Ƒumeŋutinunyalawo: Mɔfiame Nyui aɖe Na Vetting Implants And Instruments le U.S.A

Ƒumeŋutinunyalawo tiatia menye unit ƒe asi ko o. Le mamala siwo dzraa nu ɖe ​​United States kɔdziwo kple amekokoƒewo gome la, nudzralawo ƒe nyametsotso va zua afɔku ŋuti nyametsotso: nuŋlɔɖiwo ƒe megbetsitsi ate ŋu awu dɔbiagbalẽviwo, dzesidenyawo ate ŋu axe mɔ ɖe nudɔdɔwo nu, eye dometsotso siwo le wo yometiti me ate ŋu atrɔ nyatoƒoetoto sue aɖe wòazu ŋkuɖoɖo nu dzi bliboe.

Mɔfiame sia nye sidzedze ƒe afɔɖeɖe ƒe ɖoɖo: eɖe nusi 'ƒumeŋutinunyalawo' fia zi geɖe, alesi nuzazãwo ƒe kɔsɔkɔsɔa wɔa dɔe, United States ƒe sedziwɔwɔ ƒe gɔmedzenu siwo wòle be nànya, kple ɖaseɖigbalẽ nyui aɖe si nàte ŋu azã atsɔ ana ƒumeŋutinunyalawo kple dɔwɔnuwo nadzelawo nadze.

Nu vevi siwo woatsɔ ayi teƒe bubuwo

• 'Ƒeŋutinunyalawo' ateŋu afia adzɔnuwɔla, nubablawɔla, alo mamala/gbugbɔgadzraɖola—ɖe akpa siwo woawɔ me hafi nàda wo kpɔ.

• Le U.S.A. la, àdi be yease alesi FDA 510(k) ƒe mɔɖeɖe ku ɖe ƒumeŋuɖui geɖe siwo wotsɔ dea ƒumeŋuɖui me ŋu kple alesi woaɖo kpe dzesi vevi siwo fia be wowɔ ɖe se dzii dzi.

• Nudzralawo ƒe dzedze ƒe ɖoɖo sesẽ aɖe nye nuŋlɔɖi-gbãtɔ: wo yometiti, tɔtrɔwo dzi kpɔkpɔ, vidzidzi/nubablɛwo ƒe kpeɖodzi (ne esɔ), kple CAPA ƒe amehehe le vevie wu asitsatsa ŋuti nyawo.

• UDI traceability menye dzesidede nu tsitotsito ko o—enye megbeƒu na ŋkuɖoɖonudzi dzadzraɖo kple nudzraɖoƒe ƒe nyateƒetoto.

Nusi 'ƒumeŋutinunyalawo' fia (kple nusita nya la tɔtɔa ame) .

Le nuwɔna me la, amewo zãa 'ƒumeŋutinunyalawo' abe kpukpui ene na dɔwɔƒe ɖesiaɖe si ate ŋu ana ƒumeŋuɖuiwo kple dɔwɔnuwo ɣesiaɣi—plate kple screws, intramedullary nails, spinal fixation systems, joint reconstruction systems, kple instrument sets siwo hiã be woatsɔ ade wo me.

Gake nya la ɣla nya vevi aɖe: 'nudzrala' si le wò nubabla me ateŋu anye:

• Sedziwɔla / dzesidela (dɔwɔƒe si kpɔa dzesideŋkɔ, sedede ƒe nyawo ɖoɖoɖa, kple asitsatsa megbe agbanɔamedziwo dzi) .

• Nubablawɔƒe si le nu wɔm na dzesidenu bubu

• Numamãla ame alo si gbugbɔa ŋkɔ deŋgɔ (si ate ŋu atrɔ sedziwɔwɔ ƒe agbanɔamedziwo) .

Hafi nàde dzesi nudzrala aɖe la, na biabia eve me nakɔ:

1. Amekae nye mɔ̃ si nàdzra ayi U.S.A.

2. Dɔwɔƒe kae tɔe nye ɖoɖowɔwɔ ŋuti nuŋlɔɖiwo kple tɔtrɔwo dzi kpɔkpɔ ƒe ɖoɖoa?

Ŋuɖoɖo mawoe afia nusi dzi nàte ŋu aɖo kpee—kple amesi abu akɔnta ne nane trɔ.

Alesi ƒumeŋuɖui ƒe nuzazãwo ƒe kɔsɔkɔsɔ wɔa dɔe zi geɖe

Nukpɔsusu si wowɔ bɔbɔe la le ale:

1. Nusiwo wotsɔ wɔe (le kpɔɖeŋu me, titanium-kpe, cobalt-chrome, PEEK na akpa aɖewo)

2. Adzɔnuwo wɔwɔ + mɔnu tɔxɛwo (mɔ̃wo, anyigbadzinuwo wuwu, dzadzɛnyenye; kpe ɖe dɔlékuiwutikewo zazã na nusiwo me dɔlékui mele o)

3. Nubablɛ + dzesidede (si me UDI ƒe dzeside ƒe nudidiwo hã le ne esɔ)

4. Quality release + traceability records (lot/batch dziɖuɖuwo, nuŋlɔɖi siwo le abe DHR ene, ŋkuléleɖenuŋu ƒe nuŋlɔɖiwo)

5. Export/import + distribution (dukɔwo ƒe dukɔmeviwo ƒe adzɔnuwo, nudzraɖoƒewo, kɔdzi ɖoɖo ɖe amewo, nudɔdɔwo)

Le mamalawo gome la, zi geɖe la, nuzazã-kɔsɔkɔsɔ ƒe kakaɖedzi nyea 'dziɖuɖu' alo 'bu' le teƒe eve:

• Dzɔdzɔmeŋutete ƒe ɖoɖowo : Ðe dziɖuɖu kple nuŋlɔɖiwo sẽ ale gbegbe be woate ŋu ato agbalẽdzikpɔkpɔ me eye woakpɔ tɔtrɔwo gbɔ le agbanɔamedzi mea?

