Medical Device Reporting By Industry A Saudi Food & Drug Authority Program

2. Medical Device Reporting By Industry A Saudi Food & Drug Authority Program

3. Pioneering Experienced Independent Medical Device Reporting by Industry January 2008 Joel J. Nobel, MD. Founder & President Emeritus Evidence-based 3 3

4. Reporting Medical Device Problems • Why? • Who? • When? • How?

5. Why Report Medical Device Problems? • It is a regulatory requirement of the Saudi Government & a worldwide trend • Health professionals, hospitals and industry all have a moral and ethical obligation to minimize harm to patients, • Reporting medical device failures and related adverse effects helps identify and prevent similar events in the future • Reporting allows analysis of cause and focused corrective action by manufacturers

6. Why Report Medical Device Problems? • Health professionals, hospitals & industry need to minimize the risk of lawsuits by patients and families and loss of reputation caused by injuries and deaths caused by medical devices • Saudi suppliers and manufacturers need organized feedback to improve their judgment about products, processes, components and materials so they can deliver safer and higher quality products to hospitals and device users

7. What Types of Adverse Events Are Caused by Medical Devices? • Injuries to patients and hospital personnel • Deaths of patients and hospital personnel • Environmental damage • Lawsuits by patients or their families • New expenses for repair or retraining • Abandonment of a product and loss of the investment

8. Device failure Device interaction User error Maintenance error Packaging error Tampering Support system failure Environmental factor Idiosyncratic patient reaction The Causes of Medical-Device-Related Incidents

9. Typical Causes of Device Failure • Design/labeling error • Manufacturing error • Software deficiency • Random component failure • Power-supply failure • Failure of accessory

10. Overdose Suffocation/barotrauma Infection Embolism (gas/particulate) Skin lesion (puncture/cut/burn Electrocution Fire Performance failure Crushing Exsanguination Mechanisms of Device Related Injury & Death

11. Anesthesia machines Cardiac interventional catheters Cardiopulmonary bypass systems Defibrillators Dialysis systems Electrosurgical (surgical diathermy) units Disposable surgical trocars IV pumps Surgical staplers Ventilators Most Frequently Reported Harmful Devices

12. Educate Your Staff Have them: • Explore www.mdsr.ecri.org • Read case histories of deaths and injuries caused by devices used in different specialties and why they occurred • Download and publicize safety posters for specific devices

13. Who Should Report? • An authorized representative of your company who consistently keeps track of recalls and problem reports for the products you manufacture and/or distribute in KSA

14. When? • As quickly as possible

15. Hospitals are being instructed to:Protect the Patient & Staff, But Preserve the Evidence! • The first priority is to prevent further harm to patient or staff • The next highest priority is to protect the physical environment e.g. from fire • The last critical priority is to preserve the evidence so cause can be determined

16. Preserve the Evidence for Analysis • Do not move equipment, or accessories unless needed to project patient or staff from harm • Treat the location of the event as if it were a crime scene • Do not changes control settings on any equipment • Do not detach or dispose of any accessories or consumables or single use products such as cables, catheters, electrodes. tubes, humidifiers, etc. Their presence, juxtaposition and connections may prove critical in understanding the event • Make sketches or take photographs as appropriate • Document who was there, who did what, what happened. etc.

17. Hospitals are instructed on:Things Not To Do • Never, ever send or release implicated devices to suppliers or manufacturers until the analysis is complete and cause is determined. Once the device is out of your control it can be altered or be lost • Do not assume that suppliers are on your side. If investigation requires the help of the supplier be sure it is done in the hospital with your risk manager, biomedical engineer and involved health professionals and, if you wish, a representative of the SFDA present • Do not assume, once you have completed your investigation, that nothing else need be done. If litigation is possible lock the device and its accessories in an area with controlled access and preserve it and related documentation and photographs as if it will undergo additional analysis and be introduced as evidence in court

18. Protecting Your Company • If you manufacture or modify products in KSA continue to give high priority to the quality and safety of your products and good design and manufacturing practices • If you source medical devices from foreign manufacturers review your procurement and contract documents and require that you be quickly notified of recalls and problems reported to any medical device regulatory in the world so you can comply with your legal obligation to the Saudi FDA • SFDA and KSA hospitals have access to such data as soon as it is released • Don’t fall behind your customers!

19. Protecting Your Company • Require that foreign manufacturers or suppliers certify that the products they sell you have been not recalled in any nation and are not the subject of current investigation by a medical device regulatory authority • Improve your training programs for your customers since many adverse effects on patients are caused by user error • Cooperate with hospitals where accidents have occurred as they request your help to determine the cause of the problem

20. Protecting Your Company • Before purchasing products check ECRI’s Health Devices Alerts database, MAUDE database, and Healthcare Product Comparison System so you understand the product at least as well as your increasingly knowledgeable customer • Train your sales and technical personnel to appreciate product safety issues and how to access and evaluate information • Be sure your staff understands the role of the SFDA and your company obligations under the law

21. Investigation of Accidents • The ideal accident investigation effort is a collaborative one involving the hospital biomedical engineer and risk manager, associated health professionals, a specialist in accident investigations (SFDA, ECRI or other), the manufacturer and related insurance companies and legal representatives. • Carefully document investigations and findings • Search ECRI’s HAD database and MAUDE database for similar events • Share this information with foreign manufacturers

22. How? • We will now demonstrate how to report events and recalls to the Saudi Food & Drug Authority

23. Thank You