Abavelisi beZikhonkwane abali-15 abaPhezulu baseSpain (iSikhokelo sokuThenga se-2026)

Intshayelelo

Indawo yokuthengwa kwezixhobo zonyango kwicandelo lamathambo eSpain ifumana inguqu ekhawulezileyo yolwakhiwo. Iqhutywe yimimiselo engqongqo yokugcinwa kweendleko ezivela kwi-Ofisi yoMphathiswa wezeMpilo ( Ministerio de Sanidad ) kunye ne-decentralized high trauma volumes elawulwa ziinkonzo zempilo zoluntu ezizimeleyo ( Servicios de Salud Autonómicos ) -njenge-SERMAS (Madrid), SAS (Andalucía), Catsalut (Cataluña), kunye ne-SACYylón yesibhedlele sangasese (i-Cataluña), kunye ne-SACYLón yesibhedlele sabucala kunye ne-Vithas-iibhodi zokuthengwa kwesibhedlele zibeka phambili ukufakelwa kwezinto ezibonelela ngolungelelwaniso olufanelekileyo lokusebenza kwekliniki, ukhuseleko lolawulo, kunye nokuqikelelwa kohlahlo lwabiwo-mali.

Xa ulawula ukuphuka kwamathambo amade, ukukhetha i-intramedullary efanelekileyo (IM) iqabane lesikhonkwane kubalulekile ekunciphiseni iingxaki emva kokusebenza kunye nokulawula iindleko zeziko phantsi kwesakhelo seLicitaciones Públicas (IiTenda zoLuntu). Esi sikhokelo sichaza i-Top 15 ye-Intramedullary Nail Manufacturers e-Spain, egxininisa kwiipotifoliyo zabo eziphambili, udumo lwemarike, kunye neteknoloji engundoqo yokuncedisa iinjineli ze-biomedical, oogqirha bamathambo, kunye nabaphathi bokubonelela ekwenzeni izigqibo eziqhutywa yidatha.

Ukwandiswa kobuGcisa: Ukuqonda uYilo lweZikhonkwane oluKhethekileyo lwe-Intramedullary kwiNgxowa-mali yoNtuthuko yanamhlanje

Kuvandlakanyo olubanzi lwethenda yezonyango kuzo zonke iindawo ezikhokelayo zokhathalelo lwempilo, ukuthengwa kwe-orthopedic trauma kufuna ukuqonda okunzulu kobugcisa bokufakelwa koomatshini. Izikhonkwane ze-Intramedullary azisezontonga zentsimbi; utyando lwangoku lufuna uyilo olukhethekileyo lwebhayomechanical olulungelelaniswe nolungelelwaniso oluthile lokuqhekeka kunye nezifo zesigulana.

Ukunceda iibhodi zezibhedlele kunye neekomiti zotyando zilungelelanise ukufunyanwa komonzakalo, kubalulekile ukuqonda iindidi ezikhethekileyo ze-Intramedullary Nails ezilawula iithiyetha zamathambo zanamhlanje:

1. Izikhonkwane ze-Intramedullary ezinxibelelanayo (Izikhonkwane eziQinisekileyo vs. I-Cannulated)

Ukhetho phakathi koyilo lwezikhonkwane oluqinileyo kunye noluqholiweyo luchaphazela kakhulu ukuhamba komsebenzi wotyando kunye nokuphiliswa kwamathambo ebhayoloji.

• I-Cannulated Intramedullary Nails  : Ezi zikhonkwane zibonisa iziko elingenalutho, elivumela ukuba lifakwe phezu kocingo lwesikhokelo. Olu luyilo luvumela oogqirha botyando ukuba benze ukufakwa kwe-reamed, eyandisa i-medullary canal, ivumela isikhonkwane esikhulu, esomeleleyo, kwaye ifake amaqhekeza amathambo asekuhlaleni ngokuthe ngqo kwindawo yokwaphuka ukukhawulezisa ukuphiliswa.

• Izikhonkwane eziqinileyo ze-Intramedullary: Ngokuyintloko zisetyenziswa kwiindlela ezingakhange zihlaziywe, izikhonkwane eziqinileyo zihlala zikhethwa kwiindawo ezivulekileyo ezivulekileyo okanye iimeko ze-polytrauma ukunciphisa umngcipheko we-fat embolism kunye nokunciphisa ukuphazamiseka kokunikezelwa kwegazi endosteal.

