Overview of Medical Devices Problem Reporting Center

1. Overview of Medical Devices Problem Reporting Center

2. A royal decree was issued on Feb.13, 2007assigned the responsibility for regulating medical devices, in vitro diagnostic devices, prescription eye glasses, contact lenses and their solutions to the Saudi Food and Drug Authority (SFDA) A council of ministers decision was issued on June 18, 2007 gives the SFDA full authority to issue guidance that include rules and procedures of registering medical devices establishments and their products The Law of Saudi Food and Drug Authority

3. The MDPRC project is carried out in cooperation with the Emergency Care and Research Institute (ECRI) in America. The main objectives are:- To launch a fully functional web-based MDPRC to collect reports and recalls. - Assisting the MDS in the implementation of the system. - Training MDS personnel on reporting and accident investigation.

4. Goals of MDPRC 1 • To keep safety on track with the emerging medical devices market • To maintain a sharing information policy with other organization according to Global Harmonization Task Force (GHTF) mission • To reduce likeliness of occurrence of adverse incidents • To prevent likeliness of occurrence of previous adverse incidents.

5. Goals of MDPRC 2 • Increasing the overall healthcare proficiency for patients • To protect users and patients from undesired results of faulty devices. • To maintain a blame-free relation with manufacturers, suppliers and hospitals in order to increase communication efficiency and certainty of accidents.

6. Importance of MDPRCThe As part of its public mandate to protect patients and health professionals, the SFDA maintains an online MDPRC. The purpose of the system is to identify events in which: • A patient, staff member, or visitor may have suffered harm as a result of failure of a medical device

7. Importance of MDPRCThe • Medical devices fail and harm the environment • Significant medical devices failures occur and are likely to recur and harm people or the surroundings.

8. Recalls A recall is an action taken to address a problem with a medical device that violates SFDA regulation. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health

9. Recalls • A medical device recall doesn’t always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.

10. Recalls Examples of the types of actions that may be considered recalls: • Inspecting the device for problems • Repairing the device • Calibrating and adjusting settings on the device • Re-labeling the device • Destroying device • Notifying patients of a problem Medical Device recalls classified according to thepotential risk to public health.

11. Who makes the recall? In most cases, a company (manufacturer, distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a company learns that it has a product that violates SFDA regulation, it • recalls the device (through correction or removal); and • notifies SFDA. • Legally, SFDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death.

12. Who makes the recall? When a company recalls a medical device, it • Contacts directly the customers who received the product from them. • Reach others who need to be notified (for example, by issuing press releases). • supplies information to help users identify the product and take steps to minimize health consequences; and takes action to prevent the problem from happening again.

13. What is a problem report? It is the report of any event that lead or might lead to undesired or unexpected issues regarding safety of patients, users or any other person. This may include the following: • Problems with the design of the device • Untrained or unaware staff • Carelessness in use • Uninstructed modifications • Inadequate maintenance • Inappropriate conditions: storage, temperature and use

14. What should be reported? All adverse incidents, safety or quality issues regarding medical devices that caused or might cause one or all of the following: Death Serious injury Need for hospitalization, surgical or medical intervention Uncertainty of results

15. Medical devices problem reporting forms MDPR form for Healthcare Providers • MDPR can be entered by healthcare providers through http://mdprc.sfda.gov.sa Personal Info., Device Info. and Problem Desc. • The item will enter into the system for investigation. • an E-mail will be automatically sent to the reporter with the Confirmation Code and a link to access the Problem Report.

16. Medical devices problem reporting forms When accessing previously entered Problem Reports, additional information can be appended to the original description. These information do not alter information entered initially. SFDA personal may modify the original text to conform with industry standard nomenclature.

18. Medical devices problem reporting forms MDPR form for Manufacturers and Suppliers • All medical devices manufacturers and suppliers must first register http://mdprc.sfda.gov.sain order to enter Devices Recalls. • After registering, the SFDA Administrator reviews the information and activates the account. Then, a manufacturer or supplier is able to log into the account.

20. SecurityandConfidentiality of Data SFDA will share all submitted information wither recalls or reports with ECRI and other global authorities, and SFDA will ensure to hide the identity of the person who submitted the information and will not share personal data with any other parties. All personal data will be used within SFDA only.

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