Risk Management

RIS
Infographics
Here is where this template begins K
Introduction

L'instauration d'un système robuste de gestion des risques

dans le domaine des Dispositifs Médicaux (DM) est
essentielle afin d'assurer la sécurité et l'efficacité des
produits de santé. En raison de la complexité inhérente à
la conception et à l'utilisation des DM, cette approche
proactive permet d'anticiper, d'évaluer et de minimiser les
risques potentiels, contribuant ainsi à renforcer la qualité
et la fiabilité des dispositifs médicaux.
 Risques dans le
En santé, le risque est la probabilité qu'une exposition à un Domaine de la Santé
danger entraîne un préjudice. La gestion des risques vise à
minimiser ces dangers, favorisant des pratiques et
politiques qui promeuvent la santé et le bien-être.

Risques dans le
Le risque des dispositifs médicaux concerne la probabilité et la Domaine de DM
sévérité des conséquences négatives potentielles liées à leur
utilisation.
Il englobe des facteurs tels que la conception, l'utilisation incorrecte,
les défaillances techniques et les interactions avec le patient
Dispositifs
Médicaux (DM)
Les Dispositifs Médicaux (DM) sont des instruments, appareils,
équipements ou produits utilisés à des fins diagnostiques, thérapeutiques
ou de surveillance médicale.
Évolution des Enjeux de Sécurité
dans le Domaine de la Santé

 L'historique des risques dans le

domaine médical met en évidence
l'évolution des normes de sécurité Implants mammaires en silicone :
et les incidents passés qui ont
Les problèmes de rupture et de fuite ont entraîné des enquêtes
conduit à la mise en place de
approfondies, des rappels et des améliorations des procédures
réglementations strictes comme :
d'approbation des implants mammaires.

(2000)
( 1950-1960)

(1990)
Affaire du défibrillateur Guidant
Thalidomide
Des défaillances ont entraîné des rappels massifs, soulignant
La thalidomide a provoqué des malformations
la nécessité d'une surveillance continue et de protocoles de
congénitales chez les nouveau-nés, conduisant
sécurité renforcés.
à des réformes réglementaires majeures
 Gestion actuelle des
Les rappels des pompes à insuline Medtronic ont montré des risques associés aux
soucis, soulignant l'importance de vérifier la qualité pour rendre les dispositifs médicaux
appareils médicaux plus fiables Aujourd'hui, la sécurité est
Affaire des pompes à insuline Medtronic primordiale, les fabricants
gèrent les risques des produits
(2010)
et les autorités réglementaires
veillent à protéger les patients
et les utilisateurs.
(2000)

Révision des réglementations

Les règles dans le monde entier sont devenues plus strictes pour rendre les
dispositifs médicaux plus sûrs après des problèmes, afin de protéger la
santé des patients.
L'importance du management des
risques dans le domaine des DM

 Le management des risques dans le domaine des dispositifs médicaux

(DM) revêt une importance cruciale pour plusieurs raisons :

Sécurité des Patients

Innovation Responsable
Conformité Réglementaire
Cycle de Vie du Produit
Réputation des Fabricants
Protection des Utilisateurs et des Opérateurs
Réduction des Coûts

