Abakhiqizi bezinzipho abangu-15 abahamba phambili be-Intramedullary e-Portugal (Umhlahlandlela Wokuthenga wango-2026)

Isingeniso

I-landscape yokuthengwa kwemishini yezokwelapha emkhakheni wamathambo e-Portugal ihlangabezana nokuvela kwesakhiwo esisheshayo. Iqhutshwa iziyalezo eziqinile zokuqukatha izindleko ezivela eMnyangweni Wezempilo ( Ministério da Saúde ) kanye nenani eliphakeme lokuhlukumezeka eliphethwe amayunithi ezempilo endawo ( Unidades Locais de Saúde - ULS ) ngaphansi kweNational Health Service ( Serviço Nacional de Saúde - SNS )—kanye namaqembu ezibhedlela ezizimele afana neLuz Saúde, i-CUFspital board ye-procurement—i-CUF, i-Professional Board of Luz Saúde, i-CUF ama-implants anikeza ibhalansi elungile yokusebenza komtholampilo, ukuphepha okulawulwayo, nokubikezelwa kwesabelomali.

Lapho ulawula ukuphuka kwethambo elide, ukukhetha uzakwethu ofanele wezinzipho we-intramedullary (IM) kubalulekile ekwehliseni izinkinga zangemva kokuhlinzwa kanye nokuphatha izindleko zesikhungo ngaphansi kohlaka lwe -Concursos Públicos (Amathenda Omphakathi) kanye negunya lokuthenga elimaphakathi, i-SPMS ( Serviços Partilhados do Ministério da Saúde ). Lo mhlahlandlela uchaza Abakhiqizi Bezinzipho Abayi-15 Abaphezulu Be-Intramedullary e-Portugal, begxile kumaphothifoliyo abo ayinhloko, isithunzi semakethe, kanye nobuchwepheshe obuyinhloko ukusiza onjiniyela bezokwelapha, odokotela abahlinzayo bamathambo, kanye nabaphathi be-supply chain ekwenzeni izinqumo eziqhutshwa idatha.

Ukunwetshwa Kwezobuchwepheshe: Ukuqonda Imiklamo Ekhethekile Yezinzipho Ye-Intramedullary ku-Modern Trauma Sourcing

Ekuhlolweni kwethenda yezokwelapha okuphelele kuzo zonke izindawo zokunakekelwa kwezempilo ezihamba phambili, ukuthengwa kwe-orthopedic trauma kudinga ukuqonda okujulile kobuchwepheshe bemishini yokufakelwa. Izinzipho ze-Intramedullary azisezona izinduku zensimbi ezijwayelekile; ukuhlinzwa kwesimanje kudinga imiklamo ekhethekile kakhulu ye-biomechanical ehambisana nokucushwa kokuqhekeka okuqondile kanye nesifo sesiguli.

Ukusiza amabhodi ezibhedlela namakomiti okuhlinza enze lula ukuthola ukuhlukumezeka, kubalulekile ukuqonda izigaba eziyisipesheli eziyinhloko ze-Intramedullary Nails ezibusa amatiyetha esimanje amathambo:

1. Izinzipho Ze-Intramedullary Exhumanisayo (Okuqinile vs. I-Cannulated)

Ukukhetha phakathi kwemiklamo eqinile yezinzipho kanye ne-cannulated kuba nomthelela omkhulu ekusebenzeni kokuhlinzwa kanye nokuphulukiswa kwamathambo ebhayoloji.

• I-Cannulated Intramedullary Nails  : Lezi zinzipho zinendawo engenalutho, ezivumela ukuthi zifakwe phezu kwentambo yomhlahlandlela. Lo mklamo uvumela odokotela abahlinzayo ukuthi bafake i-remed, enweba umsele we-medullary, kuvumela isipikili esikhulu, esiqinile, futhi sibeke izingcezu zamathambo zendawo ngqo endaweni yokuphuka ukuze kusheshiswe ukuphulukiswa.

• Izinzipho Eziqinile Ze-Intramedullary: Ngokuyinhloko ezisetshenziswa kumasu angakahlaziywa, izinzipho eziqinile zivame ukukhethwa ekwephuleni okukhulu okuvulekile noma ezimweni ze-polytrauma ukuze kuncishiswe ubungozi be-fat embolism futhi kuncishiswe ukuphazamiseka kokunikezwa kwegazi endosteal.

