Medical Vigilance

Medical Vigilance
 
There are various directives on medical devices published by the European Commission (EC) and harmonized with the laws enacted in our country. Although the scope of these directives is different from each other, there are some points. One of them is the medical vigilance system or the more commonly known name of the Medical Device Alert System in our country. The purpose of the system is to reduce the likelihood of reoccurrence of incidents related to medical device use; protect the health and safety of patients, healthcare professionals and other users.
 

EU directives regarding this system, communiqués and guidance documents referenced in our country are as follows:

• Regulation on Active Implantable Medical Devices (90/385/EEC) – Article 15
• Medical Devices Regulation (93/42/EEC) – Article 17
• Regulation on Medical Diagnostic Devices Used In Vitro (98/79/EC) – Article 14
• Communiqué on the Procedures and Principles Regarding the Medical Device Warning System (published in the Official Gazette No. 27641, issued on 14/07/2010).
• Medical Devices (MEDDEV) Vigilance System Guide Document (January 2013/2.12-1 Rev8)
 

The most important and to be studied concepts in the Medical Device Alert System are:

• Field safety corrective actions (FSCA): An action associated with the use of a medical device currently on the market and taken to reduce the risk of death or serious deterioration in health. The manufacturer must establish FSCAs as part of the Medical Device Alert System.
• Field safety notice (FSN): A message sent by a manufacturer or manufacturer´s representative to customers or users regarding FSCAs.
• Usage errors
o Any malfunction or deterioration in the features and/or performance of a device.
o Applications that directly or indirectly cause or may lead to the death of a patient or user
o Inaccuracies in labeling or usage instructions
o Any action arising from medical devices that will cause deterioration of the health status of individuals
• Improper use: Acts or omissions resulting from behavior performed by the operator or user of the medical device outside of any risk control method determined by the manufacturer.
 

The MEDDEV guide document, which is accepted as valid in the sector regarding the Medical Device Alert System, and the communiqué published in our country, explain the roles of all stakeholders. In this context,

• producers
• national authorities
• European Commission (EC)
• notified bodies
• users

It has a duty and responsibility for the implementation of the Medical Device Warning System.


Medical Device Alert System For Manufacturers


Medical device manufacturers have many legal responsibilities regarding the products they produce. One of them is to use this warning system actively and effectively. The duties and responsibilities that the system imposes on manufacturers are as follows:

• A manufacturer or his authorized representative should inform the relevant national competent authority of faults and site safety corrective actions when reporting criteria are met.
• Responsible for investigating incidents and taking necessary corrective action.
• The manufacturer must ensure that the principles of the Medical Device Alert System are known by authorized representatives, persons responsible for product supply to the market and other authorized agents. The manufacturer should also inform about events and reports. In this way, he encounters fewer problems in fulfilling his responsibilities.
• If two or more medical devices made by different manufacturers are used together in a procurement process, each manufacturer must submit a report to the relevant national competent authority.
• Manufacturers must inform the notified body about post-production problems that affect certification.
 

As can be seen, the Medical Device Alert System defines many tasks for manufacturers. For this reason, it is beneficial to get support from a company that has expertise in this field in the process of integration into the system, in the realization of the follow-up and analysis steps. In this context, it is often inevitable to get professional help for the training of the people responsible for the system, the execution of projects through the system, and the awareness of other organizations in the sector. For this, you can contact Aşan Danışmanlık and start using the Medical Device Alert System actively and effectively.

Aşan Consulting carries out activities such as risk analysis, situation assessment, corrective actions, management of notifications from the field, etc., within the scope of Medical Device Alert System studies. It provides support to companies in order to read the directives related to medical devices correctly and to plan the studies in accordance with these regulations, laws and standards. You can also send your support requests in this regard by almost passing through Aşan Danışmanlık.