Imigangatho yeHlabathi yeHodialysis isebenza

I-Hemodialysis lunyango olusindisa ubomi kwizigulana ezinokungaphumeleli kwizintso, kwaye umgangatho osetyenziswayo kule nkqubo udlala indima ebalulekileyo ekuqinisekiseni ukhuseleko kunye nokusebenza ngonyango. Kodwa banokufumana njani ababoneleli bezempilo kunye nabavelisi bezempilo banokuqinisekisa ukuba ezi mveliso ziyahlangabezana neyona migangatho iphezulu yokhuseleko kunye neyemigangatho yokusebenza? KulaphoI-Hemodialysisimigangathoyiza kudlala. Ukuqonda eziImigaqo yeHlabathiNgaba unokunceda iiklinikhi, izibhedlele, kunye nabathengisi bagcina olona nyango luphezulu.

Kutheni le nto imigangatho ibalulekile kwizifo ze-hemodialysis?

Izixhobo zonyango kunye nezitrato ezisetyenziswa kwiHodialysis kufuneka zihlangane iimfuno ezingqongqo ezingqongqo ukuqinisekisaUkucaciswa, ukuqina, ukuchuma, kunye nokusebenza. Ukusukela kwi-dialysis ngokuthe ngqo kunye negazi legazi lesigulana, nakuphi na ukubekwa kwegazi kwisigulana kunokukhokelela kwimingcipheko enzima yempilo, kubandakanya nosulelo, ungcoliseko lwegazi, okanye ukususwa kwetyhefu ye-toxin okanye i-toxin ye-toxin.

Ngokulandela ukuqatshelwaImigangatho ye-hemodialysis, ababoneleli bezempilo banokuqiniseka ukuba iimveliso abazisebenzisayo ziyahlangana namanqanaba aphezuluukhuseleko, ukuthembeka kunye nokusebenza kakuhle. Le migangatho ikwanceda abavelisiIzixhobo ezingaguqukiyo, ezisemgangathweni eziphezuluithobela imigaqo yezempilo yehlabathi.

Imigangatho ephambili yamazwe aphesheya ye-hemodialysis

Iqela lemibutho yamazwe ngamazwe ise nokulawula imigangatho yeI-Hemodialysis, uqinisekisa ukuba bayadibana ngokungqongqointsebenzo, iimfuno kunye neemfuno zokhuseleko. Eminye yemigangatho ebalulekileyo ibandakanya:

I-1. I-ISO 23500: Amanzi kunye nomgangatho wamanzi amdaka

Ukucoceka kwamanzi kubalulekile kwi-hemodialysis, njengoko amanzi engcolileyo akwazisa izinto eziyingozi kwigazi legazi lesigulana.I-ISO 23500Nikeza isikhokelo sokulungiselela kunye nomgangatho wolwelo lwedayari, ukuqinisekisa ukuba ungcoliseko olunje ngebhakteria, izinyithi ezinzima, kwaye i-endotoxin incitshisiweyo.

2. I-ISO YO-8637: Igazi kunye nesekethe engacacanga

Le igubunge iphantsiI-Hemodialysis yegazi, izihlanganisi, kunye neenkqubo zetyhubhu, uqinisekisa ukungangqinelani kwabo ngoomatshini bokucoca i-dialysis kunye nokuthintela ukuvuza okanye ungcoliseko. Izixhobo ezisetyenzisiweyo kufuneka zibekhonaAyisiyo inetyhefu, i-biompatid, kwaye iqineukumelana nokuhamba kwegazi eliphezulu.

I-3. I-ISO 11663: Igxila kwi-hemodialysis

Ukugxila kwi-dialysis dlala indima ebalulekileyo ekususeni iityhefu zegazi.I-ISO 11663Ukuseka iiparamitha zokulawula umgangatho kwezi zinto zigxininisa ukwakhiwa kweekhemikhali kunye nokugula ukuthintela ukonakala kwesigulana.

I-4. I-ISO 7199: Ukusebenza kwe-dialyzer kunye nokhuseleko

I-DALYZERs, ikwabizwa ngokuba ziintsomi, kufuneka icime inkunkuma ngokufanelekileyo ngaphandle kokubangela ukonakaliswa kwegazi okanye ukhuselo lomzimba.I-ISO 7199Chaza iimfuno zentsebenzo, iinkqubo zokuvavanya, kunye neendlela ze-sterilic yokuqinisekisaUkususwa okungaguqukiyokwayeUKHUSELEKO LOKHUSELEKO.

