Biomedical Engineering Survey

1. Biomedical Engineering Survey Current Moral and Ethical Issues Gabriel Cap Wednesday, January 25, 2006 Morality and Ethical Issues

2. Introduction • New Technology has created new issues in the medical world. • The production of artificial limbs, organs, etc. have provided “spare-parts” to be used in surgery • These new techniques have also led to moral consequences. Morality and Ethical Issues

3. Lecture Outline • Definition of Terms • Beneficence vs.. Nonmaleficence • Redefining Death • Terminally Ill Patient • Euthanasia • Human Experimentation • Informed Consent Morality and Ethical Issues

4. More Topics • Medical Devices • Emergencies • Treatment • The Role towards the FDA process All Topics are very relevant to the decisions all engineers must make on a daily basis Morality and Ethical Issues

5. Why Discuss • We must discuss these issues for many reasons Morality and Ethical Issues

6. Definition of Terms • Morality vs.. Ethics • People have always questioned the nature of life • 16th century German philosopher Immanuel Kant posed 4 fundamental questions on life Morality and Ethical Issues

7. Morality vs.. Ethics • Morality • From the Latin “mos” • Morals are common laws that everyone knows to abide with • This conduct is not customary but universally accepted Morality and Ethical Issues

8. Morality vs. Ethics • Ethics • From the Greek ethos meaning custom • Synonymous with Latin word mos but shared entirely different meaning • Simply the philosophical view of morals • Referred to as the moral philosophy Morality and Ethical Issues

9. Ethics against Morals • Utilitarianism Theory • In any situation one should They claim that the ends will always justify the means Morality and Ethical Issues

10. Morals against Ethics • Many people believe that the ends do not justify the means • Even though the decision may seem good for all, individuals have rights that are not to be violated no matter how good the consequences might be Morality and Ethical Issues

11. Theories of Thought • Consequentialism • Nonconsequentialism Morality and Ethical Issues

12. Ethical Standards • The World Medical Association adopted a Code of Medical Ethics 1949 • Also revised 1980 and 2001 • Convey concepts of service to humankind and respect for human life. • Link to Medical Code Website Morality and Ethical Issues

13. Moral Norms • Two moral standards have been constant throughout history • Beneficence • Nonmalieficence • Recently medical caregivers are more concerned with avoiding harm than providing better benefits Morality and Ethical Issues

14. Beneficence • As new technology develops we must always ensure • “The patient deserves the best” • Instead of the old adage “Above all, do no harm” Morality and Ethical Issues

15. Specific Moral Issues • Specific situations can help set precedents for the future • Learning from previous mistakes or previous successes can help everyone benefit from the ever-changing technology Morality and Ethical Issues

16. Redefining Death • Medical Technology has helped increase the average life expectancy • In 1900 • Average Life Expectancy--47 years • Present Time • Average Life Expectancy • 74.3 yrs males and 76 years in females • Infant mortality also significantly reduced Morality and Ethical Issues

17. The Meaning of Life • In serious injury situations the question arises • What is the status of the patient? • Is the patient alive? • Example • Serious Head injury in an automobile accident • Previous Definitions of death were used before the Medical technology to sustain life were invented Morality and Ethical Issues

18. Clinical Death • One is said to be clinically dead Morality and Ethical Issues

19. Summary of Death • The Ad Hoc Committee of Harvard Med School in 1968 declared Morality and Ethical Issues

20. Brain Death • Described as • Total and irreparable loss of brain function…brainstem death Morality and Ethical Issues

21. Cheating Death • April 1975 • Karen Anna Quinlan • Brain damage sent her to a chronic vegetative state • Supreme Court agreed to remove respirator • Outcome Morality and Ethical Issues

22. Current Cases • Similar situation with the Terri Schiavo case during 2005 • Sparked new debates on the definition of death in United States • Also brought to questions whose right is it to decide when to remove artificial devices • Parents or Husband Morality and Ethical Issues

23. Conclusions on Death • Questions for Thought • Who should decide when to remove artificial devices • How long should one’s life be left barely alive in a vegetative state • Who pays for all of this? • Comments? Morality and Ethical Issues

24. Terminally Ill Patients • When is it right for medical professionals to stop treatment or administer a lethal dose to terminally ill patients? Morality and Ethical Issues

25. Euthanasia • Derived from two Greek words • Meaning “good” and “death” • In ancient times Euthanasia was commonly practice until Christian beliefs took over Morality and Ethical Issues

