Biomedical Engineering Test #3 || with 100% Errorless
Solutions.
What are the overall objectives for the risk management section? correct answers - Gain an
overview of what is meant by risk and specifically, risk management regulations in biomedical
engineering.
- Recognize the international standard for risk management for medical devices, ISO14971.
- Learn the definitions or basic concepts related to risk management including:
--- Risk
--- Harm, Hazard and Hazardous Situation
--- Severity and Occurrence
- Understand the principle activities in Risk Management including:
--- Risk Analysis, Risk Evaluation, Risk Control and Production/Postproduction information.
- Recognize some of the tools for Risk Analysis including:
--- FMEA and FTA
- Understand how risk management fits into engineering design and design control.
What is an indirect harm or an injury to a person, and an example of this? correct answers When
the harm does not come directly from the devices but as a result of an action taken based on what
info device gave.
A wrong blood sugar reading.
What is the standard for risk management for medical devices? correct answers EN ISO
14971:2012
Medical devices - Application of risk management to medical devices. (previous versions of
2000, 2007, and 2009)
Risk Management Definition: correct answers The systematic application of management
policies, procedures, and practices to the task of analyzing, evaluating and controlling risk.
Risk Management Example: correct answers All of the polices a company writes for their system
of risk management.
What do the four stages of the risk management process represent? correct answers They each
represent multiple clauses within the ISO 14971 standard that we must abide by throughout a
product's lifecycle.
Risk definition: correct answers Is the occurrence of harm and the severity of that harm.
Risk example: correct answers Death - High risk or low risk
rash - High risk or low risk
Harm definition: correct answers Physical injury or damage to the health of people either directly
or indirectly
Damage to property
, Damage to environment
It is generally the end result of a hazard/hazardous situation.
Harm example: correct answers Broken leg (person injured)
Cardiac arrest
Local reaction
Coma
Infection
Discomfort
Shock
Renal failure
Hazard definition: correct answers Is the last product event to happen.
Hazard example: correct answers Heavy traffic
Hazardous Situation definition: correct answers A hazard combined with a sequence of events.
Hazardous Situation example: correct answers When a person is hit by moving vehicle
Occurrence definition: correct answers The frequency or probability of an event
Occurrence example: correct answers Often Reported as a Ranking or Scale System
(High, Medium, Low) or (1-5)
Statistical numbers are preferred and likely with change with time and use of the product.
Severity definition: correct answers A measure of the possible consequence of a hazard
Severity example: correct answers Reported as Ranking or Scale System
(High, Medium, Low) or (1-5), etc.
Best determined by medical expert such as Chief Medical Officer (CMO)
Fault Condition Hazard: correct answers A hazard that results from some failure or misuse. Most
hazards are the result of some failure mode. An example would be if an angioplasty balloon
bursts during use.
Normal Condition Hazard: correct answers This type of hazard does not result from some failure
or misuse but rather is inherent from its intended use and design. An example is the sharp blade
of a scalpel that is a potential source of harm to users.
"Inherent by Design" (in the context of risk control) correct answers Trying to design away risk.
Needle with spring loaded cover that activates once used
FMEA: correct answers 'Failure Mode and Effects Analysis'
A step-by-step approach for identifying all possible failures in a design, a manufacturing or
assembly process, or a product or service.
Solutions.
What are the overall objectives for the risk management section? correct answers - Gain an
overview of what is meant by risk and specifically, risk management regulations in biomedical
engineering.
- Recognize the international standard for risk management for medical devices, ISO14971.
- Learn the definitions or basic concepts related to risk management including:
--- Risk
--- Harm, Hazard and Hazardous Situation
--- Severity and Occurrence
- Understand the principle activities in Risk Management including:
--- Risk Analysis, Risk Evaluation, Risk Control and Production/Postproduction information.
- Recognize some of the tools for Risk Analysis including:
--- FMEA and FTA
- Understand how risk management fits into engineering design and design control.
What is an indirect harm or an injury to a person, and an example of this? correct answers When
the harm does not come directly from the devices but as a result of an action taken based on what
info device gave.
A wrong blood sugar reading.
What is the standard for risk management for medical devices? correct answers EN ISO
14971:2012
Medical devices - Application of risk management to medical devices. (previous versions of
2000, 2007, and 2009)
Risk Management Definition: correct answers The systematic application of management
policies, procedures, and practices to the task of analyzing, evaluating and controlling risk.
Risk Management Example: correct answers All of the polices a company writes for their system
of risk management.
What do the four stages of the risk management process represent? correct answers They each
represent multiple clauses within the ISO 14971 standard that we must abide by throughout a
product's lifecycle.
Risk definition: correct answers Is the occurrence of harm and the severity of that harm.
Risk example: correct answers Death - High risk or low risk
rash - High risk or low risk
Harm definition: correct answers Physical injury or damage to the health of people either directly
or indirectly
Damage to property
, Damage to environment
It is generally the end result of a hazard/hazardous situation.
Harm example: correct answers Broken leg (person injured)
Cardiac arrest
Local reaction
Coma
Infection
Discomfort
Shock
Renal failure
Hazard definition: correct answers Is the last product event to happen.
Hazard example: correct answers Heavy traffic
Hazardous Situation definition: correct answers A hazard combined with a sequence of events.
Hazardous Situation example: correct answers When a person is hit by moving vehicle
Occurrence definition: correct answers The frequency or probability of an event
Occurrence example: correct answers Often Reported as a Ranking or Scale System
(High, Medium, Low) or (1-5)
Statistical numbers are preferred and likely with change with time and use of the product.
Severity definition: correct answers A measure of the possible consequence of a hazard
Severity example: correct answers Reported as Ranking or Scale System
(High, Medium, Low) or (1-5), etc.
Best determined by medical expert such as Chief Medical Officer (CMO)
Fault Condition Hazard: correct answers A hazard that results from some failure or misuse. Most
hazards are the result of some failure mode. An example would be if an angioplasty balloon
bursts during use.
Normal Condition Hazard: correct answers This type of hazard does not result from some failure
or misuse but rather is inherent from its intended use and design. An example is the sharp blade
of a scalpel that is a potential source of harm to users.
"Inherent by Design" (in the context of risk control) correct answers Trying to design away risk.
Needle with spring loaded cover that activates once used
FMEA: correct answers 'Failure Mode and Effects Analysis'
A step-by-step approach for identifying all possible failures in a design, a manufacturing or
assembly process, or a product or service.
