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Federal Agency for Medecines and Health Products
Federal Agency for Medicines and Health Products
(FAMHP)
Medical Device Vigilance
Lambot Damien
Materiovigilance
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Federal Agency for Medecines and Health Products
Medical Device Vigilance
1. Definitions and legal basis
1.1. Organigramme
1.2. Legal basis
1.3. Definitions
1.3.1. Materiovigilance
1.3.2. Medical Device
1.3.3. Corrective Action
1.3.4. Field Safety Corrective Action (FSCA)
1.3.5. Field Safety Notice (FSN)
2. What shall be notify?
3. Who should be notify?
4. When must incidents be notified?
5. How should incidents be notified?
5.1. Users
5.2. Manufacturers, distributors, authorised representatives
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Federal Agency for Medecines and Health Products
Medical Device Vigilance
1. Definitions and legal basis
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Federal Agency for Medecines and Health Products
1. Definitions and legal basis
1.1 Organigramme
DG
PRE
authorisation
DG
POST
authorisation
DG
INSPECTION
Marketing Authorisation
Division
(human)
Medicines
for Veterinary use
Division
Marketing Authorisation
Division
Variations & Renewals
Vigilance Division
(pharmaco, materio,
haemo, bio)
Health Products Division
Assessors Division
Proper Use Division
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Control Policy
Division
“Industry” Division
“Dispensing” Division
Special Investigation Unit
d’enquête
SOE-USE
R&D Division
(human)
Federal Agency for Medecines and Health Products
1. Definitions and legal basis
1.2 Legal basis
Royal decrees:
Royal decree 18/03/1999 (art. 11): Medical Device (MD)
Royal decree 15/07/1997 (art. 12): Active Implantable
Medical Device (AIMD)
European Directives:
Directive 93/42/EEC (MD)
Directive 90/385/EEC (AIMD)
Other:
Guideline: MEDDEV 2.12-1 rev 6: not legally binding
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1. Definitions and legal basis
1.3 Definitions
1.3.1 Materiovigilance
•
The purpose of materiovigilance is to study and follow incidents that
might result from using medical devices. It enables dangerous devices
to be withdrawn from the market and to eliminate faults in medical
devices with the intention of constantly improving the quality of
devices and providing patients and users with increased safety.
•
Materiovigilance only refers to medical devices whereas
pharmacovigilance refers to medicines.
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1. Definitions and legal basis
1.3.2 Medical Device
Medical device is defined as any instrument, equipment, material or
other article used on its own or jointly, including software required
for it to function correctly, which is intended by the manufacturer to
be used on humans for the following purposes :
•for diagnostic, prevention, control, treating or diminishing an illness
•for diagnostic, control, treating, for diminishing or compensating an injury or
handicap,
•for studying, replacing or modifying part of the anatomy or a physiological process
• for mastering conception
and whose principal intended action in or on the human body is not obtained by
pharmacological or immunological means or by metabolism but whose function can be
assisted in such a way.
More definition in the art. 1 of the law : accessory, active medical device, active
implantable medical device, custom made device.
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1. Definitions and legal basis
1.3.3: Corrective Action:
Action to eliminate the cause of a potential non-conformity
or other undesirable situation.
NOTE1: There can be more than one cause for nonconformity.
NOTE 2: Corrective action is taken to prevent recurrence
whereas preventive action is taken to prevent occurrence.
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Federal Agency for Medecines and Health Products
1. Definitions and legal basis
1.3.4.: Field Safety Corrective Action (FSCA):
A FIELD SAFETY CORRECTIVE ACTION is an action taken by a MANUFACTURER to
reduce a risk of death or serious deterioration in the state of health associated
with the use of a MEDICAL DEVICE that is already placed on the market. Such
actions should be notified via a FIELD SAFETY NOTICE.
The FSCA may include
- the return of a MEDICAL DEVICE to the supplier;
- device modification;
- device exchange;
- device destruction;
- retrofit by purchaser of MANUFACTURER's modification or design change;
- advice given by MANUFACTURER regarding the use of the device (e.g. where the
device is no longer on the market or has been withdrawn but could still possibly be in use)
A device modification can include:
- permanent or temporary changes to the labelling or instructions for use;
- software upgrades including those carried out by remote access;
- For implantable devices it is often clinically unjustifiable to explant the device.
Corrective action taking the form of special patient follow-up, irrespective of
whether any affected un-implanted devices remain available for return, constitutes
FSCA.
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Federal Agency for Medecines and Health Products
1. Definitions and legal basis
1.3.5. Field Safety Notice (FSN)
A communication to customers and/or USERs sent out by a
MANUFACTURER or its representative in relation to a Field
Safety Corrective Action.
