Teaching of Ethics In Biomedical Engineering

he wide variety of biomedical engineering activities provide a stimulating, challeng-

ing and fulfilling career. One factor that distinguishes biomedical engineering from traditional engineering fields and from other application areas is that medicine and bioi- ogy deal directly with human welfare. An undergraduate degree in biomedical engi- neering should prepare students to apply a logical problem-solving approach to the complex disciplines of physiology, biology, and medicine with a sensitivity towards clinical problems and concerns. This is true whether the students wish to become in- volved in basic research, development of new medical technology, or conduct applied research. Students from ABET-accredited undergraduate engineering programs must demonstrate an understanding of ethical Considerations in engineering practice. Over 20 biomedical engineering baccalaureate programs are accredited. This article pre- sents an outline of concepts, issues, and questions that may be used to “teach” ethics in biomedical engineering.

The development of new technology and innovation has had enormous diagnostic and therapeutic benefits. However, the cost of these sophisticated approaches has been enormous. Many ethical, economic, and moral questions are raised by these new technologies. Biomedical engineers are di- rectly involved in developing new medical technologies. Therefore, we share the re- sponsibility to develop sound technology and to see that it is applied appropriately and not indiscriminately. It is ethical, profes- sional, and humanely responsible for biomedical engineers to be involved in addressing these questions.

It is also important that these issues be addressed in the basic educational programs. The biomedical engineering undergraduate programs should include discussions on these issues to equip students with a realiza- tion of their responsibility, with the aware- ness that they will face these issues in increasing degrees and frequency, and with some professional basis for making respon- sible decisions.

An instructor cannot “teach’ ethics be- cause ethics is behavior; it is self-controlled actions and decision-making. A professor may, however, provide experiences and in- formation that lead a student to greater per-

100

Stan A. Napper Paul N. Hale, 11.

Department of Biomedical Engineering Louisiana Tech University

sonal understanding. These lessons may in- clude explaining both universal and contro- versial principles, presenting guidelines for professional conduct, and discussing exam- ples where ethical behavior was responsibly applied.

Few resources are available to assist the instructor in providing this education. A very general introduction to ethics and pro- fessionalism may be found in a freshman- l eve l i n t roduc to ry t ex t [ l ] . S o m e engineering design texts include achapter on ethics [2]. One good source of general infor- mation for biomedical engineers contains separate chapters on economics of health care, codes and regulations, and legal and ethical aspects [3].

This article describes the outline and some subject matter for these discussions in the accredited B.S. Biomedical Engineering program at Louisiana Tech University. The discussions are held within the context of the senior biomedical engineering design course. It is taught as one of the many issues that enter into responsible biomedical engi- neering design; others may include biocom- patibility, regulatory considerations, and human factors. This syllabus could be used as a separate series of seminars with the students or within the context of another junior or senior level course in biomedical engineering. I t may also be used as part of a separate course in societal and nontechnical impact of engineering and technology.

Ethical Principles In recent years, ethics and ethical behav-

ior have been a focus of much media and society attention. Cases involving political leaders and aerospace engineers have brought the subject into the open. Many executive branch appointees and Congress- men/women have been judged to be in vio- lation of ethical governmental behavior. Some engineers involved in the space shuttle design were criticized for their decisions and some were commended regarding their use

IEEE ENGINEERING IN MEDICINE AND BIOLOGY

of critical information which affected the safety of the final Challenger launch [4]. A comprehensive review of the ethical issues and priorities facing science was prepared by Sigma Xi, the national research honor soci- ety [5] . This booklet addresses the impor- t ance of e th i ca l behav io r , pe r sona l commitment, cooperation with other scien- tists, and challenging an unethical research environment when it exists.

