Incident Reports and field Safety Corrective Action ( FSCA)

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Incident Reports and field Safety Corrective
Action ( FSCA)
Eng. Essam M. Al-Mohandis Executive
Director of Surveillance and Biometrics
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Medical Devices Life Cycle
Manufacture

• Conception and Design

Packaging Labelling
Advertising
Sale
Use
Disposal
Pre-market
Post-market
On-market
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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.

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Postmarket Surveillance Inputs

• Healthcare facilities public complains .
• 2. Intl and local establishments
  (Manufacturers/AR , Distributors ) .
• 3. Other intl regulatory authorities .
• 4. NCMDR membership ( NCAR / SADS)

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What should be Reported?
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• 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.

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When to report ?
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• 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) .

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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, publicetc ) and
• - affected medical devices placed on KSA
  market as well as placed in services.
• Submit a planed action for reviewing approval
  by SFDA-NCMDR.

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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  FSNs closure .
• Determine depth of the FSNs (The FSNs may
  affect other party/ies in the supply chain e.g.
   Lay person, retail and the wholesale.etc)

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• MDS - IR7

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• Surveillance Biometrics Executive Department
• Statistics

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No. Of FSCA from 2008 to (22/11/2011) by
source
Source  2008 2009 2010 2011 Total Percentage
ECRI 7 492 653 375 1527 21.4
FDA 1080 1195 515 1184 3974 55.6
MHRA 0 149 479 413 1041 14.6
NCAR 59 70 61 73 263 3.7
NCMDR 8 52 164 103 327 4.6
BfArM 0 0 0 11 11 0.2
Total 1154 1958 1872 2159 7143 100.0
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No. Of Adverse event from 2008 to (22/11/2011) by
years
Source  2008 2009 2010 2011 Total
NCMDR 2 7 12 524 545
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• 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) .

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SBED is communicating with 221 healthcare facilities 18 Directorates health affairs 221 healthcare facilities 18 Directorates health affairs
Total number of SBED-Officers representing healthcare facilities and health regional agencies representatives 261 261
Total number of SBED-Officers representing healthcare facilities and health regional agencies representatives Biomedical Engineers  Nurses
Total number of SBED-Officers representing healthcare facilities and health regional agencies representatives 236 25
Total number of SBED-Officers for Establishments within KSA 297 297
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Accessing the National Center for Medical Devices
Reporting SFDA
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How to access NCMDR?

• Step1. Go to www.sfda.gov.sa/En/Home/

• Step2. Click on Medical Devices icon

• Step3. Click on MDES icon

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How to access NCMDR?...cont

• Step 4. Click on NCMDR icon

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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 .

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Challenges / areas of improvement Cont.

• 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 .

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Thank You ncmdr-md_at_sfda.gov.sa