Dentistry products and instruments (e.g. crowns and molds)

● Prosthetic limbs (such as hands and fingers)

● Artificial bones, tissues, and organs (e.g. hips, skulls, and kidneys)

(Hayhurst, 2014)Image (Diana, 2014)

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“The first 3D-Printed Skull Implant in the United States”

● When? March 4, 2013, only two weeks after the FDA approval.

● Who? Oxford Performance Materials (OPM)

● How? Digital image of the patient’s skull taken and used to build an imprint. Thin layers of polytherketoneketone (PEKK) printed and fused together.

(Hayhurst, 2014, p. 15)

Image (Diana, 2014)7

“The First 3D-Printed Skull Implant in the United States” Cont’d.

● Goal? Once implanted, the 3D printed skull would gradually activate bone growth, first along the edges until it becomes a portion of the patient’s cranium.

● Why PEKK? The material determines the action. PEKK is biocompatible and osteoconductive.

(Hayhurst, 2014, p. 15)8

Building Respiratory Tissue

● Using noninvasive MRI images, physicians created a tracheal splint. After being 3D printed from polycaprolactone (PCL) material, it was implanted into a patient whose respiration improved dramatically. “The splint is expected to be fully absorbed within three years” (Miller, 2014, p. 4).

Image (Diana, 2014)9

Building Cardiovascular Tissue

● Blood vessels are scanned using microcomputed tomography (micro-CT).

● This data is then used for 3D imaging and printing of new blood vessels.

● Outcome: Healthcare no longer needs to rely solely on angiogenesis to treat people with conditions such as atherosclerosis and angina (Miller, 2014).

“The shortage of organs is the driving force for making a lot of these tissues for implantation” (Giges, 2014, para. 9). -Prof. Ali Khademhosseini, Harvard Medical School

Image (Giges, 2014)

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3D Printing and Dentistry

● Dentists use “cone beam tomography, three-dimensional facial imaging, and various scanning techniques” when using 3D imaging (Kasparova et al., 2013, p. 2).

● Three main dentistry fields using 3D imaging: orthodontics, conservative dentistry, and prosthodontics.

● Current successful products created using 3D imaging: Teeth for dental implants, dental casts, crowns, and bridges. (Kasparova et al., 2013). Image (Diana, 2014)

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The Future:If the Tissue Can Be Replaced,

it Can be 3D PrintedAccording to Levine and Goldschlag (2014), society will see the following in healthcare thanks to 3D printing:● Prosthetics or organs for fetuses with defects such as cleft lip or impaired

heart valves● Replication of tumors to practice difficult surgeries to remove cancer● Creation of skin and muscle grafts● Prosthetic eyes that can actually regain vision● Mapping and printing livers for drug research to determine adverse effects

of medication without the need of human subjects12

● Limited Materials: “High strength plastic, metals” (Cornell, n.d., para. 2).

● Questionable Accuracy: “Many materials print to either +/- 0.1 mm in accuracy meaning there is room for error” (Cornell, n.d., para. 3).

What are the Challenges for 3D Printing?

● Size: “Parts created additively through 3D printing are also limited in size” (Cornell, n.d., para. 5).

Healthcare is just beginning to explore the limits of this technology.Expected challenges are:

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Who is Responsible and Qualified for the 3D “Blueprints”?

● Determining who is responsible for the design of 3D parts, especially organs, is a problem when integrating the procedure into healthcare.

● Doctors and surgeons seem to be the obvious answer but are they truly qualified to design it just because they are qualified to use the part in their patients ?

(Fenske, 2014)

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Who is Responsible and Qualified for the 3D “Blueprints”? Cont’d.

Recommendation:● Developers from around the world work through an open-source

resource to work together and create a product that is good enough to be put in another person.

If many developers work together to design 3D parts, the question now is who is liable if something goes wrong?

(Fenske, 2014)

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● Who should be held responsible if there is a fault established in the 3D print?

● Currently, if a patient tries to dispute their treatment, multiple people could be contested from the equipment constructor to the material distributor to the clinician and healthcare establishment.

(Fenske, 2014)

Who is Liable if Something Goes Wrong?

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Two Ethical Problems: ● 3D printing could be the only affordable and accessible solution for those

who can not afford the enormous price of prosthetics, but at the same time this solution poses a variety of ethical concerns (Khan, 2014).

