Medical Devices

Code:

MI074163

Acronym:

DSPMED

Keywords
Classification	Keyword
OFICIAL	Health Sciences

Instance: 2009/2010 - 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

To provide background knowledge on technical, scientific and regulatory issues related to medical devices and “in vitro” diagnostic medical devices, in order to afford the students the appropriate capabilities for a good professional performance on the different areas of this matter, namely the production, quality control, marketing authorisation, distribution, selection, purchase, storage, and dispensing.

Program

1) Introduction and General Concepts
1.1) Characterization of the concepts
1.1.1) Medical Device
1.1.1.1) Active Medical Device
1.1.1.2) Non-active Medical Device
1.1.1.3) Custom-made Medical Device
1.1.1.4) Medical device intended for clinical investigation
1.1.1.5) Systems and procedure packs
1.1.2) “In vitro” Diagnostic Medical Device
1.2) Classification of Medical Devices in risk classes
1.2.1) Rational and application criteria of the classification rules
1.2.2) Practical relevance of classification of Medical Devices
1.3) Classification of “In vitro” Diagnostic Medical Devices based on potential hazards
1.3.1) Rational and application criteria of the classification rules
1.3.2) Practical relevance of classification of “In vitro” Diagnostic Medical Devices

2) Legal framework
2.1) Marketing authorisation of Medical Devices and “In vitro” Diagnostic Medical Devices
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) The CE mark
2.6) EC conformity declaration and EC conformity certificate
2.7) Labelling and instructions for use/information of Medical Devices and “In vitro” Diagnostic Medical Devices. Harmonized symbols.
2.8) Vigilance of medical devices
2.8.1) Aims
2.8.2) Definitions and concepts
2.8.3) Organization of the Portuguese Vigilance System for Medical Devices
2.8.4) Notification of adverse incidents
2.9) Elimination of Medical Devices


3) Study of common devices
3.1) Wound healing and wound management products
3.2) Devices for ostomists
3.3) Devices for urinary incontinence
3.4) Devices for Orthopaedics
3.5) Devices for blood pressure measurement
3.6) Home test kits for self-diagnosis (blood glucose, glucose in the urine, ketones in the urine, blood cholesterol, blood triglycerides, pregnancy test and other determinations)
3.7) Others


Laboratory component
1. Carrying out pharmacopoeial tests for quality evaluation of Medical Devices.
2. Characterization and classification of different Medical Devices and “In vitro” Diagnostic Medical Devices.
3. Conformity assessment of labelling and instructions for use/information of different Medical Devices and “In vitro” Diagnostic Medical Devices.
4. Visits to community and hospital pharmacies and to a manufacturing unit of wound care Medical Devices.

Mandatory literature

Harman Robin J.; Patient Care in Community Practice, 2nd ed., Pharmaceutical Press, 2002
Sítios da Internet de carácter especializado
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 Luís Vasco Nogueira; Tecnologia farmacêutica. ISBN: 972-31-0682-5
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
Artigos de carácter especializado
Legislação específica
Gerbino Philip 300; Remington: the science and practice of pharmacy. ISBN: 0-7817-4673-6

Teaching methods and learning activities

Theoretical classes (2 x 50 minutes/week).
Laboratory classes (2 x 50 minutes/week) dedicated to plan and carry out laboratory tests and resolution of exercises.
Besides the classes, the professor is available to attend the students according to a established timetable or at a different time if previously organized.

Evaluation Type

Distributed evaluation with final exam

Assessment Components

Description	Type	Time (hours)	Weight (%)	End date
Attendance (estimated)	Participação presencial	52,00
	Total:	-	0,00

Eligibility for exams

In accordance to the current directives of Faculty of Pharmacy of the University of Porto for 2006/2007, assiduity to laboratory classes is mandatory for frequency attaining and thus for admission to the final exam.
According to the referred rules, those students whose attendance to laboratory classes is lower than 75% of the classes effectively taught are considered without assiduity, as long as these classes represent more than 50% of the classes predicted.
Attendance to theoretical classes is not mandatory.

Calculation formula of final grade

Classification of the distributed component (0-2 points) + Classification of the final exam (0-18 points)

Students with a final classification equal to or higher than 9.5 are considered approved.
Students with a final classification lower equal to or lower than 8.0 are considered as having failed.
Students with a final classification between 8.0 and 9.5 are admitted to an oral exam, covering the knowledge taught in the theoretical and laboratory classes.

Special assessment (TE, DA, ...)

In accordance to the current directives of Faculty of Pharmacy of the University of Porto for 2006/2007.

Classification improvement

In accordance to the current directives of Faculty of Pharmacy of the University of Porto for 2006/2007.

Observations

The aims and content of this subject-matter were established on the assumption that the students have previous knowledge on Anatomy, Physiology, Biochemistry, Microbiology, Immunology, Pharmaceutics and basics on Medical Devices (previously taught in the subject-matter Pharmaceutical Technology I).