2. Izikhonkwane zeCephalomedullary & Proximal Femoral Systems

Ukuqhekeka okwenzeka ekupheleni kwe-femur (ummandla we-hip), izikhonkwane eziqhelekileyo ezidibeneyo azanelanga. Iinkqubo ezikhethekileyo ze-cephalomedullary ziyafuneka ukujongana nemithwalo enzima ye-physiological.

• ULungiselelo lokutshixa uLwakhiwo ngokutsha : Olu luyilo lubonisa imingxunya ekhethekileyo yokulandela umkhondo e-engile malunga ne-130 ukuya kwi-135 degrees, ivumela izikrufu ezisindayo ukuba zidlule kwisikhonkwane ngqo kwintloko ye-femoral, zikhusele i-subtrochanteric okanye i-ipsilateral femoral shaft fractures.

• Iinkqubo ze-Anti-Rotation Helical Blade : Isetyenziswa kakhulu kwi-geriatric hip fractures, ezi nkqubo zithatha indawo ye-screws ye-lag yesiko kunye ne-compression blade. Olu luyilo lucinezela ithambo elirhangqileyo elirhoxisayo endaweni yokulisusa, linciphisa kakhulu umngcipheko wokufakelwa 'ukunqunyulwa' kwithambo le-osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ngokuxhomekeke kwindawo yokuphuka kunye nokunyaniseka kwezicubu ezithambileyo, oogqirha botyando kufuneka bakhethe ii-portal zokungena ezichaseneyo zokufakwa kwezikhonkwane.

• I-Anterograde Sourcing : Ukufakelwa kwezinto ezifakwe kwisiphelo esisondeleyo (umzekelo, ukungena kwi-trochanter ye-femur fracture). Oku kufuna ukugoba okuchanekileyo ukuze kutshatise ukugoba kwendalo ye-anatomical.

• I-Retrograde Sourcing : Ukufakelwa kwezinto ezifakwe kwi-distal end (umzekelo, ukungena ngaphezu kwedolo elihlangeneyo). Izikhonkwane ezikhethekileyo ze-retrograde femoral zibonisa iipateni zokutshixa ezikhethekileyo ze-distal ukukhusela i-distal yesithathu ye-supracondylar fractures.

Iingxilimbela zoShishino lweHlabathi kunye neempawu eziphambili

1. Stryker Corporation

Umdlali ogqwesileyo kwi-Spain's tier-1 yekliniki yabucala kunye namaziko okwenzakala kwiyunivesiti ephezulu, iStryker ese-US ithathelwa ingqalelo kakhulu ngobunjineli bayo obuchanekileyo kunye nenkxaso yorhwebo eyomeleleyo.

• IiMveliso eziPhambili: Ukutshintshwa okudibeneyo, iiplatifomu ezincedisa i-robotic (i-Mako), izixhobo ze-neurotechnology, kunye neenkqubo eziphambili zokulungiswa kwe-trauma.

• Ipotfoliyo engundoqo: Inkqubo ye-Gamma4 Trochanteric Nail System kunye ne-T2 Alpha Interlocking Nail System inikezela ngozinzo oluphezulu lomatshini kunye noqwalaselo lwesixhobo ekujoliswe kuso.

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

Ibambe isikhundla esinzulu kuwo omabini amacandelo oluntu (SNS) kunye nezibhedlele zabucala eSpain, iDePuy Synthes ifumana amashumi eminyaka ophando lwezonyango oluxhaswa yi-AO Foundation.

• IiMveliso eziPhambili: Iinkqubo ze-trauma ezibanzi, izisombululo zokuvuselela ngokubambisana, izixhobo ze-craniomaxillofacial, kunye ne-spinal biomaterials.

• Ipotfoliyo enguNdoqo: Inkqubo yeNgcali yezikhonkwane kunye ne-TFNA (i-Trochanteric Fixation Nail Advanced) zisebenzisa unyango lwesinyithi olunobunikazi olulungiselelwe i-trochanteric enzima kunye nokuphuka kwamathambo amade.

