MS2058

What are maintenance procedures for active medical devices?

• Ignoring manufacturer guidelines

• Using unapproved cleaning agents

• Monthly replacement of all components

• Regular inspections, cleaning, calibration, software updates, adherence to manufacturer guidelines

Why is equipment calibration important in the medical field?

• To save costs on maintenance

• To increase patient wait times

• To ensure accuracy and reliability of measurements for patient diagnosis and treatment.

• To decrease the quality of patient care

How are risk assessment protocols applied to medical devices?

• By outsourcing risk assessment to unqualified individuals

• By evaluating potential risks, identifying hazards, assessing likelihood and severity of harm, and implementing measures to mitigate or eliminate risks.

• By randomly selecting safety measures

• By ignoring potential risks and hazards

What is the significance of emergency response planning for medical devices?

• Emergency response planning only applies to non-medical equipment

• Emergency response planning for medical devices is essential to mitigate risks, ensure continuity of care, and protect patient safety.

• Emergency response planning does not impact patient safety

• Emergency response planning is not necessary for medical devices

Which regulatory compliance standards are relevant to active medical devices?

• ISO 27001, GDPR, IEC 62304

• ISO 13485, FDA 21 CFR Part 820, IEC 60601

• ISO 9001, HIPAA, IEC 62304

• FDA 21 CFR Part 11, ISO 14971, IEC 62366

How often should maintenance procedures be conducted for medical devices?

• Every 5 years

• According to the manufacturer's recommendations

• Once a month

• When the device breaks down

What tools are used for equipment calibration in the medical field?

• Screwdrivers, hammers, pliers

• Books, pencils, paper

• Calibrators, reference standards, measurement instruments, software, calibration certificates

• Cooking utensils, gardening tools, musical instruments

What are the key steps in conducting a risk assessment for medical devices?

• Identify benefits, Estimate severity, Evaluate probability, Assess risk level, Implement risk control measures

• Skip identification, Estimate severity, Evaluate probability, Assess risk level, Implement risk control measures

• Identify hazards, Underestimate severity, Overlook probability, Ignore risk level, Implement risk control measures

• Identify hazards, Estimate severity, Evaluate probability, Assess risk level, Implement risk control measures

Why is it important to regularly update emergency response plans?

• To confuse emergency responders

• To test the patience of employees

• To ensure plans remain relevant, effective, and incorporate lessons learned from previous incidents.

• To save money by avoiding updates

How can organizations ensure compliance with regulatory standards?

• Ignoring regulations, outsourcing compliance tasks, relying solely on self-assessment

• Implementing policies, conducting audits, providing training, using compliance software, staying informed about regulatory changes