Qualité et Efficacité
La norme ISO 31000:2009 émise par
l'Organisation internationale de normalisation
vise à fournir des principes et des lignes
directrices pour le management des risques,
tant au niveau stratégique qu'opérationnel. Son
objectif n'est pas d'uniformiser les pratiques,
mais plutôt d'harmoniser les différentes
approches existantes en matière de gestion des
risques. Publiée en novembre 2009, la norme a
été transposée en norme française (NF ISO
31000:2010) par l'AFNOR. Elle s'applique à un
large éventail d'entités, offrant un cadre souple
et adaptable pour le management des risques,
tout en favorisant une approche intégrée plutôt
que par "silos".
La norme ISO 13485:2016 définit les exigences
pour les systèmes de management de la
qualité des dispositifs médicaux (DM). Elle
intègre également des principes de gestion des
risques spécifiques aux DM, assurant ainsi la
sécurité et l'efficacité des produits. En mettant
l'accent sur la prévention et le contrôle des
risques liés aux dispositifs médicaux, cette
norme favorise la conformité réglementaire et la
satisfaction des parties prenantes. En résumé,
ISO 13485 offre un cadre complet pour la
gestion de la qualité et des risques dans le
domaine des dispositifs médicaux
La norme ISO 14971 est spécifiquement dédiée au
management des risques pour les dispositifs médicaux
(DM). Publiée en tant que norme internationale, elle
fournit un cadre systématique pour identifier, évaluer,
et maîtriser les risques associés aux DM tout au long
de leur cycle de vie. En intégrant une approche de
gestion des risques dès la conception jusqu'à
l'utilisation du dispositif, ISO 14971 contribue à assurer
la sécurité et la performance des produits médicaux,
tout en répondant aux exigences réglementaires. En
résumé, cette norme établit une méthodologie
complète pour la gestion proactive des risques dans le
secteur des dispositifs médicaux.
Les fabricants ont la responsabilité première dans le management des risques des produits
qu'ils mettent sur le marché, en identifiant, évaluant et maîtrisant les risques associés à la
conception, à la production et à l'utilisation des articles.

Les distributeurs sont également responsables de s'assurer que les produits qu'ils
fournissent respectent les normes de sécurité, en participant à la gestion des risques liés à
la distribution et au stockage des produits.

Les utilisateurs ont la responsabilité d'appliquer les instructions d'utilisation des produits de
manière appropriée, de signaler tout incident lié à la sécurité et de participer à la gestion des
risques par une utilisation correcte.

La collaboration entre fabricants, distributeurs et utilisateurs est essentielle pour un

management efficace des risques, favorisant la transparence, la communication et
l'amélioration continue de la sécurité des produits.

Dans l'ensemble, chaque acteur de la chaîne d'approvisionnement joue un rôle crucial pour
assurer la sécurité des produits, de la conception à l'utilisation, dans le cadre d'une
approche intégrée de gestion des risques.
 Risk Management Infographics

Mercury is the closest planet to the

Sun and the smallest planet

IDENTIFY ASSESS
RISK RISK Saturn is composed of hydrogen and
helium and is the ringed one

Venus has a beautiful name and is

the second planet from the Sun

REVIEW CONTROL
Mars is actually a cold place. It’s full
CONTROLS RISK of iron oxide dust
 Risk Management Infographics

Venus has a beautiful name IDENTIFY ASSESS Despite being red, Mars is
and is the second planet a very cold place full of
RISK RISK
from the Sun iron oxide dust

RISK
MANAGEME
NT
PROCESS

REVIEW CONTROL
CONTROLS RISK
Mercury is the closest Jupiter is a gas giant and
planet to the Sun and the the biggest planet in the
smallest planet Solar System
 Risk Management Infographics

REVIEW
IDENTIFY RISK ASSESS RISK CONTROL RISK
CONTROL
Jupiter is a gas giant Neptune is the Saturn is the ringed Mercury is the
and the biggest farthest planet from planet and also a gas innermost planet of
planet the Sun giant them all
 Risk Management Infographics

Venus has a beautiful name Despite being red, Mars is a

and is the second planet from very cold place full of iron
the Sun oxide dust

IDENTIFY RISK ASSESS RISK

REVIEW
CONTROL RISK
CONTROLS
Mercury is the closest planet Jupiter is a gas giant and the
to the Sun and the smallest biggest one in the Solar
one System
 Risk Management Infographics

REVIEW
IDENTIF ASSESS CONTR
CONTR
Y RISK RISK OL RISK
OL

It's the closest planet to Despite being red, Mars It's a gas giant and the Venus is the second
the Sun is a cold place biggest planet planet to the Sun
 Risk Management Infographics

IDENTIFY RISK ASSESS RISK

Venus has a beautiful name Despite being red, Mars is
and is the second planet a very cold place full of
from the Sun iron oxide dust

