Malik Snowden

SENSE OF TOUCH PROSTHESES PT II –

THE ETHICS OF PROSTHESES

Malik Snowden ()

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Malik Snowden

WHEN IT COMES TIME TO MARKET PROSTHESES: AN ETHICAL DILEMA

Niko Taylor, a biomedical engineer working for Frappuccino Medical, Inc. Currently, Taylor and his team are tasked with the development of a model of upper body prosthetics which is intended to allow it’s users to regain a sense of touch. The approach that Taylor and his team are using is called the “biomimetic approach.” This method of sensory restoration, as the name implies, utilizes mimicry to produce results. Taylor’s plan is to mimic the brain activity that is produced when a limb touches an object. In order to do this, they plan to use brain stimulation. Taylor and his team are using a method that was initially developed by Dr Sliman Bensmaia, a neuroscientist at the University of Chicago. Bensmaia’s experiments include testing the prosthetic devices with rhesus macaques. However, Taylor needs to test his devices on humans before they can be marketed. The prosthesis system utilized here consists of microelectrodes implanted in the brain (for recording and analysis of neurons’ activity and then later for the reproduction of the neurons’ activity through electric stimulation) and a bionic arm. It is definitely important that this is tested on humans before it becomes marketed to ensure, one, that it actually works considering all previous data gathered comes from monkeys, and two, that the implanted microelectrodes and the actual prosthesis are safe for human use [1][2][3]. He knows that he can tell his employer if he is placed in a situation where his judgment is overruled pertaining to the wellbeing of the users, but he also knows that he needs to hold paramount the safety, health, and welfare of the public, in this case, the users of the prostheses [1].

Unfortunately for Taylor and his team, it is getting extremely close to the time for them to propose their final product to their employer. They have already been forced to delay the release of their product on account of technical issues pertaining to the neural patterns that they would need to use to reproduce the sensation of physical feeling. Their employer has recently told them that they need to present a product soon or else they would risk losing their funding or the discontinuation of production.Unfortunately for the team, they have another problem. Not only are they nearing their deadline, they have yet to begin clinical testing on humans. Without that, they can’t be completely sure that their prostheses are entirely safe for human use [1][3]. Taylor and his team would have to check to see whether or not the materials used in the prostheses are suitable for long term use with a human in terms of the physical contact and the lifestyle of the average person in need of the devices, as well as whether or not the microelectrodes would be suitable for long term use in one’s brain, as it would not be best to have to perform constant surgeries to update the devices.

Abiding by the Codes of Ethics

While Taylor is trying to make a decision on what to do, he will have to bear in mind the components of the engineering codes of ethics. There are a multitude of constituents of not just the Code of Ethics for Engineers as provided by the National Society of Professional Engineers (NSPE), but the Biomedical Engineering Society (BMES) Code of Ethics as well, the code provided by NSPE being the more broad code which applies to all engineering professions. The code of ethics provided by NSPE consists of a multitude of canons, which would be considered fundamental by any engineer. The first canon is the most well known canon, and possibly the most relevant to Taylor’s situation. This canon states that engineers shall “hold paramount the safety, health, and welfare of the public” [1]. If Taylor chooses to allow his prosthesis to be released to the public, then he would be risking the welfare, health and safety of the public. He would be in a direct violation of the first canon of the code of ethics. Taylor would still be abiding by the other five fundamental canons of NSPE’s Code of Ethics, but there are some rules of practice that need to be seen while looking at Taylor’s situation. The first rule of practice pertaining to the first canon stats that “If engineers' judgment is overruled under circumstances that endanger life or property, they shall notify their employer or client and such other authority as may be appropriate” [1]. Taylor should alert his employer that he has doubts pertaining to whether or not the devices will function properly with humans, since they have not had the chance to go through human testing.

Not only would Taylor consider the NSPE Code of Ethics for Engineers, he would also consider the BMES Code of Ethics. The BMES Code of Laws is split into four small lists of obligations. The first list consists of the Biomedical Engineering Professional Obligations. This states that biomedical engineers shall “use their knowledge, skills, and abilities to enhance the safety, health, and welfare of the public” [3]. This is very similar to the first canon of the NSPE Code of Ethics for Engineers. This still poses a problem for Taylor as he is faced with the decision of whether or not he should release his prosthesis to the public, something that would put at jeopardy the safety, health, and welfare of the public. The second list is of the Biomedical Engineering Health Care Obligations. One of the clauses of this list states that biomedical engineers shall “consider the larger consequences of their work in regard to cost, availability, and delivery of health care” [3]. This is a canon that Taylor would need to review before making his decision. If he were to consider the consequences of releasing his prosthesis to the public, then he would see that he would jeopardizing the health of the consumers, as well as his company.

