Mahboobin 10:00
L08
THE ETHICS BEHIND USING 3D PRINTED ORGANS V. HUMAN
TRANSPLANTED ORGANS
Stephanie Viscovich (snv10@pitt.edu)
CASE STUDY: A BIOMEDICAL
ENGINEER’S DILEMMA
safest in this case. Engineer A goes through each process to
help her decide.
It’s 2028 and bioprinting has revolutionized the field of
regenerative medicine. Because of extensive research done at
the University of Pennsylvania, tissues and organs created
from 3D printing are now able to be vascularized, so they can
survive in the body with a supply of blood and nutrients [1].
This has made 3D printing organs a viable option for organ
transplant patients and other patients that are in need of new
bodily tissues.
Engineer A is a manager for a medical device company
that is in charge of carrying out the 3D printing of organs for
the patients. She has the ultimate responsibility to decide
whether one of their 3D printed organs is fit to be used in a
transplant procedure. Her most recent case is kidneytransplant patient, Patient A, who is in critical condition.
Patient A needs a transplant within the next month before it
would be too late to save him/her. Unfortunately, the patient
is not at the top of the organ transplant waiting list, so it is
unlikely that an organ will become available in just a few
weeks. Engineer A goes through the process of creating the
3D printed kidney. However, a miscalculation occurs when
determining the amount of surfactants and humectants to use.
These chemicals reduce viscosity of the cell suspension, or
bio-ink, which helps prevent clumping and makes the overall
process much smoother. However, when used, they may
cause damage to the cells and create challenges in
constructing an organ suitable for implementation [2].
Engineer A is able to produce an organ, but fears that it may
not function properly in the body if implanted. The only other
option is to wait for a kidney to become available on the organ
donor list. Engineer A has a decision to make: either to deny
the implementation of the printed organ and risk the death of
the patient, or allow the organ to be implanted, and risk its
malfunction or rejection by the body.
Safety of 3D-Printed Organs
DISCUSSION OF SAFETY OF EACH
PROCESS
Engineer A has to consider several different ethical
dilemmas when determining which course of action to take.
She has to first consider the safety and well-being of Patient
A. Fundamental Canon 1 of the National Society of
Profession Engineers’ Code of Ethics states that engineers
should always “hold paramount the safety, health, and welfare
of the public” [3]. She has to determine which option, the 3D
printed organ or the human-transplanted organ, would be the
University of Pittsburgh, Swanson School of Engineering 1
2014-10-28
The process of 3D printing biological material, or
“bioprinting”, applies 3D printing concepts to create new
tissues and organs [4]. In this process, suspensions of living
cells from the patient function as the living “ink” for the
printers [5]. To design a fully developed organ, Jordan Miller
and his research team at the University of Pennsylvania had
to develop a system for creating vasculatures for tissues. The
process starts with a mixture of glucose and sucrose that the
research team converts into a free standing 3D vascular
template using an open source 3D printer called the RepRap.
The sugar template creates a temporary set of guiding pipes
where fluid will flow. After it is printed, it is coated in a thin
layer of corn-based degradable polymer to help stabilize the
sugar. Miller and his colleagues then pour living cells around
the template to encapsulate it in what becomes solid tissue.
The sugar template dissolves, leaving a bare vascular network
through which nutrients can flow. This would allow for an
organ to be made around the vascular network using the cell
suspensions [1]. However, the cell mixtures used in the
seeding process can clump up, which slows down the whole
process. As mentioned before, chemicals like surfactants and
humectants are used to reduce viscosity and help prevent this
clumping, but they may negatively affect the functionality of
the cells and the ensuing organs [2].
Safety of Human Transplanted Organs
The process of obtaining an organ through human
transplant is quite different. The first step in a human
transplant process is matching the patient with an available
organ from a donor. This process starts when a patient is
accepted onto a waiting list at a transplant hospital. When this
happens, he/she is registered in a centralized, national
computer network that links all donors and transplant
candidates. The United Network for Organ Sharing (UNOS)
Organ Center assists with the matching, sharing and
transportation of organs by means of this computer network.
The UNOS takes special interest in kidney transplants
because they are the most prevalent, and occasionally the
UNOS headquarters will handle the matching process to find
a perfect match. When a donor is found, organ procurement
organizations (OPO), who control the logistics between the
donor, the hospital, and the potential recipient, enter donor
information into the computer network and access the
computer matching program. The computer program creates
Stephanie Viscovich
a list of potential recipients ranked according to objective
criteria specific to that organ. This criteria includes:
 blood type
 tissue type
 size of the organ
 medical urgency of the patient
 time on the waiting list
 distance between donor and recipient
Many different factors contribute to how quickly an organ
can be transported to a patient on the transplant waiting list.
