Hemodialysis ke kalafo e pholosang bophelo bakeng sa bakuli ba liphio, 'me boleng ba lisebelisoa tse sebelisoang ts'ebetsong bo bapala karolo ea bohlokoa ho netefatsa polokeho ea mokuli le kalafo e sebetsang. Empa bafani ba tlhokomelo ea bophelo bo botle le bahlahisi ba ka netefatsa joang hore lihlahisoa tsee li finyella litekanyetso tse phahameng ka ho fetisisa tsa ts'ireletso le ts'ebetso? Ke hona moolisebelisoa tsa hemodialysislitekanyetsokena papaling. Ho utloisisa tsenamelaoana ea machabae ka thusa litleliniki, lipetlele, le bafani ba thepa ho boloka tlhokomelo e phahameng ka ho fetisisa.
Hobaneng ha Litekanyetso li le Bohlokoa bakeng sa Lisebelisoa tsa Hemodialysis?
Lisebelisoa tsa bongaka le lisebelisoa tse sebelisoang ho hemodialysis li tlameha ho fihlela litlhoko tse thata tsa taolo ho netefatsabiocompatibility, durability, sterility, le katleho. Kaha dialysis e sebelisana ka ho toba le phallo ea mali ea mokuli, ho sekisetsa leha e le hofe ho boleng ho ka baka likotsi tse tebileng tsa bophelo bo botle, ho akarelletsa ho tšoaetsoa mafu, ho silafala maling, kapa ho se tlosoe ka chefo ka ho lekaneng.
Ka ho khomarela ho elelloahemodialysis e sebelisa litekanyetso tsa tšebeliso, bafani ba tlhokomelo ea bophelo ba ka kholiseha hore lihlahisoa tseo ba li sebelisang li finyella litekanyetso tse phahameng ka ho fetisisa tsatšireletseho, botšepehi, le katleho. Litekanyetso tsena li boetse li thusa bahlahisi ho hlahisatse tsitsang, tsa boleng bo holimotse tsamaellanang le melaoana ea tlhokomelo ea bophelo lefatšeng ka bophara.
Maemo a Bohlokwa a Matjhaba a Disebediswa tsa Hemodialysis
Mekhatlo e mengata ea machaba e theha le ho laola maemo alisebelisoa tsa hemodialysis, ho etsa bonnete ba hore li kopana ka thatatshebetso, thepa, le litlhoko tsa polokeho. Tse ling tsa litekanyetso tsa bohlokoa ka ho fetisisa li kenyelletsa:
1. ISO 23500: Boleng ba Mokelikeli oa Metsi le Dialysis
Ho hloeka ha metsi ke habohlokoa ha ho etsoa hemodialysis, kaha metsi a sa hloekang a ka kenya lintho tse kotsi maling a mokuli.ISO 23500e fana ka litataiso bakeng sa tokiso le boleng ba maro a dialysis, ho netefatsa hore litšila tse kang baktheria, litšepe tse boima, le li-endotoxins lia fokotseha.
2. ISO 8637: Bloodline le Extracorporeal Circuits
Tekanyetso ena e akaretsahemodialysis bloodlines, likhokahano, le tsamaiso ea li-tubing, ho netefatsa hore li tsamaellana le mechini ea dialysis le ho thibela ho lutla kapa ho silafala. Lisebelisoa tse sebelisoang li tlameha ho bae se nang chefo, e lumellana le biocompatible, ebile e tšoarellaho mamella phallo ya madi a phahameng.
3. ISO 11663: E tsepamisa maikutlo bakeng sa Hemodialysis
Dialysis concentrate e bapala karolo ea bohlokoa ho tloseng chefo maling.ISO 11663e theha litekanyetso tsa taolo ea boleng bakeng sa likhakanyo tsena, ho netefatsa sebopeho se nepahetseng sa lik'hemik'hale le sterility ho thibela kotsi ea bakuli.
4. ISO 7199: Ts'ebetso ea Dialyzer le Polokeho
Li-dialyzer, tse tsejoang hape e le liphio tsa maiketsetso, li tlameha ho sefa litšila ka nepo ntle le ho baka tšenyo ea mali kapa tšebetso ea 'mele ea ho itšireletsa mafung.ISO 7199e hlalosa litlhoko tsa ts'ebetso, mekhoa ea tlhahlobo, le mekhoa ea ho thibela likokoana-hloko ho netefatsaho tlosa chefo ho sa felenglepolokeho ea mokuli.
