Ukukhetha Icatheter Yemihlaba Yase-urinary Ezenziwe Ngelatex Ukufanele Kukusebenza

Imiphumela Yomthwalo Wemikhono Yelatex Yocatheter Yemihlaba Yase-urinary Nebiocompatibility

Ukuhambisana, ubukhulu Bekuthintela, Nobubanzi Bokugqibela: Indlela Oyenzayo Umthwalo Wemikhono Yelatex Kuyaphatha Ukuhlambuluka Kwemihlaba Yase-urethra Nokuthintela Kwesikhathi Sokuhlala

Ukuphambana kwe-latex kuyakubiza ukuthi izikhumba zokugcina amanzi ziyakhuluma ngokujabula kwezinhlobo zokugcina amanzi—kunciphisa indawo yokufaka futhi kunciphisa ukuthi izihlangothi ziyathwala. Ukuphambana kwakhe kuyakubiza ukuthi kungafani noma kungavulekile phakathi kokugcina amanzi, kuvumela ukuthi isikhumba sivuleke ngokuphambana kwezindawo eziningi. Kodwa, isibonelo se-rubber esingasemthwakweni sisebenza ngokuphambana okukhulu, kubiza ukuthi kunezinkinga zokuthwala kwezihlangothi ngokushesha noma ngokuhamba kwephesenti. Izikhumba zesi-silicone noma zesi-PTFE zisetyenziswa ngokusheshayo ukuze zicinca ukuphambana kwezinye izikhumba futhi zihlele ukuthi ziyasebenza ngokuphelele kwezinhlobo zokugcina amanzi, kunciphisa ukuthi kuzoba nezinkinga zokuthwala kwezihlangothi. Ngokuphambana kwezindawo, ukuthi amanzi ayagcina isikhumba sivuleka, kubiza ukuthi kunezinkinga zokuthwala kwezihlangothi ngokuphambana kwezinye izikhumba. Ngokuthi ukuthwala kwezikhumba kuyisibalo esikhulu sokuthi iphesenti iyadlula, futhi kuyakubiza ukuthi kufanele kucinca ukuphambana kwezinye izikhumba—kubhekana nokuphambana okuphelele kwezinye izikhumba futhi nokuthi kufanele kubhekane nokuphambana okuphelele kwezinye izikhumba. Uma kubhekana nokufaka kahle kanye nokuphatha kwezinhlobo zokugcina amanzi, izikhumba zesi-latex zisetyenziswa ngokusheshayo kubhekana nokuthi kufanele kubhekane nokuphatha kwezinhlobo zokugcina amanzi.

Ukulinganiswa kwe-protein yase-natural rubber nezinkhombiso zayo zokubhekana ngezinye izinkomo zokugcina isikhathi eside emkhakheni wokuphatha okusha

I-latex esebenzisa amaprothini okugcina—kakhulu i-hevein isoforms—okungakwazi ukufihla eminyakeni futhi ukuxhumana ne-urothelium. Nangamaphoyisa angenakwazi ukubhekana nalo, le maprothini atholakala kwenza ubukhwele obukhulu: ubuhlungu be-mucosal, ubukhwele, nokuvutha kwepitheliyo kungenza ukuthi umuntu akhathazekile noma akhathazekile ekupheleni kweminyaka. Kwezinkundla zokusebenza ngokushesha, lokhu kwenza ukuthi isikhathi sokubaluleka kwe-catheter sifanele kusheba kancane; izifundo zibonisa ukuthi izi-catheter ezinamaprothini aphelele kuzoba yizinkinga ezingapheleliyo yokususa ngokushesha okungafanele, okuyingapheleliyo kune-15%. Nakuba izindlela zokusebenza zokususa amaprothini zisheba amaprothini atholakala, ukususa kabanzi kungabikho ngokuphelele. Abasemthethweni baya kufuna ukubhekana ngezinkinga zokubaluleka kwe-latex ngaphansi kwezinkinga zokususa ngokushesha ngokwesibonelo. Umsebenzi omuhle wenza ukuthi ubhalise ukuthi umuntu wasebenzisa i-catheter ngaphambi kwalokho futhi uqinisekise ukubheka ngokujulile ukuthi kunezinkinga zokubaluleka kwe-mucosa—ukusiza ukwenza isiphumo esihlanganisiwe ngokushesha futhi ukunciphisa ukuthi kubhekwe ngokushesha kwe-urethra, ukususa futhi ukususa kabusha i-catheter, nokuthi kubhekwe ngokushesha kwezinkinga zokubhekwa ngokushesha.