● 3D printed parts might bypass critical medical regulations and pose serious health and safety risks. This is a problem that leads to the question of how does a product get FDA approval (ABA, 2014).

Ethical Concerns Regarding the 3D Printing of Low-Cost Prosthetic Limbs

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Two Recommendations:

1. Use 3D printing technology in mass production of highly customizable and inexpensive product, without the expensive testing procedures to ensure patients safety.

2. Engage in costly materials and safety tests in order to comply with medical and professional standards.

Arguments exist for the ethicality of each option, and both arguments present a valid ethical reason for pursuing one course of action over the other.(ABA, 2014).

Ethical Concerns Cont’d.

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How Does a Product Get FDA Approval?

3D imaging products produced in a hospital setting: ● If the product is unable to be put through the normal safety measures, the

FDA may not be able to give approval for use in patients.

● Even if a manufactured part was continually tested and received FDA approval, there is no way of knowing if that product is the same as the one being printed in the hospital for use in patients.

● If a system can not be set up to guarantee safety for patients it is likely that 3D printing will not be approved by the FDA.

(Fenske, 2014)19

Discussion Questions● 3D printed tissues, organs, etc. are made up by many different materials.

Most of the materials are extremely porous as to be similar to human tissues (Hayhurst, 2014).

Question 1: How will this change healthcare’s sterilization and cleaning techniques of not only the materials themselves but the machines used to print them?

● If FDA approved, 3D printers would be available to print new organs for those in need when needed, for those who could afford them (Giges, 2014).

Question 2: What criteria would a patient have to meet to qualify for a new 3D printed organ?

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● Earlier this year, physicians at a Kosair Children’s Hospital were able to use 3D printing to research defects of the patient’s heart and develop a working plan for surgery prior to operating on a child suffering from several heart defects (Lee, 2014).

Question 3: How will physicians be impacted in the future when using 3D printed organs more routinely to study disease and devise treatment plans?

● 4D printing is superior to 3D manufacturing techniques as it facilitates self-assembly of materials to manufacture parts and products, thereby speeding up the process and reducing need for labor (Miliard, 2014).

Question 4: Is 4D printing next for healthcare?

Discussion Questions Cont’d.

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Conclusion

3D printing will have a great impact on all aspects of human life. If more 3D printing is approved, nurses will have the challenge of creating leadership development programs and educational models to ensure that all nurses have expertise in using the new technology and proper teaching methods to ensure patient safety.

(Huston, 2013) 22

ReferencesABA. (2014). Panel discusses legal, ethical concerns of 3d printing. Retrieved from

http://www.americanbar.org/Cornell, S. (n.d.). Disadvantages of 3d printers. Retrieved from http://yourbusiness.azcentral.com/

Diana, A. (2014). 3d printing reshapes healthcare. Retrieved from http://www.informationweek.com/

Fenske, S. (2014). 3d printing a healthcare revolution. Medical Design Technology, 8 (4)

Giges, N. (2014). 3d-printed blood vessels. Retrieved from https://www.asme.org/

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References Cont’d.Hayhurst, C. (2014). Is this the future of medical technology?. Biomedical

Instrumentation & Technology, 48 (1), 14-23. doi: 10.2345/0899-8205-48.1.14Huston, C. (2013). Impact of emerging technology on nursing care: Warp speedahead. Online Journal of Issues in Nursing, 8(2). doi: 10.3912/OJIN.Vol18No02Man01 Khan, A. (2014). How 3d printing will revolutionize prosthetics. Retrieved from http://health.usnews.com/Kasparova, M., Grafova, L., Dvorak, P., Dostalova, T., Prochazka, A., Eliasova, H.,

&...Kakawand, S. (2013). Possibility of reconstruction of dental plaster cast from 3D digital study models. Biomedical Engineering Online, 12 (1), 1-11. doi: 10.1186/1475-925X-12-49 24

References Cont’d.

Lee, S. D. (2014). The future of 3d printing in healthcare. Retrieved from http://hitconsultant.net/Levine, B.A, & Goldschlag, D. (2014). Bioprinting: Creative disruptive

technology. Contemporary OB/GYN, 59 (1), 1-3Miller, J. (2014). The billion cell construct: Will three-dimensional printing

get us there?. Plos Biology 12Miliard, M. (2014). Is 4d printing next for healthcare?. Retrieved from http://www.healthcareitnews.com/Pellet, J. (2013). How 3d printing works. Retrieved from

http://individual.troweprice.com/25