According to the Organ Procurement and Transplantation
Network (OPTN), transplant data shows that more and more
people receive transplants every year and that an increased
number of patients are living longer lives after receiving their
organs. However, there is no doubt that there is a significant
disparity between the number of donors and the number of
patients on the waiting list. For example, during a period of
time from January to August 2014, 21,877 patients were
added to waiting list for kidney transplants, while only 7,268
were added to the donor list over the same time period
according to OPTN data. In other words, the number of
patients who needed transplants increased three times faster
than the number of available donors. This means that a patient
that is accepted onto the waiting list would have to wait for an
indeterminate period of time waiting for an organ to become
available. This data is compounded by the fact that kidney
transplant waiting list patients make up the majority of the
organ transplant waiting list. As of October 2014, there were
120, 470 waiting list candidates, and 98, 423 (81.7%) of those
were in need of kidney transplants [6].
Even if there were enough donors to compensate for every
patient on the waiting list, there’s no certainty that the
available organs would be compatible with the patients. As
mentioned before, there is an extensive matching process that
must be carried out to determine if an available kidney could
be transplanted into a potential recipient. If the donor is
classified a universal donor, they would automatically be a
match for the recipient. Otherwise, the blood type of the
donor’s kidney would have to match up with the blood type
of the patient’s. Next, the size of the available kidney would
have to be the right size to safely fit into the body of the
recipient. In addition to the physical aspects of the organ at
hand, logistics concerning the patient also play an important
role in the matching process. For example, if a kidney was a
match to two different patients, the organ would go to the
patient with the more serious health issue. If their medical
conditions were the same, the patient that had been waiting on
the waiting list for the longest period of time would be the
recipient. Another factor is the distance between the donor
and the recipient, and since organs can only survive for a
limited amount of time outside of the body after they have
been recovered, the patient closer to the location of the organ
would receive it [6]. This process is undoubtedly complicated,
but it is to ensure the survival of the patient.
After a list of potential recipients is obtained, the
procurement coordinator contacts the transplant surgeon
caring for the top-ranked patient, based on the criteria, to offer
the organ. Depending on various factors, such as the donor's
medical history and the current health of the potential
recipient, the transplant surgeon determines if the organ is
suitable for the patient. If it is not, the coordinator will
continue the process until a recipient is found. Once the organ
is accepted for a potential recipient, transportation
arrangements are made for the surgical teams to come to the
donor hospital and surgery is scheduled. The recovered
organs are stored in a cold organ preservation solution and
transported from the donor to the recipient hospital. Kidneys
typically have a one to two day preservation window from
donor to recipient. When a kidney is recovered from the
donor, laboratory tests are carried out to measure the
compatibility between the donor organ and recipient. If the
tests show that the kidney is incompatible and would be
rejected by the prospective patient’s immune system, the
doctor will deny the use of the organ for that patient. The
recovered organ would only be paired with a patient whose
body could receive the organ, eliminating the possibility that
a transplant could occur in which the transplanted organ
would be rejected [6]. This complicated system minimizes the
failures of kidney transplants, while the system of 3D printing
organs has yielded many more failures [5].
DISCUSSION OF EFFICIENCY OF EACH
PROCESS
While issues regarding the safety of Patient A should be
held “paramount” in this case, another point of interest to
consider is the length and feasibility of each process,
especially in a case like this when time is of the essence.
Article 2 of the Biomedical Engineering Health Care
Obligations Section of the Biomedical Engineering Society
Code of Ethics states that biomedical engineers involved in
health care activities shall “consider the larger consequences
of their work in regard to cost, availability, and delivery of
health care” [7]. In addition to ensuring the safety of the
patient, Engineer A has to determine which method the organ
could be delivered to Patient A efficiently and effectively.
Efficiency of 3D-Printed Organs
In comparison, there are fewer factors that influence the
implementation of a 3D-printed organ into a waiting list
candidate. The organs are fabricated from the living cells of
the patient, so they can be specifically designed to fit that
specific patient [5]. The recipient would not be limited by
location or the severity of their condition. The only factors
that affect how quickly a patient could receive an organ would
Efficiency of Human Transplant Process
2
Stephanie Viscovich
be the availability of advanced 3D printers and staff to carry
out the organ fabrication process. Since the patient wouldn’t
have to wait for a donor, they wouldn’t have to go through the
complicated match process. The 3D printer would produce a
kidney from the patient’s own cells in much less time than it
would take to find a match from an organ donor. However,
the process still isn’t perfect. There are chemicals used in the
3D synthesis of the organ which could harm a recipient once
it is in his/her body if they are used in incorrect quantities.