Ukuphatha Ukugcina Kwezinkinga Zokuhlukana Kwelatex Nokufuna Ukuthembekile Kwezinkampani

Isilinganiso Sekhulu Lokuhlukana Kwesithathu Ngokwesibonelo Esikhulayo Kwezintloko Zokubhala Nokufuna Ukubhala Okulinganiswe Ngokwesibonelo Se-CDC Nase-AUA

Ukuthi umuntu uyaphakanyiswa ngokukhulu nge-latex yomhlaba wokuphakamisa kuyisibizo esikhulu sokungasebenzi kakhulu ekubhisheni kwemithwisi yobuso. Izifundo zezindawo zisombulula ukuthi izigaba zezinkulungwane zama-1–3 zezinto zokubhishwa ziyaphakanyiswa ngokukhulu, ziyabonakala ngokushesha kwe-urticaria, rhinitis, noma anaphylaxis—kodwa ukuthi lezi zingahle kufika kuma-10% kwezindawo eziphakanyiswa kakhulu njengezindawo zezintfombi zokubhishwa kwe-spina bifida (ukuchazwa kwe-2020). I-CDC yaseminyakeni ya-2019 yokuqinisekisa ukuthi akubhishwanga imithwisi yobuso futhi i-AUA yaseminyakeni ya-2020 yokuqinisekisa ukuthi kufanele kwenziwe ngokuphelele kuyabizwa ngokuthi kufanele kuzwe amandla okuphakanyiswa ngokukhulu phambi kokubhishwa. Lokhu kufanele kusondezwe ngokuphelele ukuthi umuntu uyaphakanyiswa ngokukhulu ngezinto ezinazo latex—njengezincobo, izibhola, noma imithwisi yobuso eyadlule. Uma kubonakala ukuthi umuntu uyaphakanyiswa ngokukhulu, kufanele kubhekwe ngokushesha kwezinto ezingenalo latex. Kuvumeka ukuthi izimemo zokusebenza kwezinhlelo zokusebenza nezinhlelo zokubhishwa zizibonise ngokushesha futhi zizibhishwe ngokuphelele ukuze kuvunyelwe ukuthi umuntu ayiphakanyiwe ngokukhulu ngokungafanayo futhi akubhishwanga imithwisi yobuso.

Ukuhamba kwe-FDA 510(k) yokuvumela ngaphandle kwe-EU MDR Annex I: Izinkinga zokuthenga nokubhala izibonelo ezibalulekile zemithambo yezinyawo zokugcina amanzi

Izindlela zokuhlela izimithambo zezinyawo zokugcina amanzi zihlukana kakhulu phakathi kwe-United States ne-European Union. Indlela ye-FDA ye-510(k) iyasiza ekuboniseni ukuthi imithambo iyisilinganiso esikhulu kwe-mithambo eyavunyelwe ngokulungileyo, ngakho-ke i-EU MDR Annex I iyadinga ubonakalo oluphelele lwesayensi yokuqinisa ukuthi imithambo ibalulekile nokusebenza kahle. Ukunciphisa isivumelwano sokuhlukahluka kusobala ngokuxhasa imithambo ephathwa ngokulinganisa izindlela zokuhlela zasekhaya—ikakhulu ngokubhala izibonelo zokuthenga kanye nokubonisa ukuthi imithambo ibalulekile kuzinyawo.