5. US FDA 510(k) le CE Ho tšoaea
Bakeng sa lihlahisoa tse rekisoang kaUnited Stateslemokhatlo oa linaha tsa Iropa, lisebelisoa tsa hemodialysis li tlameha ho amoheloaFDA 510(k) tumellokapaSetifikeiti sa CE. Litumello tsena li tiisa hore lihlahisoa lia kopanaboleng bo tiileng, thepa, le litekanyetso tsa biocompatibilitypele li ka rekisoa le ho sebelisoa maemong a kliniki.
Ho netefatsa Tumellano le Hemodialysis Consumables Standards
Kopanohemodialysis e sebelisa litekanyetso tsa tšebelisohloka motsoako oateko e matla, taolo ea boleng, le ho latela melao. Mona ke kamoo bahlahisi le bafani ba tlhokomelo ea bophelo ba ka netefatsang hore ba sebelisa lihlahisoa tse sireletsehileng le tse sebetsang ka ho fetesisa:
1. Mohloli o tsoang ho Baetsi ba Pakiloeng
Kamehla khetha bafepedi horelatela melaoana ea ISO le FDA/CE. Baetsi ba netefalitsoeng ba latela litataiso tse tiileng tsa tlhahiso ho fana ka lisebelisoa tsa boleng bo holimo, tse tšepahalang.
2. Etsa tlhahlobo ea kamehla ea boleng
Tloaeloteko le netefatsoea lisebelisoa e netefatsa hore li tsoela pele ho kopanasterility, durability, le litlhoko tsa tshebetso. Sena se kenyelletsa tlhahlobo eatšilafalo ea baktheria, botšepehi ba lintho tse bonahalang, le ho lumellana ha lik'hemik'hale.
3. Koetlisa Bafani ba Bophelo bo Botle ka Tšebeliso e Sireletsehileng
Esita le lisebelisoa tse molemo ka ho fetisisa li tlameha ho sebetsoa ka nepo ho netefatsa polokeho ea mokuli. E nepahetsengkoetliso ea ho koala, ho boloka, le ho sebetsanae ka fokotsa kotsi ea tšoaetso le ho hloleha ha lisebelisoa.
4. Lekola Lintlafatso tsa Tsamaiso
Litekanyetso tsa bongaka li fetoha ha nako e ntse e ea ha lipatlisiso tse ncha le theknoloji li hlaha. Ho lula u tseba kamelaoana ea morao-rao le tsoelopelee netefatsa hore bafani ba tlhokomelo ea bophelo le bahlahisi ba tsoela pele ho finyella litekanyetso tse phahameng ka ho fetisisa.
Bokamoso ba Hemodialysis Consumable Standards
Ha theknoloji e ntse e tsoela pele,hemodialysis e sebelisa litekanyetso tsa tšebelisoli ntse li tsoela pele ho ntlafatsatšireletseho ea mokuli, katleho ea phekolo, le ho tšoarella. Lintlafatso tsa nako e tlang li ka kenyelletsa:
•Li-sensor tse bohlalelipotolohong tsa dialysis bakeng sa ho beha leihlo ka nako ea nnete
•Lintho tse ka senyehang kapa tse ka sebelisoang hapebakeng sa tšusumetso e fokolang ea tikoloho
•Li-membrane tsa filtration tse ntlafalitsoengbakeng sa ho tlosa chefo e ntlafetseng le ho lumellana le mali
Ka ho lula ka pele ho mekhoa ena e mecha, indasteri ea tlhokomelo ea bophelo e ka tsoela pele ho ntlafalaboleng ba phekolo ea hemodialysisle liphello tsa mokuli.
Qetello
Ho khomarelalitekanyetso tsa machaba tsa lisebelisoa tsa hemodialysise bohlokoa ho netefatsakalafo e bolokehileng, e sebetsang, le ea boleng bo holimo ea dialysis. Hore na o mofani oa tlhokomelo ea bophelo, mofani oa thepa, kapa moetsi, ho utloisisa le ho latela litekanyetso tsena ho ka u thusa.ntlafatsa polokeho ea mokuli, ho ntlafatsa ts'ebetso ea kalafo, le ho boloka taolo ea taolo.
Bakeng sa tataiso ea litsebi kalisebelisoa tsa boleng bo holimo tsa hemodialysis, Sinomedke mona ho tla thusa. Ikopanye le rona kajeno ho ithutalitharollo tse tšepahalang le tse lumellanangbakeng sa litlhoko tsa hau tsa dialysis.
Nako ea poso: Mar-04-2025