THE ETHICAL PROBLEMS POSED

Taylor and his team have posed a multitude of questions pertaining to the ethics of their situation and their possible actions following the realization of their imminent deadline.The ethics of biomedical engineering is something that is greatly debated. People often discuss the ethical limits, as well as legal limits of bioengineering since it is reengineering human biology [5].

Human Testing

One major problem produced here is that of the transition of medical devices from development to the market without testing on humans. This is especially important in this case, since these products are meant for long term use, both inside and attached to the human body: “safety cannot truly be insured without testing within a living system, and with implants intended to be used within the human system for many years, testing may likely need a comparative number of years” says Joseph Herkert of North Carolina State University [6]. In this situation, Taylor is faced with the decision of whether or not he should violate the code of ethics for engineers by allowing his product to be put on the market without testing it beforehand. The code of ethics for engineers consists of a canon which states that engineers are to “hold paramount the safety, health, and welfare of the public” [1]. With this violation of the code of ethics, Taylor and his team could be potentially endangering the lives of those who use their products. In a scenario pertaining to the development of prostheses involving implanting medical devices, specifically into the brain, and attaching medical devices for long term use,the engineering code of ethics is incredibly pertinent. If this code of ethics were not to be implemented, then the lives of those using products, especially medical products developed by engineers would be at risk. Not only would Taylor be violating the more general engineering code of ethics, but he would also be violating the biomedical engineering code of ethics. One of the obligations of biomedical engineers in terms of health care is to “consider the larger consequences of their work in regard to cost, availability, and delivery of health care” [3]. He would be violating this directive by not doing what is necessary to ensure the safety of the health of the consumers.When looking at the ethics of this case, it is beneficial to look at case studies that bring about similar ethical questions. There is one particular case that is not only similar to Taylor’s problem, but it brings about ethical questions that would be applicable in Taylor’s problem. A certain established premier medical device company, XMed, has just successfully launched a new product. However, the Lead Product Development Engineer has discovered that he has not signed the final phase review, so the final review of the product was never approved and never happened. After reviewing this specific case study, one could ask the question of whether or not there would be any consequences to the product’s malfunction [7]. If the product were to malfunction, not only would the patients suffer, but the company and the engineers behind the product, specifically those who were to ensure that a final inspection happened, would suffer as well. After comparing this case to Taylor’s, we could ask the same questions to him and his employer, as it is unknown what would happen with the products after the orthopedic community puts them into use. Although the product has shown positive results for monkeys, they can’t be entirely sure that the same results would be reproduced with humans, no matter how similar these rhesus macaques are to humans.

Limits: Human Enhancements

Another major problem posed is pertaining to the general evolution of prostheses. “Should biotechnology be used only to treat disease, or also to enhance people?” asks Harvard Law School Dean Elena Kagan [5].Many people worry that prostheses are going to become more than just treatments for those who undergo amputations made necessary after an accident or medical condition. Ronald Dworkin, a Harvard Law School graduate of New York University School of Law and University College, London, says that the “line between treatment and enhancement is a very fragile one, and it moves all the time” [5]. After seeing cases such as the well known story of Oscar Pistorius and his “cheetah legs” running in the Olympics, many people began to argue even further about engineers designing prostheses to give their users advantages over others [10]. In cases where people elect to have healthy limbs amputated, whether they have already had a small portion removed or none removed at all, people begin to argue about ethics. These cases make people argue whether or not it is ethical to remove healthy limbs in order to use more advanced prostheses [11][12]. After viewing these cases of elective amputations, it seems as if we are reaching the point where prosthetic technology will become so exceedingly superior to human limbs, functionally and aesthetically, that even those without injury or disability would electively amputate their limbs.Similarly, medical ethicist Dr. Bennette Foddy of Oxford University argues that “as the technology improves, we will eventually get to the point where the prosthetics function better than people’s original hands, and we may see people with perfectly healthy, functional hands, wishing to have a cybernetic replacement” [14]. Recently, there was a case study pertaining to the ethical limits of biomedical engineering. This case is about bringing a Neanderthal to life. The purpose of this case was to examine a fully analyzed Neanderthal genome in order to shed some light on the genetic differences between the Neanderthals and modern humans, as well as their significance. Researchers then extended their curiosity to attempts to bring a Neanderthal to life [9]. In this case, a similar question of ethics is raised: just because it can be done, should it? What are the limitations of biomedical engineering? Many believe that doing things such as bringing Neanderthals to life would be considered unethical and unnecessary. The question of limitations in the biomedical engineering field is one that has been discussed before. This proposes the question of whether or not more strict limitations to biomedical engineering should be implemented. “On the one hand, biotechnology raises hopes for dramatic improvements in the human condition. On the other hand, biotechnology raises fears of a ‘Brave New World’… in which the human essence is lost,” says HLS Dean Elena Kagan [5].