2. I-Cephalomedullary Nails & Proximal Femoral Systems

Ngokuphuka okwenzeka ekugcineni okuseduze kwe-femur (isifunda se-hip), izipikili ezijwayelekile ezihlanganisiwe azanele. Amasistimu e-cephalomedullary akhethekile ayadingeka ukuze kusingathwe imithwalo yemvelo eyeqile.

• Ukulungiselelwa Kokukhiya Kabusha : Le miklamo ifaka izimbobo ezikhethekile zokulandela umkhondo ezisondele cishe kumadigri angu-130 ukuya kwangu-135, okuvumela izikulufu ezisindayo ukuthi zidlule kuzipho ziqonde ngqo ekhanda lesifazane, zivikele ukuphuka kweshaft ye-femal subtrochanteric noma ipsilateral.

• I-Anti-Rotation Helical Blade Systems : Isetshenziswa kakhulu lapho kuqhekeka inqulu ye-geriatric, lawa masistimu athatha indawo yezikulufu ze-lag ezijwayelekile ezinensingo yokuminyanisa. Lo mklamo ucindezela ithambo elikhansela elizungezile kunokuba ulisuse, wehlisa kakhulu ingcuphe yokufakelwa 'ukunqunywa' ethanjeni le-osteoporotic.

3. I-Retrograde vs. Anterograde Long-Bone Nails

Ngokuya ngendawo yokuphuka kanye nobuqotho bezicubu ezithambile, odokotela abahlinzayo kufanele bakhethe izingosi zokungena eziphambene zokufakwa kwezinzipho.

• I-Anterograde Sourcing : Izimila ezifakwe kusukela ekugcineni kwe-proximal (isb, ukungena ku-trochanter ngokuphuka kwe-femur). Lokhu kudinga ukugoba kwezinzipho okunembe ukuze kufane nokugoba kwemvelo kwe-anatomical.

• I-Retrograde Sourcing : Izimila ezifakwe kusukela ekugcineni kwe-distal (isb, ukungena ngenhla nje kwelunga ledolo). Izinzipho ezikhethekile ze-retrograde femoral zifaka amaphethini okukhiya ahlukile ukuze kuvikeleke ukuphuka kwe-distal kwe-supracondylar okuyinkimbinkimbi yesithathu.

I-Global Industry Giants & Leading Brands

1. Stryker Corporation

Umdlali ovelele kumanethiwekhi azimele aphambili e-Portugal kanye nezikhungo zezibhedlela zasenyuvesi ezinevolumu ephezulu, i-Stryker yase-US ihlonishwa kakhulu ngobunjiniyela bayo obunembayo kanye nokwesekwa okuqinile kwezohwebo.

• Imikhiqizo Eyisisekelo: Ukushintshwa okuhlanganyelwe, izinkundla ezisizwa ngamarobhothi (Mako), amadivaysi e-neurotechnology, kanye nezinhlelo ezithuthukisiwe zokulungisa ukuhlukumezeka.

• Iphothifoliyo Eyinhloko: I-Gamma4 Trochanteric Nail System kanye ne-T2 Alpha Interlocking Nail System inikeza ukuzinza okuthuthukisiwe komshini kanye nokulungiselelwa kwezinsimbi eziqondisiwe.

2. I-DePuy Synthes (Johnson & Johnson MedTech)

Ibambe isikhundla esigxilile kuyo yonke imikhakha yezibhedlela zikahulumeni (i-SNS) nezizimele e-Portugal, i-DePuy Synthes isebenzisa amashumi eminyaka ocwaningo lwezokwelapha olusekelwa i-AO Foundation.

• Imikhiqizo Eyisisekelo: Izinhlelo eziphelele zokuhlukumezeka, izixazululo zokwakha kabusha ngokuhlanganyela, amadivaysi e-craniomaxillofacial, kanye nama-biomaterials omgogodla.

• Iphothifoliyo Eyinhloko: I-Expert Nail System kanye ne-TFNA (i-Trochanteric Fixation Nail Advanced) isebenzisa ukwelapha okuphathelene nensimbi okulungiselelwe ukuphuka kwe-trochanteric okuyinkimbinkimbi kanye nokuphuka kwamathambo amade.

