Vidic 2:00 L13 BRAIN-CONTROLLED PROSTHETIC ARM MAY CAUSE NERVE DAMAGE Tyler Pastorok (typ10@pitt.edu) McGlone Prostheses has just released a new prosthetic arm that works using a brain-computer interface to give the patient control of and feeling through a mechanical arm. I am the current leader of the engineering team that designed the mechanical part of the arm that is being used in conjunction with the brain-computer interface. The system works by surgically implanting neural sensors in the brain to detect brain activity. This information is then sent to a decoder, which converts the signals to commands for the arm to read and execute. The system also works in reverse. There are sensors all throughout the surface of the arm that detect pressure. These pressure signals are then encoded and sent to the brain to simulate touch. This requires very invasive and precise surgical procedures, but can immensely improve the lives of many. team, rather than as an individual. We discussed what should be done about this issue and unanimously agreed to tell our supervisors and encourage them to inform the patients who have had the system implanted. This would most likely mean that a large majority of patients would opt for the surgery to replace the old system with the new one, and McGlone Prostheses would have to compensate the patients not only for the new surgery, but for emotional damages as well. The surgery alone costs an average of $150,000 and has been performed on just over 1000 patients in the world. This means that the financial damage done is well over $100 million just for the surgeries. Unfortunately, due to the immense financial and reputational damage that would be done to the company, the owners of McGlone Prostheses have decided to keep the information quiet, and hope that none of the patients contract a severe enough form of Parkinson’s to cause the system to malfunction. THE MALFUNCTION THE DILEMMA As the head of the mechanical engineering aspects of this project, I assigned my team to different aspects of testing. Due to issues and large delays within the decoding algorithm team, we were rushed through the testing process by my supervisors. We tested the system by sending signals to and from a simulated brain, and confirming the arm behaved as it was supposed to. A section of my team was assigned to simulate disabled brains. Due to being rushed, this team overlooked some very severe cases of Parkinson’s disease in which the rapid movement in the prosthetic is too intense for the motors, causing the system to overheat. First of all, this causes the arm to stop working, which, depending on what the patient is doing, could lead to damage of property and possibly even life. Not only can this lead to malfunctions in the arm itself, but the overheating can cause a chain reaction of failures in the system, which can potentially lead to permanent nerve damage in the patient. Fortunately, we have discovered this problem before any patients have had issues with the system. Furthermore, we have even fixed the problem and finalized a new design that has been tested in more detail, and the motors have been able to hold up to worse cases of Parkinson’s than have ever been recorded. The issue is that Parkinson’s develops later in a patient’s life and cannot be tested for before early symptoms start to show. Additionally, the potential severity of the disease cannot be precisely determined. This means there is no safe way to determine which patients will have issues with the original arm, and isolate the replacement surgeries to only them. Prior to releasing our part of the product, the mechanical team and I agreed to take the blame for any mistakes as one Pros of Informing the Public BRAIN CONTROLLED ARM University of Pittsburgh, Swanson School of Engineering 1 2015-11-03 The decision to inform the public would be based primarily off of the moral obligation I hold as an engineer, and offers little to no personal gain. It does not take much research to find that it is morally wrong to withhold such information from the public. The preamble of the NSPE Code of Ethics for Engineers states that “engineers are expected to exhibit the highest standards of honesty and integrity” [1]. While there are many other clauses within this code that describe the ethical issues of withholding this information, they can all be generalized into the category of honesty and integrity. There is no denying that to exhibit such honesty and integrity, I should release the possibility of such a tragic malfunction to the public immediately. Furthermore, the ASME code of ethics states that “Engineers shall hold paramount the safety, health, and welfare of the public” [2]. Informing patients of the overheating issue will prevent those who contract severe Parkinson’s from suffering from nerve damage. Replacing the majority of already-implemented systems will mostly likely result in replacing prostheses in many patients that