26. Types of Euthanasia • Two types of Euthanasia • Passive • Active • Physician takes active part in bringing about death Morality and Ethical Issues

27. Euthanasia • The patient can also have a hand in death • Two classifications of Euthanasia • Involuntary • Voluntary • Living will website Morality and Ethical Issues

28. Rights of Death • If no living will • Who decides when to end the life of another Morality and Ethical Issues

29. Questions on Death • What would be the consequences if Euthanasia would be accepted for public use? • Unclear Guidelines • Mercy Killing • Avoid Finding Solution of Problem • Example • Nazis Morality and Ethical Issues

30. Human Experimentation • When should experiments be used on Humans • Under what conditions should such studies be performed? Morality and Ethical Issues

31. Purpose of Human Experiment • Human Experiment • Information is gathered from humans when tests are run to check the capability of new drugs and devices • Used to enhance the well being of the individual • But new drugs have not been fully tested Morality and Ethical Issues

32. Types of Experimentation • Therapeutic • Nontherapeutic Morality and Ethical Issues

33. Informed Consent • All adults have legal capacity to give legal consent • Gives the individual the option for self determination • Guided by Basic Principles Morality and Ethical Issues

34. Principles of Consent • Many principles that govern informed consent • Pg 54-57 • Highlights Morality and Ethical Issues

35. More Highlight • Many principles govern human experimentation Morality and Ethical Issues

36. Medical Device Innovation • New Medical Devices regulated by the FDA • Two categories of devices Morality and Ethical Issues

37. Medical Device Ethics • A device is cleared when • Risks to subjects are minimized • Risks to subjects are reasonable • Informed consent materials and procedures are accurate • Protecting patients information Morality and Ethical Issues

38. Ethical Issues in Emergencies • Some devices are authorized for emergency use only Morality and Ethical Issues

39. More Emergencies • The patient has a right to know all options Morality and Ethical Issues

40. Role of Engineer with the FDA • 1991 Safe Medical Devices Act went into effect • Requires a wide range of institutions to report all information on the likelihood of death from a medical device • When death is device related a report must be made and submitted to the FDA Morality and Ethical Issues

41. FDA • Increase awareness of the agency • Allows for the protection of the welfare of the patients • But, could increase lawsuits filed against physicians • Biomedical engineers need to be aware of regulations in order to be ready for the process of gaining approval from the FDA Morality and Ethical Issues

42. Conclusions • Bioengineering has a lot of topics to deal understand • Medical Devices • Emergencies • Treatment • The Role towards the FDA process • Beneficence vs.. Nonmaleficence • Redefining Death • Terminally Ill Patient • Euthanasia • Human Experimentation • Informed Consent Morality and Ethical Issues

43. Conclusions • Each topic presents new findings but also new problems • Everyone wants to see the new technology save lives • The pressure on engineers must be managed to ensure a poor product is not produced • Engineers must be sure quality of design before testing and furthermore before being used in practice Morality and Ethical Issues

44. Conclusions • Bioengineers need standards • We need standards to know where we stand on all issues • Once in the workforce we need to realize how far we are willing to go without affecting the well-being of the patients • The utmost care needs to be taken • These are real peoples lives!! Not a science experiment Morality and Ethical Issues

45. Conclusions • Errors could be damaging to advancement of technology • Errors can lead to deformities • Quality of life could be shortened and decreased • Lawsuits can slow progress to halts • Morals and Ethics in this day and age very important for engineers Morality and Ethical Issues

46. In Closing • Engineers cannot be worried about failure • As long as the necessary steps are taken all products should be well designed and safe • Even if ineffective they will not harm the patients that they are working on • With the correct precautions taken, we can change the world and make it a better, healthier, and safer place for all people to live! Morality and Ethical Issues

47. THE END • Questions? • Comments? • Concerns? • Issues? • Topics? • Rebuttals? • Arguments? Morality and Ethical Issues

48. Case Study:Stem Cell Research • Major Questions • Is the embryo a living human being • Does it have rights • Should any research be pursued • Should the government pursue research • Opinions? Morality and Ethical Issues

49. Case Study:Neonatal Intensive Care Unit • Used to keep infants warm and prevent infection • Problem: Could Cause infant to stop breathing • Solution: Engineers developed a tactile vibrator to start breathing again • Questions • How can they prove if this device is safe enough to use? • What should the approval process for this study be? • How can they accurately test device? Morality and Ethical Issues

50. THE END • Questions? • Comments? • Concerns? • Issues? • Topics? • Rebuttals? • Arguments? Morality and Ethical Issues