2020-2021 / MCPH2035-1

Medical devices including pharmaco-materiovigilance legislation

Duration

39h Th

Number of credits

 Specialised master in hospital pharmacy5 crédits 

Lecturer

Frédéric Lecomte, Hugues Malonne, Muriel Mons, Serge Van Praet

Language(s) of instruction

French language

Organisation and examination

All year long, with partial in January

Schedule

Schedule online

Units courses prerequisite and corequisite

Prerequisite or corequisite units are presented within each program

Learning unit contents

Medical device regulations (national and European) - Nomenclature and pricing rules for medical devices - Cardiovascular system: Surgery, Interventional Radiology, Rhythmology - Digestive system: endoscopy and surgery - ENT : Surgery, Audiology, Logopedics - Ophthalmology - Urology - Neurosurgery - Orthopedics - Vascular access - Economic dimension of MDs - Miscellaneous : - Dressings and ligatures - (according to available speakers) Brief introduction to the concepts of material vigilance followed by a review of Belgian, European and international regulations. Concrete examples of materiovigilance are then analysed in order to demonstrate the essential role of an effective materiovigilance system.

Learning outcomes of the learning unit

Open the student to the proper use and indication of use of medical devices in the hospital setting for which the hospital pharmacist will be responsible for the quality and with a view to optimizing patient care in the hospital and promoting the rational use of medical devices.
At the end of the course and the seminar, students will be able to :

  • Interpret the NIHDI nomenclature for the pricing of medical devices and hospital pricing rules;
  • Verify the conformity of medical devices to the regulations (Belgian and European);
  • Understand the expectations and demands of professionals and patients;
  • Restitute the essential elements in the medical fields covered during the courses for medical devices;
  • Be able to make optimal use of the tools and data bank made available to healthcare professionals. To do this, they will have to mobilize their knowledge in regulation, physiology, anatomy, knowledge of materials, pathologies requiring the use of medical devices;
  • Understand and integrate the essential role of material vigilance in hospital institutions from the point of view of Belgian, European and international regulations.
During the seminar, the students will apply the material seen in the course. In groups or alone, under the guidance of the tutors, they will work on real examples that will allow them to discover the subtleties of the material presented.

Prerequisite knowledge and skills

Planned learning activities and teaching methods

Mode of delivery (face to face, distance learning, hybrid learning)

Lecture (34h) (with guest speakers)
Seminar (2h)

Organisational adjustments related to the current health context

If necessary, teaching by videoconference or within a synchronous virtual classroom.

Recommended or required readings

Anatomy Atlas d'anatomie, AFMPS, INAMI, EUDAMED,...
Arrêté royal relatif à la notification d'un point de contact matériovigilance et à l'enregistrement des distributeurs et exportateurs de dispositifs médicaux (15 NOVEMBRE 2017).

Assessment methods and criteria

Below you will find information on the evaluation methods planned for in-person and remote exams as well as those planned for hybrid sessions. Depending on how the health crisis evolves, the chosen method will be communicated to you no later than one month before the start of the exam session.

Any session :

- In-person

written exam ( open-ended questions )

- Remote

written exam ( open-ended questions )

- If evaluation in "hybrid"

preferred in-person


Additional information:

Written exam.
Partim M. Mons & S. Van Praet: 90% of the exam.
Partim F. Lecomte: 10% of the exam - Two open questions counting for 50% of the points each. The partial mark is then reduced to 10. This partial mark has a weighting of 0.2 in relation to the total mark.

Work placement(s)

Internship see internship cursus module dispmed (ULB).

Organizational remarks

Contacts

  • Muriel Mons : muriel_mons@stpierre-bru.be  
  • Serge Van Praet : serge_vanpraet@stpierre-bru.be 
 


  • Frédéric LECOMTE, Assistant professor
    Department of Pharmacy Quartier Hôpital - Avenue Hippocrate 15 Bâtiment B 36 4000 LIEGE (Belgium)
    e-mail: f.lecomte@uliege.be