will not develop such a severe form of Parkinson’s; however, the damage done to these patients (both physically, emotionally, and financially) will be far less than if patients do experience nerve damage from the malfunction. With this trade-off in mind, informing the patients of the issue keeps in line with my obligation to regard the safety of the public. While these are only two reasons to release the information, they carry immense weight in this dilemma. Tyler Pastorok responsible for ending a whole company worth of employees’ careers. Cons of Informing the Public Releasing the details of the possible malfunction will potentially bring about many short term ramifications to myself, as well as my team of engineers and the company as a whole. I have decided, however, to ignore the ramifications that will be brought on the company since I believe that they have already made the wrong choice by withholding the details of the malfunction. First of all, I almost certainly will lose my job at McGlone Prostheses since releasing this information is going against the instructions I have been given. Not only will this affect me, but the rest of my engineering team will be blamed for overlooking this issue with victims of Parkinson’s. It is one thing for me to determine the fate of my own career, but my decision likely determines the fate of my colleagues’ careers, as well. While most of the reasons not to release the malfunction are personal ramifications, this choice does violate two areas of interest in the NSPE Code of Ethics. This code states that “Engineers shall not disclose, without consent, confidential information concerning the business affairs or technical processes of any present or former client or employer” [1]. By releasing the issue, I am releasing confidential information from my employer. This code also states that “Engineers shall perform services only in the areas of their competence.” The reason that my actions may violate this statement is that my concerns are based on a mental disease: an area in which I don’t have formal education, and am basing my opinions solely on statistics about Parkinson’s that I have found through other research. SIMILAR RECALL Recalling a medical procedure is no small feat, and is definitely not an easy process. Johnson and Johnson had an extreme situation where they had to recall their DePuy ASR hip replacements, which cost them over $4 billion in lawsuits [3]. $4 billion is a menacing number, and seems to depict a grim future for McGlone Prostheses if issues arise with this brain controlled prosthetic arm. Johnson and Johnson was able to recover, however, and this is in part because they took responsibility for their mistake and carried out the necessary actions to move past it. Taking into consideration the fact that McGlone Prostheses is on the cutting edge of brain-computer technology, it is likely that they will be given support in cleaning up their mess if they take responsibility instead of hoping the public does not find out. PROFESSIONAL OPINIONS To aid myself in debating this ethical dilemma, I have consulted two well-respected and successful engineers, both of whom are close to me and have faced ethical dilemmas of their own in the past. The first of which is Alex Houriet. He is a chemical engineer that is currently working in the advancement of graphene and recently encountered a similar situation. He was rushed through testing and released a product that later turned out to have problems that were overlooked due to the insufficient tests. Mr. Houriet did make the decision to inform his supervisors, who listened to his advice and recalled the product. Mr. Houriet told me that despite the short term financial damage done to the company, he stands by his decision as it was the morally just one, and because he made the morally just decision, he has been able to advance his career. The second professional I turned to is Dr. Lenskold, a decorated brain surgeon whom has a much deeper understanding of the physiological side of the prosthetic system in question. She informed me that the second surgery patients will have to go through to replace the system is well worth it when the risk of the malfunction is taken into account. Dr. Lenskold also brought about the point that by informing the public, I am putting the decision to replace the system in the hands of the patients, rather than the hands of the company. Patients do still have the option to take their chances and hope they don’t develop severe enough Parkinson’s. Both of these professionals agreed that promoting the safety of the patients takes clear ethical priority over the damage that will be done by revealing the mistake. All Things Considered In terms of the codes of ethics that I am obligated to abide by, I believe that there is more support in favor of informing the public. The use of the word paramount by the NSPE when describing the importance of the safety and health of the public