Nethika Ariyasinghe is from Waco, Texas. She graduated with her BS in Biomedical Engineering in May 2013 and currently is a Ph.D student in Biomedical Engineering at USC. In her free time, she enjoys running and exploring Los Angeles.
During their lifetime, many Americans may suffer from organ failure or damage. Organ transplants or grafts are a solution to this problem. One source of replacement organs and grafts is cadaveric organs that are taken from hospitals or funeral homes. Biomedical Tissue Services (BTS), a human tissue recovery firm, was shut down for stealing cadaver parts from funeral homes by forging consent forms. Some patients who received BTS parts contracted serious diseases. The BTS case raises two important questions: What are justifiable practices for taking organs from a source? How do we ensure these sources have consented to have their organs used? This paper will first discuss the misuse of organs by BTS and the ethical problems this case raises. Then I will evaluate various methods for obtaining organs that are suggested in scientific literature. This paper aims to determine an ethical practice for obtaining organs, and I will also suggest that physicians and dentists should purchase organs and grafts from places accredited by the American Association of Tissue Banks which meet high safety and quality control standards.
THE CASE OF BIOMEDICAL TISSUE SERVICES
In 2005, authorities discovered that BTS, a bone and tissue recovery company, illegally took body parts from cadavers at funeral homes and sold them without permission from the families of the deceased. Some funeral homes gave BTS employees bodies believing the bodies would be cremated, but instead, the body parts were sent to tissue processing companies around the United States . In other cases, consent forms were forged so BTS could take body parts from the deceased, and then plastic piping was placed into the bodies to conceal signs of theft .
BTS also forged medical history records, including the age of the deceased and cause of death, to conceal that many of the corpses did not meet federal regulations . Federal regulations require that donors must be under the age of 65 and cannot have a serious disease, infection, or cancer . Investigators discovered that BTS had harvested organs from people older than 80 who had died of serious diseases such as cancer. By using unhealthy and elderly donors, BTS endangered the lives of the patients who had received BTS body parts .
After authorities discovered that BTS used sources that did not meet the Food and Drug Administration (FDA)’s regulations, the FDA ordered a recall of BTS products, and health officials advised physicians to test recipients for HIV, hepatitis, and other diseases . This recall affected more than just organ transplant patients; it also affected the patients who had received grafts or tissues from BTS body parts. Many people across the United States had to undergo medical testing for sexually transmitted diseases. There have been at least 2 reported cases of disease from BTS body parts: one recipient contracted syphilis, and another tested positive for HIV and hepatitis C. There was also a case of surgery failure: a woman who had received an ACL replacement from BTS had to undergo another surgery after her first tendon failed .
By taking cadaver organs without permission, BTS desecrated the bodies of the deceased. Most cultures believe that the deceased and his family have the right to determine what happens to the deceased’s body after death. BTS infringed on that right by not obtaining either party’s consent before harvesting the cadaver organs. Many families also take part in funeral ceremonies with the body; these ceremonies can be a way for families to deal with their grief. By stealing the deceased’s organs, BTS employees disrespected what was left of the family’s loved one and disrupted the family’s grieving process.
BTS also compromised the safety of patients who received grafts or transplants. Appropriate measures were not taken to ensure that donors met federal regulations. The American Medical Association (AMA)’s Principles of Medical Ethics states that while a patient is under a physician’s care, the wellbeing of the patient is his primary concern. By not ensuring that patients received healthy cadaver parts, the physicians failed to uphold this guideline. The AMA’s Principles of Medical Ethics also states that a physician is responsible for improving public health; therefore, it is the physicians’ responsibility to confirm that transplant organs and grafts are taken from healthy sources . Because dentists use tissue grafts in oral surgeries, they also must ensure that tissue donors meet federal regulations. The American Dental Association (ADA)’s Principles of Ethics include statements similar to those in the AMA’s Principles of Ethics , and so dentists are also responsible for making sure that donor organs are healthy. The current method for harvesting donor organs does not require dentists and physicians to confirm the health of harvested organs. The current system must be changed so dentists and physicians can ensure that they are giving patients sterile body parts.
