Incident Reports and field Incident Reports and field Safety Corrective Action Safety Corrective Action

( FSCA)( FSCA)

Eng. Essam M. Al-Mohandis Executive Director of Surveillance and Biometrics

Medical Devices Life CycleMedical Devices Life Cycle

Conception and Design

Manufacture Packaging Labelling

Advertising Sale Use Disposal

Pre-market On-market Post-market

Postmarket SurveillancePostmarket 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 Postmarket Surveillance InputsInputs

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 What should be Reported? 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.

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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) .

When to When to report ?report ? W

hen

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 Surveillance & Biometrics Executive DepartmentExecutive Department

StatisticsStatistics

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%

No. Of Adverse event from 2008 to (22/11/2011) by years:

Source   2008 2009 2010 2011 Total

NCMDR 2 7 12 524 545

• 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 with221 healthcare facilities

18 Directorates health affairs

Total number of SBED-Officers representing healthcare facilities and health regional agencies

representatives

261

Biomedical Engineers

 Nurses

236 25

Total number of SBED-Officers for Establishments within KSA

297

Accessing the National Center Accessing the National Center for Medical Devices Reporting for Medical Devices Reporting

SFDASFDA

How to access NCMDR?Step1. Go to www.sfda.gov.sa/En/Home/

Step2. Click on Medical Devices icon Step3. Click on MDES icon

• Step 4. Click on NCMDR icon

How to access NCMDR?...cont

Challenges / areas of Challenges / areas of improvementimprovement

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 Challenges / areas of improvement …Cont.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 YouThank You

ncmdr-md@sfda.gov.sancmdr-md@sfda.gov.sa