Lect Flashcards
(119 cards)
1
Q
What is Clinical Engineering?
A
Clinical Engineering integrates engineering principles into healthcare to manage and optimize medical devices, ensuring safety and functionality.
2
Q
What are the primary concerns of Clinical Engineering?
A
- Medical devices and the environment in which they are installed
- Computerized Maintenance Management System (CMMS)
- Calibration
- Understanding regulations and standards related to design, manufacturing, testing, and distribution.
3
Q
As a clinical engineer, what is your primary role regarding medical devices in a hospital?
A
Ensuring device functionality and safety
4
Q
What does R&D in healthcare focus on?
A
Developing, testing, and refining new medical technologies and solutions to improve patient care.
5
Q
What should a clinical engineer prioritize during R&D for a new medical device?
A
Its safety and clinical effectiveness
6
Q
What is the purpose of Power Backup Systems (UPS) in healthcare?
A
Provide backup power to life-supporting devices during outages.
7
Q
What is a tender?
A
A formal process for acquiring goods or services through competitive bids.
8
Q
What should a clinical engineer focus on when preparing specifications for a tender?
A
Detailed performance and safety standards for equipment
9
Q
What does zoning contribute to in clinical engineering?
A
Ensures proper workflow and minimizes contamination risks
10
Q
What is the role of the FDA?
A
Regulates medical devices in the U.S., ensuring they are safe and effective for patient use.
11
Q
What are the three main classifications of medical devices by the FDA?
A
- Class I: tongue depressors, stethoscopes
- Class II: infusion pumps, X-ray, ECG
- Class III: Pacemaker, ICDs, VADs.
12
Q
What does CE Marking indicate?
A
Compliance with European safety, health, and environmental standards.
13
Q
What is Planned Preventive Maintenance (PPM)?
A
Scheduled maintenance to prevent device breakdowns, ensuring reliability and safety.
14
Q
Why is PPM critical for medical devices?
A
To extend the lifecycle and prevent malfunctions
15
Q
What is the clinical engineer’s role in medical equipment planning?
A
Ensuring equipment placement aligns with workflow and safety standards
16
Q
What are the stages of the device life cycle?
A
- Conception
- Incubation
- Birth
- Growth
- Maturity
- Decline
- Death
17
Q
What are Room Data Sheets?
A
Documents that outline the functional requirements, equipment, and spatial needs of a specific room in a healthcare facility.
18
Q
What is the difference between a floor plan and a loaded floor plan?
A
- Floor plan: Basic layout of spaces, walls, and doors
- Loaded floor plan: Includes details about equipment, utilities, and functional arrangements.
19
Q
What is the role of an OEM in medical equipment?
A
Manufacturing base components
20
Q
What does a hospital master plan aim to achieve?
A
Long-term operational efficiency
21
Q
Why are FGI standards important in hospital design?
A
To optimize patient care environments
22
Q
How does IHFG support global healthcare facility design?
A
By promoting internationally recognized best practices
23
Q
What is a Quality Management System (QMS)?
A
A framework of policies and processes that ensure the consistent quality of medical devices and compliance with regulatory standards.
24
Q
What does the IEC develop standards for?
A
Electrical technologies, including medical equipment.
25
Why are IEC standards important for medical devices?
They guarantee electrical safety and compatibility.
26
What does HIO Supply Chain involve?
Managing resources, procurement, and distribution specific to healthcare facilities and medical devices.
27
What is the key goal of an efficient HIO Supply Chain?
Ensuring timely delivery and quality
28
What does MD-Distribution refer to?
The supply chain logistics of medical devices.
29
What does MD-Operation primarily involve?
Maintaining and ensuring device usability
30
What is the role of regulatory bodies in medical device management?
Ensuring compliance and safety
31
What are the main conditions for accepting a medical device by the FDA?
* Effectiveness
* Safety
32
What is a risk-benefit analysis for devices with unavoidable risks?