Definitions and Basic Precepts Certain definitions and principles pro-

vide a framework in which classroom dis- cussions can occur. How can ethics be defined? Ethics may be defined as the ac- cepted principles of right and wrong, espe- cially those governing a profession [ 6 ] . However, ethics is also self-controlled, in- stinctive decision-making where the relative merit of positive and negative considera- tions are subjective. Another definition ap- propriate for engineers is: “the study of systematic methodologies which, when guided by individual moral values, can be useful in making value-laden decisions”[7]. Ethical analysis is analysis of adecision with respect to the values in conflict within the decision [SI. This analysis requires iden- tification and ranking of the related values. The identification of values and the process of ranking can be taught. However, the ac- tual ranking is the key to the decision and can not be taught.

Ethical precepts exist at different levels. For example, a vast majority of humans would agree to the principles of “tell the truth,’’ “keep your promises,” and “permit no harm.” Others such as “use resources wisely’’ or “protect the rights of the individ- ual” may be more difficult to practice and may conflict with other values. Two founda- tions of medical ethics are the traditional norms of beneficence (the provision of medical benefits) and nonmaleficence (the avoidance of harm) [9]. These basic medical values are traced back to the Greek physician Hippocrates, who advised, “As to disease, make a habit of two things - to help, or at least to do no hann.”

Modem medical conduct depends more on justice and fair distribution of hanns and benefits than on these traditional ethical norms. The new technologies require new standards of medical conduct. Biomedical

0739-51 75/93/53 0001993 December 1993

engineers must fulfill their responsibility to decide for themselves and to educate others in an objective manner.

Another question is that of authority over the body of the newly dead. It is general policy that, to avoid conflict of interest, the Organs for sale could transplant medical team be different from the medical team that cares for the dying person. Legislation in the United States al- lows people to make the donation without too much red tape. Many state drivers li- censes provide a mechanism for organ dona-

Ethical Rules Rules are explicit commandments that

dictate proper conduct [7] . One type of rule involves sound engineering practice, such as regulatory legislation, technical manuals,

solve the availability

problems, but Some handbooks, or published standards. Another type of rule is intended to provide a path to a correct decision, as dictated by the collec- tive wisdom of the professional society. This set of rules is usually very broad and situ- ations arise where a question is not covered by the rules or is covered by several contra- dictory rules. Codes of Ethics for profes- sional conduct provide some such rules.

Systems of Ethics The path to a solution of a particular

question depends on the system of ethics one chooses to apply. Different systems of ethics place higher priorities on different values. The choice of which system of ethics to apply is a personal decision. Three examples of ethical systems are the utilitarian, the egalitarian, and the libertarian [lo]. Utilitari- anism suggests that ethical questions may be answered by a semi-technical equation, bal- ancing and optimizing alternatives by as- signing value to benefits and costs to society. The egalitarian system measures the well- being of society by the condition of the worst-off person in that society, on any par- ticular issue. Libertarianism seeks to mini- mize harm to all individuals in a society, in which the winners must somehow compen- sate the losers. The American legal system incorporates some aspects of each of these systems [IO]. Other classifications are based on motive or appeals for ethical behavior, including teleological (do right because it works), deontological (do right because it is your duty), or cognitive (do right because it is natural and intuitive).

Moral Values The fundamental basis for ethical deci-

sion-making is an individual’s own moral values. Although moral values may be ac- quired (learned), they cannot be taught be- cause they are the product of strong parental, cultural, and religious factors. So teaching of ethics is limited to identifying the role of rules, encouraging students to be aware of their own moral values, presenting examples of the application of different ethical sys- tems, and analyzing decisions.

The remainder of this paper attempts to identify many of the ethical issues and deci- sions inherent in modem medical technol- o g y . T h e s e i s sues inc lude o r g a n transplantation and artificial organs: re-

ethically questionable

situations would occur

search in nc\\ hiomcclical tcchnology, in- cluding lit inicii i t t ‘ \ t in f and ;uiimal testing; physical. emot iond . and fimncial costs; de- veloping itlid reftilatin? neu technology; and new i\wc\.

