TOWARDS A GUIDED AND PHASED INTRODUCTION OF HIGH-RISK MEDICAL DEVICES IN BELGIUM

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Maria de Veen
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CÉLINE POUPPEZ (EQUAL), PIERRE SLEGERS (EQUAL), IRM

1 TOWARDS A GUIDED AND PHASED INTRODUCTION OF HIGH-RISK MEDICAL DEVICES IN BELGIUM HANNE BAEYENS (CMS DEBACKER), CÉLINE POUPPEZ (EQUAL), PIERRE SLEGERS (EQUAL), IRM VINCK (KCE), FRANK HULSTAERT (KCE), MATTIAS NEYT (KCE) KCE, 2015

2 Too many examples PIP (fraud) Metal-on-metal hip implants Renal denervation Endobronchial valves Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis TAVI Sometimes: US (PMA) Catheter ablation provides the answers Fake hip Fake Mesh 2

3 Background EU system: CE label & Notified Bodies (NB) Safety, Performance, No efficacy, no transparency Changes on a EU level Unique Device Identification (UDI) System, Special NBs, Eudamed, EU Commission, EU Parliament, EU Council Efficacy? RCT? Belgium: Plan Medische Hulpmiddelen 3

4 Scope & research questions Focus High-risk medical devices and implants After receiving CE label Before (conditional) reimbursement Research question Which measures do/can exist to support a guided introduction of high-risk medical devices in Belgium ( European regulation) 4

National measures Member states have the possibility to take appropriate measures to prevent (potential) risks to public health, both within and outside the harmonized fields.

5 National measures Member states have the possibility to take appropriate measures to prevent (potential) risks to public health, both within and outside the harmonized fields. These measures need to be justified, necessary, and proportional to their objective, namely the protection of consumer health. Harmonized field placing on the market, first use Non-harmonized field routine use 5

6 Within harmonized fields Articles 8 and 18 of Directive 93/42, if the devices do not comply (safety & performance) Article 14b, if there is a (potential) risk associated with the product (and not with the associated use of the high-risk device) Belgium could transitionally add the obligation to test a high-risk medical device in the context of RCTs before using it in routine Proportionality 6

7 Outside the harmonized fields Distribution, sale, in-use requirements, advertising or reimbursement of medical devices Centres of excellence Selection criteria Practice guidelines Takes time too late? 7

8 Outside the harmonized fields Clarification of the health care professionals responsibilities Information is the central element to allow the health professional to consider the use of the device and for patients to make an informed choice. Mentioning that a medical device received a CE marking is not considered sufficient. 8

9 Outside the harmonized fields Self-regulating systems IDEAL framework (innovation, development, exploration, assessment, long-term FU) Dutch guidelines for the safe introduction and use by professionals of new medical innovations Setting up such a self-regulatory system will very probably stand the test of proportionality. + several advantages 9

10 Recommendations Europees belangen van de patiënt centraal moeten stellen klinische werkzaamheid Onderzoeksgegevens publiek toegankelijk ~EUDAMED CE-markering hoog-risico medische hulpmiddelen instantie(s) die over de nodige klinische kennis zouden moeten beschikken 10

11 Recommendations Nationaal Objectieve en volledige informatie Interventie & alternatieven geïnformeerde toestemming van de patiënt in het medisch dossier (potentieel) risico artikel 8 en 18 van Richtlijn 93/42 artikel 14b systemen voor het verzamelen van nationale gegevens verbeteren (~Healthdata.be) (referentie)centra 11

12 Recommendations implementatie van een zelfregulerend systeem elk gebruik van een nieuw hoog-risico medisch hulpmiddel wordt gemeld en verantwoord deel van het ziekenhuis kwaliteitssysteem volgen van dit stappenplan impact op de beroepsaansprakelijkheid 12

13 Colophon Author(s): Hanne Baeyens, Céline Poupez, Pierre Slegers, Irm Vinck, Frank Hulstaert, Mattias Neyt Publication date: 09 July 2015 Domain: Health Services Research (HSR) MeSH: Device Approval ; Equipement and Supplies ; European Union ; Government regulation NLM Classification: W82 (Biomedical technology) Language: English Format: Adobe PDF (A4) Legal depot: D/2012/10.273/72 Copyright: KCE reports are published under a by/nc/nd Creative Commons Licence This document is available on the website of the Belgian Health Care Knowledge Centre. 13

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