Medical Devices

Code:

MI074163

Acronym:

DSPMED

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2018/2019 - 2S

Active?	Yes
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	14	Official Curriculum	3	-	3	52	81

Teaching language

Portuguese

Objectives

To provide students with a thorough knowledge on the technical, scientific and regulatory aspects of Medical Devices and “in vitro” Diagnostic Medical Devices, in order to give them the necessary skills for a good professional performance in the different fields of these matters, namely in manufacturing, quality control, marketing authorization, wholesale distribution, selection, acquisition, storage, preserving, counseling and dispensing.

 

Learning outcomes and competences

Learning outcomes:
At the end of the course, students should master the technical, scientific and regulatory aspects of Medical Devices and “in vitro” Diagnostic Medical Devices.

Skills:
Appropriate skills for a good professional performance in the different fields of these matters, namely in manufacturing, quality control, marketing authorization, wholesale distribution, selection, acquisition, storage, preserving, counseling and dispensing.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

The Program of this subject has been organized under the assumption that students have knowledge of Anatomy, Histology, Physiology, Biochemistry, Microbiology, Pharmacology, Immunology and Pharmaceutical Technology.

Program

1) Introduction and General Concepts
1.1) Characterization of concepts
1.1.1) Medical Device
1.1.1.1) Active Medical Device
1.1.1.2) Nonactive Medical Device
1.1.1.3) Custom-made Medical Device
1.1.1.4) Medical Device intended for clinical investigation
1.1.1.5) Medical Device systems and sets for medical procedures
1.1.2) “in vitro” Diagnostic Medical Devices
1.2) Classification of Medical Devices in risk classes
1.2.1) Fundamentals of classification and application criteria
1.2.2) Practical implications of the classification of the Medical Devices
1.3) Classification of “in vitro” Diagnostic Medical Devices in risk classes
1.3.1) Fundamentals of classification and application criteria
1.3.2) Practical implications of the classification of “in vitro” Diagnostic Medical Devices

2) Regulatory issues
2.1) Placing of Medical Devices and “in vitro” Diagnostic Medical Devices on the market
2.2) Conformity Assessment of Medical Devices and “in vitro” Diagnostic Medical Devices
2.3) Competent Authority and its functions
2.4) Notified Body and its functions
2.5) CE marking
2.6) EC declaration of conformity and EC certificate of conformity
2.7) Labelling and leaflet / instructions manual of Medical Devices and “in vitro” Diagnostic Medical Devices. Harmonized symbols.
2.8) Vigilance of Medical Devices
2.8.1) Objectives
2.8.2) Definitions and concepts
2.8.3) Organization of the Medical Devices National Vigilance System
2.8.4) Notification
2.9) Collection and disposal of Medical Devices

3) Study of the most common devices
3.1) Dressing material
3.2) Devices for ostomy
3.3) Devices for urinary incontinence
3.4) Devices for Orthopedics
3.5) Sutures
3.6) Devices for drainage, dilatation and irrigation
3.7) Devices for compression therapy
3.8) Devices for measuring blood pressure
3.9) “in vitro” Diagnostic Medical Devices for self-testing (glycemia, glycosuria, ketonuria, cholesterol, plasma triglycerides, pregnancy)
3.10) Other self-tests

Mandatory literature

Harman Robin J 340; Patient care in community practice. ISBN: 0-85369-450-8
Rocha Marília João; Feridas. ISBN: 972-798-176-3
Elias, C.; Brandão, D.; Candeias, E.; Cunha, E.; Rigueiro, G.; Mesquita, M; Rocha, P; Manual de material de penso com acção terapêutica, Ordem dos Farmacêuticos - Conselho do Colégio de Farmácia Hospitalar, 2012. ISBN: 978-989-98069-1-7
Soares Maria Augusta 340; Medicamentos não prescritos. ISBN: 972-98579-8-9
Harman Robin J.; Development and control of medicines and medical devices. ISBN: 0-85369-567-9
Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 972-31-0682-5 (Vol. 2)
Finkel Richard; Pocket guide for nonprescription product therapeutics. ISBN: 0-7817-3788-5
Gerbino Philip 300; Remington: the science and practice of pharmacy. ISBN: 0-7817-4673-6
Artigos de carácter especializado
Sítios da Internet de carácter especializado
Legislação específica

Complementary Bibliography

Cerezo, A.; Pires, F.; Loureiro, R.; Dispositivos Médicos Não Activos, Conselho do Colégio de Especialidade de Farmácia Hospitalar da Ordem dos Farmacêuticos, 1999

Teaching methods and learning activities

Theoretical classes: 2 x 50 minutes / week.
Practical/Laboratorial classes: 2 hours / week, for planning and conducting laboratory tests and exercises.

In addition to the established schedules for lectures and laboratory classes, the professor is available to meet students at any time previously agreed.

keywords

Health sciences > Pharmacological sciences > Pharmacy
Health sciences > Pharmacological sciences
Health sciences

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	80,00
Trabalho laboratorial	20,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	45,00
Frequência das aulas	45,00
Trabalho de campo	10,00
Total:	100,00

Eligibility for exams

The attendance to laboratory/practical classes is a prerequisite for obtaining frequency.

Calculation formula of final grade

EVALUATION COMPONENTS:

DISTRIBUTED COMPONENT - valued on the basis of works presented by the students in the practical/laboratory classes along the term (20%).

FINAL EXAM - written exam that focuses on all matters actually taught in lectures and practical/laboratorial classes along the term (80%).

Students with a score lower than 9.5 in the final exam are considered failed.

Students with a score equal to or higher than 9.5 in the final exam are admitted to the final score calculation.


FINAL SCORE CALCULATION (0-20):

(Final exam score x 0.8) + (Distributed component score x 0.2)

Students with a final score equal to or higher than 9.5 are considered approved.
Students with a final score lower than 9.5 are considered failed.


ORAL EXAM:
Students who have obtained final score equal to or higher than 9.5 may voluntarily apply for an oral exam in order to improve their score on the Curricular Unit.
Students should deliver the application in SGAE 48 hours after publication of the scores.
Oral examination covers all matters actually taught in lectures and practical/laboratorial classes along the term.
When an oral exam occurs, the final score is only dependent on the performance of the students on this exam. 

Special assessment (TE, DA, ...)

According to FFUP Assessment Standards and to the laws applicable to each specific situation.

Classification improvement

According to FFUP Assessment Standards.