REVIEW CONTROL
CONTROLS RISK
Mercury is the closest Jupiter is a gas giant and
planet to the Sun and the the biggest one in the Solar
smallest one System
Risk Management Infographics

IDENTIFY RISK
Venus has a beautiful name and is the
second one from the Sun

ASSES RISK
Mercury is the closest planet to the Sun
and the smallest one

REVIEW CONTROL
Despite being red, Mars is a cold place full
of iron oxide dust

CONTROL RISK
Jupiter is a gas giant and the biggest planet
in the Solar System
 Risk Management Infographics
RISK ASSESSMENT
MATRIX
CERTAI LO MODERA HIG EXTRE EXTRE
N W TE H ME ME

LIKE LO MODERA HIG HIG EXTRE

LY W TE H H ME
LIKELIHO

POSSIB LO MODERA MODERA HIG HIG

OD

LE W TE TE H H

UNLIKE LO LO MODERA MODERA MODERA

LY W W TE TE TE

RAR LO LO LO LO LO
E W W W W W

INSIGNIFICA MINO SIGNIFICA MAJO CATASTROPH

NT R NT R IC

SIGNIFICAN
CE
 Risk Management Infographics

Mercury is the closest planet

1º risk to the Sun

Saturn is the only planet in

2º risk the Solar System with rings

Despite being red,

3º risk Mars is a cold place

Venus has a beautiful name,

4º risk but it’s hot
 Risk Management Infographics
MEDIUM RISK
Despite being red, Mars is
a very cold place full of
iron oxide dust

LOW RISK RIS HIGH RISK

Mercury is the closest K Jupiter is a gas giant and
planet to the Sun and also the biggest planet in the
the smallest one Solar System
 Risk Management Infographics
IDENTIFY RISK ASSESS RISK
Venus has a beautiful name
and is the second planet A Despite being red, Mars is
a very cold place full of
from the Sun iron oxide dust

C
REVIEW CONTROL
CONTROLS RISK
Mercury is the closest
planet to the Sun and the
D Jupiter is a gas giant and
the biggest planet in the
smallest one Solar System
 Risk Management Infographics

Saturn is the only planet with

Identify risk rings of them all

Despite being red,

AsseSs risk Mars is a cold place

Review The Sun is the star at the

center of the Solar System
control
Jupiter is the biggest planet of
Control risk them all
 Risk Management Infographics

NEPTUNE MERCURY
Neptune is the farthest
1º Mercury is the closest
planet from the Sun 5º planet to the Sun
RISK
MANAGEM
ENT 2º MARS
Despite being red,
4º Mars is a cold place

3º
JUPITER SATURN
Jupiter is the biggest It’s composed of
planet of them all hydrogen and helium
 Risk Management Infographics
RISK
CONSEQUENCE
FIRST RISKS Low Medium High

Mercury is the closest planet to the Sun

and the smallest planet

High
LIKELIHOOD
SECOND RISKS

Medium
RISK
Saturn is composed of hydrogen and
helium and is the ringed one

THIRD RISKS
Low
Venus has a beautiful name and is the
second planet from the Sun

Risk Level: Low Medium High

 Risk Management Infographics

1º IDENTIFY RISK ASSESS RISK 2º

Jupiter is a gas giant and the Neptune is the farthest
biggest planet in the Solar planet from the Sun and the
System fourth-largest

REVIEW CONTROL CONTROL RISK

Saturn, the ringed planet, is Mercury is the closest planet
composed mostly of to the Sun and the smallest
hydrogen and helium one of them all
3º 4º
 Risk Management Infographics

A
57% RISK
MANAGEM
ENT
Venus has a beautiful
name and is the
second planet from
the Sun