Organ Transplantation and Artificial Organs

Organ Transplantation Beginnins with blood transfusion during

World War 1. many different internal organs have been transplanted as new medical knowledge and cxpcricnce developed. The general advantages of organ transplants in- clude: I ) tranqAants normally have the same shape and size as the organs they replace, 2) transplant5 may exhibit self-repair and adap- tation, and 3 ) they require no external power source. The most frequently transplanted or- gans are the kidney. the cornea, and the skin. Other organs less frequently transplanted are the heart, the lung, the liver, the pancreas, bone marrou. ovaries, and testicles. The his- tory and development of transplantation i s reviewed by Varga I I I ] . Organ transplanta- tion imposes some critical ethical decisions involving the donor, the recipient, and the costs to society.

The critical question that must be ad- dressed, even for those who have volun- teered their organs to be used after death, is when does a person die‘? Brain death, as indicated by a flat electroencephalogram, has become acceptable as a definition of death. However, reasonable doubt may re- main for some cases.

- tion after death. In some countries, organs may be transplanted from the recently dead unless the person has registered an objec- tion. However, the United States is very protective of the rights of an individual. Are Americans willing to make a similar law to overcome the shortage of donor organs?

For obvious reasons, the use of living donors is limited to paired organs and to parts of the human body that regenerate. The principle of totality states that a diseased organ may be amputated or excised for the good of the whole organism. Healthy organs may not be amputated because that would be an act of weakening one’s health I l l ] .

If the principle of totality is interpreted in light of a person’s humanity and relationship to all of mankind, then perhaps the response would be different. A human being’s ra- tional and social nature, the “totality” of a person’s humanness, guides one to come to the help of one’s fellow human beings, as long as one does not expose one’s self to grave danger. This interpretation permits transplantation of organs from live donors.

If it is morally acceptable to donate one’s organs to another human, is it a moral obli- gation to do so? A civil court case upheld the rights of one individual to deny his compat- ible bone marrow to a cousin. The ill cousin’s chance of living beyond one year would have risen from 25 percent to 60 percent with the transplantation. The well cousin refused to undergo the surgery and could not be compelled I l l ] .

Only about 20 percent of usable organs are harvested and not all are able to be actu- ally implanted. Organs for sale could solve the availability problems, but some ethically questionable situations would occur. A worldwide black market for kidneys from unrelated donors is flourishing as of 1985 [ 121. In China, “criminals” are executed by a shot in the head, preserving other organs. Coincidentally, wealthy residents of Hong Kong may travel to China for a kidney trans- plant. So, how much is a kidney worth? Of course, in the U.S. it i s illegal to buy and sell organs, except for blood and semen [131.

The use of animal tissues and organs for transplantation into humans has been prac- ticed with success for hundreds of years 11 I ] . Heart valves. grafted vessels, and su- tures are just a few of the animal tissues that have been used without significant ethical

December 1993 IEEE ENGINEERING IN MEDICINE AND BIOLOGY I01

question. Recent years have seen an increase in concern for the rights of animals. A sig- nificant conflict in values arose in 1984 when an infant in California, known as Baby Fae, survived for three weeks with a baboon heart taken from a sacrificed animal. How- ever, animal heart valves, called xenografts, are routinely accepted by the general public. The general issue of animals used in research is discussed below.

Artificial Organs Artificial organs have several advantages

over organ transplants. Artificial organs can be made more available through manufac- turing and distribution, thus overcoming the shortage problem and avoiding the question of organ donation. Artificial organs, when carefully designed and built for biocompati- bility, do not require the strong and costly immunosuppressive drugs that accompany organ transplants. For some organ replace- ments, the prosthetic can be made more cos- metic than the original.

Development and use of artificial organs involves some questions that are distinct from those of organ transplants. The totally implant- able artificial heart raises several important issues. In some cultures, the heart is viewed as the center of human emotions. Psychological difficulties may be imposed on users of artifi- cial hearts and those who live with them. Some may object to the simple idea of replacing human body parts with unthinking, unfeeling, unreal mechanical parts. Acceptance of such anti-technological ideas may be growing among the general population due to recent movies and television programs. On the other hand, artificial heart valves, joints, and blood vessels are routinely implanted. Are these im- planted devices more or less acceptable than external prosthetic limbs? The artificial heart, and other artificial organs, can conceivably be built to function for many years. They may keep working beyond an age when the natural organs have deteriorated. How then would the decision be made to “turn off’ the heart and who would make this decision? How could we decide whether to continue to recharge or re- place the energy source when the recipient reaches age IOO? And who owns the explanted device after the patient dies?

