Chapter 5 Regulations And Standards

Front 1

Statues

Back 1

Written law adopted by a legislative body that governs city, state or country

Front 2

Regulations

Back 2

Rules issued by administrative agencies that have the force of law

Front 3

Standards

Back 3

basic parameters for processes, products, services and measurement

Front 4

Regulatory standards

Back 4

Mandated by governing agency

Front 5

Voluntary standards

Back 5

Guidelines or recommendations for best practices to provide better patient care

Front 6

Best practice

Back 6

A method or technique that has consistently shown best outcome

Front 7

Regulation, regulatory and voluntary standards ate issued by

Back 7

Federal ,state and local governing agencies

Front 8

Voluntary standards provide significant assistance to healthcare personnel because they are developed according to

Back 8

Best practices

Front 9

U.S Food and drug administration (FDA) is a ______ agency (voluntary or regulatory)

Back 9

Regulatory

Front 10

Responsibility of U.S Food and drug administration (FDA)

Back 10

Federal agency responsible for ensuring that food, cosmetics, human and veterinary drugs, biological products, medical devices, and electronic products that emit radiation are safe and effective for public use

Front 11

FDA class 1 devices

Back 11

Low risk devices, most hand held surgical instruments, ultrasonic cleaners

Front 12

Class 1 device are exempt from

Back 12

Premarket notification approval know as 510k

Front 13

FDA Class 2 Devices

Back 13

Devices that pose potential risk. Devices includes sterilization equipment, biological and chemical indicators

Front 14

Class 2 are required to submit

Back 14

510k before they can sell these products

Front 15

FDA Class 3 devices

Back 15

regulated devices, includes heart valves, pacemakers and other life sustaining devices

Front 16

Class 3 devices must obtain a

Back 16

Premarket approval (PMA) from FDA to demonstrate product safety and efficacy

Front 17

Pre and postmarket requirements are needed by

Back 17

FDA

Front 18

The safe medical devices act of 1990 requires

Back 18

Health care facility to report medical devices malfunction to the FDA, withing 10 days

Front 19

FDA MedWatch program is designed

Back 19

For involuntary reporting of device-related problems

Front 20

FDA class 1 recall

Back 20

High risk. Reasonable chance the product will cause serious health problems or death

Front 21

Class 2 recall less serious

Back 21

chance that the device will cause problems

Front 22

Class 3 recall low risk

Back 22

Use of the product is not likely to cause adverse health consequences

Front 23

Is Centers for disease control and prevention voluntary or regulatory

Back 23

Voluntary

Front 24

What is the centers for disease control and prevention

Back 24

It works to promote health and quality of life by preventing and controlling disease, injury, disability and by responding to health emergencies

Front 25

Is U.S department of transportation voluntary or regulatory

Back 25

Regulatory

Front 26

Enforces laws relating to the transportation of medical waste

Back 26

Department of transportation

Front 27

Is U.S environment protection agency voluntary or regulatory

Back 27

Regulatory

Front 28

environmental protection agency is responsible for

Back 28

For minimizing greenhouse gasses, toxic emissions, regulating the reuse of solid waste, controlling indoor air pollution and developing and enforcing pesticides regulation

Hint 28

5 roles

Front 29

Green house gases are

Back 29

Any gas that absorbs solar radiation including carbon dioxide, methane, ozone, florocarbons and ethylene oxide

Hint 29

5 gases

Front 30

Who regulates disinfectants and all disinfectants use in the CS department

Back 30

EPA

Front 31

Is Occupational safety and health administration voluntary or regulatory

Back 31

Regulatory

Front 32

Osha is responsible for

Back 32

Protecting workers from occupational caused illnesses and injuries

Front 33

Osha also oversee

Back 33

Occupational exposure to bloodborne pathogens, guidelines for the use of ethylene oxide sterilization

Front 34

Is the centers for Medicare and Medicaid services voluntary or regulatory (CMS)

Back 34

Voluntary

Front 35

Medicare is

Back 35

Medical insurance program that serves those over the age of 65

Front 36

Medicaid is

Back 36

Federal and state assistance program that pays covered medical expenses for low-income individuals

Front 37

Health insurance portability and accountability act (HIPPA) duties

Back 37

Establishes national standards to protect patient medical records and other personal health information

Front 38

Is department of health services voluntary or regulatory

Back 38

Regulatory

Front 39

department of health service is responsible for

Back 39

Local health safety standards

Front 40

Is Association for the advancement of medical instrumentation (AAMI) voluntary or regulatory

Back 40

Voluntary

Front 41

What is the responsibility of Association for the advancement of medical instrumentation (AAMI)

Back 41

Development, management and use of safe and effective medical technology.

Front 42

Is American national standards institute voluntary or regulatory

Back 42

Voluntary

Front 43

Is Association of periOperative registered nursing voluntary or regulatory

Back 43

Voluntary

Front 44

Association of periOperative registered nurses responsibility

Back 44

They develop nationally recognized evidence base standards, recommended practices, and guidelines

Front 45

The association for professionals in infection control and epidemiology voluntary or regulatory

Back 45

Voluntary

Front 46

What is the responsibility of the association for professionals in infection control and epidemiology

Back 46

Organization whose Members work to prevent healthcare associated infections (HAIs)

Front 47

Is International standards organization voluntary or regulatory

Back 47

Voluntary

Front 48

What is the responsibility of the International standards organization (ISO)

Back 48

They give state-of-the-art specifications for products, service and good practice

Front 49

Is The joint commission voluntary or regulatory

Back 49

Voluntary

Front 50

What is The Joint Commission responsible for

Back 50

They develops standards for health care facilities, They also conduct onsite surveys at least every 3 years.

Front 51

Technical information reports (TIRs)

Back 51

Address the use, care and processing of devices and systems

Front 52

Is occupational safety and health administrative voluntary or regulatory

Back 52

Regulatory

Front 53

National fire protection association responsibility

Back 53

International organization that works to reduce the burden of fire and other hazards around the world

Front 54

United States pharmacopeia national formulary

Back 54

Create and revises standards for the purity of medicines, drug substance and dietary supplements

Front 55

world health organization responsibilities

Back 55

Combat disease, especially key infectious diseases, and to promote the general health of people worldwide

Front 56

society of gastroenterology nurses and associates responsibilities

Back 56

Establishes standards and guidelines relating to the processing of flexible underscopes