Are 3D printed human organs a possibility in the near future?

By: Aminat Sanusi

Medically 3D printed human organs have the possibility to save many lives. The United Network for Organ Sharing controls the American transplant system and lists patients in need of an organ transplant. Procedures such as kidney and liver transplants are possible with living donors. But patients on the list for transplants of the heart and lungs are not so lucky. Imagine the infinite possibilities of being able to print a human organ to save a life, instead of waiting until someone died to use theirs? With constant innovation in medicine and the legal field trying to keep up, maybe in this decade or the next, medical trials of 3D printed organs will be a success.

In 2020, the average kidney transplant cost $442,500 and 3D printers cost up to $100,000. The expensive costs of organ transplant surgery come from the transport costs and the actual surgery of implanting the organ. Affordability and insurance coverage issues may arise from time to time but nothing extremely unusual from a normal organ transplant. Nevertheless, accessibility wouldn’t be a huge issue because the organ is created with the patient’s own cells versus a living or non-living organ donor.

What are the current regulations of 3D printed medical devices?

Medical 3D printing has already enhanced treatment for certain medical conditions such as joint replacements and prosthetic limbs. The Food and Drug Administration (FDA) is currently in charge of the regulation of products made and used in the medical field by a 3D printer. The FDA regulates 3D medical devices by categorizing them into groups based on their levels of risk. Regulatory control increases from Class I to Class III, with Class I devices posing the lowest risk to patients. Some requirements apply to the medical devices before they are marketed (premarket requirements), and others apply to the medical devices after they are marketed (postmarket requirements). 

The FDA also regulates the information and application process that the 3D printed medical device seeking acceptance should include. In 2016, the FDA issued a draft guidance to assist manufacturers who are producing medical devices through 3D printing with design, manufacturing, and testing considerations. The guidance categorizes two major topic areas: design and manufacturing considerations which addresses the quality sy draft guidance tstem of the device, and device testing considerations which addresses the type of information that should be included in premarket notification submissions. The FDA continues to evaluate submissions of new 3D printed medical devices to determine its safety and effectiveness.

How are 3D printed organs made?

The possibility of printing 3D human organs is in the near future with organ bioprinting. According to a 2019 medical study, organ bioprinting is the use of 3D printing technologies to assemble multiple cell types, growth factors and biomaterial in a layer-by-layer fashion to produce bioartificial organs that ideally imitate their natural counterparts. The ability to recreate organs with the patient’s own cells is key to avoiding the risk of the patient rejecting the organ or dying before they could be matched with a healthy organ.

Dr. Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, and Dr. Jennifer Lewis, a professor at Harvard University’s Wyss Institute for Biologically Inspired Engineering, discuss and explain the process of bioprinting. To begin the process of bioprinting an organ, the doctors need the patient’s cells, so they either choose to do a biopsy of an organ or surgically remove a piece of tissue from the patient’s body. Now the cells need to grow outside of the body, so it’s placed into an incubator that way it’s constantly fed nutrients. Next the cells are mixed with a gel which is similar to glue to create a printable mixture of living cells. Typically the gel is made out of collagen or gelatin. 

For the printing process, the 3D printer is programmed with the patient’s imaging data from X-rays or scans and then loaded with the bioink, which is the gel mixed with the patient’s cells, into the printing chamber to print the organ. Much similar to a regular printer that has cartridges filled with different colored ink, the 3D printer fills up its cartridges with cells. The printing process could take hours to weeks depending on the type of organ that is being printed.

As technological innovation becomes more successful and precise, 3D-printed organ transplants will likely become reality. However, there are current challenges involved with 3D bioprinted organ transplants. The first issue is the functioning of the 3D bioprinted organ is still undergoing testing and trials. The second issue is the uncertainty of how FDA regulations will control the manufacturing and testing of the 3D bioprinted organs. Lastly, the accessibility and affordability of the 3D printed organs is currently limited. 

3D bioprinted organs are created to be complex like a human organ and there are still many challenges to overcome with getting the printed organ to properly function alongside the other human organs in the body. It is still unclear how FDA regulations will be able to control the usage and safety of the product versus the manufacturing and engineering of the product. While there are already procedures in place for 3D printed medical devices like prosthetic limbs which could potentially be applied to bioprinted organs, the regulation of device testing may change because of the use of human cells to print the organs. 

So what comes next?

3D printed medical devices already exist. But why stop there? Why not 3D print human organs? In the award-winning American medical drama television series Grey’s Anatomy, the surgeon 3D printed a part of a human heart and surgically implanted it into the patient. Although the idea of it seems plausible on TV, the reality is a 3D printed human organ has yet to be implanted into a human body. However, that does not mean that 3D printing has not been utilized in the medical field.

Telemedicine to the Rescue? Mail Order Abortion in Times of Crisis

By: H.R. Fitzmorris

Since the time of the Comstock Act, reproductive healthcare seekers have turned to networks outside of the traditional doctor’s office to circumvent legal and social obstacles. Almost 60 years after the restriction of mail-order contraception was abandoned, Americans have once again—with the aid of the internet— found themselves relying on the post office to meet reproductive healthcare needs through telehealth. And once again, they face the familiar struggle of navigating complex webs of overlapping regulations and political hostility limiting their access to vital resources and information. However, the healthcare crisis spurred by the COVID-19 pandemic, and the resulting regulatory and legal changes, have helped abortion and reproductive healthcare seekers circumvent some of the most burdensome barriers to access. The question now is whether, together, technological advancement in online telehealth and the relaxation of state and federal regulations will be enough to address the “access crisis” that will ensue if the current onslaught of draconian abortion laws survives legal challenges.