3. CZMEDITECH

Njengesizinda samandla esaziwayo emhlabeni wonke kumishini yezokwelapha yamathambo, I-CZMEDITECH isungule indawo ekhulayo yokuhlinzeka ngempahla emakethe yaseNingizimu Yurophu, kubandakanya nePortugal. Idume ngokuvala igebe phakathi kobunjiniyela bokunemba bezinga eliphezulu laseJalimane kanye nokusebenza kahle kokukhiqiza, inkampani inikeza iphothifoliyo egcwele yokuhlukumezeka ephethe izimvume zezokwelapha zamazwe ngamazwe eziqinile—okuhlanganisa ne-ISO 13485, izitifiketi ze-CE—okuyenza ibe uzakwethu ofanelekayo we- Hospitais Universitários enkulu kanye namanethiwekhi okuthola inzuzo aphezulu e-ULS okuthola usizo oluphezulu lwaseYurophu.

Imigqa Yomkhiqizo Eyisisekelo ye-CZMEDITECH

• I-Orthopedic Trauma Systems: Ukuxhuma Okuthuthukile Izinzipho ze-Intramedullary , i-Anatomical Amapuleti okukhiya nezikulufa, kanye Amasistimu Wokulungisa Wangaphandle.

• Izixazululo Zokulungisa Umgogodla : I-Anterior / Posterior Cervical & Thoracolumbar Systems, Amakheji e-Interbody Fusion, kanye nezinduku zokulungisa umgogodla.

• Izimila ze-Cranio-Maxillofacial (CMF) : Iphrofayili ye-Titanium Plates ne-Mesh Systems yephrofayili ephansi kakhulu yokwakhiwa kabusha kobuso.

• Amathuluzi Amandla Okuhlinza Nezesekeli: Imishini Yamathambo Esebenza Kakhulu, Amasaha Anyakazayo, namakhithi ethuluzi lokuvala inzalo afanayo.

• Amasevisi Enziwe ngokwezifiso e-OEM/ODM : Ukukhiqizwa kwemishini yezokwelapha efinyelela ekupheleni eklanyelwe ukucaciswa kwesibhedlela somhlaba wonke.

• Iphothifoliyo Yezinzipho Eziyinhloko kanye Nokuxhumana:

  • I-Femoral Intramedullary Nail: Yakhiwe kusukela ku-implant-grade Titanium Alloy (Ti-6Al-4V ELI), enokugoba kwe-anatomical okuthuthukisiwe nokucushwa kokukhiya okunezinhlelo eziningi ukuze kuhlinzekwe ukulungiswa okuqinile kokuphuka kweshaft okuyinkimbinkimbi.

  • I-Tibial Intramedullary Nail: Idizayinelwe ngezinketho zokukhiya eziguqukayo eziqhubekayo kanye nephrofayili ekheniwe, ekhuthaza ukuthwala isisindo kusenesikhathi kanye nokusheshisa ukuphulukiswa kwamathambo.

  • I-Humeral Intramedullary Nail: Isixazululo esikhethekile somkhawulo ongaphezulu esisiza indlela yokuhlasela kancane, ukunciphisa ukuphazamiseka kwezicubu ezithambile kanye nokuvikela i-rotator cuff.

  • I-Proximal Femoral Nail Antirotation - PFNA : Ifaka isistimu ye-helical blade elungiselelwe iziguli ezikhulile ezine-osteoporotic bone structures, iqinisekisa ukumelana okuphakeme ngokumelene nokusikwa ngesikhathi sokulungiswa kwe-trochanteric fracture.

4. Zimmer Biomet Holdings, Inc.

I-Zimmer Biomet ihlanganisa amapulatifomu okunakekelwa kwezempilo edijithali nobuchwepheshe bokulungisa be-musculoskeletal premium, isebenzela amanethiwekhi amakhulu ezempilo emadolobheni amakhulu kulo lonke elasePortugal.

• Imikhiqizo Eyisisekelo: Amamethrikhi ezempilo edijithali aqondanisiwe, ukushintshwa okuhlanganyelwe, izingxenyekazi zehadiwe yemithi yezemidlalo, nezifakelo zokuhlukumezeka.

