Kev Tswj Xyuas Kev Lag Luam, Kev Lag Luam Kev Lag Luam Risks, Thiab Kev Lag Luam Yav Tom Ntej Rau Laparoscopic Cannulas

https://www.laparoscopyhospital.com/v5.htm

Laparoscopic cannulas raug cais raws li Class II lossis IIb cov cuab yeej kho mob hauv kev lag luam loj thoob ntiaj teb (EU MDR Txoj Cai 8 feem ntau muab IIb yog qhov cuam tshuam thiab npaj rau luv luv - siv sijhawm, txawm hais tias qee lub xeev cov tswv cuab tswj hwm lawv li IIa; US FDA 510 (k) xav tau kev sib piv nrog cov cuab yeej ua ntej; Tuam Tshoj NMPA tswj lawv li Class II cov cuab yeej kho mob, yuav tsum tau sau npe. Kev nruj nruj ntawm cov kev cai tsis ntev los no tau cuam tshuam loj rau kev lag luam ecosystem: EU Kev Tswj Cov Khoom Siv Kho Mob (EU MDR 2017/745) xav tau siab dua -cov pov thawj kho mob qib (CER- Cov Ntawv Qhia Tshuaj Ntsuam Xyuas yuav tsum suav nrog tiag-cov ntaub ntawv ntiaj teb lossis cov ntaub ntawv nyeem meta- tshuaj xyuas.18), txuas ntxiv mus txog 4 lub hlis. Kev nce nqi ntawm kev ua raws cai rau SMEs tau nrawm lawv txoj kev tawm lossis kev yuav, tau txais txiaj ntsig zoo rau cov tuam txhab lag luam uas tau txais daim ntawv pov thawj MDR. Tuam Tshoj txoj kev NMPA的同品种比对 tseem siv tau, tab sis tsis ntev los no nce kev tshuaj ntsuam xyuas ntau zaus tsom rau kev ua kom tsis muaj menyuam (ISO 11135 EO sterilization validation, sterility test, BI culture), first packaging integrity, and products retention samples. Cov tuam txhab tsis ua raws li - ntsib kev pheej hmoo ntawm kev ncua kev tsim khoom thiab kev kho kom raug.

Nyob rau theem kev xa khoom, cov kev pheej hmoo loj nyob hauv cov nqi hloov pauv thiab thaj chaw cuam tshuam ntawm cov khoom siv kho mob sab saud (PC, PEEK, kho mob silicone roj hmab) thiab 316L stainless hlau tubing. Cov neeg muab khoom siab tshaj -kawg PC pellets thiab PEEK resins yog thoob plaws ntiaj teb (Tebchaws Asmeskas, Tebchaws Asmeskas, Nyij Pooj), thiab kev xa khoom qeeb thiab nce nqi tau tshwm sim xyoo 2022-2023, yuam cov tuam txhab lag luam hauv tsev koom ua ke txhim kho kev kho mob- qib lwm cov ntaub ntawv nrog cov chaw tsim khoom hloov kho hauv zos; precision pwm rau silicone roj hmab seals (yuav tsum flash Tsawg dua los yog sib npaug rau 0.05mm) kuj ib zaug tso siab rau cov neeg muag khoom German thiab Nyij Pooj tab sis tam sim no maj mam ua hauv zos. Kev nce lub zog thiab cov nqi zog hauv kev txhaj tshuaj molding sector tau ua rau cov cheeb tsam tsim khoom hauv South Tuam Tshoj thiab Yangtze River Delta kom ua tiav cov kab sib dhos ua ke (kev tshuaj xyuas pom + neeg hlau thauj khoom / tshem tawm), compressing cov neeg ua haujlwm feem ntau ntawm 25% mus rau qis dua 8% kom tswj tau cov paj laum tag nrho.

Lub hauv paus kev lag luam hauv cheeb tsam tau qhia meej qhov sib txawv: North America (Asmeskas) tseem yog lub lag luam loj tshaj plaws (suav txog li 33% -38% thoob ntiaj teb), uas tau tsav los ntawm ASC nthuav dav thiab nyiam rau siab -kawg kho qhov muag / pov tseg cannulas, tab sis cov nqi raug txwv los ntawm GPOs; Teb chaws Europe ntsib qhov kev ua raws li MDR siab, hloov qeeb ntawm cov khoom lag luam uas twb muaj lawm, tab sis cov nqi them rau siab - cov khoom kawg tuaj yeem khaws cia; Asia-Pacific (tshwj xeeb yog Tuam Tshoj, Is Nrias teb, Sab Qab Teb Asia) yog qhov nrawm tshaj plaws - cheeb tsam loj hlob (CAGR 12%–13%), nrog Tuam Tshoj "Thiab Lub Nroog Project" + Is Nrias teb Ayushman Bharat kev tuav pov hwm kev noj qab haus huv nthuav dav tsav laparoscopic saws hauv tsev kho mob theem nrab, nrog kev thov feem ntau rau kev pov tseg kev lag luam 5/1 hli; Latin America (Brazil, Mexico) thiab Middle East (Saudi Arabia, UAE cov haujlwm kho mob hauv nroog) tau tshaj tawm cov kev xav tau ntxiv nrog kev tsim kho tsev kho mob ntiag tug, tab sis feem ntau nyiam nruab nrab -ntau cov khoom xa tuaj lossis siab- nqi- cov khoom siv hauv Suav teb. Africa yog nyob rau hauv nws cov me nyuam mos, txwv los ntawm kev nkag mus ntawm cov cuab yeej laparoscopic.

Lub hauv paus tseem ceeb hauv 5-10 xyoo tom ntej no yog peb npaug: ① Ib zaug-chaw nres nkoj ntau-channel platforms (LESS/NOTES) txhawb nqa hauv gynecology thiab xaiv cov kab mob gallbladder raws li tus neeg mob xav tau kom zoo nkauj, sawv cev rau qib siab -tus nqi tshiab; ② Neeg hlau- sib xws siab- kawg cannulas scaling li nrog rau installation ntawm domestic phais neeg hlau; ③ Kev sau npe hauv zos + kev sib sau ua ke hauv kev lag luam tawm tshiab (xws li KD cov chaw tsim khoom hauv Thaib teb, Nyab Laj) kom txo cov nqi se thiab nce cov nyiaj tau los tag nrho. Cov teeb meem tseem ceeb suav nrog kev txo tus nqi txuas ntxiv los ntawm kev yuav khoom hauv nruab nrab, homogeneous qis-kev sib tw nqi, thiab cov khoom siv raw khoom. Kev tsom xam pom tau hais tias cov tuam txhab muaj cov khoom lag luam ua tiav (los ntawm qhov yooj yim mus rau kho qhov muag rau cov neeg hlau- sib xws), tuav ob qho MDR / FDA dual ntawv pov thawj, thiab muaj tus kheej - tswj kev txhaj tshuaj molding thiab sealing thev naus laus zis yuav ua tus thawj coj hauv kev sib koom ua ke ntawm kev lag luam tom ntej, thaum lawv qhov chaw tsis tu ncua {15} qhov chaw tsis tu ncua ntsws.