Podcast
Questions and Answers
What is one benefit of using rehabilitation devices?
What is one benefit of using rehabilitation devices?
- They are exclusively used for pain management.
- They eliminate all medical errors.
- They assist patients in gaining functionality and independence. (correct)
- They replace the need for medical professionals.
Which class of medical devices is considered high risk according to MDD-Risk Based Classification?
Which class of medical devices is considered high risk according to MDD-Risk Based Classification?
- Class D (Class-III) (correct)
- Class B (Class-II a)
- Class C (Class-II b)
- Class A (Class-I)
Which example represents a Class-II medical device according to USFDA classification?
Which example represents a Class-II medical device according to USFDA classification?
- Heart valves
- Infusion pumps (correct)
- Adult incontinence pads
- Elastic bandages
What is a benefit of medical devices in terms of cost and time?
What is a benefit of medical devices in terms of cost and time?
What is a common issue that medical devices help to reduce?
What is a common issue that medical devices help to reduce?
Which of the following devices is classified as Class II?
Which of the following devices is classified as Class II?
What is the risk classification for a pacemaker?
What is the risk classification for a pacemaker?
Which of the following is an example of a Class I device?
Which of the following is an example of a Class I device?
What type of risk is associated with Class II devices?
What type of risk is associated with Class II devices?
Which device is NOT classified under Class III?
Which device is NOT classified under Class III?
Among the following examples, which one represents Class I risk?
Among the following examples, which one represents Class I risk?
Class III devices typically involve which level of risk?
Class III devices typically involve which level of risk?
Which of these devices is categorized as Class II due to its risk level?
Which of these devices is categorized as Class II due to its risk level?
What is one of the primary uses of a medical device?
What is one of the primary uses of a medical device?
Which of the following is an example of a medical device used for monitoring?
Which of the following is an example of a medical device used for monitoring?
What characteristic distinguishes medical devices from pharmaceuticals?
What characteristic distinguishes medical devices from pharmaceuticals?
Which of the following medical devices is used for control of conception?
Which of the following medical devices is used for control of conception?
Why is the metabolic impact of monitoring devices significant?
Why is the metabolic impact of monitoring devices significant?
What is a function of medical devices related to injury or handicap?
What is a function of medical devices related to injury or handicap?
Which of the following statements is true regarding the abilities of medical devices?
Which of the following statements is true regarding the abilities of medical devices?
What type of medical device is a hip replacement considered to be?
What type of medical device is a hip replacement considered to be?
Flashcards
Rehabilitation Devices
Rehabilitation Devices
Medical devices that help patients regain functionality and independence after an injury or illness.
Conception Control Devices
Conception Control Devices
Medical devices used to control conception, including preventing pregnancy or assisting with achieving pregnancy.
Medical Device Classification
Medical Device Classification
Medical devices categorized by their level of risk and intended use.
Class I Medical Devices
Class I Medical Devices
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Class III Medical Devices
Class III Medical Devices
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Risk Level of Medical Devices
Risk Level of Medical Devices
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Risk Management for Medical Devices
Risk Management for Medical Devices
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Medical Device Regulations
Medical Device Regulations
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Medical Device Quality Assurance
Medical Device Quality Assurance
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What is a medical device?
What is a medical device?
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How are medical devices used for Diagnosis?
How are medical devices used for Diagnosis?
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How are medical devices used for Monitoring?
How are medical devices used for Monitoring?
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How are medical devices used for Treatment?
How are medical devices used for Treatment?
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How are medical devices used to address Injuries or Handicaps?
How are medical devices used to address Injuries or Handicaps?
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How are medical devices used for Conception Control?
How are medical devices used for Conception Control?
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How are medical devices used to control Body Functions?
How are medical devices used to control Body Functions?
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What are the benefits of using Medical Devices?
What are the benefits of using Medical Devices?
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Study Notes
Course Information
- Course: Pharmaceutical Dosage Form and Drug Delivery Systems
- Level: Finals
- Institution: Our Lady of Fatima University, College of Pharmacy
- Lecturer: Instructor- College of Pharmacy
- Location: Valenzuela, Quezon City, Antipolo, Pampanga, Cabanatuan, Laguna
- Platform: Zoom
- Date: (Specific date not provided)
- Time: (Specific time not provided)
Topics
- Medical Devices
Outcomes
- Students will demonstrate knowledge of the classes of medical devices.
- Students will demonstrate understanding of the functions of medical devices.
- Students will demonstrate competence in the use of medical devices.
Videos to Watch
- Topic 9: Parenterals (https://www.youtube.com/watch?v=5uI8EA2cRDw)
- Topic 9: Sterile Compounding (https://www.youtube.com/watch?v=cf9Y3xP2oTo)
- Topic 10: Liposomal Technology (https://www.youtube.com/watch?v=vUqwIL5IgS8)
- Topic 10: Liposome: A Technological Marvel (https://www.youtube.com/watch?v=KQA9YlhgTQc)
- Topic 11: Medical Devices Classification as per FDA (https://www.youtube.com/watch?v=33VO6olowQg&t=8s)
Medical Devices
- A medical device is an instrument, apparatus, in-vitro reagent, implant, or related article intended for use in diagnosing disease, treating, mitigating, or preventing disease, affecting body structure or functions, without achieving its primary function through chemical action.
Types of Medical Devices
- Diagnosis, prevention, monitoring, treatment, or alleviation of disease: (e.g., Urinary catheter)
- Diagnosis, monitoring, treatment, alleviation of, or compensation for an injury: (e.g., Bone cement)
- Investigation, replacement, or modification of anatomy or physiological process: (e.g., Hip replacement)
- Control of conception: (e.g., Condoms)
- Devices not achieving primary function through pharmacological, immunological, or metabolic actions.
Benefits of Medical Devices
- Enhanced diagnosis, monitoring, and treatment by monitoring environmental, nutritional, and psychosocial factors and determining the appropriate course of action. (e.g., Stethoscopes, blood pressure monitors, urinary catheters)
- Faster recovery by assisting patients regain functionality and independence. (e.g., Prosthetics, mobility aids)
- Control of conception through assisting in the achievement or management of pregnancy. (e.g., Birth control, condoms, ultrasound machines)
- Cost and time efficiency for diagnosis and treatment by reducing the time and cost of these procedures.
- Reduced risk of errors by improving patient safety and quality of care by preventing errors, adverse drug events and other harms via automation.
Medical Device Classification
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Class I: Low to moderate risk devices (e.g., Electric toothbrush, tongue depressors, oxygen masks, bandages, hospital beds).
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Class II: Moderate to high risk devices (e.g., Catheters, blood pressure cuffs, pregnancy test kits, syringes, blood transfusion kits).
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Class III: High risk devices (e.g., Breast implants, pacemakers, defibrillators, high-frequency ventilators, cochlear implants, implanted prosthetics).
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FDA Approval Process is dependent on the class of the device
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Class I: No FDA approval required, but must register device with FDA
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Class II: FDA clearance is required (usually via 510(k))
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Class III: FDA approval is required (via Premarket Approval process, PMA)
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