Evaluating whether the benefits of a medical device clearly outweigh its risks.
33
What is a tender in the context of medical equipment?
A formal offer or bid to supply goods or services.
34
What is the optimal timing for device changes according to the time-dependent graph?
During the maturity phase, just before entering the decline stage.
35
What should a clinical engineer assess during renovations of a surgical ward?
Current infrastructure, necessary equipment updates, and compliance with safety standards.
36
What is the primary role of medical equipment planners?
Choosing and placing equipment in rooms, ensuring compatibility with space dimensions
## Footnote
Medical equipment planners focus on the layout and functionality of medical devices within healthcare settings.
37
Why is the placement of trauma rooms adjacent to diagnostic imaging important?
To expedite the scanning and treatment of patients, reducing transfer times
## Footnote
Quick access to imaging can significantly impact trauma outcomes.
38
What are some key devices found in an operating room?
* Surgical Lights
* Anesthesia Machines
* Patient Monitoring Systems
## Footnote
These devices are essential for conducting surgical procedures safely and effectively.
39
What is the purpose of uninterruptible power supply (UPS) systems in hospitals?
To provide backup power to essential devices during power failures
## Footnote
UPS systems are critical for life-support equipment in intensive care and operating rooms.
40
What is the function of resuscitation equipment in hospitals?
To revive patients in cases of cardiac or respiratory arrest
## Footnote
Key devices include defibrillators, ventilators, and CPR machines.
41
Where should defibrillators be strategically placed in hospitals?
In high-traffic areas such as ED, ICU, and hallways
## Footnote
Immediate access can be critical for cardiac arrest patients.
42
What are room data sheets?
Documents providing detailed information about each room's functionality and spatial requirements
## Footnote
They guide the design and management of healthcare spaces.
43
What guidelines are essential for healthcare facility planning?
International Health Facility Guidelines (IHFG)
## Footnote
These guidelines cover room layout, safety, and privacy.
44
What are the lighting needs in surgical rooms?
Both ambient and focused lights for operations
## Footnote
Proper lighting is critical for precision during surgeries.
45
What is the lifecycle of medical equipment?
Stages from concept to post-launch, including initiation, design, validation, and maintenance
## Footnote
Each phase is crucial for ensuring the equipment meets clinical needs.
46
What is the difference between analog and digital radiography?
* Analog Radiography: Less costly initially, high operational expenses
* Digital Radiography: Higher upfront cost, reduces running costs
## Footnote
Digital systems often provide long-term savings through efficiency.
47
What is the significance of stakeholder collaboration in clinical engineering?
Ensures devices meet regulatory standards and practical needs
## Footnote
Collaboration involves manufacturers, healthcare providers, and regulatory bodies.
48
What is a reporting survey in healthcare planning?
A structured assessment capturing specific requirements and functional details of healthcare spaces
## Footnote
It ensures compliance with operational, safety, and regulatory standards.
49
How does effective hospital layout improve patient care?
By grouping related departments to enhance workflow and safety
## Footnote
For example, placing imaging equipment near emergency rooms allows for quicker diagnostics.
50
What is the role of clinical engineers in hospitals?
Responsible for device maintenance, repair, and compliance with operational standards
## Footnote
They play a critical role in ensuring medical devices function effectively.
51
What is the difference between primary and tertiary care?
* Primary Care: Preventive care and basic health services
* Tertiary Care: Specialized hospitals for severe and complex conditions
## Footnote
Tertiary care facilities have advanced technology and staffing.
52
Fill in the blank: The acronym for RESUS stands for _______.
[Resuscitation Equipment Support Unit Services]
## Footnote
RESUS focuses on the organization and availability of resuscitation equipment.
53
What can happen if a hospital's equipment lifecycle is poorly managed?
Missed checks during setup could impact future operations
## Footnote
Proper management is crucial for maintaining equipment functionality.
54
What is Tertiary Care?