One concern over the artificial heart is that the recipient of a temporary device will be given priority for a heart transplant, cre- ating even greater inequities. A related con- cern is that the recipient of the temporary implant may become permanently depend- ent on it. Complications may arise that create a high risk for a human heart transplant [ 121.

Choice of Recipient Another ethical problem that effects both

organ trans-plantation and artificial organ

implantation is the choice of recipient. With more humans in need of organs than there are organ donors or approved artificial or- gans, difficult decisions must be made. Tri- age is a term for making critical medical care decisions under conditions of limited re- sources of time, materials, or caregivers, such as during military combat. The impor- tant underlying question in triage is: What are the most important criteria? A little coax- ing will help the student suggest many po- tential criteria. Subjective criteria such as need, benefit, social worth. or usefulness would inevitably lead to discrimination charges. Even objective criteria such as free market enterprise (highest bidder) or draw- ing lots have significant ethical problems and are difficult to apply [ I I]. A study by the Agency for Health Care Policy and Research (AHCPR) found that between 1986 and 1987. higher income patients or those with private insurance were twice as likely to receive heart transplants, despite contraindi- cations, than poorer. non-privately insured patients with no contra-indications [ 141.

One of the simplest methods is by age. One reason both Barney Clark and William Schroeder wanted artificial hearts (first and second recipients) was that they were both over 50 and thus were not eligible to receive heart transplants. The British National Health Service practices triage by bureau- cratic delay. The principle of first come, first served, for the limited number of govern- ment-funded transplants inevitably kills off a certain number of applicants [ 151.

Conducting Research in New Biomedical Technology One of the complex choices in the>&-

opment of new medical technology is decid- ing when laboratory and animal testing are sufficient and when human tests should be conducted. The decision seems always in- herently premature because of basic uncer- tainties about potential outcomes for the first human subjects [ I ? ] . According to the Nuremberg Code, the human test is war- ranted when there is an expectation that its results will be fruitful. when the knowledge sought cannot be gained by other means. and when the researchers take care that no ran- dom or unnecessary features are part of the protocol. Many such studies for new medical devices have been conducted with patients who have not responded to accepted altema- tives and whose conditions are so critical as to “justify” the risks.

How can human subjects be protected from both harms and wrongs where medical innovation and experimentation are con- cerned? Four different mechanisms have evolved [ 161: 1 j the regulatory service of the FDA, 2) informed consent before participa-

tion, 3) the human experimentation commit- tee or institutional review board, and 4) the American legal system of lawsuit and re- course. A complete discussion of medical device liability and risk management is pre- sented by Price [ 171.

Before the FDA approves a new device for marketing, a clinical investigation in- volving human subjects is performed to de- termine the potential benefits for the patient and to identify risks. The FDA monitors the safety and effectiveness of medical devices through a system of device classification, general controls, performance standards, and pre-market approval. The medical de- vice regulatory process and the role of the FDA is presented in the course.

What does informed consent mean for a terminally ill patient for whom the risk is high, with or without the experimental treat- ment? The 17-page consent form that Wil- liam Schroeder and his family signed spelled out everything that could go wrong. The document had been expanded since the days of Barney Clark to include the problems that Clark had encountered [ 151. Limitations on adequately informing a patient involve the patient’s inability to fully understand all of the implications of the treatment, the risks, and the probabilities of success or failure. The patient may have a tendency to be less objective due to the desire for a successful outcome [ 181.

Informed consent requires that the inves- tigators: w describe the study (procedures, duration, purpose) w state the foreseeable risks w tell of any benefits expected

describe alternative treatments assure confidentiality of participation and

patient information w describe any compensation, without coer- cion w provide names of who to call if problems occur or if the subject desires to leave the study, and w assure that refusal to participate will not produce prejudice or loss of benefits.