5. I-US FDA 510 (k) kunye no-CE Mark

Ngeemveliso ezithengisiweyo kwiAmazwe Amanyene kwayeudibano lwaseyurophu, i-hemodialysis enesifo kufuneka ifumaneI-FDA 510 (k) imvumeokanyeIsiqinisekiso se-CE. Ezi zamkeli ziqinisekisa ukuba iimveliso ziyahlanganaumgangatho ongqongqo, izinto, kunye nemigangatho ye-biomitiseNgaphambi kokuba zithengiswe kwaye zisetyenziswe kuseto lweklinikhi.

Ukuqinisekisa ukuthotyelwa kwemigangatho ye-hemodialysis

IntlanganisoImigangatho ye-hemodialysisifuna indibaniselwano yeUvavanyo olungqongqo, ulawulo lomgangatho, kunye nokuthotyelwa komthetho. Nantsi indlela ababoneleli ngayo ababoneleli kunye nababoneleli bezempilo abanokuqinisekisa ukuba basebenzisa ezona mveliso zikhuselekileyo nezona zisebenzayo:

1. Umthombo ovela kubavelisi abaqinisekisiweyo

Soloko ukhetha abathengisiBambelela kwi-ISO kunye ne-FDA / ye-FE / ye-CE / CE. Abavelisi abaqinisekisiweyo balandela imigaqo-nkqubo yeMveliso engqongqo yokuzisa umgangatho ophezulu, onokuthembeka.

2. Yenza uvavanyo lomgangatho oqhelekileyo

IndlelaUkuvavanywa kunye nokuqinisekiswayezinto ezinokuthengiswa ziyaqinisekisa ukuba ziyaqhubeka nokudibanaukungena, ukuqina, kunye neemfuno zomsebenzi. Oku kubandakanya uvavanyo lweUngcoliseko lwentsholongwane, ukuthembeka kwezinto ezibonakalayo, kunye nokungafani kwemichiza.

3. Qeqesha ababoneleli bezempilo ekusebenziseni okukhuselekileyo

Nokuba ezona zinto zininzi zininzi maziphathwe ngokuchanekileyo ukuqinisekisa ukhuseleko lwezigulana. KufanelekileUqeqesho kwi-Sterilization, ukugcinwa, kunye nokuPhathainokunciphisa umngcipheko wokosuleleka kunye nokusilela kwezixhobo.

4. Ukubekwa kweliso kuhlaziyo lolawulo

Imigangatho yezonyango ivela ixesha elide njengophando olutsha kunye netekhnoloji. Ukuhlala unolwazi malunga neImigaqo yamva nje kunye nenkqubela phambiliUkuqinisekisa ukuba ababoneleli bezempilo kunye nabavelisi baqhubeka nokudibana neyona migangatho iphezulu.

Ikamva leMigangatho yokuSebenza yeHodialysis

Njengoko inkqubela phambili yetekhnoloji,Imigangatho ye-hemodialysiszivela ukuphuculaUKHUSELEKO LOKHUSELEKO LOKHUSELEKO, UKUSETYENZISWA KOMOPHI. Uphuhliso lwexesha elizayo lunokubandakanya:

•Izixhobo ze-smartKwisekethe idayala yokuhlolwa kwexesha lokwenyani

•Izixhobo ezinokutsha okanye ezinokuphinda zisebenzeUkucuthwa kwempembelelo yendalo esingqongileyo

•I-membrane ephuculweyoUkuphucula ukususwa kwe-toxin kunye nokuhambelana kwegazi

Ngokuhlala ngaphambili kwezi mveliso mveliso, ishishini lokhathalelo lwempilo linokuqhubeka nokuphuculaUmgangatho wonyango weHmodialysiskunye nezigulana.

Ukuqukumbela

Ukubambelela kwiImigangatho yamazwe jikelele ye-hemodialysisibalulekile ekuqinisekiseniikhuselekile, esebenzayo, kunye ne-syreysis ekumgangatho ophezulu. Nokuba ungumboneleli wezempilo, umboneleli, okanye umenzi, ukuqonda kunye nokuhambelana nale migangatho kunokwenzekaukuphucula ukhuseleko lwezigulana, ukuze wenze intsebenzo yonyango, kwaye ugcine ukuthotyelwa komgaqo.

Isikhokelo sengcali kwiI-Hemodialysis ephezulu ye-hemodialysis, Sisonilapha ukunceda. Nxibelelana nathi namhlanje ukuze uphononongeIzisombululo ezinokuthenjwa nezihambelanaNgeemfuno zakho zokudangala.