3. CZMEDITECH

Njengendlu yamandla eyaziwayo kwihlabathi kwizixhobo zonyango zamathambo, I-CZMEDITECH iseke indawo yobonelelo olwandiswayo kwimarike yaseMazantsi Yurophu, ngakumbi eSpain. Yaziwa ngokuvala umsantsa phakathi kobunjineli benqanaba lokuqala lobuchwephesha baseJamani kunye nokhuphiswano oluphezulu lwemveliso, inkampani ibonelela ngephothifoliyo ebanzi yokwenzakala ebambe iziqinisekiso zonyango ezingqongqo zamazwe aphesheya-kubandakanywa ne-ISO 13485, iziqinisekiso ze-CE-iyenza iqabane elifanelekileyo lee -Hospitals Universitarios ezinkulu kunye nothungelwano lwezempilo lwabucala olufuna ukufumana inzuzo ephezulu yaseYurophu.

• IiNkqubo zeTrauma ye-Orthopedic: I-Advanced Interlocking Izikhonkwane ze-Intramedullary , i-Anatomical Iipleyiti zokutshixa kunye nezikrufu, kunye Iinkqubo zokuLungisa ngaphandle.

• Izisombululo zoLungiso lweSpine : I-Anterior / Posterior Cervical & Thoracolumbar Systems, i-Interbody Fusion Cages, kunye ne-Spinal Fixation Rods.

• Ukufakelwa kwe-Cranio-Maxillofacial (CMF) : IiPlates ze-Titanium ze-Ultra-low kunye ne-Mesh Systems zokuvuselela ubuso.

• Izixhobo zaMandla okuSebenza kunye neZincedisi: I-High-performance Orthopedic Drills, i-Oscillating Saws, kunye neekhithi zesixhobo sokulinganisa inzala.

• Iinkonzo ze-OEM/ODM ezenzelwe wena : Ukwenziwa kwesixhobo sonyango esisekugqibeleni esilungiselelwe ukucaciswa kwezibhedlele zehlabathi.

• IPotfoliyo Yezikhonkwane ze-IM kunye noNxibelelwano:

  • Isikhonkwane se-Femoral Intramedullary: Yenziwe kwi-implant-grade ye-Titanium Alloy (Ti-6Al-4V ELI), ene-curvature ye-anatomical ephuculweyo kunye ne-multi-planar locking configurations ukubonelela ukulungiswa okuqinileyo kwiifractures zeshaft eziyinkimbinkimbi.

  • I-Tibial Intramedullary Nail: Idizayinelwe ngeendlela eziqhubela phambili zokutshixa eziguqukayo kunye neprofayili ye-cannulated, ukukhuthaza ubunzima bokuqala kunye nokukhawuleza ukuphulukiswa kwamathambo.

  • I-Humeral Intramedullary Nail: Isisombululo esikhethekileyo esiphezulu esiphezulu esiququzelela indlela encinci, ukunciphisa ukuphazamiseka kwezicubu ezithambileyo kunye nokukhusela i-rotator cuff.

  • I-Proximal Femoral Nail Antirotation - PFNA : Iquka inkqubo ye-helical blade elungiselelwe izigulane ezikhulileyo ezinezakhiwo zamathambo e-osteoporotic, ziqinisekisa ukuxhathisa okuphezulu ngokuchasene nokusikwa ngexesha lokulungiswa kwe-trochanteric fracture.

4. Zimmer Biomet Holdings, Inc.

I-Zimmer Biomet idibanisa amaqonga okhathalelo lwempilo yedijithali kunye ne-premium ye-musculoskeletal fixation technologies, ekhonza iinkqubo ezinkulu zezempilo kwi-metropolitan kwi-Spain.

• IiMveliso eziPhambili: Iimetriki zempilo ezilungelelanisiweyo zedijithali, ukutshintshwa ngokudibeneyo, izixhobo zamayeza ezemidlalo, kunye nokufakelwa kwe-trauma.

• IPotfoliyo Engundoqo: Inkqubo Yezikhonkwane zeNdalo ineegophe ze-anatomical eziyilelwe ukuba zilungele iimophologies zezigulane ezahlukeneyo kwiintlanga ezininzi zaseYurophu.