Essentially, doctors and engineers must put their trust in a
machine to output the right amount of chemicals. The 3D
printing process is efficient with regard to speedy production
of the organ, which is crucial if the patient is in critical
condition. The problem becomes how effective the organ is
once it is in the body.
Engineer A could draw insight from the biography and
corresponding movie, “Gifted Hands: The Ben Carson Story.”
Ben Carson, a 20th Century African-American neurosurgeon,
faced a situation in 1987 that had life or death implications. A
couple with twins conjoined at the head asked Dr. Carson to
perform surgery on the twins to separate them; however, up
until this point, these surgeries had always resulted in the
death of one of the twins. Dr. Carson took the risk, and ended
up saving the lives of both children [10]. In this case, Dr.
Carson complied with Article 2 of the Biomedical
Engineering Health Care Obligations Section of the
Biomedical Engineering Society Code of Ethics. He did not
deny the family “delivery of health care,” as stated in the
Code. When the couple asked him to go through with the
surgery, he fulfilled their request accordingly, and ended up
saving their children [6].
In August of 2014, a 2-year-old girl in Illinois, born
without a trachea, received a windpipe 3D-printed with her
own stem cells. Each strip of windpipe tissue took about 45
minutes to print, and it took another two days for the cells to
grow and mature. In this case, a 3D-printed windpipe was the
girl’s only chance of survival. The doctor and the engineer
involved in the case knew that there was no guaranteeing the
organ would be accepted by her system. They knew that an
organ created from the girl’s own cells would dramatically
lower the risk of rejection, so they went through with the
surgery [11]. Although the risky procedure jeopardized the
safety of the patient, the girl would have died if she didn’t
receive the organ. Since there was no “safer” option, the
doctors and engineers behind the surgery and the organ
synthesis did not violate Fundamental Canon 1 of the National
Society of Professional Engineers’ Code of Ethics [3].
In Engineer A’s scenario, there exists another alternative
to the 3D printed organ. It may be worth it for Engineer A to
put off the surgery for two to three weeks to see if a match is
found with a kidney donor. If donor becomes available and
Patient A’s body is compatible with the kidney, then Patient
A would have a much higher chance of surviving post-surgery
than if the 3D organ was implanted instead. If Engineer A
chooses to implant the 3D organ, and after the procedure is
complete, a kidney from a donor becomes available, it would
be too dangerous to do a second surgery to implant the donor
kidney. A human organ transplant would not jeopardize the
patient’s safety and the Code would not be violated. On the
other hand, refusing to implant the 3D-printed kidney while
the patient is in critical condition could go against the
patient’s right to proper health care [2].
DISCUSSION OF ETHICS IN
TECHNOLOGY AND ENGINEERING
Engineer A must consider several things before coming to
a final decision in this scenario as it pertains to ethics in
engineering. Because the situation pertains to a newer
technological innovation that has yet to be perfected, she
would have to consider the risks behind using it to produce
something that will have a direct impact on an individual’s
survival. In the book Ethics for Biomedical Engineers, it
states:
“While the advancement of technology has brought about
many improvements and conveniences to the lives of people,
it can also inflate the damages to human lives when mishaps
involving technology occur” [8].
This quote is particularly applicable in this case, because
the “mishaps (sic) involving technology” could refer to the
miscalculation of the amount humectants and surfactants.
Since Engineer A is not 100% confident that the
miscalculation won’t harm the patient once she implants the
organ, she must decide if it is worth it to implant it anyway,
since it is likely the patient’s only chance of survival. Despite
the many benefits of using 3D printing, there are still mistakes
that can be made. These mistakes can have dire consequences
in a case such as this one. On the other hand, in the system of
human organ donation, technology is relied upon heavily in
the form of computers. Computers are largely responsible for
the successful pairing of patient and donor. However, as
mentioned in Ethics for Bioengineers, “when computers are
‘down,’ the individual, the local economy, the country, and
even the world can be affected” [9]. So in the case of a
computer system malfunction in the UNOS, all the patients
on the waiting list who need to be matched with a donor would
have to wait even longer for an organ. The difference with the
method of human organ donation is that this process gives the
patient a much higher chance of living, they just have to wait
longer for the organ.