B 43%
 Risk Management Infographics

HIG
Close monitoring Requires monitoring Intensive

H
IMPAC required and management management

MEDIU
Risk may be
Management Management
M
accepted, but
T

recommended required
requires monitoring

Risk acceptable,
LO
W

Acceptable risk Managed

requires regulation

LO MEDIU HIG
W M
LIKELIH H
OOD
 Risk Management Infographics

IDENTIFY REVIEW CONTROL

ASSESS RISK
RISK CONTROL RISK
Mercury is the Jupiter is the biggest It's composed of Neptune is the
smallest in the Solar planet in the Solar hydrogen and also farthest planet from
System System of helium the Sun
 Risk Management Infographics

RISK MANAGEMENT
EVALUATION
REVIEW
IDENTIF ASSESS CONTR
CONTR
Y RISK RISK OL RISK
OL
Mercury is the closest planet Despite being red, Saturn is composed of It’s the farthest one
to the Sun Mars is a cold place hydrogen and helium from the Sun
 Risk Management Infographics
15% 25%
Venus has a beautiful Despite being red, Mars is
name and is the second a very cold place full of
planet IDENTIF iron oxide dust
Y
RISK

RISK
MANAGEM
REVIEW ENT ASSESS
CONTROLS PROCESS RISK

45% 75%
Mercury is the closest Jupiter is a gas giant and
CONTROL
planet to the Sun and the RISK
the biggest planet in the
smallest one Solar System
 Risk Management Infographics

60%

75%

70%

IDENTIFY RISK ASSESS RISK CONTROL RISK

Despite being red, Neptune is the farthest planet Mercury is the closest planet
Mars is a cold place from the Sun to the Sun
 Risk Management Infographics

IDENTIFY
RISK
ASSESS
RISK
PAST RISK

MERCU SATUR
MARS
RY
Mercury is the closest Despite being red,
N
Saturn is a gas giant and
planet to the Sun Mars is a cold place has several rings
 Risk Management Infographics

1st 2nd 3rd 4th 5th

NAIVE AWARE DEFINED MANAGED ENABLED

Venus has a Mercury is the Despite being red, Jupiter is a gas Mercury is the
beautiful name and closest planet to the Mars is a very cold giant and the closest planet to the
is the second one Sun and the place full of iron biggest planet in Sun and the
from the Sun smallest one oxide dust the Solar System smallest one

STRUCTU
RE
 Risk Management Infographics

60% 50% 40% 30%

IDENTIFY REVIEW CONTROL
ASSESS RISK
RISK CONTROL RISK
Mercury is the closest Venus is the second Jupiter is the biggest Neptune is the farthest
planet to the Sun planet from the Sun planet of them all from the Sun
 Risk Management Infographics

25% 85% 40% 50%

It's the closest one It's the one only Mars is actually a Jupiter is the
to the Sun with rings cold place biggest planet
Review
Identify risk Assess risk Control risk
control
 Risk Management Infographics

Mercury is the closest one and the Neptune is the eighth and the
smallest of them all farthest-known planet

Despite being red, Mars is actually a Saturn is composed mostly of

cold place hydrogen and helium

Jupiter is the biggest one in the Solar Earth is the only planet with life in
System the Solar System

REVIEW CONTROLS CONTROL RISK

 Risk Management Infographics

50% 30%
REVIEW
IDENTIFY RISK
Mercury is the smallest
CONTROL
Neptune is the eighth and
planet of them all farthest-known one

40% 20%
ASSESS RISK CONTROL RISK
Despite being red, Mars is Jupiter is a gas giant and
actually a cold place the biggest one
 Risk Management Infographics
IDENTIFY
RISK
Despite being red, Mars is a very
cold place
20%
ASSESS RISK
Neptune is the farthest planet from
the Sun
30%
REVIEW
CONTROL
Mercury is the smallest planet in
the Solar System
40%
CONTROL
RISK
It’s composed of hydrogen and
also of helium
50%
 Risk Management Infographics

REVIEW
IDENTIFY RISK ASSESS RISK CONTROL RISK
Mercury is the smallest Despite being red, Mars is
CONTROL
Jupiter is a gas giant and Neptune is the eighth and
planet of them all actually a cold place the biggest one farthest-known one
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