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Quizzes > Quizzes for Business > Healthcare

Take the Medical Equipment Management Knowledge Test

Assess Your Medical Device Management Skills

Difficulty: Moderate
Questions: 20
Learning OutcomesStudy Material
Colorful paper art depicting a medical equipment management knowledge test quiz.

Ready to explore your skills with this medical equipment management quiz? This engaging test is ideal for biomedical engineers, clinical staff, and students aiming to master equipment management knowledge test essentials. You'll sharpen your inventory control and maintenance planning abilities while comparing your scores with similar quizzes. Curious about related challenges? Try the Medical Knowledge Assessment Quiz or dive into the Equipment Setup and Procedures Knowledge Test next. Customize any question freely using the editor to suit your learning goals.

Which organization publishes the IEC 60601 standard for medical electrical equipment safety?
International Electrotechnical Commission (IEC)
International Organization for Standardization (ISO)
U.S. Food and Drug Administration (FDA)
World Health Organization (WHO)
The IEC publishes international standards including IEC 60601 for safety and performance of medical electrical equipment. ISO creates general quality standards, and FDA regulates in the United States but does not publish IEC standards.
In equipment maintenance, what does the acronym "PM" stand for?
Preventive Maintenance
Predictive Monitoring
Performance Measurement
Planned Modification
"PM" stands for Preventive Maintenance, which involves scheduled servicing to reduce the likelihood of equipment failure. It is distinct from corrective or predictive maintenance approaches.
Which inventory control method classifies items by their monetary value and usage frequency into categories A, B, and C?
ABC Classification
FIFO Inventory
Just-In-Time Ordering
Economic Order Quantity
ABC classification sorts inventory into three categories based on annual consumption value and usage frequency. Category A items are high-value or critical, B items are moderate value, and C items are low-value bulk items.
What term describes a physical label used to uniquely identify and track a medical device?
Asset Tag
Maintenance Log
Calibration Certificate
Purchase Order
An asset tag is a label affixed to equipment containing a unique identifier used for tracking location, maintenance history, and asset management. This facilitates accurate inventory control and documentation.
Which type of maintenance is performed after a device has failed?
Corrective Maintenance
Preventive Maintenance
Predictive Maintenance
Routine Maintenance
Corrective maintenance refers to actions taken after equipment failure to restore it to operational status. Preventive and predictive maintenance occur before failures, and routine maintenance includes regular checks and servicing.
Which FDA regulation outlines requirements for the quality system of medical device manufacturers?
21 CFR Part 820
21 CFR Part 11
21 CFR Part 58
21 CFR Part 805
21 CFR Part 820 outlines the FDA's Quality System Regulation (QSR) for medical device manufacturers. It defines requirements for design controls, production processes, and quality assurance.
Which risk management tool systematically identifies potential failure modes in medical equipment?
Failure Modes and Effects Analysis (FMEA)
SWOT Analysis
Root Cause Analysis
Pareto Chart
Failure Modes and Effects Analysis (FMEA) is a systematic method to identify potential failure modes and their effects on equipment performance. It helps prioritize risks based on severity, occurrence, and detectability.
What software system is commonly used to schedule, track, and document maintenance activities?
Computerized Maintenance Management System (CMMS)
Enterprise Resource Planning (ERP)
Hospital Information System (HIS)
Customer Relationship Management (CRM)
A CMMS is specialized software that schedules maintenance tasks, tracks completed work orders, and records equipment history. This centralizes documentation and improves maintenance efficiency.
In ABC inventory classification, group A items are characterized by which of the following?
High value and low quantity
Low value and high quantity
Moderate value and moderate quantity
High turnover and low value
Group A items in ABC classification have the highest value or criticality despite lower consumption volume. This category requires tight control and frequent review of stock levels.
Which of the following exemplifies predictive maintenance?
Vibration analysis to detect early bearing wear
Replacing filters at fixed intervals
Repairing equipment post-failure
Performing daily cleaning
Predictive maintenance uses condition-monitoring techniques like vibration analysis to detect early signs of wear before failure. This allows targeted servicing only when indicators show degradation.
ISO 13485 for medical devices requires alignment with which risk management standard?
ISO 14971
ISO 9001
ISO 14001
ISO 27001
ISO 13485 specifies requirements for a medical device quality management system and references ISO 14971 for risk management principles. The alignment ensures consistent hazard analysis and risk control.
Calibration of medical equipment involves which primary activity?
Comparing measurements against known standards and adjusting
Cleaning internal components
Replacing worn parts
Documenting usage history
Calibration compares an instrument's output against a traceable standard and makes necessary adjustments to ensure measurement accuracy. It does not involve cleaning or part replacement, which are separate tasks.
Which maintenance scheduling strategy is based solely on elapsed time or usage intervals?
Time-based Maintenance
Condition-based Maintenance
Reliability-centered Maintenance
Run-to-Failure Maintenance
Time-based maintenance schedules servicing at fixed intervals regardless of actual equipment condition. It differs from condition-based maintenance that relies on real-time performance data.
In the EU, MDR refers to what regulatory framework?
Medical Device Regulation
Medical Device Registration
Manufacturer Device Requirements
Medical Diagnostic Rules
The Medical Device Regulation (MDR) is the EU regulation governing the production and distribution of medical devices. It replaced the earlier Medical Device Directive (MDD) with stricter safety requirements.
In Failure Modes and Effects Analysis, the Risk Priority Number (RPN) is calculated by multiplying which factors?
Severity, Occurrence, Detection
Likelihood, Cost, Time
Failure Rate, Impact, Cost
Severity, Frequency, Complexity
RPN in FMEA is the product of severity, occurrence, and detection ratings, quantifying risk associated with failure modes. This helps teams rank and address the most critical issues first.
A critical ventilator has exceeded its annual calibration interval by two months. What is the appropriate immediate action?
Remove it from service and perform calibration
Continue use until the next scheduled PM
Document the delay and monitor performance
Outsource it for corrective maintenance
Exceeding calibration intervals can compromise equipment accuracy; removing the ventilator from service and recalibrating immediately ensures patient safety. Documenting delays alone is insufficient without corrective action.
An FMEA yields an RPN of 150, above the acceptable threshold of 100. What should be the next step?
Implement corrective actions to reduce the RPN
Accept the risk and proceed
Increase inspection frequency without changes
Decommission the equipment
An RPN above the acceptable threshold indicates heightened risk, necessitating corrective actions to mitigate failure modes. Simply accepting or monitoring the risk does not comply with risk management best practices.
Under ISO 13485, where must records of nonconforming products and corresponding corrective actions be documented?
Corrective and Preventive Action (CAPA) records
Quality Manual
Design History File
Maintenance Logbook
ISO 13485 requires documentation of nonconformities and corrective actions within the CAPA records. These records demonstrate how issues are investigated, documented, and resolved to prevent recurrence.
Statistical analysis shows an increase in device failures after three months of service. Which strategy best addresses this trend?
Shorten the preventive maintenance interval based on failure data
Switch to run-to-failure maintenance
Increase the monetary value in ABC classification
Reduce the frequency of inspections
Adjusting the preventive maintenance schedule based on failure data ensures maintenance aligns with real-world performance. Shortening intervals can reduce unexpected downtime and improve reliability.
During a regulatory audit, which document is least likely required under ISO 13485 for equipment management?
Patient medical records
Maintenance procedures
Calibration certificates
Inventory control logs
ISO 13485 focuses on quality management documentation such as maintenance procedures, calibration certificates, and inventory logs. Patient medical records are outside the scope of equipment management requirements.
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Learning Outcomes

