dispositifs medicaux - world health organization€¦ · medicamentos y alimentos (invima) decree...
TRANSCRIPT
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Séminaire sur les Politiques Pharmaceutiques à l'attention des
experts francophones . 18-04-013
Dispositifs medicaux
Adriana Velazquez Berumen: Coordinatriz Dispositifs Medicaux
Département des Médicaments Essentiels et des Produits de Santé
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Dispositifs medicaux sont essentiels
XXI C. beaucoup manque les plus essentiels
Qu’ est ce que vous allez faire?
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Title Link to PDF file
World Health Assembly Resolution:
WHA60.29 Technologies Sanitaires
http://www.who.int/entity/medical_devices/policies/re
solution_wha60_r29-fr.pdf
DISPOSITIFS MÉDICAUX : COMMENT
RÉSOUDRE
l’inadéquation ?
http://whqlibdoc.who.int/publications/2012/97892425
64044_fre.pdf
Développement de politiques relatives aux
dispositifs médicaux
http://whqlibdoc.who.int/publications/2012/97892425
01636_fre.pdf
Évaluation des technologies de la santé :
dispositifs médicaux
http://whqlibdoc.who.int/publications/2012/97892425
01360_fre.pdf
Evaluation des besoins en
dispositifs médicaux
http://whqlibdoc.who.int/publications/2012/97892425
01384_fre.pdf
Processus d’acquisition :
guide pratique
http://whqlibdoc.who.int/publications/2012/97892425
01377_fre.pdf
Dons de dispositifs médicaux :
considérations relatives à leur
demande et à leur attribution
http://whqlibdoc.who.int/publications/2012/97892425
01407_fre.pdf
Introduction à la gestion du parc des
équipements médicaux
http://whqlibdoc.who.int/publications/2012/97892425
01391_fre.pdf
Programme de maintenance
des équipements médicaux :
présentation générale
http://whqlibdoc.who.int/publications/2012/97892425
01537_fre.pdf
Système de gestion de
maintenance assistée par
ordinateur
http://whqlibdoc.who.int/publications/2012/97892425
01414_fre.pdf
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Definitions
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Differences entre dispositifs medicaux
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Differences entre dispositifs medicaux et
produits pharmaceutiques
Diversité
taille,complexite, utilisation, plus de 20,000 types
Duree d’utilisation
tres variable, quelques minutes jusqu’a dizaines de annees.
Mode d’action
effects locaux et physiques sur l’organism, pas systemiques
ou pharmacologiques.
Utilisation
besoin de formation et support technique, maintenance
Reglementation
selon le risque associe a leur utilisation.
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5 a: accesibilite, adequation, disponibilite,
accesibilite economique, acceptabilite
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Serie technique de la OMS sur les dispositifs
medicaux
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Politique et plan sanitaire national pour les
besoins de la population
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Pays qui ont une politique de technologies de la Sante
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Pays disposant d’une entite pour la mise en ouvre de la politique relative aux technologies de la Sante
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Pays disposant d’une liste nationale de dispositifs medicaux approuves pour l’achat et le remboursement
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Evaluation de technologies de la sante
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Evaluations de besoins de dispositifs
medicaux
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OMS information du pays example: Canada Health Canada Legislation (2011) &
Regulations (2008)
Safety Alerts Adverse Reaction and
Medical Device
Problem Reporting
Adverse
Reaction
Database
Health Canada
Address Locator 0900C2
Ottawa, Ontario
K1A 0K9
Email: [email protected]
Telephone: 613-957-2991
Chile Instituto de Salud Púlica Legislation (2009)
Regulations (1999)
Current Regulations
(2011)
Safety Alerts Mesa Central
(56-2) 5755 101 Information
(56-2) 5755 201 Contact
Colombia Instituto Nacional de
Vigilancia de
Medicamentos y
Alimentos (INVIMA)
Decree (2009)
Resolution (2010)
Safety Alerts Health reporting
forms
Headquarters
Carrera 68D # 17 - 11/21
Bogota, Colombia
Switch Telephone: 2948700
Costa Rica Ministerio de Salud Regulations
Other regulations
Safety Alerts Adverse reaction
reporting
Ministry of Health - 2009,
Street 16, Avenues 6 and 8 -
San Jose, Costa Rica, Phone:
(506) 2223-0333
Cuba Centro Para el Control
Estatal de
Medicamentos, Equipos
y Dispositivos Médicos
(CECMED)
Regulations Safety Alerts [email protected]
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Information du pays
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www.who.int/ medical devices/ en
Merci!!!
OMS
Publications du Pays
OMS publications
(2008-2012)