5. Smith & Nephew plc

Ngokusebenza ngokuthe ngqo okusebenzayo kunye nee-hubs ze-Logistics ezomeleleyo kulo lonke elaseNtshona Yurophu, i-UK-based Smith & Nephew igqwesa kukhathalelo oluphezulu lwamanxeba kunye neenkqubo ezikhethekileyo zokwenzakala.

• IiMveliso eziPhambili: Iinkqubo zokulawula amanxeba aphezulu, izixhobo zokubonwa kwe-arthroscopy, kunye ne-orthopedic trauma hardware.

• Ipotfoliyo enguNdoqo: Inkqubo ye-TRIGEN Interlocking Nail System ibonakalisa umphezulu okhethekileyo ogqityiweyo olungiselelwe ukulawula imilenze ephantsi kakhulu kunye nokwaphuka kwe-humeral.

6. B. Braun Melsungen AG (Aesculap)

Ukumela incopho yobunjineli baseJamani enembali enkulu kunye nobukho benkampani eSpain (ikomkhulu e-Rubí, e-Barcelona), i-B. Braun ibonelela ngamaziko eklinikhi aseSpain ngolungelelwaniso oluhlala luhleli, oluchanekileyo olwenziwe ngokuchanekileyo.

• IiMveliso eziPhambili: Iinkqubo zonyango lwe-Infusion, izixhobo zotyando, ukufakelwa komgogodla, kunye ne-hardware ye-trauma yesakhiwo.

• Ipotifoliyo engundoqo: Inkqubo yeTargon eHlangeneyo yeNail ibonelela ngokuchaneka okuphezulu kokutshixa ngokufuna ukwakhiwa kwakhona kwethambo elide le-femur kunye nezakhiwo ze-tibia.

7. I-Medtronic plc

Ngelixa ixhaphake kakhulu kwizincedisi-ntliziyo kunye nezixhobo zomqolo, i-osteo-division yesakhiwo se-Medtronic ibonelela kwiimfuno ezintsonkothileyo zokulungiswa komonzakalo phakathi kwamaqela ezempilo engingqi yaseSpain.

• IiMveliso eziPhambili: I-hardware yomgogodla, iiplatifomu ezihamba phambili zokuhamba, izixhobo ze-neurosurgery, kunye nokufakelwa kwe-trauma ekhethekileyo.

• Ipotfoliyo enguNdoqo: Uyilo lwezixhobo eziguquguqukayo ezidityaniswe nolungelelwaniso oludityanisiweyo lwendalo yonke olulungele ukwakhiwa ngokutsha kwamathambo anzima.

8. Orthofix Medical Inc.

I-Orthofix iyagqwesa ekudibaniseni intanda-bulumko yokulungiswa kwangaphakathi nangaphandle, ibonelela ngokhetho olulodwa lohlengahlengiso lwebhayoloji kwiingcali zamathambo kulo lonke elaseSpain.

• IiMveliso eziPhambili: Izakhelo zokulungisa zangaphandle, unyango lokuvuselela amathambo, kunye neendibano ezikhethekileyo ze-intramedullary-lengthening.

• Iipotifoliyo ezingundoqo: Iinkqubo ezikhethekileyo zabantwana kunye nezikhonkwane ezincinci ezigxile ekulawuleni i-intertrochanteric enzima okanye iziphene zamathambo e-shaft.

9. Acumed LLC

I-Acumed igxile ekuchanekeni kwe-anatomical yokwaphuka okuphezulu, ibonelela ngezixhobo ezikhethekileyo ezithandwa ngamagxa kunye neengcali ezisezantsi kwizibhedlele eziphambili zaseSpain.

• IiMveliso eziPhambili: Iiplati zokukhiya i-anatomical, iinkqubo ze-osteotomy ezikhethekileyo, kunye neentonga ezijoliswe kuzo eziphezulu ze-intramedullary.

• Ipotfoliyo engundoqo: Izikhonkwane ze-humerary ezisezantsi kunye neerodi ze-forearm eziyilelwe ukunciphisa ukufakwa kwezicubu ezithambileyo.