The system of local, institutional review boards is designed to safeguard the rights and safety of human subjects. These boards assure that risks to subjects are minimized, informed consent is documented, selection of subjects is equitable, the experiment is monitored for safety, and the course ofcon- fidentiality and privacy is respected [ 181.

An important question is the definition of success in human therapeutic research. With Barney Clark, the surgeon, Dr. William DeVries, said that if Clark had no regrets then the procedure was successful. Dr. Jarvik, the biomedical engineer who de-

102 IEEE ENGINEERING I N MEDICINE AND BIOLOGY December I993

signed the artificial heart, felt that for the procedure to be called a success, the patient must say it was worth it. Another problem is the possible conflict of clinical trials with therapeutic obligation [ 191. The question in- volves possibly changing a therapy during a controlled clinical study because of the ob- ligation to care for the patient. Such altera- t i ons m a y p r o d u c e i n c o m p l e t e o r inconclusive results

Too often in biomedical research, the designer and developer of a product i s also involved in its evaluation. The potential fame and financial benefits in development and evaluation of any new device or proce- dure may effect the objectivity of those in- volved. This conflict leads to a temptation, deliberate or unconscious, to a biased or subjective evaluation. The public concern over scientific fraud and misconduct has increased and, perhaps, the number of inci- dents has actually increased as well.

Some people, including medical re- searchers, would say that we should not do animal research when only humans stand to benefit. Students, as well as practicing pro- fessionals, need to know the ethical implica- tions of this argument. The rights and conditions of animals used in biomedical research are protected by standards for use, care, and transportation through various fed- eral and nongovernmental organizations. The entire issue is discussed in a White Paper by the American Medical Association 1201.

Many factors affect the choice of an experi- mental animal for a particular investigation. These include costs, size, handling, and appro- priateness for similarity to humans in parame- ters of interest [21]. The scientific ethical question of whether the results will be valid if a less expensive animal is chosen is an old problem. Another potential factor is the resis- tance to animal experimentation by animal rights group. In describing the general consid- erations in the choice of an animal, Conti also presents the “animal rights problems.” Ba- boons have “severe animal rights problems” while goats and pigs have “minimal animal rights problems.” This creates the potential for poorer quality in science because of political or social pressure.

Costs of Health Care Some of the most stimulating discussions

in the classroom result from considering the physical, emotional, personal, and societal costs of modern health care. Every one, in- cluding students, can relate very personally to these factors.

Physical and Emotional Costs In addition to the financial costs to the

patient, the family, and to society, the physi- cal and emotional costs of illness are enor-

mous, 111 < I poi‘iii ~ ~ i i i i i l c d .‘Dialysis: A Poem.” 1 I 2 I .I cliroiiil ~I i , i l ! \ I \ Ipitient con- veys much 01’ the I’cclin~\ 01’ ;I technology- dependent Iil’c. “‘Do ! 011 tahe this machine in s ickno\ .ind in hcaltli t i l l death do you part?’ I do.” ” I am the final c.s\ence of the technologicxl age. llc\h coii,joiiicd with plas- tic.” Thew ptira$e\ I’rom the poem are so poignant atid evocati\ e o l the ethical issues that we ha\r f x c d ;I\ ;I \ociet> and as a profession.

Two of the iiio$t iiitcrcsting reflective comment$ after Williani Schi-oecier’s artifi- cial heart implantation came from his wife and from ;I In\vyer. Mxgarct Schroeder said “Bill thought he’d eithcr die or yet better. If he had anticipated the hard\hip this has been on the fa mil^. he might not have done it.” George Anna\. chair of the Legal Problems in Medical Practice Coininittee of the American Bar Awxiation, said ”It’s sad to think that ;in artificial heart costs a quarter of a tnillivii ciollars. then a customized van, then a custoniixcd house to keep a guy going who in the end spends hi\ life watching basketball games on TV and the next day can’t remember which team won.” [ I S ]

Economic Worth of an Individual: ?Just Do It

When (insured) people are sick, they and their families are rarely concerned with the cost of care. Everyone wants the best health care available, regardless of the cost and regardless of who has to pay in the end. At the turn of the century, most people died at home, fairly quickly of infectious diseases.

