Pharmaceutical Dosage Form Finals

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Questions and Answers

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?

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?

Heart valves

Infusion pumps (correct)

Adult incontinence pads

Elastic bandages

What is a benefit of medical devices in terms of cost and time?

They can provide specific treatments at less cost and time. Signup and view all the answers

What is a common issue that medical devices help to reduce?

Medication errors and adverse drug events. Signup and view all the answers

Which of the following devices is classified as Class II?

Blood pressure cuffs Signup and view all the answers

What is the risk classification for a pacemaker?

High Risk Signup and view all the answers

Which of the following is an example of a Class I device?

Reusable surgical scalpel Signup and view all the answers

What type of risk is associated with Class II devices?

Moderate to High Risk Signup and view all the answers

Which device is NOT classified under Class III?

Surgical gloves Signup and view all the answers

Among the following examples, which one represents Class I risk?

Non-electric wheelchair Signup and view all the answers

Class III devices typically involve which level of risk?

High Risk Signup and view all the answers

Which of these devices is categorized as Class II due to its risk level?

Pregnancy test kits Signup and view all the answers

What is one of the primary uses of a medical device?

To aid in diagnostics of diseases Signup and view all the answers

Which of the following is an example of a medical device used for monitoring?

Blood glucose monitor Signup and view all the answers

What characteristic distinguishes medical devices from pharmaceuticals?

They do not achieve their primary intended effects through chemical action Signup and view all the answers

Which of the following medical devices is used for control of conception?

Condoms Signup and view all the answers

Why is the metabolic impact of monitoring devices significant?

They can identify psychosocial factors affecting health. Signup and view all the answers

What is a function of medical devices related to injury or handicap?

Bone cement for orthopedic procedures Signup and view all the answers

Which of the following statements is true regarding the abilities of medical devices?

They enhance diagnosis and treatment options. Signup and view all the answers

What type of medical device is a hip replacement considered to be?

An implant for anatomical modification Signup and view all the answers

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

Class I: Low to moderate risk devices (e.g., Electric toothbrush, tongue depressors, oxygen masks, bandages, hospital beds).
Class II: Moderate to high risk devices (e.g., Catheters, blood pressure cuffs, pregnancy test kits, syringes, blood transfusion kits).
Class III: High risk devices (e.g., Breast implants, pacemakers, defibrillators, high-frequency ventilators, cochlear implants, implanted prosthetics).
FDA Approval Process is dependent on the class of the device
Class I: No FDA approval required, but must register device with FDA
Class II: FDA clearance is required (usually via 510(k))
Class III: FDA approval is required (via Premarket Approval process, PMA)

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Description

Prepare for your finals in Pharmaceutical Dosage Form and Drug Delivery Systems with this quiz focused on medical devices. Test your understanding of various classes and functions of medical devices, ensuring you are well-equipped for the exam. Review important topics like parenterals and liposomal technology to reinforce your knowledge.