• Iphothifoliyo Eyinhloko: Uhlelo Lwezinzipho Zemvelo luhlanganisa ama-anatomical curvature aklanyelwe ukulingana nama-morphology eziguli kulo lonke ulwazi lwabantu lwaseNtshonalanga Yurophu.

5. Smith & Nephew plc

Ngokusebenza okuqondile okusebenzayo kanye namahabhu wezinto ezisetshenziswayo aqinile kulo lonke elase-Iberia, uSmith & Nephew ozinze e-UK uphumelela kakhulu ekunakekelweni kwenxeba okuthuthukisiwe kanye nezinhlelo zokuhlukumezeka ezikhethekile.

• Imikhiqizo Eyisisekelo: Izinhlelo ezithuthukisiwe zokulawula amanxeba, imishini yokubona nge-arthroscopy, kanye nehardware ye-orthopedic trauma.

• Iphothifoliyo Eyinhloko: I-TRIGEN Interlocking Nail System inezindawo ezikhethekile eziqediwe ezilungiselelwe ukuphatha isitho esingaphansi esiqinile kanye nokuphuka kwe-humeral.

6. B. Braun Melsungen AG (Aesculap)

Imele isiqongo sobunjiniyela baseJalimane abanomlando omkhulu wezinkampani nezokuthutha e-Portugal (ikomkhulu lawo e-Queluz DE Baixo), i-B. Braun ihlinzeka izikhungo zomtholampilo zase-Portugal ngokulungiselelwa kokuhlukumezeka okuhlala isikhathi eside, okunembayo okwenziwa ngokunemba.

• Imikhiqizo Eyisisekelo: Amasistimu okwelapha ngokufaka, amathuluzi okuhlinza, izimila zomgogodla, nezingxenyekazi zekhompuyutha zokuhlukumezeka kwesakhiwo.

• Iphothifoliyo Eyinhloko: I-Targon Interlocking Nail System ihlinzeka ngokunemba kokukhiya okuphezulu kokufuna ukwakhiwa kabusha kwezakhiwo ezinamathambo amade e-femur kanye ne-tibia.

7. I-Medtronic plc

Nakuba ibusa kakhulu kuma-pacemakers nakumadivaysi omgogodla, i-structural osteo-division ye-Medtronic ibhekelela izidingo eziyinkimbinkimbi zokulungisa ukuhlukumezeka okuningi ngaphakathi kwamaqoqo ezempilo esifunda sase-Portuguese.

• Imikhiqizo Eyisisekelo: Izingxenyekazi zekhompuyutha zomgogodla, amapulatifomu okuzulazula athuthukile, amadivaysi e-neurosurgery, nokufakelwa okukhethekile kokuhlukumezeka.

• Iphothifoliyo Eyinhloko: Imiklamo yezinsimbi eguquguqukayo ebhangqwe nokucushwa okuhlanganayo kwendawo yonke efanele ukwakhiwa kabusha kwamathambo okuyinkimbinkimbi.

8. I-Orthofix Medical Inc.

I-Orthofix ihamba phambili ekuhlanganiseni amafilosofi okulungisa angaphakathi nangaphandle, enikeza izinketho eziyingqayizivele zokulungisa kabusha kwebhayoloji kochwepheshe bamathambo kulo lonke elase-Portugal.

• Imikhiqizo Eyisisekelo: Amafreyimu okulungisa angaphandle, izindlela zokwelapha ezikhuthaza ukukhula kwamathambo, namahlanganisela akhethekile okwandisa izitho ze-intramedullary.

• Iphothifoliyo Eyinhloko: Izinhlelo ezikhethekile zezingane kanye nabantu abadala ezigxilile ezigxile ekulawuleni ukukhubazeka okunzima kwe-intertrochanteric noma shaft bone.

9. I-Acumed LLC

I-Acumed igxile ekunembeni kwe-anatomical kokuqhekeka komkhawulo ongaphezulu, ukuhlinzeka ngamakhithi akhethekile athandwa ochwepheshe abangaphansi kwehlombe nengalo engenhla ezibhedlela ezizimele eziphambili zase-Portugal.