WHAT CAN BE DONE TO ENSURE DONOR CONSENT
Currently, donor consent may be expressed on a driver’s license or in a health care directive. In some states, if a person has not indicated organ donation preferences before death, relatives of the deceased are asked if they want to donate the deceased’s body . This method can affect the donor, his family, and patients negatively, as seen in the BTS case. BTS took advantage of this system by forging papers saying relatives consented to donating the deceased’s body parts. As a result of the forgery done by BTS employees, patients received subpar organs.
“Ethics of Organ Transplantation,” a paper by the Center for Bioethics at the University of Minnesota suggests several methods for dealing with the issue of donor consent . First, the paper suggests using organs taken from a living person. Consent of a living donor would be easier to confirm than that of a deceased donor, and using living donors would prevent people from forging consent forms. Another benefit of a live donation is that the donation can be prearranged. Prearranging the donation allows the patient (the receiver of the donated organ) to begin taking anti-rejection drugs before the transplant, which increases the chances of the surgery being successful. Relatives of patients can be used as live donors, meaning live donors could be better matches to the patients than cadavers . The downsides to using a live donation are that the donor may suffer from discomfort, infection, and other health consequences; moreover, the donor may feel pressured into donating by family. In addition, while the patient will have the support of a transplant surgeon or the medical team, the donor has no such advocate to give them guidance or advice . Another downside that the paper does not mention is that all organs cannot be taken from a living donor: for example, a heart transplant cannot be done using the heart of a live donor. Furthermore, there may not always be a living donor available, and so there needs to be other options for patients who need transplants.
“Ethics of Organ Transplantation”  also suggests using alternative organs such as animal organs, artificial organs, stem cells, or aborted fetuses. Experiments are still being conducted on animal organs, and more testing needs to be done before they can be used. There are concerns that using animal organs could spread animal bacteria and viruses to humans. Artificial organs are a potential option, but if they are costly, not all patients may be able to afford them. Even if the price of artificial organs was not a concern, these organs are not an ideal option because they may not be as effective as real organs. The last two alternatives that “Ethics of Organ Transplantation” suggests—using stem cells and aborted fetuses—are considered ethically or morally objectionable by some people; these options are not feasible right now .
After suggesting the use of live or alternative organs instead of cadaver organs, the Center for Bioethics at Minnesota  suggests using presumed consent as an alternative to the current system for donor consent. Presumed consent means that upon death, a person’s organs will be taken once he dies unless he has specified that he does not want to donate his organs . The presumed consent approach could still result in organs being taken without consent. For instance, if the form stating the deceased opted out of donating is lost, then the deceased’s organs could still be donated. Another disadvantage of presumed consent is that this method burdens people with the requirement of opting out of donating their organs. Also, the public would have to be well-informed about the presumed consent policy so they would know to opt out if they did not want to be an organ donor. Because of the aforementioned disadvantages, the Center for Bioethics at Minnesota does not recommend this option .
The last alternative the Center for Bioethics at Minnesota  suggests is mandated choice. Mandated choice means that every person would have to indicate whether they wish to be an organ donor on their driver’s license or income tax form . A law requiring mandated choice would allow the government to have a larger role in determining who donates organs . Enforcing mandated choice would take the decision of donating the deceased’s organs out of the donor’s relatives’ hands, which would prevent situations like the BTS case from happening in the future. Another advantage to using this method is that unlike presumed consent, mandated choice reflects the idea that people have the freedom to govern what happens to their body, even after death.