Highly specialized hospitals that provide care for severe and complex conditions
## Footnote
Tertiary centers are equipped with advanced diagnostic and therapeutic equipment like CT scanners and MRI machines.
55
What distinguishes Quaternary Care?
The highest level of specialized care, often found in university hospitals or specialized centers
## Footnote
Examples include cancer and transplant centers that offer advanced technology and experimental treatments.
56
What is the significance of space planning in hospitals?
Allocating dedicated areas for specific services based on demand
## Footnote
For example, a cardiology hospital may have 20–30 rooms solely for imaging equipment.
57
Why is post-launch feedback essential in usability engineering?
It drives design improvements and updates for medical devices
## Footnote
Feedback from clinicians and patients leads to enhancements like ergonomic handles on portable dialysis machines.
58
Fill in the blank: The phase of hospital planning that sets the overall structure and goals is called _______.
[Master Planning]
59
What are the three levels of care in hospitals?
* Primary Care
* Secondary Care
* Tertiary/Quaternary Care
60
What is the primary objective of a feasibility study in hospital planning?
To assess project viability and focus on investment returns
## Footnote
Clinical engineers estimate equipment costs critical for budgeting.
61
What role do clinical engineers play during the construction phase of a hospital?
They ensure spaces are equipped correctly for medical devices
## Footnote
This includes compliance with safety standards and operational needs.
62
True or False: Regulatory bodies only enforce safety standards for medical devices.
False
## Footnote
They also ensure effectiveness and compliance with international standards.
63
What does MTBF stand for and what does it measure?
Mean Time Between Failures; it measures the reliability of medical equipment.
64
What is the importance of ISO 13485 in medical device management?
It emphasizes quality management systems and risk management throughout the product lifecycle.
65
What happens if pre-installation setup fails to meet required standards?
It can lead to last-minute adjustments or failures during equipment installation.
66
How do Quality Management Systems (QMS) impact healthcare facilities?
They ensure consistency, safety, and quality standards in healthcare operations.
67
What is the role of stakeholders in the medical-industrial complex?
They include manufacturers, healthcare providers, and regulatory bodies that influence device development and healthcare quality.
68
Fill in the blank: The main goal of asset management in healthcare is to ensure _______.
[cost efficiency, safety, and effectiveness]
69
Why is validation important in medical device development?
It ensures the device is practical and effective for intended users in real-world conditions.
70
What is the significance of lifecycle management (LCAM) in medical equipment?
It incorporates international standards like ISO 55000 throughout the equipment lifecycle.
71
What factors should be considered in hospital space planning?
* Volume of patients
* Types of diagnostics
* Specialized services
72
True or False: Clinical engineers are involved in the early construction phase of a hospital.
False
## Footnote
They become essential in later stages to ensure readiness for medical equipment.
73
What is a critical aspect of maintaining medical devices?
Regular calibration to ensure accurate measurements and compliance with medical standards.
74
What is ISO 13485?
A standard focusing on quality management systems specifically for medical devices
## Footnote
It emphasizes the importance of risk management throughout the product’s lifecycle.
75
Why is risk management crucial in clinical engineering?
It ensures that potential hazards are identified and mitigated, enhancing patient safety.
76
What must be evaluated for each component of medical equipment?
Specifications including ambient temperature, humidity, and atmospheric pressure.
77
What is required for personnel involved in medical equipment management?
They must possess necessary qualifications and certifications.
78
What does IEC 60601-1 outline?
General requirements for the safety and essential performance of medical electrical equipment.
79
What is a key focus of medical equipment design?
Single-fault safety, ensuring safety under single-fault conditions.
80
What is the maximum percentage sample size for testing medical devices within a year?
About 1%
81
What does ISO emphasize in medical device management?
Risk management throughout the lifecycle.
82
What is a critical aspect of clinical engineering?
Ensuring the safe, effective, and efficient use of medical devices in healthcare.
83
What are the stages of the medical equipment life cycle management (LCM)?