• Imikhiqizo Eyisisekelo: Amapuleti okukhiya e-anatomical, amasistimu akhethekile we-osteotomy, nezinduku ze-intramedullary ezihlosiwe eziphezulu.

• Iphothifoliyo Eyinhloko: Izinzipho ze-humeral intramedullary ezisezingeni eliphansi nezinduku zengalo zangaphambili ezidizayinelwe ukunciphisa ukufakwa kwezicubu ezithambile.

10. I-Globus Medical, Inc.

Ngemuva kokuhlanganiswa kwayo okunemininingwane ephezulu kwakamuva neNuVasive, iGlobus Medical ikhulise ngokushesha ukuhlukumezeka kwayo kanye nokwakhiwa kabusha kwamanethiwekhi okunakekelwa kwezempilo azimele eNingizimu Yurophu.

• Imikhiqizo Eyisisekelo: Izixazululo eziphelele ze-musculoskeletal, i-hardware yomgogodla ethuthukisiwe, kanye nokuzulazula kwe-robotic-assisted trauma.

• Iphothifoliyo Eyinhloko: I-CAPTIVATE Trauma System, equkethe izinsimbi ezilula ezidizayinelwe ukuhlobana okuphumelelayo kwe-femur ne-tibia.

11. I-Wright Medical Group NV (A Stryker Company)

Isebenza phakathi komndeni ohlukumezekile wakwa-Stryker, ifa le-Wright Medical elingaphansi komkhawulo ophansi kanye ne-hardware ye-foot-and-ankle ihlala iyinketho ephezulu ekwakhiweni kabusha okuhlangene okuyinkimbinkimbi nokuhlanganiswa e-Portugal.

• Imikhiqizo Eyisisekelo: Izimila zangaphezulu, ukushintshwa kwamaqakala okuphelele, kanye nokuxhunyelelwa kwamathambo okuthuthukisiwe kwe-orthobiologic.

• Iphothifoliyo Eyinhloko: I-Special Retrograde hindfoot kanye nezinduku zokuhlanganisa iqakala ezidizayinelwe ukuhlinzwa okuyinkimbinkimbi kwe-arthrodesis.

12. I-Aap Implantate AG

I-Aap Implantate ingumkhiqizi ozinze eJalimane oqashelwa ukwethula izimbotshana zesiliva ezintsha kanye nobuchwepheshe bokukhiya i-antibacterial eklanyelwe ukunciphisa izifo ezihambisana nokufakelwa.

• Imikhiqizo Eyisisekelo: Umndeni wepuleti lokukhiya le-LOQTEQ kanye nezimila zokuhlukumezeka ze-antibacterial eziboshwe ngesiliva.

• Iphothifoliyo Eyinhloko: Amasistimu wokuhlanganisa ama-titanium angakheniwe futhi aqinile akhelwe ukunciphisa izinkinga zangemva kokuhlinzwa ngesikhathi sokungenelela kwamathambo amade.

13. CarboFix Orthopedics Ltd.

I-CarboFix iyingqalabutho kubuchwepheshe be-carbon-fiber, ihlinzeka ngesiphakamiso senani elikhethekile lokuhlinzwa kwamathambo okuhlobene ne-oncology kuzo zonke izikhungo zomdlavuza ezikhethekile zase-Portugal.

• Imikhiqizo Eyisisekelo: I-Carbon fiber reinforced polymer plates, izipikili ze-carbon structural, kanye nokufakelwa kwe-radiolucent trauma.

• Iphothifoliyo Eyinhloko: I-Piccolo Composite Nails, evumela izithombe ezicacile, ezingenazo izinto ezenziwe nge-artifact ngesikhathi sokulandelela i-oncological kanye nokuqondiswa kokwelashwa ngemisebe.

14. I-MicroPort Scientific Corporation

Isebenzisa ingqalasizinda yezimboni enwetshiwe, i-MicroPort isakaza izinketho ezingabizi kakhulu, zenhliziyo nemithambo yegazi kanye nezamathambo kuwo wonke amashaneli aseNingizimu Yurophu ukuze kuhlangatshezwane nemikhawulo eqinile yesabelomali sesibhedlela.