  1. Identify regulatory standards for medical equipment management
  2. Analyse equipment maintenance protocols and schedules
  3. Evaluate risk management strategies for device safety
  4. Apply inventory control best practices
  5. Demonstrate accurate equipment tracking and documentation
  6. Master preventive maintenance planning

Cheat Sheet

  1. ISO 14971 Risk Management Essentials - Think of ISO 14971 as your safety coach for medical devices: it walks you through spotting hazards, estimating risks, and applying the right controls. Mastering this framework not only boosts compliance but also makes you a patient-safety champion. Correctly formatted link
    2. ISO 14971 on Wikipedia
  2. Designing a Preventive Maintenance Calendar - A custom maintenance calendar is like a fitness plan for your equipment: it keeps everything in tip-top shape. By blending manufacturer advice with real-world use patterns, you'll dodge surprise breakdowns and extend each device's lifespan. Correctly formatted link
    3. Preventive Maintenance Guide
  3. Applying a Risk-Based Management Approach - Prioritize your maintenance tasks like a pro by rating each device's potential impact on patient care. This savvy strategy ensures your critical gear gets VIP treatment, keeping everyone safer when it counts. Correctly formatted link
    4. Risk-Based Approach Wikipedia
  4. Keeping Spot-On Inventory Records - Imagine a flawless spreadsheet that tracks every make, model, serial number, and location - no more frantic searches before a procedure. Accurate logs speed up maintenance, compliance checks, and audits, so you can focus on learning, not hunting. Correctly formatted link
    5. Medical Equipment Management Wiki
  5. Documenting Every Maintenance Move - Clear, step-by-step records of all your upkeep activities are like your device's personal diary: troubleshooting nightmares become a thing of the past. Plus, auditors love neat documentation when they come knocking. Correctly formatted link
    6. Medical Equipment Management Wiki
  6. Training Staff on Equipment Care - Think of effective training as the secret sauce to safe device handling and infection control. Well-prepared teammates mean fewer mistakes, smoother workflows, and healthier patients. Correctly formatted link
    7. AASM Equipment Maintenance Fact Sheet
  7. Performing Regular Inspections & Tests - Routine checkups and functional tests are like annual physicals for your machines: they catch wear and tear before a critical failure. Early fixes save stress (and sometimes lives) down the road. Correctly formatted link
    8. Preventive Maintenance Guide
  8. Leveraging CMMS for Smarter Maintenance - A Computerized Maintenance Management System is your digital sidekick to schedule, track, and report every task. No more sticky notes or forgotten jobs - just streamlined efficiency. Correctly formatted link
    9. Preventive Maintenance Guide
  9. Staying Updated on Industry Trends - Medicine and tech evolve fast - your checklist should too! Regularly scout for new regulations, innovations, and best practices to keep your knowledge cutting-edge. Correctly formatted link
    10. Preventive Maintenance Guide
  10. Mastering Infection Control Protocols - Proper cleaning and sterilization after each use are non-negotiable to stop cross-contamination in its tracks. Follow manufacturer advice and health guidelines to keep patients - and your gear - germ-free. Correctly formatted link
    11. AASM Equipment Maintenance Fact Sheet
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