Now, more than 70 percent die expensively in well-equipped hospitals of slow, degen- erative diseases [IS].

Distributive Justice Distributive justice is an important re-

source allocation question that should in- volve biomedical engineers. Distributive justice demands an equitable distribution of the goods available to society as a whole. With the enormous costs of organ transplan- tation and artificial organ development and implantation, society must decide how to allocate limited medical and financial re- sources.

The question is more of how to spend the resources available for medical and health care than of how much can we afford to spend theoretically. The Emerson Hospital in Massachusetts estimates that the bill for William Schroeder’s operation would cover 790 days of hospital care or full treatment for 11 3 patients with an average stay of one week each [ 151. The cost of a liver transplant would finance a year’s operation of a San- Francisco inner-city clinic that provides 30,000 office visits. Are all sick people be- ing treated equitably or is a relatively small group of organ recipients being favored at the expense of others? Should more money be spent on preventing disease or trying to cure more people with less serious illnesses. Should every hospital have an MRI or CT?

We may consider also the indirect bene- fits of new technology. Dr. Denton Cooley, the noted Houston heart surgeon, argues that spin-offs from the artificial heart program would be invaluable, even if the heart itself fails. The development of new valves, new biocompatible products, and new miniaturi- zation techniques would be significant enough for justification [lS].

Government Payment The decision in 1972 to provide Medi-

care coverage for the costs of dialysis and kidney transplants was a costly one. The first year’s bill for the kidney dialysis payments came to $241 million for 10,300 patients. The estimate had been $140 million for 5.000 to 7,000 patients. After 10 years, the number of patients soared to 82,000 at a cost of $2 billion; many of these patients are dying cancer victims and nursing home oc- togenarians [IS]. This precedent is contrary to current cost-cutting efforts and could be economically disastrous if extended to other trans-plantation programs. The gross annual costs of a therapeutically viable artificial heart may be $ 2 5 5 billion per year for 17,000 to 35,000 implants [12].

The Medicare Prospective Payment Sys- tem with its diagnostic-related groups (DRGs). was an attempt by Congress to con-

December 1993 IEEE ENGINEERING IN MEDICINE AND BIOLOGY 103

trol the rising costs of health care. Medicare had contributed, in part, to the rise through its cost-based reimbursement. The new sys-

Developing and Regulating New Technology

cide whether or not to report the problem to a higher authority. The Code of Ethics for Engineers suggests a responsibility by the

tem creates more incentives for cost effec- t i v e m e d i c a l s e r v i c e s . B i o m e d i c a l engineering students need to be somewhat familiar with the implications of DRGs and UR (utilization review) [22].

Just Saying NO The costs of organ transplantation are

staggering: heart transplants between $100,000 and $200,000, liver transplants at $135,000 plus a year of rehabilitation, bone marrow transplants up to $60,000. Barney Clark incurred a hospital bill of $200,000 not including $9,000 for the artificial heart plus $7,400 for its pump, and $3,000 or so per year that it would have cost him if he had survived [ 151.

Former Colorado Governor Richard Lamm is noted for his remarks on the subject of health care costs during the initial flurry of artificial heart implants in 1984. He de- clared [15], “we’ve got a duty to die and get out of the way with all of our machines and artificial hearts, so that our kids can build a reasonable life.” These comments call on humans to accept the inevitability of disease and death.

Deciding how to say no honestly and with integrity is one of the most difficult ethical questions that must be faced in the coming years. Some form of rationing or restriction will be required. What quantity and quality of hospital care do people have a right to expect? As Governor Lamm puts it, “We give food stamps but we don’t give people the right to go to [an expensive res- taurant] for dinner” [ 151.

