Transcript When to report

Incident Reports and field Safety
Corrective Action ( FSCA)
Eng. Essam M. Al-Mohandis
Executive Director of Surveillance and Biometrics
Medical Devices Life Cycle
Conception
and Design
Manufacture
Pre-market
Packaging
Labelling
Advertising
On-market
Sale
Use
Disposal
Post-market
Postmarket Surveillance
• Collection of information on the quality, safety and
performance of medical devices;
• Assessment / Evaluation;
• Investigation; and
• Reaction to data on medical devices performance after
placed on the market.
Postmarket Surveillance
Inputs
1. Healthcare facilities & public complains .
2. Int’l and local establishments
(Manufacturers/AR , Distributors ) .
3. Other int’l regulatory authorities .
4. NCMDR membership ( NCAR / SADS)
What should
be Reported?
Any malfunction or deterioration in the
characteristics and/or performance of a medical
device, as well as any inadequacy in the labeling
or the instructions for use, which has led, or
might have led, to the death of a patient, user or
third person, or to a serious deterioration in the
state of health of a patient, user or third person.
W
When to
report ?
• Adverse events that result in unanticipated
death or unanticipated serious injury or
represent a serious public health threat must
be reported immediately by the manufacturer,
authorized representative, importer or
distributor.
• All other reportable events must be reported
as soon as possible by the manufacturer,
authorized representative, importer or
distributor following the date of awareness of
the event (according to GHTF jurisdiction
issuing market authorization) .
W
Medical devices subjected to Field safety notice
distributed in KSA market, the establishment shall:
•
Maintain traceability system for surveillance purposes.
•
Report to SFDA any FSN/ adverse event might become aware of its occurrence
online, through the following link: (http://ncmdr.sfda.gov.sa) .
•
Provide list of:
- related customer/s planned to notified (hospitals, clinics, public…etc ) and
- affected medical devices placed on KSA market as well as placed in services.
•
Submit a planed action for reviewing & approval by SFDA-NCMDR.
Medical devices subjected to Field safety notice
distributed in KSA market, the establishment shall:
Cont…
•
Submit determinant date for implementing agreed on action plan & closing the FSN.
•
Any related communication to FSN with concerned customer/s shall approved by
SFDA before send out.
•
Periodic submission of progress report concerning the FSN approved action.
•
Effectiveness checks reports , showing action plan implemented and FSN’s closure .
•
Determine depth of the FSN’s (The FSN’s may affect other party/ies in the supply
chain e.g. Lay person, retail and the wholesale.etc)
MDS - IR7
Surveillance & Biometrics
Executive Department
Statistics
No. Of FSCA from 2008 to (22/11/2011) by source:
Source
2008
2009
2010
2011
ECRI
FDA
MHRA
NCAR
NCMDR
BfArM
7
1080
0
59
8
0
492
1195
149
70
52
0
653
515
479
61
164
0
375
1184
413
73
103
11
Total
1154
1958
1872
2159
Total
1527
3974
1041
263
327
11
7143
Percentage
%21.4
%55.6
%14.6
%3.7
%4.6
%0.2
%100.0
No. Of recalls by source:
2008
1080
492 653
375
2010
2011
1195 1184
515
7
0
ECRI
2009
FDA
479 413
149
MHRA
59 70 61 73
NCAR
8 52
164
NCMDR
103
0 0 0 11
BfArM
No. Of Adverse event from 2008 to (22/11/2011) by years:
Source
2008
2009
2010
2011
Total
NCMDR
2
7
12
524
545
No. Of Adverse event
No. Of Adverse event from 2008 to (22/11/2011) by years:
524
2
7
12
*2008
*2009
*2010
*2011
• Total FSCA where corrective actions implemented & closed are equal to
4083 which %57 of the total .
• Total FSCA and adverse events reflect unrecognized distributors are
equal to 1541 which 21.6% of the total .
• Total FSCA and adverse events that transferred to compliance &
enforcement are equal to 112 which 0.1% of the total ( up to date) .
SBED is communicating with
Total number of SBED-Officers representing
healthcare facilities and health regional agencies
representatives
Total number of SBED-Officers for
Establishments within KSA
221 healthcare facilities
18 Directorates health affairs
261
Biomedical
Engineers
Nurses
236
25
297
Accessing the National Center
for Medical Devices Reporting
SFDA
How to access NCMDR?
Step1. Go to www.sfda.gov.sa/En/Home/
Step2. Click on Medical Devices icon
Step3. Click on MDES icon
How to access NCMDR?...cont
• Step 4. Click on NCMDR icon
Challenges / areas of
improvement
1.
Limited No. of establishments that report reportable adverse
events to SFDA through NCMDR .
2.
Limited No. of registered establishments officers in the
NCMDR
( Total number of the registered officers in the system 297 while
registered establishments in the MDNR are 1200 ?? ) .
3. Slowness in response from the establishments on their medical
devices subjected to FSN they marketed in KSA .
Challenges / areas of
improvement …Cont.
5.
Inaccurate information in official letters issued by
establishments on their planned corrective action .
4.
Non-complying with SFDA requirements during follow up
communication with the establishments .
Thank You
[email protected]