• What is the NCMDR?
• What are the goals of NCMDR?
• What is the important of NCMDR?
• What is an adverse event?
• What should be reported?
• What is a recall?
• Who should make a recall?
• How can I report an adverse event?
• How can an establishment make a recall?
• Is it safe to report (Confidentiality)?
• What is a medical device?
• What is the in vitro diagnostic device (IVDD)?
• What is medical devices accessories?

National Center for Medical Device Reporting (NCMDR) is an organization managing a database of information on safety and performance related aspects of medical devices and capable of taking appropriate action on any confirmed problems.

Establishment of NCMDR was in order to achieve following goals to:

• Improve protection of the health and safety of patients, users and others.
• Disseminate relevant device related information which may reduce the likelihood of, or prevent repetition of adverse events, or alleviate consequences of such repetition.
• Execute a key aspect of the SFDA's post-market activities.
• Encourage collaboration between manufacturers and health care facilities to identify and investigate adverse events associated with medical devices and take appropriate action.
• Encourage the reporting of adverse events by medical device institutions and users, manufacturers, authorized representatives and organizations involved in supplying medical devices to the KSA.
• Provide a database of information on the safety and performance of medical devices that is suitable for the exchange of adverse events information with other Regulatory Authorities.

As part of its public mandate to protect patients and health professionals, Saudi Food and Drug Authority (SFDA) maintains an online medical devices reporting system. 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 or misuse of a medical device
• Medical devices fail and harm the environment
• Significant medical devices failures occur and are likely to recur and harm people or the surroundings.

It is the report of any event that leads or might lead to undesired or unexpected issues regarding safety of patients, users, janitors 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

A recall is an action taken to address a problem with a medical device that violates SFDA law. 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.

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.

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

SFDA classifies medical device recalls into three categories, representing the potential risk to public health:

• Class I High risk
• Class II Medium risk
• Class III Low risk

In most cases, a establishment (manufacturer, authorized representative, importer and distributor, or other responsible party) recalls a medical device on its own (voluntarily). When a establishment learns that it has a product that violates SFDA law, it

• Recalls the device(through correction or removal from service); and
• Notifies SFDA.

Legally, SFDA can require a establishment to recall a device. This could happen if a establishment refuses to recall a device that is associated with significant health problems or death.

When an establishment recalls a medical device, it

• Contacts directly the customers who received the product from them, and takes steps to 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.
• Takes action to prevent the problem from happening again.

Device reporting can be entered by healthcare providers, manufacturers, authorized representative, distributors and public. To enter a new device report by either healthcare providers or manufacturers, authorized representative, distributors and public first you must click on the "Click here to Report" at home page to transfer you to new page. If you are healthcare provider go to the first paragraph to report medical device adverse event and also the Manufacturers, authorized representatives, importers and distributors are not required to log in prior to submitting Adverse Events Reports. However, logging in prior to entering a Report ensures that your identifying information is automatically entered. (e.g., e-mail address, name, organization). But if you logged in, manufacturers, authorized representatives and distributors can click on the Device report tab on the top menu bar. The device report entry page is divided into two sections. The first section contains your personal information which is pre-populated with information in your profile. You can make any changes you may wish. All fields marked with a red asterisks (*) are required.

The Device Information section (Figure 1) provides NCMDR information about the device that is involved in the adverse event. All fields should be entered as completely as possible. All fields marked with a red asterisks (*) are required

Figure 1: Device Information

Please use the text box (Figure 2) to describe the hazard or adverse event in detail. Include how it was discovered, any action you took, and the response of any manufacturers , authorized representative and distributors. Please also mail or fax any related correspondence when possible. Sketches, photographs, or copies of portions of operating manuals are often helpful in describing the Adverse Event, especially if the affected device is not available for examination at SFDA. Retain all disposable accessories involved in an incident. Please do not send any devices to SFDA until requested. All fields marked with a red asterisks (*) are required.

Figure 2: Adverse Event Description

After all three sections of the adverse event report have been completed, The item will enter into the system for investigation as well as an E-mail will be automatically sent to the reporter with the Confirmation Code and a link to access the adverse event report. The Confirmation Code allows users to access previously entered Adverse events report (Figure 3). When accessing previously entered Adverse events reports, additional information can be appended to the original description. These information do not alter information entered initially. NCMDR staff may modify the original text to conform with industry standard nomenclature.

Figure 3: viewing Pre-entered Problem Report

All medical-devices manufacturers , authorized representative, importer and distributors must first register (Figure 4) in order to enter Devices Recalls. After registering, the SFDA Administrator reviews the information and activates the account. Then, a manufacturer , authorized representative, importer and distributors is able to log into the account.

Figure 4: Registration Form

All manufacturers , authorized representative,importer and distributors must log in to view existing Devices Recalls or enter new Devices Recalls (Figure 5). Manufacturers , authorized representative and distributors are not required to log in prior to submitting Problem Reports. However, logging in prior to entering a Report ensures that your identifying information is automatically entered. (e.g., e-mail address, name, organization)

Figure 5: Logging In

SFDA will share all submitted information whether 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.

Medical device: means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
• investigation, replacement, modification, or support of the anatomy or of a physiological process,
• supporting or sustaining life,
• control of conception,
• disinfection of medical devices,
• providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.

In-vitro medical device: means a medical device, whether used alone or in combination, intended by the manufacturer for the in-vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles.

Accessory: means a product intended specifically by its manufacturer to be used together with a medical device to enable that medical device to achieve its intended purpose.