Medical Devices

Code:

MI074163

Acronym:

DSPMED

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2013/2014 - 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	72	Official Curriculum	4	-	4	52	108

Teaching language

Portuguese

Objectives

Provide students with a thorough knowledge on the technical, scientific and regulatory aspects concerning 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 this course, students should master the technical, scientific and regulatory aspects related to 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 Device and “in vitro” Diagnostic Medical Devices. Symbology harmonized.
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 more common devices
3.1) Dressing material
3.2) Devices for individuals ostomates
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 measuring blood pressure
3.8) “in vitro” Diagnostic Medical Devices for self-testing (glycemia, glycosuria, ketonuria, cholesterol, plasma triglycerides, pregnancy)
3.9) 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
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)
Cerezo, A.; Pires, F.; Loureiro, R.; Dispositivos Médicos Não Activos, Conselho do Colégio de Especialidade de Farmácia Hospitalar da Ordem dos Farmacêuticos, 1999
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

Teaching methods and learning activities

Theoretical classes: 2 x 50 minutes / week.
Practical/Laboratory classes: 2 hours / week, for planning and conducting laboratory tests and exercises
In addition to the established schedules for lectures and laboratory classes, teachers are available to meet students at any time previously agreed.

keywords

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

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	90,00
Trabalho laboratorial	10,00
Total:	100,00

Calculation formula of final grade

EVALUATION COMPONENTS:
- DISTRIBUTED COMPONENT is valued on the basis of works presented by students in the practical/laboratory classes along the term, reaching a maximum score of 2 (0-2).
- FINAL EXAMINATION consists on a written exam that focuses on all matters actually taught in lectures and practical / laboratory classes along the term, reaching a maximum score of 18 (0-18).
FINAL SCORE
Final score is calculated by the following way:
Final examination score (0-18) + Distributed Component score (0-2)
Students with a final score equal to or greater than 9.5 are considered approved.
Students with a final score lower than 9.5 are considered failed.
ORAL EXAMINATION:
Students who have obtained final score greater than or equal to 9.5 may voluntarily apply for an oral examination in order to improve their score on the subject.
Students should deliver the application in SGAE 48 hours after publication of the ratings.
Oral examination covers all materials actually taught in lectures and practical / laboratory classes along the term.
When an oral examination occurs, the final score is only dependent on the performance of the students on this examination.