WHAT SHOULD BE DONE

After reviewing Taylor’s situation, I believe that there is in fact an ethical decision that he and his team can come to. To recapitulate, Taylor and his team of engineers were told that they would need to produce a final version of the prosthesis that they were developing soon as their deadline was approaching fast. As with the development of all prostheses, they should have ran clinical trials with the devices, testing them on humans. It has already been shown that these prostheses function properly with rhesus macaques as they were the original test subjects, but it can’t be guaranteed that the same results would be produced when tested with humans. As seen in a recent case study pertaining to testing artificial joint replacements in both humans and animals, it is not enough to only run tests using animals. In this case, a design engineer has developed a new design for a hip prosthesis. The shape and materials of this have never been used before so it is best that the implant is tested by implantation in an animal before being used in humans. The engineer found that dogs have previously been used to test joint replacements with positive results. However, one case was troubling. In this case, artificial joints were implanted in dogs and had very high success rates. When it was time for implementation of the devices in humans, the prostheses had a very high failure rate [8].Cases that involve the introduction of foreign objects to the subject’s body such as this one stress the importance of testing devices on humans after positive results from animal testing. So given Taylor’s situation which is rather similar to the one previously mentioned, one might ask whether or not Taylor should submit his product to his employer as it is, having only been tested on the rhesus macaques, or if he should run the risk of losing his funding or being forced to abandon the project by not submitting anything at all. If Taylor were to go ahead and allow the orthopedic community to begin distributing these devices, then he would run the risk of having similar results as in the aforementioned case. He would run the risk of the prostheses failing after being given to their users.Because he would be violating the NSPE Code of Ethics for Engineers as well as the BMES Code of Ethics by putting the safety, health, and welfare of the public at risk, Taylor should not allow his prosthesis to be released. Although he may damage his reputation, as well as the reputation of his company, he would be avoiding the possible consequences of releasing medical devices without human testing.

REFERENCES

[1] (2014). “NSPE Code of Ethics for Engineers.” National Society of Professional Engineers. (online journal).

[2] K. Azizi. (2012). “Chicago Neuroscientists Aim to Develop First Prosthesis with Sense of Touch.” University of Chicago. (Online Article).

[3](2014). “Code of Ethics.”Biomedical Engineering Society.(Online Journal).

[4] V. Thorpe. (2013). “’Bionic Man’ Warns of Ethical Minefield.” The Guardian. (Online Article).

[5] B. Colen. (2007). “Legal, Ethical Limits to Bioengineering Debated.” Harvard Gazette. (Online Article).

[6] J. Herkert. (2004). “Engineering Research and Animal Subjects.” U.S. Department of Health & Human Services. (Online Article).

[7] “To Release, or Not to Release: An Engineer’s Perspective.” Stanford University. (Case Study).

[8] E. Myers, J. Bird. “The New Hip.” Online Ethics Center. (Case Study).

[9] E. Queen. “Bringing a Neanderthal to Life.” Online Ethics Center. (Case Study).

[10] H. Berkes. (2012) “Studying Oscar Pistorius: Does The 'Blade Runner' Have An Advantage?” NPR. (Online Article).

[11] (2012). “Oscar Pistorius and the Ethics of Prosthetics.” Saporta Report. (Online Article).

[12] N. Olson. (2012). “Oscar Pistorius Now… Elective Amputation in 10 Years?” IEET. (Online Article).

ADDITIONAL RESOURCES

N. Bowdler. (2011). “Bionic Hand for ‘Elective Amputation’ Patient.” BBC News. (Online Article).

A.Okeowo. (2012). “A Once-Unthinkable Choice for Amputees.” NY Times. (Online Article).

ACKNOWLEDGEMENTS

I would like to thank Adam Bottenfield and John MacLaughlin for helping me stay awake all night Saturday night and until the wee hours of the morning the following night. Without them, I wouldn’t be able to finish this paper on time.

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