Idivaysi yezokwelapha yinoma iliphi idivaysi okuhloswe ukuthi lisetshenziselwe ukwelashwa. Ngakho-ke yini ehlukanisa insiza yezokwelapha kusuka kudivayisi yansuku zonke ukusetshenziswa kwayo okuhlosiwe. Amadivaysi ezokwelapha asiza iziguli ngokusiza abahlinzeki bezokunakekelwa kwempilo ukuba bahlole futhi belaphe iziguli futhi basize iziguli ukunqoba ukugula noma izifo, ukuthuthukisa ikhwalithi yempilo yazo. Amandla abalulekile ezinobungozi ayenzeka uma usebenzisa idivaysi ngezinhloso zokwelashwa futhi ngaleyo ndlela amadivaysi ezokwelapha kumele abonakale ephephile futhi esebenza ngempumelelo ngokuqiniseka okufanele ngaphambi kokulawula ohulumeni bavumela ukuthengiswa kwensiza ezweni labo. Njengomthetho ojwayelekile, njengoba ubungozi be-device obuhambisana nabo bunyusa inani lokuhlola elidingekayo ukuthola ukuphepha kanye nokusebenza kahle nakho kuyakhuphuka. Ngaphezu kwalokho, njengoba ingozi ehambisana nayo inyusa inzuzo engaba khona esigulini nayo kumele ikhuphuke.

Ukutholwa kwalokho okungathathwa njengedivayisi yezokwelapha ngezinsuku zamazinga wanamuhla emuva kakhulu ngo-c. 7000 BC eBaluchistan lapho odokotela bamazinyo beNeolithic basebenzisa khona imishini yokuzivivinya yensengetsha nezintambo. [1] Ukufundwa kwemivubukulo kanye nezincwadi zezokwelapha zaseRoma kukhombisa nokuthi izinhlobo eziningi zemishini yezokwelapha zazisetshenziswa kabanzi ngesikhathi seRoma lasendulo. [2] E-United States kwaze kwafika ngomthetho weFederal Food, Drug, and Cosmetic Act (FD & C Act) ngo-1938 lapho amadivayisi wezokwelapha alawulwa khona. Kamuva ngo-1976, Izichibiyelo Zedivayisi Yezokwelapha kuMthetho we-FD & C zasungula umthethonqubo wokubheka nokwengamela njengoba sazi namuhla e-United States. [3] Umthethonqubo wedivayisi yezokwelapha eYurophu njengoba sazi namuhla uqale ukusebenza ngo-1993 yilokho okwaziwa ngokuhlanganyela ngokuthi yi-Medical Device Directive (MDD). NgoMeyi 26, 2017 i-Medical Device Regulation (MDR) ingene esikhundleni se-MDD.

Amadivaysi ezokwelapha ayahlukahluka ekusebenzeni okuhlosiwe kwawo nasezinkombeni zokusetshenziswa. Izibonelo zisusela kumadivaysi alula, asengozini ephansi njengokucindezelwa kolimi, ama-thermometers ezokwelapha, amagilavu ​​alahlwayo, kanye namakamhede okulala kuya kumadivaysi ayinkimbinkimbi, anobungozi obukhulu afakiwe futhi axhasa impilo. Isibonelo esisodwa samadivayisi anobungozi obukhulu yileso esine-software Eshumekiwe njengama-pacemaker, futhi ezisiza ekuhlolweni kokuhlolwa kwezokwelapha, ukufakwa kwezihlakala, kanye nezindlala zokuhlinzwa. Izinto eziyinkimbinkimbi njengezindlu zokufakwa okuhlanganisiwe zenziwa ngenqubo ejulile yokudonswa phansi nokujula okungadonswanga. Ukwakhiwa kwamadivayisi ezokwelapha kuyingxenye enkulu yomkhakha wobunjiniyela obusebenza ngezinto eziphilayo.

Imakethe yezokusetshenziswa komhlaba wezokwelapha yafika cishe ezigidini ezingama-US $ 209 billion ngonyaka we-2006 [4] kanti kwakulinganiselwa ukuthi yayiphakathi kwezigidi ezingama- $ 220 nezizigidi ezingama-US $ 250 ngonyaka ka-2013. [5] Izwe laseMelika lilawula ~ 40% wemakethe yomhlaba elandelwa yiYurophu (25%), Japan (15%), kanye nomhlaba wonke (20%). Yize ngokuhlanganyela iYurophu inesabelo esikhudlwana, iJapan inesabelo sesibili semakethe yezwe ngobukhulu. Amasheya amakhulu kunazo zonke emakethe eYurophu (ngokuhleleka kwesabelo semakethe) kungokwaseJalimane, i-Italy, iFrance ne-United Kingdom. Umhlaba wonke uhlanganisa izifunda ezifana (hhayi ngokulandelana) i-Australia, Canada, China, India ne-Iran. Lo mbhalo udingida ukuthi iyiphi into eyakha insiza yezokwelapha kulezi zifunda ezahlukahlukene futhi kulo lonke lesi sihloko kuzoxoxwa ngalezi zindawo ngokulandelana kwezabelo zabo ezimakethe zomhlaba.

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