The History of Telehealth and How It Works

The concept of telehealth has existed in some form or another for decades. Telehealth, according to the Mayo Clinic, “is the use of digital information and communication technologies, such as computers and mobile devices, to access health care services remotely and manage your health care.” Some clear advantages of telehealth are the ability to access care without the additional cost and burden of traveling to a doctor’s office, increased access to information and records, and increased speed of communication with healthcare providers.

There are, however, drawbacks. The regulatory system managing telehealth providers is fragmented between state and federal requirements, and insurance coverage of telehealth appointments varies according to location and provider. Licensure requirements currently depend on the location of the patient, so some specialist services or medical providers may not be licensed to provide care to patients in certain locations. Additionally, access to telehealth can be impeded by restrictive interpretations of existing state statutes and regulations. For example, state requirements that clinicians conduct an in-person physical exam of a patient before providing telehealth or issuing a prescription can dramatically impede the utility of telehealth for certain patients.

Currently telehealth makes up a small portion of the health industry as a whole. A study conducted from March 1, 2020 through November 30, 2021 revealed that the vast majority of Americans prefer in-person healthcare, “and the total addressable market for telehealth is less than 1% of the health economy.” However, the lessons learned throughout the COVID-19 pandemic may spur further expansion and increased interest in telehealth.

Covid-19 Changes

The COVID-19 pandemic upended the normal operation of innumerable day-to-day activities for most Americans. Once simple tasks became onerous, if not impossible. Notably, routine healthcare became extremely difficult to schedule when COVID exposure risks closed doctors’ offices, and the industry as a whole buckled under extreme demand. Faced with restricted access to in-person office visits due to lockdown orders and overwhelmed providers, patients turned to telemedicine just as quarantined workers turned to Zoom.

In order to facilitate patient access to healthcare, Congress introduced a myriad of temporary regulatory relaxations and measures such as increased Medicare and Medicaid coverage of telehealth services, HIPAA flexibility, and notably, allowed authorized providers to prescribe controlled substances via telehealth, without the need for an in-person medical evaluation.

This affected not just those with pulled muscles, allergic reactions, or people with other routine but time-sensitive ailments that a quick 15-minute chat with a doctor and a quick prescription would clear up. Those experiencing unwanted pregnancies, who faced the daunting prospect of delayed access to care in understandably time-sensitive situations, also were faced with lockdown and quarantine orders in the most abortion-friendly states. In hostile states, the harm of existing restrictive abortion regulations increased under COVID-19 (such as those requiring multiple in-person clinic visits like mandatory waiting periods and ultra-sound requirements). Additionally, some states that were hostile to abortion seized the opportunity to label abortion care as “non-essential,” thereby entirely restricting abortion access.

These restrictions made early access to safe, reliable, and self-administrable abortion care all the more vital. Medical abortion, which is achieved through the simple administration of a single or multi-dose pill, is available up to 10 weeks from conception. Prior to the COVID-19 pandemic, the reach of medical abortion through telemedicine was limited by “specific restrictions on mifepristone in the United States as well as laws that specifically prohibit telemedicine for abortion.” Specifically, the FDA required that either of the two abortion pills be dispensed in a medical clinic, in-person.

However, with the relaxation of the restrictions placed on telemedicine providers that came with the governmental response to COVID, the FDA relaxed the in-person requirement and allowed abortion pills to be obtained by mail, eliminating the need for a doctor visit and the resulting delay in access. Initially this relaxation was temporary, but in December, 2021, the FDA announced that the change will be permanent. Though a welcome reduction in barriers to safe and effective abortion access, states are still free to place their own restrictions on telemedicine providers that offer their services in their jurisdictions. Currently, 19 states prohibit telemedicine facilitated abortions.

Without these barriers, telemedicine can potentially increase abortion access to abortion seekers in underserved, isolated communities. Telemedicine was, in a limited way, able to address severe need in a crisis that strongly necessitated these services. For abortion seekers in the United States, the crisis is far from over. Current restrictive state statutes and attempts to overturn Roe v. Wade continually threaten access to the constitutional right to choose to terminate a pregnancy. In many states, local access to abortion care could disappear entirely in the coming years. What remains unclear is whether further expansion of access to telemedicine will be able to help fill these gaps and what policy changes will be necessary in order to do so. 

Banking on Your Child’s Future: Is There Sufficient Legal Recourse Against the Unregulated Private Cord Blood Bank Industry?

bankingBy Robin Hammond

Cord blood and tissue banking has significantly increased in the past few years, with 2.6% of parents using private banks and over a thousand transplants from public banks. Some benefits are concrete, and others speculative. The stem cells collected can be used to treat several diseases, including leukemia, lymphoma, anemia, and some immune system disorders. Currently, there are over 200 registered clinical trials currently underway around the world investigating the role that stem cells may play in the various systems of the human body, including Macular Degeneration and Cerebral Palsy.

The standards for public and private banks vary like night and day. As with many emergent technologies, the regulation of private banks has been slow. Currently, private banks only need to provide the FDA with their business name and address to be FDA registered. In contrast, public banks are licensed by the FDA and are responsible for adhering to strict quality standards including documentation on processing, storage and sterility, and site inspection. Additionally, public banks are coordinated by Be The Match®, which works with doctors and researchers to improve cord blood transplantation and education as mandated by the Stem Cell Therapeutic and Research Act of 2005 and Reauthorization Act of 2010. Continue reading