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Medical Device Vigilance
2. What shall be notify?
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2.What shall be notify?
any dysfunction or any change of the characteristics and/or
performance of a device, and any inadequacy in the labelling or
instructions, which might lead to or have led to death or serious
relapse in the state of health of a patient, a user or a third party.
- any technical or medical reason related to the characteristics or
performance of a device for reasons shown in the previous paragraph
and having led to the systematic withdrawal from the market by a
manufacturer of devices of the same type.
-
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2.What shall be notify?
Not only must one notify serious incidents which have
actually taken place but also the cases where there was a risk
of a serious incident but that incident was avoided thanks to
the attention and action of the relevant people.
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2.What shall be notify?
Definition of an serious incident:
An incident is considered serious if it has one of the following
consequences or could have had such a consequence:
death, an illness or a handicap
a permanent lesion of a function or structure
the need for a medical or surgical operation
for a prolongation of a surgical operation
incorrect results of examinations leading to an
incorrect diagnostic or treatment
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2.What shall be notify?
Examples:
1. An infusion pump stops, due to a malfunction, but gives an
appropriate alarm (e.g. in compliance with relevant
standards) and there was no injury to the patient.  do not
need to be reported.
2. An infusion pump stops, due to a malfunction of the pump,
but fails to give an appropriate alarm; there is no patient
injury. This should be reported as in a different situation it
could have caused a serious deterioration in state of health.
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2.What shall be notify?
3. An aortic balloon catheter leaked because of
inappropriate handling of the device in use, causing a
situation which was potentially dangerous to the patient. It
is believed that the inappropriate handling was due to
inadequacies in the labelling. This incident should be
reported.
4. A defect is discovered in one (hitherto unopened) sample
of a batch (lot) of a contact lens disinfecting agent that
could lead to incidence of microbial keratitis in some
patients. The MANUFACTURER institutes a FSCA of this batch.
The FSCA should be reported.
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2.What shall be notify?
5. Loss of sensing after a pacemaker has reached end of life.
Elective replacement indicator did not show up in due time,
although it should have according to device specification.
This INCIDENT should be reported.
6. The premature revision of an orthopedic implant is
required due to loosening. Although no cause is yet
determined, this INCIDENT should be reported.
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Federal Agency for Medecines and Health Products
Medical Device Vigilance
3. Who should be notify?
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Federal Agency for Medecines and Health Products
3. Who should notify?
Not only the manufacturers or their representatives but also persons
distributing devices, notified bodies, practitioners and people
responsible for receiving and/or delivering devices should all signal
incidents to : Federal Agency for Medicines and Health Products –
Vigilance Division.
Email address : [email protected]
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Medical Device Vigilance
4. When must incidents be notified?
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4. When must incidents be notified?
Incidents must be notified as quickly as possible using the
quickest means possible. Incidents that have led to death or
serious injury must be notified immediately.
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Medical Device Vigilance
5. How should incidents be notified?
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5. How should incidents be notified?
5.1 User (pharmacist, doctors)
www.fagg-afmps.be
Human use
Medical devices and their accessories
How should incidents be notified
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5. How should incidents be notified?
5.2. Manufacturers, distributors, authorised representatives,…
http://ec.europa.eu/enterprise/sectors/medicaldevices/index_en.htm
Market surveillance and vigilance
Reference documents
Guidance
2.12 Market surveillance (Manufacturer Incident Report and
Field safety Corrective Action)
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5. How should incidents be notified?
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5. How should incidents be notified?
Documents to provide (FSCA):
- The traceability data for Belgium (list of Belgian Customers,
with quantities provided per lot number).
- The model letter in our national languages (FSN)
- Once available evidence that the users have received the
letter and reconciliation data.
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Federal Agency for Medecines and Health Products
Links :
Federal Agency for Medecines and Health Products :
http://www.faggafmps.be/en/human_use/health_products/medical_devices_accessories/materiovigilance/index.jsp
Belgian legislation:
http://www.fagg-afmps.be/fr/humain/produits_de_sante/dispositifs_medicaux/legislation/index.jsp
Market Surveillance and Vigilance on European Commission Web Site:
http://ec.europa.eu/enterprise/sectors/medical-devices/market-surveillance-vigilance/index_en.htm
Forms:
-Distributor / Manufacturer /Authorized representative / …:
FSCA: http://ec.europa.eu/enterprise/sectors/medicaldevices/files/meddev/report_form_field_safety_corrective_action_en.doc
Incident: http://ec.europa.eu/enterprise/sectors/medicaldevices/files/meddev/report_form_manufacturers_incident_report_en.doc
- User:
http://www.faggafmps.be/fr/binaries/Copie%20de%20vigilance%20report%20%20FR%20vers.041104_tcm29127060_tcm291-27060.xls
Email address of Health Product Division and Medical Device Vigilance Unit:
[email protected]
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