FINAL COURSE OF ACTION
Engineer A reviews all the different factors before making
a final decision on whether or not to use the 3D-printed organ.
First, with regard to safety, she decides that a human
transplant would be safer, because there is a thorough process
POSSIBLE SOURCES OF INSIGHT
3
Stephanie Viscovich
[9] M. Frize. (2011). “Ethics for Bioengineers.” Synthesis
Lectures on Biomedical Engineering. (Online Journal).
doi:10.2200/S00393ED1V01Y201111BME042
carried out to make sure that an organ is compatible with the
body of the recipient. Engineer A is still not confident about
the 3D printed organ, doubting whether it would be properly
functional in the body. Despite this, Engineer A does not think
it is feasible for Patient A to wait for a human transplant
because the matching process can be lengthy, and given the
severity of Patient A’s condition, a kidney needs to be
transplanted as soon as possible. So, just as Ben Carson did,
Engineer A takes a risk, hoping that a positive result will be
the outcome, just like it was for the doctor. However,
Engineer A realizes she could be jeopardizing the safety of
the patient, which is a violation of the NSPE Code of Ethics
for Engineers. Therefore, she complies with Section II,
Article f of the Code by reporting her decision to give Patient
A the 3D printed organ in question to the NSPE, and awaits
future response and/or consequences [3].
[10] “Gifted Hands: The Ben Carson Story.” (2011, April 10).
(video). http://www.youtube.com/watch?v=hE1-XmqPo5k
[11] T. Miller. (2014, January 27). “New York docs’ 3Dprinted windpipe may one day let patients breathe easier.”
Daily
News.
http://www.nydailynews.com/lifestyle/health/new-york-docs-3d-printed-windpipe-representsfuture-transplants-article-1.1589497
ADDITIONAL SOURCES
“Adoption of a Safe Component” Stanford Bioscience.
(Research
Report).
http://biodesign.stanford.edu/bdn/resources/ethicscases.jsp
REFERENCES
R. Berry. (2013, April 9). “Ethical and Policy Problems in
Synthetic Biology: Emergent Behaviors of Integrated Cellular
Systems (EBICS).” Online Ethics Center for Engineering.
(Research
Report).
http://www.onlineethics.org/Resources/Cases.aspx
[1] E. Waltz. (2012). “Scientists Build Vascular Network
Using Sugar and a 3-D Printer.” Institute of Electrical and
Electronics Engineers Spectrum. (Online Article).
http://spectrum.ieee.org/techtalk/biomedical/devices/scientists-create-vascular-networkusing-sugar-and-a-3d-printer
“What’s the angle? (Case 1010).” Texas Tech UniversityEthics
Cases.
(Research
Report).
http://www.depts.ttu.edu/murdoughcenter/products/cases.ph
p
[2] C. Khatiwala., R. Law., B. Shepherd., S. Dorfman., M.
Csete. (2014). “3D Cell Bioprinting for Regenerative
Medicine Research And Therapies.” World Scientific.
(Research
Report).
http://www.worldscientific.com/doi/pdf/10.1142/S15685586
11000301
ACKNOWLEDGMENTS
I’d like to thank my writing instructor, Julianne McAdoo,
for meeting with me in the writing center and revising my
paper. I’d also like to thank my fellow engineering peers, who
helped guide me along the paper, and helped me revise.
I’d also like to acknowledge the website for the “Organ
Procurement and Transplantation Network”. The website is
run under the supervision of the Health and Resources
Services Administration of the United States Department of
Health and Human Services, and provides a plethora of
information on organ transplants and donors.
The librarians at Hillman Library were also a great help
with finding books relevant to engineering ethics.
[3] (2007). Code of Ethics for Engineers. National Society of
Professional Engineers. (Print).
[4] (2014). “3D printing.” Encyclopedia Brittanica. (Online
Encyclopedia
Entry).
http://www.britannica.com/EBchecked/topic/593719/3Dprinting
[5] H. Lipson., M. Kurman. (2013). “Fabricated: The New
World of 3D Printing.” (Online Book).
[6] (2014). “The Organ Procurement and Transplant
Network”. United States Health Resources and Services
Administration.
(Online
Database).
http://optn.transplant.hrsa.gov/
[7] (2004). Code of Ethics. Biomedical Engineering Society.
(Print).
[8] J.Y.A. Foo., S.J. Wilson., A.P. Bradley., W. Gwee., D.K.W. Tam. (2013). “Ethics for Biomedical Engineers.” New
York. Springer. (Online Book). Pp. 1
4