By Mr. Bader E. ALoufi, Head, Post-Market Clinical Evaluation, Medical Devices Sector, Saudi Food and Drug Authority (SFDA), delivered at the Global Forum 2020 Medical Devices and Safety session.

1. GLOBAL FORUM2020
3 R D
S A V I N G L I V E S S U S T A I N A B L Y:
SUSTAINABLE PRODUCTION IN THE HEALTH
SECTOR GLOBAL FORUM | 2020 RIYADH
Post Market
Surveillance
Activities to Ensure
the Safe Use of
Medical Devices
Presented by: Bader Aloufi
Saudi Food and Drug Authority

2. Agenda
Background
Pre-market Activities
Post-market Reactive Activities
Post-market Proactive Activities
Efforts during COVID-19 pandemic
GLOBAL FORUM 2020

3. Background: Medical Devices
Lifecycle
Conception
and Design
Manufacturing
Packaging
Labelling
Marketing
Authorization
Advertising Sale Use Disposal
Pre-market On-market Post-market

4. Pre-Market Activities

5. Post-Market Activities
Reactive Activities
 To resolve existing risks
Proactive Activities
 To avoid potential risks

6. Reactive Activities
Model of Work
Incidents NCMDR
 Public
 Healthcare Providers
 Manufacturers/ARs
Investigation
Field Safety
Corrective
Actions

7. Reactive Activities
Statistics
Incidents Reports Field Safety Corrective Action
2020 34,586 5,616
Total accumulative data 59,634 63,761
*Including the gathered cases
Communication
Direct communication with
manufacturers or their ARs
Direct communication with ≈1000 SFDA
officers at hospitals
Further communication through:
 Weekly reports: To highlight the gathered international and local Field Safety Corrective Actions
 Safety communications: To describe the SFDA's current analysis of an issue and contain specific regulatory
approaches and clinical recommendations for patient management. (200 published SC so far)

8. Proactive Activities
Model of Work
Safety
Signals
Risk
Analysis
Post-Market
Evaluation
 Whenever the benefit-risk ratio is altered
 Accumulation of reports at the NCMDR
 Risks identified by other sources
Analyze risks considering the
manufacturer documentations
Analyze risks considering other
reliable sources

9. Proactive Activities
Model of Work
Post-MarketEvaluationMethodology
Clinical Paper Review - Conduct a systematic review on the
topic to generate an evidence
Clinical Experience Review
- Review the NCMDR report
- Review the position of other regulators
Saudi Users Experience
- Consult related Saudi society
- Consult experts in the field

10. Proactive Activities
Statistics
Risk Analysis Reports (2019-2020)
Examples
Analysis of risks associated with dental amalgam filling
Analysis of risks associated with of contact lenses
Analysis of risks associated with laparoscopic power morcellations
Analysis of risks associated with spinal implant systems
Post-Market Evaluation Studies (2019-2020)
Examples
Post-market evaluation for the safety of textured breast implant
Post-market evaluation for the safety of transvaginal mesh
Post-market evaluation for the safety of paclitaxel eluting stents
Post-market evaluation for the safety of peritoneal dialysis
Integration with Experts and Specialized Societies:
 To get inputs during the evaluation process of medical devices
 During 2020: 180 Saudi expert, and 6 specialized medical societies

11. Proactive Activities
Safe-use of Medical Devices at
Saudi Healthcare facilities
A guideline
Development
Evaluating Saudi
Healthcare facilities
- Correct observations
- Produce a databank
To clarify the SFDA requirements for
the safe-use of medical devices
considering the best practices
To ensure following Saudi healthcare
facilities to the SFDA requirements
for the safe-use of medical devices
- To avoid risks resulting from
misuse of medical devices
- To acquire data that reflect the
current practices

12. Proactive Activities
Safe-use of Medical Devices at Saudi
Healthcare facilities: Statistics
In 2019
50 sites
In 2020
200 sites
…
By 2022
450 sites
The evaluation requirements contains 69 elements, which cover:
o Procedures related to medical devices
o Qualifications of BME staff
o Availability of calibration tools
o Management maintenance system
o Practices related to selected high risk devices

13. Efforts During COVID-19 Pandemic
Conduct research in related topics to
ensure the safe-use of medical devices
- Issues to be Encountered to Avoid the Transmission of COVID-
19 through Medical Devices
- An Evaluation for the Reliability of Antibodies Lateral
Flow Rapid Diagnostic Tests for the Qualitative Detection
of COVID-19
Effective communication with
public and healthcare providers
- Safety communication publications (54 in 2020)
- Workshops and Webinars (14 events)
Increase Awareness regarding the
best practices in utilizing PPE
- Practices When Using Masks and Gowns during
the (COVID-19) Outbreak
- Recommendations of Non-contact Infrared
Thermometers during (COVID-19)
Working closely with healthcare providers
for issues of high demand devices
- Resolve issue relate to IVDs Unauthorized Test Kits for
Diagnose (COVID-19)
- Working with related parties to ensure a proper supply of
high demand devices without altering the patient safety.

14. GLOBAL FORUM2020
THANK YOU