• Imikhiqizo Eyisisekelo: Ama-stents enhliziyo ahlasela kancane, amajoyinti okwenziwa ahlangene, kanye nezingxenyekazi zekhompuyutha zokulungisa ukuhlukumezeka okuphelele.

• Iphothifoliyo Eyinhloko: Amasistimu wezinzipho ahlanganisiwe e-intramedullary aklanyelwe ukuphindaphinda, amasu okufaka alula.

15. Wego Ortho (Weigao Group)

I-Wego Ortho ingelinye lamaqoqo ezokwelapha amakhulu kakhulu e-Asia, iletha izifakelo ezinokwethenjelwa kakhulu zebanga lezokwelapha ezihlangabezana nezidingo ezinzima zomtholampilo zaseYurophu.

• Imikhiqizo Eyisisekelo: Imishini yokulungisa umgogodla, amapuleti okuhlukumezeka kwesakhiwo, izitho zokwenziwa ezihlangene, nezinto ezisetshenziswayo zokuhlinzwa eziyinyumba.

• Iphothifoliyo Eyinhloko: Uhlu olubanzi lwezinzipho ezihlala isikhathi eside ze-titanium ezibophanayo ezenzelwe izinkontileka zamathenda omphakathi abiza izindleko e-Portugal.

── PRODUCT SELECTION MATRIX ──

Imibuzo Evame Ukubuzwa (FAQ)

Q1: Ingabe izinzipho ze-intramedullary ezidingekayo emakethe yesiPutukezi zidinga Ukumakwa kwe-CE ngaphansi kwe-EU MDR?

Yebo, ngokuphelele. Kulandela ukusetshenziswa okugcwele kwe-European Medical Device Regulation (MDR 2017/745), zonke izinzipho ze-intramedullary ezithengiswa e-Portugal kufanele zibe ne -CE Mark evumelekile ngaphansi kwemihlahlandlela ye-MDR . Izimila ze-Class IIb kanye ne-Class III ze-orthopedic zibhekana nokuhlolwa okuqinile komtholampilo, ukucwaningwa kwamadokhumenti obuchwepheshe, kanye nokulandela umtholampilo kwangemuva kwemakethe (PMCF). Abaphathi bokuthengwa kwempahla kufanele baqinisekise ukuthi noma yimuphi umkhiqizi wamazwe ngamazwe, njenge-CZMEDITECH, uhlinzeka ngeSimemezelo Sokuvumelana futhi ubhaliswe ngokugcwele kusizindalwazi se -EUDAMED .

Q2: Yiziphi izimfuneko ezithile zokubhalisa nge-INFARMED?

Ngisho ne-CE Mark esebenzayo, noma iyiphi idivayisi yezokwelapha esabalaliswa ngaphakathi kwe-Portugal kufanele ibhaliswe futhi yaziswe ku- INFARMED ( Autoridade Nacional do Medicamento e Produtos de Saúde, IP ) ngengosi kazwelonke yokubhalisa idivayisi yezokwelapha. Amabhizinisi endawo kufanele aqinisekise ukuthi idatha yedivayisi ilayishwa ngokugcwele kusizindalwazi se-INFARMED ngaphambi kokuba imikhiqizo ithengiswe ngokusemthethweni noma ihanjiswe ngamathenda ezibhedlela zikahulumeni.

Q3: Kungani izinhlelo ze-Helical Blade (ezifana ne-PFNA) zibekwe phambili kakhulu ku-Unidades Locais de Saúde (ULS)?

I-Portugal ibhekene nezibalo zabantu abaguga kakhulu, okuholela emazingeni aphezulu okuphuka kwe-osteoporotic proximal femoral (hip) ezibhedlela zikahulumeni. Izikulufu ze-lag zendabuko zivame ukuhluleka 'ukusika-ngaphandle' komshini ezakhiweni zamathambo aphukayo. Ukuthola amasistimu athuthukile njenge-PFNA ye-CZMEDITECH, esebenzisa i-helical blade eguquguqukayo ukuze iminyanise esikhundleni sokubhoboza izicubu zethambo, kukhulisa ukuzinza okujikelezayo futhi kuvimbela ngokuphawulekayo ukubuyiselwa kwesibhedlela okumba eqolo—inkomba yokusebenza ebalulekile yesabelomali semitholampilo yamanethiwekhi esimanje e-ULS.