• Dɔwɔwɔ ƒe amehehe : Ðe woate ŋu agblɔ ɣeyiɣi siwo woatsɔ awɔ dɔa, ŋutete, kple kadodo ɖi ale gbegbe be woaƒo asa na nudzraɖoƒewo ƒe vɔvɔ kple tenderwo ƒe kpododonua?

United States ƒe sedziwɔwɔ ƒe gɔmedzenu siwo gɔme wòle be nàse hafi nàŋlɔ nudzralawo ƒe ŋkɔ kpuiwo

Mehiã be nànye sedziwɔwɔ ŋuti nunyala bibi hafi adze na ƒumeŋutinunyalawo o—gake ehiã be nàse nusiwo ŋu woate ŋu aɖo kpee (kple esiwo womate ŋu aɖo kpee o) gɔme nyuie.

1) FDA 510(k): nusi wònye kple nusita wòle vevie

Wowɔ ɖoɖo ɖe ƒumeŋuɖui geɖe ŋu be wonye atikewɔnuwo le U.S.A., eye mɔ̃ ƒomevi geɖe gena ɖe asi me to FDA ƒe 510(k) mɔ dzi (nyatakaka do ŋgɔ na asitsatsa).

FDA ƒo nu tso 510(k) ƒe dɔbiagbalẽvi ƒomevi geɖe ŋu eye wòde dzesii be, le mɔ̃ ƒomevi aɖewo siwo gɔme wose nyuie gome la, woate ŋu azã Mɔ si Wotu Ðe Dedienɔnɔ Kple Dɔwɔwɔ Dzi le 510(k) ƒe ɖoɖoa me—afisi amesiwo ɖoa wo ɖee la ɖoa ŋu ɖe dɔwɔwɔ ƒe dzidzenu siwo FDA de dzesii ŋu tsɔ wu be woatsɔ wo asɔ kple wo nɔewo ƒe dodokpɔ tẽ le go aɖewo me. Kpɔ FDA ƒe Dedienɔnɔ Kple Dɔwɔwɔ Ŋuti Mɔ si Wotu na 510(k) ƒe nyawo ɖoɖoɖa.

Nusi nàwɔ abe numamãla ene: bia wò nudzrala be wòana 510(k) xexlẽdzesi siwo sɔ na mɔ̃ siwo koŋ nèɖo be yeama, eye nàwɔ nuŋlɔɖi si dzi wokpɔna le akpa ƒe xexlẽdzesi siwo wɔa nɔnɔmetata na mɔɖeɖe siwo dzi nàto ŋu.

2) Kpɔ egbɔ be dɔwɔƒea ƒe ŋkɔ ŋɔŋlɔ kple mɔ̃wo ƒe ŋkɔ ŋɔŋlɔ (gake se nusi mefia o gɔme) .

FDA naa dɔwɔƒewo ƒe ŋkɔ ŋɔŋlɔ kple mɔ̃wo ƒe ŋkɔ ŋɔŋlɔ ŋuti nyatakakawo nɔa anyi to dutoƒo dɔwɔnuwo dzi, siwo dometɔ aɖewoe nye FDA ƒe Search Registration and Listing ƒe axa (si do ƒome kple nyatakakadzraɖoƒe si woate ŋu adi).

Esia ɖea vi na kpeɖodzi be dɔwɔƒe aɖe le ɖoɖoa me kple dɔwɔna/mɔ̃ siwo woŋlɔ ɖi—gake mele be woabu ŋkɔ ŋɔŋlɔ/ŋlɔɖi ɖeɖeko be enye kpeɖodzi be adzɔnuwo ƒe nyonyome ɖo kpe edzi o.

3) UDI traceability: nya gɔmedzenuawo

FDA wɔ UDI ƒe ɖoɖoa be woatsɔ ade dzesi mɔ̃wo to wo mama kple wo zazã me. Gɔmedzedze nyui aɖee nye gbegbɔgblɔ si me kɔ FDA UDI ƒe gɔmedzenufiafiawo (DI kple PI) ..

Le ɖoƒe kɔkɔ aɖe me la:

• DI (Device Identifier) ​​dea dzesi mɔ̃a ƒe nɔnɔme/tɔtrɔ.

• PI (Production Identifier) ​​ateŋu anye lot/batch, serial number, kple production data bubuwo.

Nusita wòle be mamalawo natsɔ ɖe le eme: UDI nye megbeƒu ŋutɔŋutɔ si na ŋkuɖodzinyawo wɔwɔ, nudzraɖoƒewo ƒe nyateƒetoto, kple mɔkpɔkpɔ siwo li be woate ŋu akpɔ wo yome le anyime (kