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Guidelines on a Medical Devices Vigilance
System APPENDIX 3
INITIAL INCIDENT
REPORT FORMAT
DESTINATION
1.Competent Authority Address
2. Reporting firm name:
a) 0 Manufacturer
0 Authorised representative within EEA
b) Address
c) Contact person name
d) Telephone number ____________________________________
e) Telefax number ____________________________________
f) Report date ____________________________________
3. Manufacturer name . ____________________________________________________
Medical device commercial name ____________________________________
Kind of device (e.g. pacemaker, diathermy machine, ...)
____________________________________________________________
Model or catalogue number ____________________________________
Serial number(s) or lot number(s)
Accessories/associated devices (if applicable)
Software version (if applicable)
Identification number of Notified Body involved in conformity assessment (if applicable)
____________________________________________________________________
Reporting firm is aware of other similar incidents having an impact on the current
report __Y/N
If yes, the countries to which these have been reported, and the report reference
numbers are listed below
Incident reported by (user or other source)
Telephone number: __________________________________
Date reported____________________________
Incident date_______________________________:
Incident description :
Outcome : (e.g. death, deterioration in health,)
Manufacturer’s preliminary comments
Current location of device (if known)
Expected date of follow-up report
Corrective action (if any)
Projected timing
Submission of this report does not, in itself, represent a conclusion by the
manufacturer anulor authorised representative or the competent authority that the content
of this report is complete or accurate, that the device(s) listed tailed in any manner
and/or that the device(s) caused or contributed to the alleged death or deterioration in
the state of the health of any person.
FINAL REPORT FORMAT
DESTINATION
1.Competent Authority Address
2. Reporting firm name:
a) 0 Manufacturer
0 Authorized representative within EEA
b) Address
c) Contact person name
d) Telephone number ____________________________________
e) Telefax number ____________________________________
f) Report date ____________________________________
3. Manufacturer name .
_________________________________________________
Medical device commercial name ____________________________________
Kind of device (eg. pacemaker, diathermy machine, ...)
____________________________________________________________
Model or catalogue number ____________________________________
Serial number(s) or lot number(s)
Accessories/associated devices (if applicable)
Software version (if applicable)
Identification number of Notified Body involved in conformity assessment (if applicable)
____________________________________________________________________
Reporting firm is aware of other similar incidents having an impact on the current
report __Y/N
If yes, the countries to which these have been reported, and the report reference
numbers are
listed below
Incident reported by (user or other source)
This device has been distributed within the following EEA countries:
Date of initial report______________________________________________:
Result and conclusion of manufacturers investigation:
Further investigation (if any)
Corrective action (if any)
Projected timing
Submission of this report does not, in itself, represent a conclusion by the
manufacturer anulor authorised representative or the competent authority that the content
of this report is complete or accurate, that the device(s) listed tailed in any manner
and/or that the device(s) caused or contributed to the alleged death or deterioration in
the state of the health of any person.
APPENDIX 5
EXAMPLES OF
INCIDENTS WHICH THE MANUFACTURER
SHOULD (OR SHOULD NOT) REPORT
The following examples are for illustrative purposes only, and are for the guidance of
the manufacturer in determining wh4ther a report should be made to a Competent Authority.
The examples are intended to show that there is a considerable judgmental element
in the decision on whether to report.
1. A patient dies after the use of a defibrillator:
- where there is no indication of any problem with the defibrillator or its instructions,
then the incident should not be reported, as death is not an improbable outcome in such a
situation.
- where there is an indication of a problem with the defibrillator or its instructions,
then the incident should be reported.
2. A patient receives a burn during the use, in accordance with the manufacturer's
instructions, of surgical diathermy:
- depending on the significance of the burn1 this should normally be reported,
as such an injury is not normally expected.
3. A patient receives a burn during the use in an emergency of an external
defibrillator:
- depending on the significance of the burn, this should not normally be reported, as the
fl'.'3k of such bums may have been accepted in view of potential patient benefit.
4. An infusion pump stops due to a malfunction, but gives an appropriate alarm
- this should not be reported, as it is a single fault condition, for which the
manufacturer has made provision.
5. 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 a "near incident": in a different situation it
could have caused an injury.
