Lesson Notes By Weeks and Term v4 - SHS 3

Lesson Video

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Performance objectives

• Describe the role of regulatory agencies in the production and marketing of therapeutic devices.
• Discuss the importance of safety and effectiveness in medical devices.
• Identify the consequences of fraudulent advertising.
• Explain how regulatory agencies mitigate risks associated with medical devices.

Lesson summary

This lesson explores the critical role of 'gatekeepers' in our healthcare system. When you or a family member uses a blood pressure monitor, a blood glucose meter, or even a simple bandage, how can you be sure it is safe and works correctly? In Ghana, we have specific organisations called regulatory agencies that protect us from fake, substandard, and dangerous medical devices. Understanding their work is crucial for our personal health and for the health of our nation. We will focus on Ghana's own Food and Drugs Authority (FDA) and Ghana Standards Authority (GSA), understanding how they ensure the medical equipment in our hospitals and pharmacies is fit for purpose.

Lesson notes

A. What is a Medical Device?

A medical device is any instrument, apparatus, machine, implant, or related article intended for use in the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. They do not achieve their main intended action by pharmacological (drug-like), immunological, or metabolic means. Examples range from simple to complex: Simple: Tongue depressors, bandages, condoms, thermometers. Moderate: Blood pressure monitors, blood glucose meters, infusion pumps, surgical gloves. Complex: Pacemakers, MRI scanners, dialysis machines, ventilators. B. What are Regulatory Agencies?

A regulatory agency is a government body responsible for creating and enforcing rules and standards within a specific industry to protect the public. In healthcare, their primary goal is to ensure that all products, including medical devices, are safe, effective, and of high quality. C. Key Regulatory Agencies in Ghana for Medical Devices

In Ghana, the two main institutions are the Food and Drugs Authority (FDA) and the Ghana Standards Authority (GSA). Food and Drugs Authority (FDA) Ghana

Evaluation guide

• Discuss the role of regulatory agencies in the production and marketing of medical
• devices.
• Structuring Talk for Learning: Learners discuss the role of regulatory agencies such as Food and
• Drugs Authority and Ghana Standards Authority in ensuring that medical devices for sale and in use are