Valstybinė akreditavimo sveikatos priežiūros veiklai tarnyba prie Sveikatos apsaugos ministerijos (Akreditavimo tarnyba) nuolat tikrina medicinos priemonių atitikimą teisės aktų reikalavimams. Reaguojant į viešas abejones bei skundus dėl turniketų, kurie nuo liepos 1 d. privalomi automobilių vaistinėlėse, kokybės, Akreditavimo tarnyba savo iniciatyva suaktyvino turniketų kokybės stebėseną ir tikrinimus.
Akreditavimo tarnyba planuoja patikrinti rinkoje esančių 8-ių gamintojų turniketų kokybę. Šie patikrinimai yra dalis priežiūros veiksmų, susijusių su vaistinėlių atnaujinimu. Patikrinimai buvo atliekami ir pernai, kuomet buvo sustabdytas teisės aktų reikalavimų neatitinkančių turniketų platinimas, o gamintojams nurodyta ištaisyti neatitikimus.
Akreditavimo tarnyba taip pat kviečia gyventojus aktyviai pranešti apie reikalavimų neatitinkančias priemones el. paštu [email protected]
Akreditavimo tarnyba primena, kad siekdama patikrinti ar Lietuvos vartotojams siūlomi įsigyti turniketai atitinka taikomų teisės aktų reikalavimus, 2022 metais atliko teikiamų Lietuvos rinkai turniketų vertinimą. Patikrinimo metu įvertinta dešimties gamintojų turniketai, kurie buvo platinami Lietuvoje.
Patikrinimo metu buvo nustatyti įvairūs šių medicinos priemonių ženklinimo bei naudojimo instrukcijose teikiamos informacijos pažeidimai. Didžioji dalis gamintojų pašalino nustatytus pažeidimus, todėl platinimo draudimas buvo atšauktas. 2 gamintojų turniketus buvo uždrausta teikti rinkai.
Į ką reikėtų atkreipti dėmesį prieš perkant turniketus
Primename, kad būtina atkreipti dėmesį į ženklinimą. Norėdami įsitikinti, kad turniketai atitinka saugos reikalavimus, vartotojai turėtų atkreipti dėmesį į šiuos ženklinimus:
- medicinos priemonės pakuotė ir pati medicinos priemonė turi būti paženklinta atitikties ženklu „CE“;
- turi būti nurodyti medicinos priemonės gamintojo duomenys. Jei gamintojas įsisteigęs ne Europos Sąjungoje, turi būti nurodyti gamintojo įgaliotojo atstovo Europos Sąjungoje duomenys;
- medicinos priemonės etiketėje turi būti nurodytas:
- partijos numeris
- galiojimo data
- nuoroda (tekstu arba simboliu), kad medicinos priemonė yra vienkartinio naudojimo
- prie medicinos priemonės privalo būti pridėta lietuvių kalba parengta naudojimo instrukcija.
Atkreipiame dėmesį, kad automobilių vaistinėlėse esančių turniketų paskirtis – sustabdyti galūnių kraujavimą iki Greitosios medicinos pagalbos tarnybos atvykimo.
Kaip reikia teisingai naudoti šias priemones galima pažiūrėti čia: bit.ly/3Xyw4O1
SAM Komunikacijos skyriaus ir Akreditavimo tarnybos informacija
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