Lester C. Thurow, Dean and Gordon Y. Ballard Professor of Economics at the Alfred P. Sloan School of Management of the Mas- sachusetts Institute of Technology, makes some crucial points concerning the cost of new medical technology and saying no to some of its use and development [23]. The American health care industry is now twice as large as the defense budget, 12 percent of GNP. With the rising costs of treating the growing number of AIDS victims, with the rising costs and number of heart transplants, with the rising number of elderly Americans and their increased health care needs, with the rising cost of health insurance for em- ployees and retirees, expenditures must be limited. Biomedical engineers may be viewed as a source of these costs or as a source of solutions. We need to support our professional organizations that participate in the debate. We also need to develop personal positions with deliberate forethought.

Need for Commercialization Medical devices must be commercial-

ized in order to ensure the cost of develop- m e n t . m a n u f a c t u r e , d i s t r i b u t i o n , improvement and regulation [ 181. Factors such as market size and market competition may influence the decision as to commercial development of new products. This may lead to a lack of interest in orphandevices, quality control, and safety in non-regulated coun- tries.

Devices that would benefit few patients. even though greatly needed by them, have fewer prospects for development. Biomedi- cal engineers should be aware of this in their design and should consider their involve- ment in support of such “orphan” devices or drugs. The major influence and the potential personal involvement of future engineers are discussed in the class.

Quality control is an ethical and a scien- t i f ic issue for biomedical engineers . Biomedical devices are subject to basic en- gineering design constraints and to long- term degradation effects. Also, foreign materials present may have various deleteri- ous effects [18]. The role of quality assur- a n c e in d e s i g n , manufac tu r ing , and marketing also needs to be addressed [ 171.

In most Third World countries, guide- lines for product testing and performance arc less strict than in North America or Europe. Clinical data from the use of a product in a Third World country may be used to gain approval for manufacturing and selling the product in the U.S. [18]. Would you support this strategy for “more rapid health care de- velopment?”

Another issue raised by the development of medical technology lies in the context of corporate, for-profit medicine [24]. The de- velopment and marketing of the Jarvik heart by Symbion, Inc. and the underwriting of the permanent implant series by Humana, Inc. provoked substantial criticisms. Humana provided the heart and its drive system to William Schroeder without charge. They provided free rooms at the hospital for the entire Schroeder family (six grown children and their families). Humana also prepared a specially designed house with a built-in air system for the heart’s drive [ 151. The mo- tives of Humana, Inc. may be questioned when the publicity and profit potential are realized.

A common ethical decision for engineers in many areas is when to report a potential safety hazard. When employer administra- tive channels do not respond in a “safe and responsible” manner. the engineer must de-

engineer to the public and also to the em- ployer [7].

Need for Regulation The FDA, through its regulatory and en-

forcement functions, imposes some ethical decisions on the medical technology com- munity. The basic ethical issue for which the FDA was created and now serves is the conflict between the manufacturer’s com- mercial interest and society’s interest in as- suring that new medical devices are safe and effective. The full and sincere implementa- tion of FDA regulations provides guidelines for some of the questions facing biomedical engineers.

Even with a formalized system of codes, regulations, or ethics, loopholes may re- main. In reviewing reports of fatal problems with an anesthesia machine made by Puri- tan-Bennett, the FDA and a Congressional subcommittee found the company using a technicality to avoid reporting a malfunc- tion. The company claimed that “a lawsuit is not a complaint,” even though 28 lawsuits had need filed against it over the problem 1101.

New Issues New questions will certainly arise as new

technology is developed. As an example, in recent years developments in fertility medi- cine have produced some sensational and agonizing situations: e.g. the case of Baby M. in early 1987. Mary Beth Whitehead had contracted to be a surrogate mother for the embryo of William and Elizabeth Stem. Ms. Whitehead could not bear to give up the child she bore and a lawsuit resulted. An- other recent case involved a family who knew. through prenatal testing, that their infant in the womb was hydrocephalic. They had decided before the child’s birth to give its organs to another child. The family had much difficulty in finding a hospital that would agree to their decision and provide supportive medical care for the unfortunate baby for a few days of life. Other important questions include to whom do frozen em- bryos belong? and What rights do they have?

