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Haley Bryant
Mrs. Crist
English IV
10 November 2016

Health Care Officials Insuring the Safety of 3D Printing

Imagine a patient was about to get a 3D device in them, would you as a patient be
worried about the safety measures? The safety of receiving a medical 3D printed device is a very
important to insure that everything goes as planned. The wellness and safety of the patient
becomes a major concern to doctors and healthcare officials. In order for the doctors to have a
successful transplant they must take all safety measures. As medical 3D printing is evolving,
healthcare officials are insuring the safety of receiving a customized 3D printed device by
performing specialized test and safety measures.
First of all, the customization of a 3D printed device is complex, it requires special test
and safety measures that must be taken for the patient to qualify. For example, Given the
numerous materials utilized in 3D printing, a variety of sterilization processes can potentially be
employed (Morrison). There are many materials used to build a device they must insure that the
device is sterile before it it given to the patient. According to research, Regardless of the
sterilization process, 3D-printed implants require the same validation of SAL as any other
medical implant and results must be presented to the FDA as a part of the marketing application
(Morrison). The requirements to receive a medical 3D printed device are basically the same as
any other medical implant done. Morrisons research says, Validation will be performed using a
battery of testing, including biological indicator testing, pyrogenicity and endotoxin testing, and

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residual EtO gas testing (Morrison). In order for them to validate that the patient is fit enough
for the 3D device, they require several tests to be done as a safety precaution.
Secondly, the regulation of a medical 3D printed device plays a major role in transplant
surgery to insure the safety and wellness of the patient. For example, regulatory rules for
orthopaedic insoles should be different from rules for 3D-printed surgical guides, implants and
plates, since the latter will require more stringent quality requirements (Vancraen). Rules and
regulations are different for different types of 3D printed devices. According to Vancraens
article, our opinion is that the very broad custom-made medical devices category does not
accurately address the needs and potential risks of using 3D printing to design, produce and use
patient-specific medical devices. Vancraen believes that medical 3D printed devices do not
specify on the potential risks and hazards that the patient has. The article also says, each device
is designed and manufactured based on a patient's medical image data, which ensures a perfect fit
with his/her unique anatomy (Vancraen). The patient must endure several different test to have
the perfect fit for the patient's 3D printed device.
Lastly, when in surgery doctors must work together as a team in order to have a
successful and safe surgery. For example, before initiating a surgery, it is extremely vital for the
whole surgical team to collaborate for an effective surgery, the fundamental of those are that
there should be comprehensive understanding of the condition of the patient and how to apply
the surgical knowledge in the right manner (AlAli). The safest way to complete a 3D printed
device transplant is when the whole surgical team works together. For example, while the
current practice might be adequate for surgical planning in some cases, other complex cases
require a better understanding that will lead to better results, decreased incidence of
complications, and decreased time or surgical procedures (AlAli). The better understanding

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doctors have of the cases, makes it safer for the patient and the success rate is much higher. For
example, 3D printing possesses the ability to produce similar type of models of body organs and
structures. This has generated a lot of interest in the field of surgical planning among different
surgical specialties (AlAli). 3D printing is a complex surgical speciality, that requires special
planning to be done before the transplant.
As medical 3D printing is evolving, health care officials are insuring the safety of
receiving a customized 3D printed device by performing specialized test and safety measures.
Medical 3D printing is a very difficult speciality and it requires specialized test to be performed
on the patient to see if they will qualify. Getting a 3D printed device in a patient is a form of
transplant surgery and it takes tons of practice and specialized surgical planning. It will take a
whole surgical team to plan a safe and a successful surgery, and in order for the patient to have a
successful transplant she must be completely fit for the printed device.

Works Cited
AlAli, Ahmad B., Michelle F. Griffin, and Peter E. Butler. "Three-Dimensional Printing Surgical
Applications." Eplasty: Open Access Journal Of Plastic Surgery 15.(2015): 352-367.

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Academic Search Complete. Web. 19 Oct. 2016.
Morrison, Robert J, et al. "Regulatory Considerations In The Design And Manufacturing Of
Implantable 3D-Printed Medical Devices." Clinical And Translational Science 8.5
(2015): 594-600. MEDLINE. Web. 18 Oct. 2016.
Vancraen, Wilfried. "Innovation Outpacing EU Regulation: The Case for Medical 3D Printing."
Medtech Views. N.p., 2014. Web. 18 Oct. 2016.