10. Globus Medical, Inc.

Ukulandela ukudityaniswa kwayo kwiprofayili yamva nje kunye ne-NuVasive, iGlobus Medical iye yandisa ngokukhawuleza ukwenzakala kwayo kunye nokwakhiwa kwakhona kuthungelwano lwezempilo lwabucala kuMazantsi eYurophu.

• IiMveliso eziphambili: Izisombululo ezibanzi ze-musculoskeletal, i-hardware ye-spinal ephezulu, kunye ne-robotic-assisted trauma navigation.

• Ipotfoliyo enguNdoqo: Inkqubo yeCAPTIVATE yeTrauma, enesixhobo esilungelelanisiweyo esenzelwe ukudibanisa ngokufanelekileyo kwe-femur kunye ne-tibia.

11. I-Wright Medical Group NV (iNkampani ye-Stryker)

Ukusebenza ngaphakathi kwintsapho ye-Stryker trauma, i-Wright Medical's legacy esezantsi kunye ne-foot-and-ankle hardware ihlala iyona khetho ephezulu yokwakhiwa ngokutsha okudibeneyo kunye nokudibanisa eSpain.

• IiMveliso eziPhambili: Ukufakelwa kwamathambo aphezulu, ukutshintshwa kwe-ankle epheleleyo, kunye ne-orthobiologic bone grafts.

• Ipotfoliyo engundoqo: I-Retrograde retrograde hindfoot kunye ne-ankle fusion rods eyilelwe utyando olunzima lwe-arthrodesis.

12. Aap Implantate AG

I-Aap Implantate ngumvelisi osekwe eJamani owamkelwa ukwazisa izinto ezintsha zokugquma isilivere kunye nobuchwepheshe bokutshixa beantibacterial eyenzelwe ukunciphisa usulelo olunxulumene nokufakelwa.

• Iimveliso eziphambili: Usapho lwe-LOQTEQ lokutshixa ipleyiti kunye nokufakelwa kwe-antibacterial trauma efakwe ngesilivere.

• Ipotfoliyo engundoqo: Iinkqubo ezidityanisiweyo ze-titanium ezinamatonki neziqinileyo ezakhelwe ukunciphisa iingxaki zasemva kokusebenza ngexesha longenelelo lwamathambo amade.

13. CarboFix Orthopedics Ltd.

ICarboFix nguvulindlela kwitekhnoloji ye-carbon-fiber, ebonelela ngexabiso elikhethekileyo lotyando olunxulumene ne-oncology kumaziko omhlaza akhethekileyo eSpain.

• IiMveliso eziPhambili: Iiplate ze-polymer eziqiniweyo zeCarbon fiber, izikhonkwane zekhabhoni zesakhiwo, kunye nokufakelwa kwe-radiolucent trauma.

• Ipotfoliyo enguNdoqo: Izikhonkwane zePiccolo Composite, ezivumela umfanekiso ocacileyo, ongenazo izinto zakudala ngexesha lokulandelelwa kwe-oncological kunye nokujolisa kunyango lwemitha.

14. I-MicroPort Scientific Corporation

Isebenzisa isiseko semizi-mveliso esandisiweyo, iMicroPort isasaza iindleko zokonga, umthamo ophezulu wentliziyo kunye nonyango lwamathambo kuwo onke amajelo akuMazantsi Yurophu ukuhlangabezana nemiqobo engqongqo yohlahlo lwabiwo-mali lwesibhedlele.

• Iimveliso eziphambili: I-stents ye-cardiovascular invasive encinci, i-prostheses edibeneyo, kunye ne-hardware yokulungisa i-trauma epheleleyo.

• Ipotfoliyo enguNdoqo: Iisistim ezidityanisiweyo zezikhonkwane ze-intramedullary ezenzelwe ukuphinda-phinda, ubuchule bokufaka obulungelelanisiweyo.

15. Wego Ortho (Weigao Group)

I-Wego Ortho yenye yeendibano ezinkulu zonyango zase-Asiya, inikezela ngokufakelwa kwemigangatho yezonyango ethembekileyo ehlangabezana neemfuno ezingqongqo zeklinikhi zaseYurophu.

• IiMveliso eziPhambili: Izixhobo zokulungisa umqolo, iipleyiti ze-structural trauma, i-prostheses edibeneyo, kunye nezinto ezisetyenziswayo zotyando eziyinyumba.