Indlela yokuthenga	FDA 510(k) (United States)	EU MDR Annex I (European Union)
Ukuthenga kabefore ukuthengiselwa	ukuthenga kwe-510(k) ngezibonelo zokuthenga kanye nezibonelo zokuthenga kwezinyawo, ukuthenga kwezinyawo zokuthenga, nokuthenga kwezinyawo zokuthenga.	Ukuthenga kwezibonelo zokuthenga kwe-Annex II, isibonelo sokuthenga kwezinyawo, ukuthenga kwezinyawo zokuthenga kwe-ISO 10993, nokuthenga kwezinyawo zokuthenga kwe-risk management.
Izibonelo zokuthenga	Kufanele kubhaliwe "Iyafunda isilatex sengcali yesintu" futhi lisibhalwe ukuthi yiziphi izinto ezisemthwakathini; kufanele kubhaliwe ukuthi akusizo kubantu abanemphilo yomzimba wokuphazimula isilatex.	Kufunele kubhekeka i-UDI, i-IFU ngazo zonke izilungu zase-EU, nokubhala amazwi okuhlonipha amaphroteni okuphazimula okufanana nezinkinga zokuphepha nokusebenza (GSPR) 10.4.5.
Ukubhala amaphroteni okuphazimula	Ukubhala emaphaketheni kanye nokubhala emazwini okubhala kufanele kubhaliwe ukuthi kuyiwe isilatex; ukubhala inani lamaphroteni kusho kakhulu kodwa akukho mthetho owodwa wokubhala.	Ukubhala amazwi okuhlonipha ngokucacile uma inani lamaphroteni libe phakade kwezinkinga zokuphepha kwesintu; kufanele kubhaliwe ukuthi kuyiwe isilatex sokuphazimula uma kuyiwe.
Emva kokuthengiswa	Ukubhala amaphroteni okuphazimula ngendlela ye-MedWatch.	Ukuphatha kwezikhathi zemva kokuthengiswa (PMS), ukuphatha kwezikhathi zemva kokuthengiswa kwezincwadi zokuphepha (PMCF), nokubhala kumabhalo waseNingizimu Afrika.

Nakuba i-FDA inqubeka ekubeni igama eliqinile libonakala, i-MDR inqubeka ngendlela yokusebenza yezinto zonke—kunqubeka ukuthi kufanele kube nenkxaso yezindlela zokuphatha kanye nokuthi kufanele kubekho ubuchwepheshe obuhle bokuphatha kwempilo yezinto zonke. Abasemthwakweni bakufanele bavumelane nesibonelo sokubhekana nesizinda nesibonelo sokuthi abasendleleni bafanele bakhiphe izindaba zokusebenza zokubhekana nesizinda sokuzilungiselela kwezindawo zokuthengiswa.

Ukukhetha Ngokusebenzisa Iziphakamiso: I-Catheters Zase-urinary Zase-Latex Nokulingana Nokuthi Kunezinye Izingxenye Ezinamandla Emthwakweni Yokuphatha Okulungile

Ukulinganiswa kwe-CAUTI, ukuthenga kwe-catheter, nokuthenga kwezibonelo zokuthenga kwezincwadi phakathi kwe-latex, i-silicone, kanye ne-hydrophilic catheters (iziphakamiso zokuthenga zase-Joint Commission)

Ukukhetha ikathetha yomzimba wokuhlanza emzimbeni we-urinary latex kufuneka kubhekwe ngokulinganisa ngamashusho ase-Joint Commission okuvikela ukungena kwemithwalo—futhi kufanele kubonwe izinkinga zokugcina phakathi kwezindawo zokusebenza, zokusebenzisa, nezokulandela amalungu. Umthwalo wokuphinda-phinda owodwa wokubhekana nokuzwa kwe-bacteria wabonisa ukuthi kukhona izibonelo eziningi kakhulu zokuzwa nge-latex kunge-silicone catheters, okuthi kubonisa ukuthi kunezinkinga ezingaphezulu zokuzwa kwe-CAUTI. Izindlela zokufaka kuyaphinda kuyahlanzwa: ubukhulu bokufaka kwe-latex kusiza ukufaka kwanqaba, kodwa ubukhulu bekho kwe-friction esikhundleni sokufaka kusiza ukuthi kwenzeke umsindo wesikhundla sokuhlanza; ubukhulu bokufaka kwe-silicone kungasiza ukufaka kwanqaba kodwa kusiza kakhulu ukuvikela ukuzwa kwe-encrustation. Amakathetha okufaka kwe-hydrophilic kusiza kakhulu ukufaka kwanqaba—amaphuzu amaningi abonisa ukuthi kune-98%—futhi kusiza ukunciphisa izinkinga zokufaka kwe-micro-injuries. Ukuthi kubhalwe kanye kuyisisekelo esifanele: ukubhekana kwe-Joint Commission kufuna ukubhekana kusuku sonke ngokuthi kuyafakwa ngani, ukubhalwa kwe-dwell-time ngokucophelela, nokubhalwa kohlobo lwamakathetha—ukungabhalwa kuyasiza ukuthi kungabi nesivumelwano. Amasiteki afaka amakathetha we-silicone noma we-hydrophilic ayabona ukunciphisa kwe-CAUTI futhi kwezinkinga zokuzwa kwe-latex, kodwa kunezinkinga eziningi zokuthenga. Ukufikiswa emazishini okulandela amalungu, iziprojekthi ezifuna ukusivumelana kufanele zibhalwe ngokucophelela ukuthi kune-CAUTI ngokulinganisa ngama-1,000 catheter-days, ukuphumeza kwanqaba kokufaka kwe-catheter ngamaprosenthi, nokubhalwa kucophelela konke okufakwa kwe-urinary catheter—ngaphandle kokuthi yiphi na uhlobo lwamakathetha.

