Medical Devices

Code:

MI074163

Acronym:

DSPMED

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2012/2013 - 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	73	Official Curriculum	4	-	4	52	108

Teaching language

Portuguese

Objectives

Provide students with a thorough understanding of the technical and scientific aspects and regulations concerning Medical Devices and Diagnostic Medical Devices "in vitro" in order to give them the right skills for a good professional performance in the different aspects of this matter, in particular manufacturing, quality control, marketing, wholesale distribution, selection, acquisition, stockpiling, retention and dismissal.

 

Learning outcomes and competences

 

Working method

Presencial

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

The Course Program was established on the assumption that students have knowledge of Anatomy, Histology, Physiology, Biochemistry, Microbiology, Immunology and Pharmaceutical Technology.

Program

Theoretical part 1) Introduction and General Concepts 1.1) Characterization of concepts 1.1.1) Device Doctor 1.1.1.1) Active Medical Device 1.1.1.2) Medical Device Not Active 1.1.1.3) Medical Device Made by Measure 1.1.1.4) Medical Device 1.1.1.5 Clinical Investigations) Systems and Kits Medical Devices Intervention 1.1.2) Medical Device Diagnostics "in vitro" 1.2) Classification of Medical Devices on the risk class 1.2.1) Fundamentals of classification and application criteria 1.2. 2) Practical implications of the classification of Medical Devices 1.3) Classification of Diagnostic Medical Devices "in vitro" based on potential risks 1.3.1) Fundamentals of classification and application criteria 1.3.2) Practical Implications of the Classification of Diagnostic Medical Devices "in vitro" 2) Regulatory Aspects 2.1) Marketing of Medical Devices and Diagnostic Medical Devices "in vitro" 2.2) Conformity Assessment of Medical Devices and Diagnostic Medical Devices "in vitro" 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 certificate of conformity 2.7) Labelling and Package Insert / informative Medical Device and Diagnostic Medical Devices "in vitro". Symbology harmonized. 2.8) Monitoring of Medical Devices 2.8.1) Objectives 2.8.2) 2.8.3 Definitions and concepts) Organization of the National Surveillance of Medical Devices 2.8.4) Notification 2.9) Collection and disposal of Medical Devices 3) Study of more devices common 3.1) Material think 3.2) Devices for ostomates 3.3) devices for urinary incontinence 3.4) Devices for Orthopedics 3.5) Wire suture 3.6) Devices drainage, irrigation expansion and 3.7) devices for measuring blood pressure 3.8) Devices for self-testing (glycemia, glycosuria, ketonuria, cholesterol, plasma triglycerides, and other self-test pregnancy autodeterminações) 3.9) Other Lab Part 1. Trials pharmacopoeial quality evaluation of Medical Devices. 2nd. Characterization of multiple copies Medical Device and Diagnostic Medical Devices "in vitro" and their classification according to the degree of risk that its use entails. 3rd. Verification of conformance labels and instruction leaflets / newsletters of several copies Medical Device and Diagnostic Medical Devices "in vitro". 4th. Study visits to pharmacies and hospitals and a production unit of dressing material and distribution of medical devices.

 

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

 

keywords

Social Sciences, Commerce and Law > Basic programmes
General programmes > Basic programmes
General programmes > Basic programmes > Basic programmes
General programmes > Basic programmes
Health sciences

Evaluation Type

Distributed evaluation with final exam

Assessment Components

Description	Type	Time (hours)	Weight (%)	End date
Attendance (estimated)	Participação presencial	68,00
	Exame	2,00	90,00	2013-07-31
	Trabalho laboratorial	22,00	10,00	2013-07-31
	Total:	-	100,00

Eligibility for exams

 Under the Standards Assessment FFUP for the academic year 2011/2012, attendance at laboratory classes is a prerequisite for obtaining frequency and, consequently, for the admission of students to the final examination. According to the Standards Assessment FFUP for the academic year 2012/2013, a student meets attendance if the number of truancy laboratory does not exceed 25% of the classes provided. With regard to lectures is not mandatory compliance of attendance.

Calculation formula of final grade

.COMPONENTS OF ASSESSMENT: A distributed component is valued on the basis of work submitted by students in practical classes / laboratory during term time, reaching a maximum of 2 values. The final exam is worth 18 marks, consisting of a written test which covers all materials actually taught in lectures and practical classes / laboratory during term time. CALCULATION OF FINAL CLASSIFICATION: Classification of distributed component (0-2 values) + ranking final exam (0-18 points) Students with final rating equal to or greater than 9.5 are considered approved. Students with a final grade lower than 9.5 are considered disapproved. ORAL EXAM: Students who have obtained final grade greater than or equal to 9.5 may require oral exam, which will cover all materials actually taught in lectures and practical classes / laboratory during term time. The application will be delivered in SGAE until 48 hours after the publication of the ratings.

 

Special assessment (TE, DA, ...)

In accordance with the Standards Assessment FFUP for the academic year 2012/2013.
 

Classification improvement

 In accordance with the Standards Assessment FFUP for the academic year 2012/2013.