One of the drawbacks of mandated choice is that people would have to trust that their health care providers will do everything possible to save a person’s life, even if that person has designated that they want to be an organ donor . Another drawback is that mandated choice would create a class of non-donors, some of whom may have made the decision not to donate based on a lack of understanding of what being a donor means. Also, it is still uncertain how effective mandated choice policies are; studies of Sweden’s mandated choice policy have come to conflicting conclusions. Sweden implemented a mandated choice law in 1996. Before implementing the law, health authorities distributed pamphlets about organ donation to the Swedish people. These pamphlets asked if the individual desired to donate his organs after death. Sweden then instituted a law requiring all citizens to decide whether or not to donate their organs at death. The United States President’s Council on Bioethics concluded that Sweden now has lower donation rates than other Western countries . However, Dr. John McArdle states that donations increased in Sweden by 600,000 . More studies on the effects of mandated choice must be conducted in order to conclude whether this is a feasible option for organ donation.
After considering the effects of each of these options (living or alternative organs and presumed consent) on the deceased, the family of the deceased, and the patients receiving transplant organs, we can conclude that the best option is mandated choice. Using mandated choice ensures that the wishes of the deceased are obeyed and avoids the emotional distress and health risks caused by live and alternative organ donation, respectively. However, using mandated choice does not solve either of the ethical problems brought to light by the BTS case: using mandated choice does not confirm that tissue providers have taken only organs that were meant to be donated nor does this method ensure that donated organs are healthy.
ENSURING THE STERILITY OF DONATED BODY PARTS
One of the ethical problems that mandated choice does not solve, ensuring that organs are healthy, can be addressed by analyzing the role of medical professionals in the BTS case. Physicians and dentists’ failure to confirm that donated organs were sterile affected past and future recipients of donated body parts. Those who received stolen organs ran a high risk of contracting serious illnesses, and future patients may not trust their surgeons, physicians, and dentists because these medical professionals had failed to ensure that past patients received sterile organs. Patients have the right to know that they receive healthy organs.
Physicians and dentists can assure recipients that their new organs are disease-free by obtaining tissues only from sources accredited by the American Association of Tissue Banks (AATB). Even though the FDA has ultimate authority, AATB can make sure that tissue banks abide by FDA regulations. By accepting AATB accreditation, tissue banks agree to comply with AATB’s safety regulations, which include on-site inspections of the tissue bank’s processing facilities . The donor screening program that the AATB advises tissue banks to use also reduces the chance that patients receive contaminated body parts: a study using a method similar to the one endorsed by AATB concluded that this type of method has a one in 1.67 million risk of harvesting bones from a donor with HIV .
The American Medical Association and American Dental Association did not suggest using AATB-accredited sources before the BTS incident. Afterwards, the Journal of the American Dental Association published a paper that advocated the use of AATB-accredited sources, but the AMA still has not suggested using accredited sources. Having both the AMA and ADA state that medical professionals should use AATB-accredited sources would encourage physicians and dentists to do so. Then, to mitigate patient’s fears about receiving unhealthy body parts, the AMA and ADA should tell doctors and dentists to tell their patients they use AATB-accredited sources, similar to how medical professionals post their AMA or ADA membership. Even though the ADA recommended using AATB-accredited sources, it did not advise dentists to inform patients that tissues are coming from accredited sources.
By using AATB-accredited sources, physicians and dentists would know that the tissue bank they use met two sets of standards: the FDA’s and AATB’s. The AMA and ADA could encourage doctors and dentists to use AATB-accredited sources in order to increase the use of only accredited sources. The AMA and ADA could also suggest that medical professionals display a sign stating that their tissues come from an AATB-accredited source. These suggestions would prevent companies like BTS, who may not follow federal regulations, from being used. These suggestions would also assure patients that they are being given healthy body parts.
Although this paper offers some solutions to prevent cases like the BTS situation from happening again, more research must be done to make sure that this system is satisfactory. More research should also be done to see if the methods used to track the organs in the BTS case were as efficient as possible to keep patients from receiving bad organs. The efficiency of the current tracking system could also be researched by determining how quickly recipients of BTS parts were informed. While we have the technology to use cadavers to replace malfunctioning organs, we also must make sure that we have proper safety guidelines and procedures in place to optimize the benefits that come from this technology.
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