It was a priority Nr 1 to create a simple to use online solution, which is accessible from everywhere. In our vision we see all the data submission and management processes participants – manufacturers, distributors, professional users and, of course, a Competent Authority’s staff – are being equal partners.
The second but not less important task was to create a system which can provide an opportunity to trace the medical device during one’s lifecycle. It would be extremely useful in case the Estonian Competent Authority should receive any critical vigilance information connected to one or another medical device.
Using the forward-looking approach the Database was created with possibility to describe the medical device with the serial or LOT/serial number accuracy (UDI’s dynamic part), also it is possible to mark where a device is taken into use. Should the device move to another facility, it is possible to add another connection to a new owner and as a result, by using such a descriptions history, we are able to trace the medical device while it is moving from one hospital to another. Such a precise description is needed only in the place of taking into use (health care facilities), so the manufacturers and distributors do not have to provide more data than it is necessary to identify the medical devices model (UDI’s static part). In the future it will be possible to add medical device into Database by scanning an UDI code.
Even more! In the new Database it will be technically possible to link specific devices to specific patients, so we can find potentially affected patients in case we have to face yet another “PIP-MOM-whatever” problem. The patients are easily reachable and the necessary safety information will be delivered to them. Actually, we are talking here about a universal solution that will successfully fulfil the role of an implant’s registry. Thanks to (once again!) forward-looking solution there is no longer any need to develop a separate system.
An important feature of the new system is that it is possible to store user manuals for medical devices and make them searchable and visible for all the users, including the lay users. Moreover! Smaller health care providers can keep in the new Database their own data about their equipment and maintenance works. This in turn ensures the storage of data and simplifies cooperation with the Surveillance Authority.
Reporting adverse incidents has become really simple and does not take remarkably much time anymore. All the printable and fill-in forms have been eliminated from the reporting process and replaced with a filling of a few additional data fields in the section of already existing device. Data application process is simple enough, so it can be managed by any health care system employee without needing him or her to do great preliminary work.
As we all know very well, it is not possible to ensure the safety of a medical device without a close cooperation between medical device users, manufacturers and Competent Authorities. The key to the successful cooperation is getting quick and adequate feedback from the device users. In case the medical device should cause problems or even prove to be dangerous, and there is reason to believe that the problem is caused by an error that has been made during the designing or manufacturing process, then it is most likely an Adverse Incident. In such situation the professional user has to find the device model from the Database and to add a brief description of the case. Then provided data will be proceeded by Competent Authority’s responsible officer. In case the affected device is not presented in the Database, the rapporteur can add the new device into the Database by himself.
The entire exchange of information takes place within the system and the Competent Authority’s officer has the opportunity and obligation to verify all the presented data. In case the data needs to be upgraded or there is a need to deliver any information to the data provider, the Competent Authority’s officer uses the communication module in order to transmit information to the Database User. The communication module operates bilaterally and the entire information exchange is recorded within the Database linked to the particular medical device and the organisation. If necessary, it is possible to recall the dialogue and there is no need to spend time rifling through the letter archives.
And it is free!
Using of the entire system is absolutely free for all the categories of users – manufacturers, distributors and health care providers.
Just try it!
Anyone can access the training version of the Database at http://msakoolitus.sm.ee. It is just a training version, where you can feel free to play through the Database operations without damaging the real data in any way.
The actual Database is located at http://msa.sm.ee
If you have any question about Estonian Medical Devices Database, please contact us at mso|ä|terviseamet.ee
The very first idea about logic of the new Medical Devices Database was produced by the Medical Devices Department (Estonian Health Board) in the end of 2007.
The order was placed by Estonian Ministry of Social Affairs.
The used financial resource spent was nearly 150,000 € (VAT included).
The developer organisation was Piksel OÜ.
Estonian Health Board
Medical Devices Department
Põllu 1a, 50303 Tartu, Estonia
Phone: +372 744 7425