• Ipotfoliyo enguNdoqo: Uluhlu olubanzi lwezikhonkwane ezidityanisiweyo zetitanium ezilungiselelwe iindleko zoluntu lwekhontrakthi yethenda yengingqi eSpain.

── IMVELISO YOKUKHETHA MATRIX ──

Imibuzo Ebuzwa Rhoqo (FAQ)

I-Q1: Ngaba izikhonkwane ze-intramedullary ezifunekayo kwimarike yaseSpain zifuna i-CE Marking phantsi kwe-EU MDR?

Ewe, ngokupheleleyo. Ukulandela ukunyanzeliswa okupheleleyo kwe-European Medical Device Regulation (MDR 2017/745), zonke izikhonkwane ze-intramedullary ezithengiswa eSpeyin kufuneka zithwale i -CE Mark efanelekileyo phantsi kwezikhokelo ze-MDR . Ukufakelwa kwamathambo kuKlasi IIb kunye noKlasi III lujongene novavanyo olungqongqo lweklinikhi, uphicotho lwamaxwebhu obugcisa, kunye nolandelelo lwezonyango lwasemva kokuthengisa (PMCF). Abaphathi beentengo kufuneka baqinisekise ukuba nawuphi na umenzi wamazwe ngamazwe, njenge-CZMEDITECH, unikezela ngeSibhengezo sokuThotyelwa kwaye ubhaliswe ngokupheleleyo kwi- database ye-EUDAMED .

I-Q2: Ziziphi iimfuno ezikhethekileyo zokubhalisa kunye ne-AEMPS yaseSpain?

Nokuba nge-CE Mark esebenzayo, nasiphi na isixhobo sonyango esisasazwa ngaphakathi eSpain kufuneka saziswe kwi- AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) nge- Aplicación de Comunicación de Comercialización de Productos Sanitarios (CCPS). Abarhwebi abavela kumazwe angaphandle kunye nabasasazi bendawo kufuneka kwakhona babe neLicencia Previa de Funcionamiento de Instalaciones (iPhepha-mvume lokuSebenza kwaPhambi kweZibonelelo), beqinisekisa ukongamela okupheleleyo kwasekhaya phambi kokuba iimveliso zibe nokubhidelwa ngokusemthethweni kwiithenda zengingqi.

I-Q3: Kutheni iinkqubo ze-Helical Blade (ezifana ne-PFNA) zibekwe phambili kakhulu kwiinkonzo zempilo zengingqi (umzekelo, i-SERMAS, i-SAS)?

ISpain ineyona ndawo iphakamileyo elindelekileyo yokuphila kunye neyona ndawo indala yabantu eYurophu, ekhokelela kumthwalo omkhulu wokuqhekeka kwe-osteoporotic proximal femoral. Izikrufu zesiqhelo ze-lag zihlala zisilela ngoomatshini 'ukusika-ngaphandle' kwithambo elibuthathaka. Ukufumana iinkqubo eziphambili ezifana ne-PFNA ye-CZMEDITECH, esebenzisa i-helical blade eguquguqukayo ukuze icinezele kunokuba ikhuphe izicubu zethambo, inyusa uzinzo olujikelezayo kwaye ithintele ngokubonakalayo ukufundwa kwesibhedlele esinexabiso eliphezulu kunye nohlaziyo-iinqobo eziphambili zokufumana amanqaku kwiikontrakthi zobonelelo zikawonke-wonke zeminyaka emininzi.

I-Q4: Umthetho wethenda woluntu waseSpain (LCSP) unachaphazela njani ukufunwa kwezikhonkwane ze-IM?

Ngaphantsi koMthetho weZibhambathiso zeCandelo loLuntu lwaseSpain ( Ley de Contratos del Sector Público - LCSP ), ukuthengwa kwesibhedlele sikarhulumente akunakusekelwe kuphela kwixabiso. Iithenda zicwangciswe malunga nokuThengwa okuSekwe kwiXabiso , apho ukufaneleka kwezobugcisa (ukuthotyelwa kwezinto ezifana neBanga lesi-5 i-Titanium ASTM F136, i-ergonomics ye-instrumentation, ukulandelwa, kunye neenkcukacha zekliniki) zifikelela kwi-50-60% yamanqaku ewonke. Abavelisi ababonelela ngeeprofayili zoomatshini beprimiyamu ngobuchule bokwenza izinto (ezifana ne-CZMEDITECH) babambe ukhuphiswano olunamandla.

