Istanbul Health and Technology University INFORMATION PACKAGE / COURSE CATALOGUE
| Pharmacy | |||||
| Bachelor | TR-NQF-HE: Level 6 | QF-EHEA: First Cycle | EQF-LLL: Level 6 | ||
Course General Introduction Information
| Course Code: | ECZ005 | ||||
| Course Name: | Medical Devices | ||||
| Course Semester: |
Fall |
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| Course Credits: |
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| Language of instruction: | TR-EN | ||||
| Course Requirement: | |||||
| Does the Course Require Work Experience?: | No | ||||
| Type of course: | Area Ellective | ||||
| Course Level: |
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| Mode of Delivery: | Face to face | ||||
| Course Coordinator : | Dr.Öğr.Üyesi SAMET ÖZDEMİR | ||||
| Course Lecturer(s): | Assoc. Prof. Samet Özdemir | ||||
| Course Assistants: |
Course Purpose and Content
| Course Objectives: | The purpose of this course is to inform pharmacy students about the medical devices used in the field of pharmacy. This course also introduces the medical devices that are frequently used medically through case studies in light of the relevant legislation. |
| Course Content: | 1. Basic information about medical devices 2. Classification of medical devices 3. Regulations and regulations regarding medical devices 4. Product safety in medical devices 5. Sales, promotion and advertising activities of medical devices 6. Registration processes of medical devices (ÜTS) 7. Raw materials used in medical devices (medical plastics, polymers and adhesives) 8. Midterm exam 9. Needle, cannula and catheters 10. Medical devices used in the cardiovascular field 11. Medical devices used in the pulmonary field 12. Medical devices used in diabetes 13. Care materials used for wound care and hygiene 14. Orthoses and Prostheses 15. Medical devices used for diagnostic purposes |
Learning Outcomes
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The students who have succeeded in this course;
1) Learns national and international regulations regarding medical materials and products. 2) Gains knowledge about medical supplies or products available in pharmacies and hospitals. 3) Have basic knowledge about the use of basic medical products or devices (sphygmomanometer, glucometer, prosthesis, orthosis, dressing materials, etc.) and their introduction to the user. 4) Gains the ability to follow innovations and developments in medical device technologies. |
Course Flow Plan
| Week | Subject | Related Preparation |
| 1) | Basic information about medical devices | Lecture presentations |
| 2) | Classification of medical devices | Lecture presentations |
| 3) | Regulations and regulations regarding medical devices | Lecture presentations |
| 4) | Product safety in medical devices | Lecture presentations |
| 5) | Sales, promotion and advertising activities of medical devices | Lecture presentations |
| 6) | Registration processes of medical devices (ÜTS) | Lecture presentations |
| 7) | Raw materials used in medical devices (medical plastics, polymers and adhesives) | Lecture presentations |
| 8) | Midterm exam | Lecture presentations |
| 9) | Needle, cannula and catheters | Lecture presentations |
| 10) | Medical devices used in the cardiovascular field | Lecture presentations |
| 11) | Medical devices used in the pulmonary field | Lecture presentations |
| 12) | Medical devices used in diabetes | Lecture presentations |
| 13) | Care materials used for wound care and hygiene | Lecture presentations |
| 14) | Orthoses and Prostheses | Lecture presentations |
| 15) | Medical devices used for diagnostic purposes | Lecture presentations |
Sources
| Course Notes / Textbooks: | P. Ogrodnik, Medical Device Design Innovation from Concept to Market, second edition, Academic Press (2020) Naidoo, S. Medical Device Handbook For Europe [Book]. Arcler Press (2023) |
| References: | P. Ogrodnik, Medical Device Design Innovation from Concept to Market, second edition, Academic Press (2020) Naidoo, S. Medical Device Handbook For Europe [Book]. Arcler Press (2023) |
Course - Learning Outcome Relationship
| No Effect | 1 Lowest | 2 Medium | 3 Highest |
| Program Outcomes | Level of Contribution | |
| 1) | Access, evaluate and apply up-to-date scientific knowledge in the field of pharmacy | 2 |
| 2) | It conveys information to patients, health personnel and society on all matters related to drugs. | 1 |
| 3) | Has the necessary knowledge about the therapeutic effects, drug forms, pharmacokinetic properties, stability and incompatibilities of drug active substances and can use this information. | |
| 4) | Recognizes, controls and standardizes quality assurance issues and processes of all pharmaceutical-related products. | |
| 5) | Has knowledge and equipment about the administration and use of the drug to the patient, advises on rational and safe drug use, and supports pharmacovigilance practices. | 1 |
| 6) | Has knowledge about the production and production technologies of natural and synthetic pharmaceutical raw materials. | |
| 7) | Have knowledge about the concepts related to the functioning, maintenance and pathology of biological systems that form the basis of human health. | 2 |
| 8) | Has sufficient knowledge and application skills on research, development and production of pharmaceutical and cosmetic products. | |
| 9) | Plans and implements all subjects within the scope of pharmacy services in the hospital. | 1 |
| 10) | Has knowledge about licensing conditions, data protection, patent and pharmacoeconomics in pharmaceuticals. | |
| 11) | She/He is administratively and technically equipped in every field where the pharmacy profession is responsible by law, and produces solutions to problems in line with scientific data / evidence. | 3 |
| 12) | Combines basic and applied sciences with pharmacy profession practices and uses them in the field of pharmacy. | 1 |
| 13) | Has sufficient knowledge and application skills on physical, chemical, biological and toxicological analyzes of pharmaceutical, biotechnological and radiopharmaceutical products. | |
| 14) | Acts in accordance with ethical and legal principles in the field of pharmacy. | 2 |
| 15) | Has the necessary competencies to work with colleagues and other health professionals in terms of communicative, managerial and social skills. | 2 |
| 16) | Provides consultancy on medicinal plants, herbal supplements and food supplements. | |
| 17) | Knows pharmaceutical care practices, understands and evaluates drug interactions. | 2 |
| 18) | Knows the risks associated with the use of drugs and other chemical substances and laboratory practice. |
Learning Activity and Teaching Methods
| Anlatım | |
| Bireysel çalışma ve ödevi | |
| Course | |
| Homework | |
| Soru cevap/ Tartışma |
Measurement and Evaluation Methods and Criteria
| Yazılı Sınav (Açık uçlu sorular, çoktan seçmeli, doğru yanlış, eşleştirme, boşluk doldurma, sıralama) | |
| Sunum | |
| Bilgisayar Destekli Sunum | |
| Örnek olay sunma |
Assessment & Grading
| Semester Requirements | Number of Activities | Level of Contribution |
| Attendance | 28 | % 0 |
| Presentation | 12 | % 40 |
| Final | 1 | % 60 |
| total | % 100 | |
| PERCENTAGE OF SEMESTER WORK | % 40 | |
| PERCENTAGE OF FINAL WORK | % 60 | |
| total | % 100 | |
İş Yükü ve AKTS Kredisi Hesaplaması
| Activities | Number of Activities | Aktiviteye Hazırlık | Aktivitede Harçanan Süre | Aktivite Gereksinimi İçin Süre | Workload | ||
| Course Hours | 28 | 2 | 56 | ||||
| Presentations / Seminar | 12 | 1 | 12 | ||||
| Homework Assignments | 12 | 1 | 12 | ||||
| Final | 1 | 1 | 1 | ||||
| Total Workload | 81 | ||||||