New ethical and regulatory dilemmas arise in medicine as computers are used to control medical instruments. In 1985, the FDA reported that recalls of medical devices because of computer faults had roughly dou- bled over the previous five years [25]. The FDA regulates all computer products for medical use when competent human inter- vention cannot effectively override the ma- ch ine ‘ s act ion. Biomedical engineers involved in the development of medical sys-

104 IEEE ENGINEERING I N MEDICINE AND BIOLOGY December 1993

tems should be concerned with the uses and possible hazards of computer control. Veri- fying that a particular computer program does exactly what it is supposed to do is very difficult and often all possible inputs and consequences cannot be fully checked. However, the system developer is by far the most qualified to verify its performance.

Case Studies A common approach to teaching engi-

neering ethics is the presentation and discus- s ion of case s tud ies . The case of a misconnected selector valve on a ventilator is presented in Saha and Saha [6] along with the case of a nurse who was suspended for giving a patient information about her con- dition against doctor’s orders. The problems of Shiley. Inc. (later, Pfizer) in dealing with fractures in one of their artificial heart valves is presented by Fielding [26]. Cases of un- ethical biomedical research are reported by Saha and Saha [ 1 81. An excellent source of hypothetical cases involving liability, regu- lation, and other ethical issues in medical device development appeared in the IEEE Engineering in Medicine and Biolozy Magazine from June, 1986 through June. 1988, in the Engineering and the Law col- umn. Specific examples from the instruc- tor’s experience or from those of a guest presenter naturally add relevancy to the dis- cussion. It is important to follow the scien- tific news for current topics and issues.

Conclusion Biomedical engineers must indeed be ex-

perienced in scientific and engineering de- sign principles. Problem identification, design criteria, modeling, alternative solu- tions, optimization. and other stages in the engineering design process require study. training, and practice, and form the founda- tion of biomedical engineering education. Presentation and discussion of ethical issues and questions provides a stimulating supple- ment to the basic education. The students enjoy this part of the course very much. Classes with students from other countries add much to the variety and interest. Guests with legal experience (product liability. ex- pert witness) are especially interesting. The discussion of ethics reveals some non-obvi- ous factors that can be significant in the design, manufacture, marketing, or clinical use of medical devices. Biomedical engi- neers need relevant exposure to these ideas and issues at an early stage in their career. prior to being faced with apersonal decision.

Statz A. Napper- is Associate Professor of Biomedical Engineering and Coordinator of Instructional Programs for the Biomedical Engineering Department at Louisiana Tech

U n i v e r s i t y . H e re- ce ived the B.S. and P h . D . d e g r e e s i n biomedical engineer- i n g f r o m L o u i s i a n a Tech in 1980 and 1985, respect ively. H e has served as Vice Chair- man for Awards and

Career Development and Vice Chairman for Professional Development for the Biomedical Engineer ing Divis ion of ASEE. He is currently Program Chair ( 1995) for BED of ASEE. He is the found- ing executive director of Alpha Eta Mu Beta , the nat ional honor society for biomedical engineers. He is a former Stu- dent Representative to the AdCom of IEEE EMBS.

Address correspondence to Stan A. Napper, Ph.D., P.O. Box 10348 Depart- ment of Biomedical Engineering, Lou- isiana Tech University, Ruston, LA 71272.

Pair1 N . Hale, J I . . is Pro- fessor and Department Head of the Biomedical Engineering Department at Louisiana Tech Univer- sity.HehastheB.S.degree from Lamar Tech, the M.S. degree from the Uni- versity of Arkansas and the

Ph.D. degree kom Texas A&M University. These degrees were in industrid engineering, with the doctoral degree emphasizing human factors engineering. Dr. Hale is a member of the Education Committee of the IEEE EMBS and an ABET Program Evaluator for Bioen- gineering. He is Past Chair of the Council of Chairs of Bioengineering and Biomedical En- gineering. and is the Program Chair and Chair- Elect of the Biomedical Engineering Division of the American Society for Engineering Edu- cation.

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December 1993 IEEE ENGINEERING I N MEDICINE AND BIOLOGY 105