Q4: Ngabe ukuthengwa kwempahla endaweni eyodwa nge-SPMS kunomthelela kanjani ekutholweni kwezipikili ze-IM?

I- SPMS ( Serviços Partilhados do Ministério da Saúde ) iphethe izivumelwano zohlaka ezimaphakathi, zeminyaka eminingi ( Acordos-Quadro ) zemishini yezokwelapha e-Portugal. Amathenda omphakathi ahlola iziphakamiso ngokusekelwe kwinhlanganisela yokufaneleka kobuchwepheshe (ukuthobela okubalulekile njenge-Titanium yeBanga lesi-5, ukuzinza kwemishini, ne-ergonomics yezinsimbi) kanye nokusebenza kahle kwezomnotho. Abakhiqizi bomhlaba wonke abangahlinzeka ngezinhlelo eziphelele, ezithobela imithetho ezinhlakeni zokukhiqiza ezincintisana kakhulu (njenge-CZMEDITECH) babekwe njengezinketho ezinhle kakhulu zokuwina izinkontileka zezempilo zomphakathi ezisekelwe umthamo.

Q5: Yiziphi izilawuli zokulandela umkhondo nezilebula eziyisibopho ngaphakathi kwasetiyetha ezisebenza ngesiPutukezi?

I-Portugal isebenzisa ngokuqinile i-European UDI (Unique Device Identification) uhlelo. Zonke izipikili ze-intramedullary nesikulufu esixhumene kufanele zibe nebhakhodi efakwe ikhodi (DataMatrix) ehlinzeka ngokulandeleka okuphelele kusukela esitezi sokukhiqiza kuya kurekhodi lezempilo ledijithali lesiguli ( Registo de Saúde Eletrónico ). Ukwengeza, amalebula womkhiqizo namabhukwana wemiyalo ( Instruções de Utilização ) kufanele anikezwe ngokucacile ngesi- Portuguese ukuze athobele imithetho zokuphepha kazwelonke.

Q6: Ingabe amaqembu ezibhedlela zasePortugal angakwazi ukuhlanganisa imigqa yokuhlukumezeka eminingi evela kumkhiqizi oyedwa wamazwe ngamazwe?

Yebo, futhi lokhu kukhuthazwa kakhulu ngezindleko nokuthuthukiswa kokuphatha. Ukuhlanganisa imigqa yokuhlukumezeka ngozakwethu oyedwa oqondile kuvumela amaqembu ezibhedlela zase-Portuguese (njenge-CUF noma i-Luz Saúde) noma i-ULS yesifunda ethenga indawo emaphakathi ukuze azuze emnothweni wesilinganiso. Ukuthola okuvela kumkhiqizi odidiyelwe ofana ne-CZMEDITECH kuvumela inethiwekhi yesibhedlela ukuthi ithole Izinzipho Zowesifazane, Izinzipho Ze-Tibial, amapuleti okukhiya e-anatomical, namathuluzi wamandla wezokwelapha ngesikhathi esisodwa—ukuqondisa ukulawulwa kwe-invoyisi yokuphatha, ukunciphisa ukugcwala kwempahla, kanye nokuqinisekisa ukuhlelwa kwethuluzi lokuhlinza elisezingeni kunethiwekhi yegumbi lokuhlinza.

Isiphetho

Ngenkathi izinhlobo zefa zendabuko zaseNyakatho Melika kanye nase-Europe Emaphakathi ziqhubeka nokuba nezabelo zemakethe ezibalulekile zomlando ezikhungweni ze-tier-1 zase-Portugal, izimfuno ezikhulayo zezimali ku- Serviço Nacional de Saúde (SNS) ziqhubekisele phambili ukubheka kubakhiqizi abagugile, abagunyazwe emhlabeni jikelele. Abahlinzeki bayathanda I-CZMEDITECH iletha isiphakamiso senani esiphoqelela kakhulu samayunithi okuhlukumezeka esimanje asePortugal ngokufanisa izitifiketi zezokwelapha zase-Europe (CE / ISO) kanye nezinto zokusetshenziswa zebanga lokutshala ezinezakhiwo ezithuthukiswe kakhulu.