Design and Manufacturing, Supply and Installation, Operations and Maintenance, End-of-Life Disposal.
84
What percentage do maintenance costs account for annually?
7–10% of device costs.
85
What is Preventive Maintenance (PM)?
Maintenance aimed at reducing unexpected downtime and failure rates.
86
What criteria might lead to the replacement of a medical device?
Device obsolescence, frequent malfunctions, or safety concerns.
87
What is the purpose of Failure Mode and Effects Analysis (FMEA)?
To identify potential failure modes of a medical device, assess consequences, and develop mitigation strategies.
88
What are the three components of risk evaluation in FMEA?
Severity (SEV), Occurrence (OCC), Detection (DET).
89
What does the Risk Priority Number (RPN) formula calculate?
RPN = SEV × OCC × DET.
90
What is the goal of Planned Preventive Maintenance (PPM)?
To perform maintenance at specified intervals, typically every few months.
91
What is Predictive Maintenance (PDM)?
Maintenance based on monitoring equipment condition to predict failures.
92
What is Risk Based Maintenance (RBM)?
Maintenance frequency determined by assessing the risk posed by equipment.
93
What is a daily inspection in medical equipment maintenance?
A daily check by operators to ensure equipment readiness.
94
What is the purpose of proper installation in medical equipment?
To prevent operational inefficiencies or failures.
95
What is the role of continuous training in clinical engineering?
To ensure staff are trained on proper usage and maintenance of devices.
96
What does the acronym FMEA stand for?
Failure Mode and Effects Analysis.
97
True or False: ISO 13485 focuses specifically on the safety of medical electrical equipment.
False
## Footnote
ISO 13485 focuses on quality management systems for medical devices.
98
Fill in the blank: The __________ is responsible for maintenance, management, training, budgeting, and business processes related to the facility’s assets.
[O&M manager]
99
If a device operates but does not meet its original specifications, should it be considered safe? Why or why not?
No, a device operating outside its original specifications should not be considered safe, as the specifications ensure proper functioning and safety margins. Deviation could lead to unpredictable risks, reduced performance, or non-compliance with safety standards.
100
What is the recommended frequency for performing PPM?
Every 3 months
101
What is the purpose of monitoring the condition of equipment?
To detect the onset of equipment degradation
102
How is maintenance scheduled according to equipment performance?
Just before equipment experiences a loss of performance
103
What factors determine the frequency of maintenance?
The risk associated with the equipment
104
In case of a conflict of interest, what priority is given?
Higher risk device
105
What is the relationship between risk level and maintenance frequency?
Higher risk leads to more frequent maintenance
106
What is Corrective Maintenance also known as?
Reactive, Breakdown or Run-to-Failure maintenance
107
When is Corrective Maintenance performed?
When the equipment fails
108
What type of equipment is suitable for Corrective Maintenance?
Disposable or low cost equipment with little or no risk
109
What is Calibration?
The process of verifying that output is within acceptable limits
110
What is an example of Calibration in medical devices?
Adjusting a baby incubator's temperature display
111
What is a Maintenance Contract?
A contract between the hospital and a servicing company for medical equipment
112
What is the purpose of a Computerized Maintenance Management System (CMMS)?
To track all events and actions related to medical equipment and associated costs
113
What key data is necessary to build a CMMS? List three.
* Job number
* Inventory number
* Equipment name
114
What should a CMMS be able to do? Name two functionalities.
* Create work orders
* Track scheduled services
115
What is the difference between Static and Dynamic information in CMMS?
* Static: Never updated, represents a moment in time
* Dynamic: Regularly updated, reflects current status
116
True or False: The latest version of information must be clear to the end user as per industry regulations.
True
117
Fill in the blank: CMMS tracks the _______ of a device.
downtime
118
What types of data classification exist in CMMS?
* Proprietary
* Standard
119
What is the purpose of estimating the cost of ownership in CMMS?
To analyze whether maintaining equipment is cost-effective compared to replacement
