BMAT Risk Assessment & Management 3 — Questions and Answers
Question 1: A public health authority is assessing the risk of a novel pathogen outbreak. Which quantitative measure best expresses the likelihood of an individual becoming infected after exposure?
- Attack rate (Correct answer)
- Case fatality rate
- Basic reproduction number (R0)
- Incidence density
Correct answer: Attack rate
The attack rate measures the proportion of exposed individuals who develop infection, directly expressing individual infection risk.
Question 2: Which risk transfer mechanism shifts financial consequences of a risk to a third party without eliminating the hazard?
- Risk avoidance
- Insurance (Correct answer)
- Engineering controls
- Hazard elimination
Correct answer: Insurance
Insurance transfers the financial burden of a realised risk to an insurer, but the underlying hazard remains.
Question 3: In Bow-Tie analysis, 'barriers on the left side' of the top event are designed to:
- Mitigate consequences after an incident
- Prevent the top event from occurring (Correct answer)
- Escalate recovery actions
- Identify recovery targets
Correct answer: Prevent the top event from occurring
Left-side barriers in a Bow-Tie diagram are prevention controls that block the threat pathways leading to the top event.
Question 4: When a medical device manufacturer conducts a pre-market risk assessment, which international standard provides the primary framework for medical device risk management?
- ISO 9001
- ISO 14971 (Correct answer)
- ISO 45001
- ISO 31000
Correct answer: ISO 14971
ISO 14971 is the internationally recognised standard specifically for the application of risk management to medical devices.
Question 5: A researcher reports a relative risk (RR) of 0.6 for a new preventive intervention. This means the intervention:
- Increases risk by 60%
- Reduces risk by 40% (Correct answer)
- Has no effect on risk
- Doubles the baseline risk
Correct answer: Reduces risk by 40%
An RR of 0.6 means the intervention group has 60% of the risk of the control group, representing a 40% reduction.
Question 6: During risk prioritisation, which quadrant of an impact-probability matrix should receive IMMEDIATE management attention?
- Low probability, low impact
- Low probability, high impact
- High probability, low impact
- High probability, high impact (Correct answer)
Correct answer: High probability, high impact
Risks that are both highly probable and high impact require immediate action as they pose the greatest overall threat.
Question 7: A health service introduces mandatory hand hygiene audits. This is an example of which risk management approach?
- Risk acceptance
- Risk monitoring and review (Correct answer)
- Risk avoidance
- Risk appetite setting
Correct answer: Risk monitoring and review
Mandatory audits are a monitoring and review mechanism used to verify that control measures remain effective over time.
BMAT Risk Assessment & Management 3
A public health authority is assessing the risk of a novel pathogen outbreak.
Which quantitative measure best expresses the likelihood of an individual becoming infected after exposure?