Organization : Saudi Food & Drug Authority
Type of Facility : National Center For Medical Devices Reporting
Country: Saudi Arabia
Website : http://ncmdr.sfda.gov.sa/
National Center For Medical Devices Reporting :
The National Center for Medical Devices Reporting (NCMDR) is devoted to receive any adverse event reports and recalls about any medical devices from healthcare facilities as well as manufacturer all around KSA, studying them and working together with manufacturers and suppliers to take the right action and assuring the proper safe performance.
Related : Saudi Food & Drug Authority Medical Devices National Registry : www.statusin.org/10098.html
NCMDR also aims to cooperate with the other international safety alert reporting centers to exchange reports received about medical devices used anywhere.
What are the goals of NCMDR?:
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.
What is the important of NCMDR?:
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.
What is an adverse event?:
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
What should be reported?
1) An Event has Occurred
Typical events are:
** A malfunction or deterioration in the characteristics or performance.
** A malfunction or deterioration should be understood as a failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer’s instructions.
** The intended purpose means the use for which the device is intended according to the data supplied by the manufacturer on the labeling, in the instructions and/or in promotional materials.
** An inadequate design or manufacture.
** This would include cases where the design or manufacturing of a device is found deficient.
** An inaccuracy in the labeling, instructions for use and/or promotional materials. Inaccuracies include omissions and deficiencies.
** Omissions do not include the absence of information that should generally be known by the intended users.
** A significant public health concern.
** This can include an event that is of significant and unexpected nature such that it becomes alarming as a potential public health hazard, e.g. human immunodeficiency virus (HIV) or Creutzfeldt-Jacob Disease (CJD).
Use Error:
** Use Error Resulting in Death or Serious Injury/ Serious Public Health Concern
** Use error related to medical devices, which did result in death or serious injury or serious public health concern, should be reported to the SFDA.
** Use errors becoming reportable
Use errors become reportable to the SFDA when you:
** Note a change in trend (usually an increase in frequency), or a change in pattern of an issue that can potentially lead to death or serious injury or public health concern.).
** Initiates corrective action to prevent death or serious injury or serious public health concern.
2) The Event Led to One of the Following Outcomes
** Death of a Patient, User or Other Person.
** Serious Injury of a Patient, User or Other Person.
Serious injury (also known as serious deterioration in state of health) is either:
Life threatening illness or injury.
Permanent impairment of a body function or permanent damage to a body structure.
** A condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.
** The interpretation of the term “serious” is not easy, and should be made in consultation with a medical practitioner when appropriate.
** The term “permanent” means irreversible impairment or damage to a body structure or function, excluding minor impairment or damage.
** Medical intervention is not in itself a serious injury. It is the reason that motivated the medical intervention that should be used to assess the report ability of an event.
** No Death or Serious Injury Occurred but the Event Might Lead to Death or Serious Injury of a Patient, User or Other Person if the Adverse Event Recurs.
** All events do not lead to a death or serious injury. The non-occurrence of such a result might have been due to circumstances or to the timely intervention of health care personnel.
** The event is considered “adverse” if in the case of reoccurrence, it could lead to death or serious injury.
** This applies also if the examination of the device or a deficiency in the information supplied with the device, or any information associated with the device, indicates some factor which could lead to an event involving death or serious injury.
** Include relevant information that might impact the understanding or evaluation of the adverse event AND that is not included elsewhere in this report.
3) The Manufacturer’s Device is Associated with the Event:
In assessing the link between the device and the event, the manufacturer should take into account:
** The opinion, based on available information, from a healthcare professional
** Information concerning previous, similar events
** Other information held by the manufacturer
This judgment may be difficult when there are multiple devices and drugs involved. In complex situations, it should be assumed that the device was associated with the event.
What is a recall?:
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
Who should make a recall?:
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.
How can I report an adverse event?:
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.