Biomedical Engineering Survey

Morality and Ethical Issues 1

Biomedical Engineering Survey

Current Moral and Ethical Issues

Gabriel Cap Wednesday, January 25, 2006


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.


Lecture Outline

Definition of Terms Beneficence vs.. Nonmaleficence Redefining Death

Terminally Ill Patient Euthanasia

Human Experimentation Informed Consent


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


Why Discuss

We must discuss these issues for many reasons


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 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 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


Ethics against Morals

Utilitarianism Theory In any situation one should

They claim that the ends will always justify the means


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


Theories of Thought

Consequentialism

Nonconsequentialism


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


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


Beneficence

As new technology develops we must always ensure

“The patient deserves the best” Instead of the old adage “Above all, do

no harm”


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


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


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


Clinical Death

One is said to be clinically dead


Summary of Death

The Ad Hoc Committee of Harvard Med School in 1968 declared


Brain Death

Described as Total and irreparable loss of brain

function…brainstem death


Cheating Death

April 1975 Karen Anna Quinlan

Brain damage sent her to a chronic vegetative state

Supreme Court agreed to remove respirator

Outcome


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


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?


Terminally Ill Patients

When is it right for medical professionals to stop treatment or administer a lethal dose to terminally ill patients?


Euthanasia

Derived from two Greek words Meaning “good” and “death” In ancient times Euthanasia was

commonly practice until Christian beliefs took over


Types of Euthanasia

Two types of Euthanasia Passive

Active Physician takes active part in bringing

about death


Euthanasia

The patient can also have a hand in death Two classifications of Euthanasia

Involuntary

Voluntary

Living will website


Rights of Death

If no living will Who decides when to end the life of

another


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


Human Experimentation

When should experiments be used on Humans

Under what conditions should such studies be performed?


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


Types of Experimentation

Therapeutic

Nontherapeutic


Informed Consent

All adults have legal capacity to give legal consent

Gives the individual the option for self determination

Guided by Basic Principles


Principles of Consent

Many principles that govern informed consent Pg 54-57 Highlights


More Highlight

Many principles govern human experimentation


Medical Device Innovation

New Medical Devices regulated by the FDA

Two categories of devices


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


Ethical Issues in Emergencies

Some devices are authorized for emergency use only


More Emergencies

The patient has a right to know all options


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


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


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


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


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


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


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!


THE END

Questions? Comments? Concerns? Issues? Topics? Rebuttals? Arguments?


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?


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?


THE END

Questions? Comments? Concerns? Issues? Topics? Rebuttals? Arguments?

Documents

Biomedical Engineering Survey