Imibuzo Evame Ukubuzwa

Izinqubomgomo eziphakeme zokusebenzisa izicathulo zocingo lwe-urinary zini?

Izicathulo zocingo lwe-urinary zase-latex zinamandla okukhanya nokuphepha okuhle, okusiza ukuthi zihambisane neziqu zocingo lwe-urinary futhi zimshane indawo yokufaka. Zaphatha futhi ukuthi ilumeni yazo ibe libe ngeminyaka eyadlulayo.

Ukuchitha kufaka kanjani ubungakanani bezicathulo zase-latex?

Ukuchitha njenge-silicone noma PTFE kunciphisa kakhulu ukuchitha kwesikhwama, okunciphisa isivumelwano sokuchitha kwezicathulo zocingo lwe-urinary. Lokhu kusiza ukuthi izicathulo zibe libonakalise kakhulu kwezinto ezibonakalayo kanye nokunciphisa ukuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary ngeminyaka eyadlulayo.

Izidingo zokubhekwa kwezicathulo zocingo lwe-urinary zase-latex zini?

Izidingo zivela kuzo zizokuthi zihlabele amasiko, ukuchitha okuphakeme okuyenza ukuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary, nokuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary kubantu ababhekwe kahle. Ngeminyaka eyadlulayo, ukubhekwa kwezicathulo zocingo lwe-urinary kungaciphisa ukuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary, okunciphisa ukuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary.

Kungani ukuthi kubhekwe kahle kwezicathulo zocingo lwe-urinary kubhekwe kahle kwezicathulo zocingo lwe-urinary?

Yenza ukubhala phansi kahle kwezinkinga zokuphazimula ngaphambi kokwenza isikhathi sokusebenzisa izinkampani ngokulandela imithombo ye-CDC ne-AUA. Uma umuntu osebenzisa ikampani yase-latex, sebenzisa izinkampani ezingenakho i-latex ukuze uvikiswe kwezinkinga zokuphazimula.

Izimali zokuhlanganisa kwezinhlangano zokuguqula ziziphi ezibalulekileyo kwezinkampani zase-latex zokufihla kwemifula?

Emhlabeni wase-United States, ukuvumwa kwe-FDA 510(k) kudinga izidata ngokuthi inkampani iyathola kanjani nokuthi kuneziprothini zingakanani, futhi kufanele kubhalelwe kusuka kwezinkampani izinkinga zokuphazimula. Kwe-EU MDR kufanele kwenziwe umbono omkhulu ngokugcina isikhathi sokusebenza kwezinkampani ngezibonelo zokusebenza kanye nezimali zokubhala phansi kahle.

Kungani izinkampani zesiSilicone noma zesiHydrophilic zingcono kunezinkampani zase-latex ukuncima izinkinga zokufihla kwemifula kwezinkampani?

Yebo, izinkampani zesiSilicone noma zesiHydrophilic ziyatholakala ngokuvamile njengokuthi zingabhekise kancane kwezibhakteriya futhi zingakhathali kancane kwezibhakteriya, okuncima kakhulu izinkinga zokufihla kwemifula kwezinkampani.