6 An infusion pump delivers the wrong dose because of an incompatibility between the
pump and the infusion set used:
- If the combination of pump and set used was in accordance with the instructions for use
for either pump or set, then the incident should be reported;
- If the combination was used against the instructions for use for both pump and set, then
the incident should not be reported.
7. An aortic balloon catheter leaked because of inappropriate handling of the device
in use. causing a situation which was potentially dangerous to the patient.
- If the inappropriate handling was in any way due to inadequacies in the
labelling, then the incident should be reported as a "near incident".
- If the labelling clearly indicated that such handling was inappropriate, then the
incident need not be reported.
8. A catheter fractured during insertion, with no suggestion of inappropriate
handling. The fracture occurred in such a position that the broken part could easily be
withdrawn. However, this was clearly a fortunate circumstance as if the catheter had
fractured in a slightly different position then surgical intervention would have been
necessary to retrieve the broken end.
- This should be reported as a 'near incident.
9. Glass particles are found in a contact lens vial
- This should be reported as a near incident.
10 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 recall of this batch should be reported.
APPENDIX 7
EXTRACTS FROM DIRECTIVES
RELATING TO "MEDICAL DEVICES VIGILANCE
1. Council Directive 90/385/EEC of 20 June 1990
on the approximation of the laws of the Member States relative to active
implantable medical devices
A. Article 8
- Member States shall take the necessary steps to ensure that information brought to their
knowledge regarding the incidents mentioned below involving a device is recorded and
evaluated n a centralized manner:
a) any deterioration in the characteristics and performances of a device, as well as
any inaccuracies in the instruction leaflet which might lead to or might have led to the
death of a patient or to a deterioration in his state of health;
b) any technical or medical reason resulting in withdrawal of a device from the market
by the manufacturer.
Member States shall, without prejudice to Article 71 forthwith inform the Commission
and the other MemberStates of the incidents referred to in paragraph 1 and of the relevant
measures taken or contemplated.
- Annexes 2.4,5
Extracts
an undertaking by the manufacturer to institute and keep up-dated a post-marketing
surveillance system. The undertaking shall include an obligation for the
manufacturer to notify the competent authorities of the forlowing incidents immediately on
learning of them
i) any deterioration in the characteristics or performances, and any inaccuracies in
the instruction leaflet for a device which might lead to or have led to the death of a
patient or a deterioration in his state of health;
ii) any technical or medical reason resulting in withdrawal of a device front the
market by the manufacturer.
2. Council Directives 93/42/EEC of 14 June 1993 concerning
medical devices
A. Article 10 Information on incidents occurring following placing of devices on the
market
1. Member States shah take the necessary steps to ensure that any information
brought to their knowledge in accordance with the provisions of this Directive,
regarding the incidents mentioned below involving a Class I, Ca ll or Ill device is
recorded and evaluated centrally:
a) any malfunction or deterioration in the characteristics and/or performance c}f a
device, as well as any inadequacy in the labelling or the instructions for use which might
li3ad to or might have led to the death of a patient or user or to a serious deterioration
in his state of health:
b) any technical or medical reason in relation to the characteristics or performance of
a device for the reasons referred to in subparagraph (a), leading to systematic recall of
devices of the same type by the manufacturer.
2. Where a Member State requires medical practitioners or the medical
institutions to inform the competent authorities of any incidents referred to in
paragraph 11it shall take the necessary steps to ensure that the manufacturer
of the device concerned or his authorized representative established in the
Community, is also informed of the incident.
3. After carrying out an assessment, if possible together with the manufacturer, Member
States shall, without prejudice to Article 8, immediately inform the Commission and
the other Member States of the incidents referred to in paragraph 1 for which relevant
measures have been taken or are contemplated.
- Annexes 2.4 and 5
Extracts
- an undertaking by the manufacturer to institute and keep up to date a
systematic procedure to review experience gained from devices in the post-production phase
and to implement appropriate means to apply any necessary corrective action. This
undertaking must inclu~ie an obligation for the manufacturer to notify the competent
authorities of the following incidents immediately on learning of them
i) any malfunction or deterioration in the characteristics and/or
performance of a device, as well as any inadequacy in the instructions for use which might
lead to or might have led to the death of a patient or user or a serious deterioration in
his state of health;
ii) any technical or medical reason connected with the characteristics or perf~,rmance
of a device leading for the reasons referred to in subparagraph (i) to systematic recall
of devices of the same by the manufacturer.
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