SHS3 Biomedical Science · Semester 2 Week 13: Therapeutic Device

Lesson notes

Learning Objectives

Indicator: 3.3.2.LI.3 - Discuss the role of regulatory agencies in the production and marketing of medical devices.

By the end of the lesson, learners can:

Identify the key regulatory agencies in Ghana responsible for overseeing the production, importation, and marketing of medical devices and state their specific mandates.
Explain the steps a manufacturer must complete to obtain regulatory approval for a medical device in Ghana, from pre-market evaluation to post-market surveillance.
Analyse the consequences of fraudulent advertising of medical devices on public health and consumer trust, using specific examples.
Justify the importance of regulatory oversight by linking unsafe devices to potential patient harm during assembly, use, or maintenance of therapeutic devices.
Demonstrate ethical reasoning by evaluating the principles (truthfulness, honesty, integrity) that guide regulatory decisions on medical device advertising.

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Curriculum details

Strand: Biomedical Intervention (Strand 3)
Sub-strand: Therapeutic Device (3.2)
Content standard: 3.3.2.CS.1 - Demonstrate an understanding of the interconnections among components of therapeutic devices and explain the medical device regulation process. 3.3.2.LO.1 Identify constituent components of a therapeutic device, develop an operating manual for a medical device and describe the regulatory processes for medical devices.
Indicator: 3.3.2.LI.3 - Discuss the role of regulatory agencies in the production and marketing of medical devices.
Suggested placement: Semester 2, Week 13 (Week 33 of the year)
Our suggestion, laid out in curriculum order across three terms of twelve weeks. NaCCA does not fix the week, so follow your school's scheme of learning.
Curriculum reference: NaCCA curriculum document, p. 99

Exemplars (from the NaCCA curriculum)

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 safe and effective. Class brainstorms the effect of fraudulent adverts on equipment sales and how regulatory institutions can help.
Teaching and Learning Resources:
- Medical device
- Projector
- Internet
- Textbook
- Sample
- Regulatory
- manual documents
Assessment (3.3.2.AS.3). The document marks these depth-of-knowledge levels for this indicator: Level 2 Skills of conceptual understanding; Level 4 Extended critical thinking and reasoning.
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