I-Q5: Luluphi ulawulo lokulandelelwa olufunekayo kwizikhonkwane ze-intramedullary ngaphakathi kwezibhedlele zaseSpain?

ISpain inyanzelisa ngokungqongqo inkqubo ye -UDI (Unique Device Identification) phantsi kwegunya le-EU. Isikhonkwane ngasinye se-intramedullary kunye nesikrufu esivalekileyo kufuneka sibe nenkqubo yokulandela ibhakhowudi (DataMatrix) ebonelela ngokulandeleka okupheleleyo ukusuka kumenzi ukuya kwirekhodi yempilo ye-elektroniki yesigulana (EHR). Abasasazi bendawo kufuneka bagcine iinkqubo zokulandela umkhondo weqashiso/ibhetshi engenakufezekiswa ukuze benze ukukhumbula ngokukhawuleza okanye izilumkiso zokhuseleko ukuba ziphawulwe yi-AEMPS.

I-Q6: Ngaba amaqela okhathalelo lwempilo yaseSpain angadibanisa imigca emininzi yokwenzakala evela kumenzi omnye wamazwe ngamazwe?

Ewe, kwaye oku kukhuthazwa kakhulu kwiindleko kunye nokuphucula ulawulo. Ukudibanisa imigca yokwenzakala ngeqabane elinye elithe ngqo okanye umsasazi ogunyazisiweyo womthombo omnye uvumela amaqela ezibhedlele zaseSpain (ezifana neHM Hospitales okanye iQuirónsalud) okanye ukuthengwa kwengingqi ukuze kuxhamle kuqoqosho lwesikali. I-Sourcing evela kumvelisi odibeneyo onjenge-CZMEDITECH ivumela inethiwekhi yesibhedlele ukuba ifumane izikhonkwane ze-Femoral, izikhonkwane zeTibial, iipleyiti zokutshixa i-anatomical, kunye nezixhobo zamandla zonyango ngaxeshanye-ukulungelelanisa ukulawulwa kwe-invoyisi yolawulo, ukunciphisa imithwalo yekhabhoni ehambelana nomthwalo, kunye nokuqinisekisa ukucwangciswa kwezixhobo zotyando ezisemgangathweni kwinethiwekhi yegumbi lokusebenza.

Ukuqukumbela

Ngelixa iibrendi zemveli zaseMntla Melika kunye nakuMbindi Yurophu ziqhubeka nokubamba izabelo ezibalulekileyo zezentengiso kumaziko e-Spain tier-1, ukunyuka kwamabango emali kwiSistema Nacional de Salud (SNS) kuqhubele phambili ukubheka phambili, kubavelisi abaqinisekisiweyo behlabathi. Ababoneleli abanje nge-CZMEDITECH bazisa isindululo sexabiso esinyanzelisayo kwiiyunithi zomothuko zala maxesha zaseSpain ngokuthelekisa iziqinisekiso zonyango zaseYurophu (CE MDR) kunye nokufakelwa kwebakala lemathiriyeli ekrwada enezakhiwo eziphuculwe kakhulu.

Ukuqukumbela

Ngelixa iibrendi zelifa lemveli kuMntla Merika kuMbindi Yurophu ziqhubeka nokubamba izabelo ezibalulekileyo zezentengiso kumaziko e-Spain akwinqanaba loku-1, ukunyuka kwamabango emali kwiSistema Nacional de Salud (SNS) kuqhubele phambili ukubheka phambili, kubavelisi abaqinisekisiweyo behlabathi. Ababoneleli bayathanda I-CZMEDITECH inikezela ngexabiso elincomekayo lexabiso leeyunithi zomothuko zangoku zaseSpain ngokuthelekisa izatifikethi zonyango zaseYurophu (CE / ISO) kunye nokufakelwa kwemigangatho yemathiriyeli ekrwada enezakhiwo eziphuculwe kakhulu.