3 - MORAL AND ETHICAL ISSUES

Question 1

represents the codes of conduct of a society

Answer 1

Morality

Question 2

the study of right and wrong, of good and evil in human conduct

Answer 2

Ethics

Question 3

When a cell group that has been determined is transplanted, it will not assimilate with the other cells but will grow into cells that comprise the original organ it was destined to become

Answer 3

Stem Cell

Question 4

one that may have a direct benefit for the patient

Answer 4

Therapeutic Experiment

Question 5

examples of therapeutic experiment

Answer 5

nonconventional radiotherapy, pacemakers, artificial kidneys

Question 6

inhibits the progress of malignant cancer

Answer 6

Nonconventional radiotherapy

Question 7

provides the necessary electrical stimulation for proper heart function

Answer 7

Pacemakers

Question 8

mimic nature’s function and remove poisons from the blood

Answer 8

Artificial kidneys

Question 9

• Provides additional knowledge without direct benefit to the person
• Studies the impact of infection from the hepatitis virus or the malarial parasite
• Procedures involved in cardiac catheterization

Answer 9

Nontherapeutic Research

Question 10

• Fundamental in both ethics and law
• Educates a patient about the risks, benefits, and alternatives of a given procedure or intervention
• The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention

Answer 10

Informed Consent

Question 11

Can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose

Answer 11

Medical Device

Question 12

• Purpose for which they were designed, be robust and avoid harm to the patient and operator
• Adverse events are being reported, including severe and fatal events
  1. Medication side effects
  2. Injury
  3. Psychological harm or trauma
  4. Death
• Regulations aim to ensure that medical devices become safer, of better quality, and have a better design

Answer 12

Medical Device Regulation

Question 13

Reasons for Regulation

Answer 13

1. safety
2. uniform requirements
3. promote innovation
4. free movement of goods
5. compensation

Question 14

• Enhances the health of the patient
• Medical devices must not harm those who use or operate them

Answer 14

Safety

Question 15

risk of implants and pacemakers

Answer 15

High safety risk

Question 16

risk of contact lenses and adhesive plasters

Answer 16

Low safety risk

Question 17

• Standardizing the basic design and requirements
• Any technology may be used as long as the process and final product comply with the essential requirements
• Allows the identification of safety issues to take corrective action

Answer 17

Uniform Requirements

Question 18

• Regulatory oversight can shift the emphasis to truly beneficial change in the form of safer, more effective, or less expensive devices
• Indigenous product development will also be encouraged, for domestic as well as foreign sales, if regulations in the manufacturing country are harmonized with those of the exporting countries

Answer 18

Promote Innovation

Question 19

• Uniform standards allow goods to be imported and exported
• Transparency as to device compliance with regulatory standards and pricing regulation is also ensured

Answer 19

Free Movement of Goods

Question 20

Strict regulation allows patients to be compensated for harm caused by device defects

Answer 20

Compensation