means that this statement should be held above others in situations that apply to conflicting clauses. This means that even though I am releasing confidential information, and that I am concerned based on a small piece of information outside of my expertise, it is more important that I promote the health of the patients with the prosthetic arm. To do so, I should publish the details of the malfunction. Since this comparison nullifies the ethical standards in support of withholding the information, the only reasons left not to release the information are the ramifications to myself and my colleagues. While I am personally ready to accept the consequences of my mistake, I do believe that it is not my right to determine the fate of my colleagues’ careers. Since I did not directly make the mistake that lead to this malfunction, I cannot honestly report on the situation without also damaging at least one of my colleagues’ careers. Additionally, the fact that McGlone Prostheses withheld this information could possibly do enough damage to end the company, so I could be MY DECISION 2 Tyler Pastorok In order to be as fair as possible to all parties involved in this dilemma, I will inform everyone already involved that I will be releasing the details of the malfunction to the public. I will first inform my team of engineers, offering them the opportunity to assist in the publication of our findings. This will provide anyone on my team the opportunity to join me in making the ethically just choice, and upholding our integrity as engineers. After this, I will inform my supervisors: giving them one last chance to take responsibility and inform the patients themselves. My hopes in doing this is that McGlone Prostheses will understand that their only chance left of recovering from this mistake is releasing the information themselves. If I am successful in persuading McGlone Prostheses to do this, I will be able to solve the problem while not violating any parts the codes of ethics previously mentioned. In doing this, I will be able to prove to the engineering community that I am willing to take responsibility for the mistakes I’m involved in, and abide by the regulations set forth by the community. ADDITIONAL SOURCES (2014). “Public Health and Safety—Delay in Addressing Fire Code Violations.” National Society of Professional Engineers. (online article). http://www.nspe.org/sites/default/files/BER%20Case%20No %2013-11-FINAL.pdf R. Wilson. “Ethical Issues of Brain Computer Interfaces (BCI).” International Association for Computing and Philosophy. (online article) http://www.iacap.org/proceedings_IACAP13/paper_41.pdf “To Release, or Not to Release: An Engineer’s Perspective.” Stanford biodesign. (online article) http://biodesign.stanford.edu/bdn/ethicscases/21releasequesti on.jsp “The Cost of Integrity.” webGuru. (online article). http://www.webguru.neu.edu/professionalism/casestudies/cost-integrity S. Lenskold. (2015). Email A. Houriet. (2015). Email ADVICE TO OTHERS ACKNOWLEDGMENTS Reflecting on this entire issue, it is evident to me that there was a very easy way of preventing all of this from happening before the prosthetic arm was released. All I had to do was resist the pressure applied by my supervisors to test the system in less time than needed. The costs of delaying the release of the prosthetic arm would have been a drop in the bucket compared to the millions, or even billions, of dollars that will be spent attempting to clean up the mess that McGlone Prostheses has created. Because I allowed my supervisors to rush my team and me through testing, there are now over 1000 patients recovering from surgery that will have to repeat the entire process in order to protect themselves against nerve damage that could be caused by our system. I advise anyone, not just engineers, to avoid cutting corners at all costs, because the long run consequences of cutting corners will far exceed the extra time and money needed in the short run to get it right the first time. I would like to thank my team of engineers at McGlone Prostheses for assisting me in the development and testing of the prosthetic arm. I would also like to thank the National Society of Professional Engineers and The American Society of Mechanical Engineers for providing the community with sound ethical guidelines. I give a final thank you to my fellow professionals, Alex Houriet and Samantha Lenskold for offering advice towards my decision in this difficult dilemma. REFERENCES [1] (2007). “NSPE Code of Ethics for Engineers.” National Society of Professional Engineers. (Online article). http://www.nspe.org/resources/ethics/code-ethics [2] (2012). “Society Policy” American Society of Mechanical Engineers. (Online article). https://www.asme.org/getmedia/9EB36017-FA98-477E8A73-77B04B36D410/P157_Ethics.aspx [3] (2015). “DePuy ASR Hip Recall Information.” Drugwatch.com. (Online Article). http://www.drugwatch.com/depuy-hip/recall.php 3 Tyler Pastorok 4