The Agency for Medicines and Medical Devices of Bosnia and Herzegovina (BiH) made an announcement concerning the worrying media reports about blood sugar measuring devices that allegedly show wrong data, and which were distributed to patients in the Federation of BiH (FBiH).
“Apparatus and sensors for measuring blood sugar from different manufacturers are registered in the register of medical devices of BiH. A detailed list with more information about the medical devices in question that are registered in the Register of medical devices of BiH is available on the website of the Agency,“ they stated.
They say that, if there is a suspicion of malfunctioning or an unwanted occurrence of a medical device, participants in the system for monitoring unwanted occurrences of medical devices (patients, healthcare workers, distributors, representatives of the manufacturer and the manufacturer) are obliged to report the unwanted occurrence to the Agency by mail, fax or e-mail.
“The reporting procedure is explained in detail by the Rulebook on the monitoring of an unwanted occurrence related to medical devices (material vigilance, vigilance of medical devices). In the event of a report of an unwanted occurence of a medical device, the Agency notifies the holder of the approval and the manufacturer by letter, and requests the submission of a report on safety – corrective action,” it was announced from the Agency for Medicines and Medical Devices of BiH.
They point out that blood glucose meters and sensors are not the same medical devices and work on different principles.
E.Dz.
