Medical Devices

Code:

MI074163

Acronym:

DSPMED

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2020/2021 - 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	18	Official Curriculum	3	-	3	52	81

Teaching language

Portuguese

Objectives

To provide students with technical, scientific and regulatory knowledge underlying Medical Devices and In Vitro Diagnostic Medical Devices, in order to provide them the necessary scientific bases and professional skills, namely in manufacturing, quality control, placing on the market/regulatory affairs, wholesale distribution, selection, acquisition, storage, counseling and dispensing.

Learning outcomes and competences

Learning outcomes:

In the end, the student should master the technical, scientific and regulatory aspects inherent to Medical Devices and In Vitro Diagnostic Medical Devices.

 

Skills:

In the end, the student should have developed general and specific skills in the fields of Medical Devices and In Vitro Medical Devices, namely in manufacturing, quality control, placing on the market/regulatory affairs, wholesale distribution, selection, acquisition, storage, counseling and dispensing.

Working method

Presencial

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

The syllabus of the Curricular Unit was designed on the assumption that students have knowledge on Anatomy, Histology, Physiology, Biochemistry, Pharmaceutical Chemistry, Microbiology, Pharmacology, Immunology, Pharmaceutical Technology, Pathophysiology and Pharmacotherapy.

Program

1) Introduction

1.1) Definitions and 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) Experimental Medical Device
1.1.1.5) Procedure Packs of Medical Devices

1.1.2) “In Vitro” Diagnostic Medical Devices

1.2) Classification of Medical Devices based on the inherent potential hazard level

1.2.1) Risk classes

1.2.2) Fundamentals of classification and application criteria

1.2.3) Practical implications of the classification of the Medical Devices

1.3) Classification of “in vitro” Diagnostic Medical Devices based on the inherent potential hazard level

1.3.1) Fundamentals of classification and application criteria

1.3.2) Practical implications of the classification of “In Vitro” Diagnostic Medical Devices

2) European regulatory frameworks of Medical Devices and “In Vitro” Diagnostic Medical Devices

2.1) Placing on the market

2.2) Conformity assessment

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. Harmonized symbols.

2.8) Vigilance

2.9) Recall and discard of Medical Devices and “In Vitro” Diagnostic Medical Devices

3) Study of the most common devices in Community and Hospital Pharmacy

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) Others “In vitro” Diagnostic Medical Devices for self-testing

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
Artigos de carácter especializado
Sítios da Internet de carácter especializado
Legislação específica

Complementary Bibliography

Gerbino Philip 300; Remington: the science and practice of pharmacy. ISBN: 0-7817-4673-6
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 / Laboratory classes: 2 hours / week. Aimed at the planning and execution of laboratory tests and performing exercises.

In addition to the established schedules for 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 practical / laboratory classes is a prerequisite for obtaining frequency and, therefore, for the admission of the students to the final exam of the Unit.

According to the FFUP Student Assessment Standards, the student fulfills the attendance requirements if the number of absences to practical / laboratory classes not exceed 25% of scheduled classes.

In the theoretical classes it is not compulsory to comply with attendance.

Calculation formula of final grade

COMPONENTS OF THE EVALUATION:

DISTRIBUTED COMPONENT (0-20) – valued on the basis of the works presented by students at the practical / laboratory classes along the term (20%);

FINAL EXAM (0-20) – written exam that focuses on all matters actually taught in lectures and practical / laboratory classes along the term (80%).

 

Students with a score equal to or higher than 9.5 (0-20) in the final exam are considered approved.

Students with a score less than 9.5 (0-20) in the final exam are considered failed.

 

FINAL SCORE CALCULATION (0-20):

Final Exam Score x 0.8  +  Distributed Component Score x 0.2

Special assessment (TE, DA, ...)

In accordance to the FFUP Student Assessment Standards and the applicable legislation.

Classification improvement

In accordance to the FFUP Student Assessment Standards.