Proizvodnja prvog bh. respiratora moguća sredinom godine, čekaju se neophodni certifikati
Proizvodnja prvog bh. respiratora u Gradačcu mogla bi početi sredinom ove godine, nakon što se izvrši kliničko ispitivanje uređaja koje je planirano u Univerzitetskom kliničkom centru u Tuzli, potvrđeno je za Klix.ba.
Prije godinu je tim stručnjaka kompanije TMD Group iz Gradačca, uz potporu medicinskih profesionalaca iz Univerzitetskog kliničkog centra u Tuzli, izradio prototip prvog bh. respiratora.
Podsjetimo, iza osnivanja TMD Groupe stoji i premijer Federacije BiH Fadil Novalić. Iako se njegovo ime trenutno ne nalazi u registru osnivača ove kompanije, Novalić je povezan sa osnivanjem ove kompanije i to prema vlastitom priznanju još u aprilu prošle godine.
Nekoliko mjeseci kasnije, tačnije koncem prošle godine, uređaj za vještačko disanje teško oboljelih pacijenata dobio je certifikat Centra za testiranje i evaluaciju medicinskih uređaja (MD-TEC) u Velikoj Britaniji, koji potvrđuje da respirator postiže visok nivo funkcionalnost u intenzivnoj njezi.
Ispitivanja u UKC-u Tuzla
Time su otvorena vrata za njegov daljnji razvoj, uz kliničko ispitivanje i certificiranje komponenti. Kako saznaje Klix.ba, procedura ispitivanja funkcionalnosti uređaja će biti obavljena u Univerzitetskom kliničkom centru u Tuzli, a pored domaćih stručnjaka u tome će učestvovati i profesionalci iz Velike Britanije.
“Univerzitetski klinički centar u Tuzli s našom kompanijom je već potpisao ugovor, a to će sada uslijediti i s britanskim kliničkim centrom. Cjelokupan proces će biti obavljen u Bosni i Hercegovini i mi očekujemo da će on biti završen do ljeta ove godine”, kazao je za Klix.ba direktor TMD Groupa Adem Hanić.
U toku proces certifikacije kompanije
Za potrebe proizvodnje prvog bh. respiratora kompanija TMD Group ranije je osnovala i firmu “TMD Medical Components and Devices” i trenutno je u toku proces njene certifikacije.
“Mi smo angažovali konsultantsku kompaniju koja u saradnji s ovlaštenim evropskim centrima trenutno radi na procesu certifikacije. Nadamo se da će i to sve biti završeno do ljeta, nakon čega bismo krenuli u proizvodnju respiratora. Nažalost, kod nas sve procedure idu izuzetno sporo, pa tako i ove naše o kojima govorimo”, dodao je Hanić.
Ideja za nastanak prvog visokosofisticiranog uređaja u Bosni i Hercegovini rodila se početkom pandemije koronavirusa, koja je izazvala veliku potražnju za respiratorima na svjetskom tržištu.
Prototip uređaja za vještačko disanje u Gradačcu je kreiran na osnovu jednog od respiratora, u vlasništvu Univerzitetskog kliničkog centra u Tuzli, a nedugo nakon toga je i redizajniran te upućen u Veliku Britaniju na testiranje.
U svom finalnom obliku bh. respiratori bit će namijenjeni za evropsko i svjetsko tržište, a gradačačka kompanija će se baviti i razvojem te proizvodnjom drugih medicinskih uređaja i opreme, poput oksigenatora, elektromehaničkih kreveta, hirurških noževa, određenih pomagala i slično. Na ovakav način u Bosni i Hercegovini će zaživjeti nova grana industrije koja dosad nije bila zastupljena.
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