First cycle
degree courses
Second cycle
degree courses
Single cycle
degree courses
School of Medicine
PHARMACY
Course unit
TECHNOLOGIES IN MEDICAL DEVICES AND IN VITRO DIAGNOSTICS
MEP3051855, A.A. 2018/19

Information concerning the students who enrolled in A.Y. 2014/15

Information on the course unit
Degree course 5 years single cycle degree in
PHARMACY (Ord. 2009)
FA1732, Degree course structure A.Y. 2009/10, A.Y. 2018/19
N0
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Number of ECTS credits allocated 6.0
Type of assessment Mark
Course unit English denomination TECHNOLOGIES IN MEDICAL DEVICES AND IN VITRO DIAGNOSTICS
Department of reference Department of Pharmaceutical and Pharmacological Sciences
E-Learning website https://elearning.unipd.it/dsf/course/view.php?idnumber=2018-FA1732-000ZZ-2014-MEP3051855-N0
Mandatory attendance
Language of instruction Italian
Branch PADOVA
Single Course unit The Course unit can be attended under the option Single Course unit attendance
Optional Course unit The Course unit can be chosen as Optional Course unit

Lecturers
Teacher in charge MARGHERITA MORPURGO CHIM/09

ECTS: details
Type Scientific-Disciplinary Sector Credits allocated
Core courses CHIM/09 Applied Technological Pharmaceutics 6.0

Course unit organization
Period First semester
Year 5th Year
Teaching method frontal

Type of hours Credits Teaching
hours
Hours of
Individual study
Shifts
Lecture 6.0 48 102.0 No turn

Calendar
Start of activities 01/10/2018
End of activities 18/01/2019
Show course schedule 2019/20 Reg.2018 course timetable

Examination board
Board From To Members of the board
6 Commissione a.a. 2018/19 03/12/2018 30/09/2019 MORPURGO MARGHERITA (Presidente)
REALDON NICOLA (Membro Effettivo)
DAL ZOTTO MARISA (Supplente)
FRANCESCHINIS ERICA (Supplente)

Syllabus
Prerequisites: In order for the students to better understand the topics of this course, it is suggested they have already attended the following classes:
- Tecnologia e legislazione farmaceutica;
- Tossicologia e farmacoviglianza;
- Biochimica e biochimica applicata medica;
- Microbiologia e profilassi generale delle malattie infettive.
Target skills and knowledge: Topics of the course:
Definition and classification of medical devices (MD) and in vitro diagnostics (IVD) according to EU and US legislations;
Properties and requirements of materials (plastics, ceramics and metals)employed in MDs and IVDs: mechanical and chemical properties, biocompatibility, stability, resistance to sterilization processes). Tools and methods for materials testing. Body signal transducing systems; In vitro diagnsotic technologies: basic principles and technologies for analyte detection and signal trasduction for clinical diagnostics application. Requirements and process for market authorization in EU and USA.


Upon completing the exam, the student will be able to recognize and calssiifiy different medical devices based on their application, the risks for the end users according to current legal requirements. The student will be able to recognize the different materials adopted in MDs and plan compatibilty and stability studies. In addition, the student will understand the principles behind a MD/IVD design
Examination methods: Written test with a combination of open questions and quitzes.
Assessment criteria: Each test question will have a score, for a total of 30 points available.

In case a student will want to improve her/his score, it will be possible to integrate the exam with an oral test

The exam questions will aim at understanding if the students have learned the differnt topics of the course and are able to integrate them with independent ad critical thinking.
Course unit contents: - critical aspects in design and production of Medical devices.
- basic properties of materials used in medical devices and their minimal requirements according to the MD intended use.
- Basic concepts in body signal transduction systems odopted in MDs for body sign measurements.
- Concepts in MD design from the perspective of both the producer and the end user.
- legal and technical requirements from an idea to the final product.

The program
- material sciences: material requirements, mechanical and physico chemical properties: biodegradable and biodegradable polymers, plastics and their fillers, metals,glasses, ceramics and composites .
- bulk and surface properties and the methods for testing
- Phenomena occurring at the interface between the device and the human body, biocompatibility, biodegradation, immunogenicity, adverse reactions in general.
- Biomedical signal transduction, technologies adopted to read biological signs: pysical (temperature, movement, flow, optical, electrochemical, biopotential) and chemical (bioanalytes)
- basic concepts in medical device design and evaluation
-regulatory affairs: the route from design to market according to EU and USA legal requirements
Planned learning activities and teaching methods: 48 hours of class. Experts from industry and hospital pharmacy will be invited as guests. A visit to a MD factory is possible, dependin on host availability and budget.
Additional notes about suggested reading: Course contents have been extracted from different books, all available at the department library. The exact reference to the books will be provided during the course and indicated in the course slides.
Textbooks (and optional supplementary readings)
  • B.D Ratner, A.S Hoffman, FJ Schoen, JE Lemons, Biomaterials science: an introduction to materials in medicine, third edition. Oxford, UK: Academic Press, 2013. Cerca nel catalogo
  • D Boher, Sources of contamination in medicinal products and medical devices. Hoboken, New Jersey: Wiley, 2012. Cerca nel catalogo
  • VR Sastri, plastics in medical devices; properties, requirements and applications. Oxford, UK: Elsevier, 2010. Cerca nel catalogo
  • AYK Chan, biomedical device technology. Springfield, Illinois: Charles C Thomas Publisher LTD, 2007. Cerca nel catalogo
  • TR Kucklick, The medical device R&D handbook, 2nd ed.. --: CRC press, 2012. Cerca nel catalogo

Innovative teaching methods: Teaching and learning strategies
  • Problem based learning
  • Action learning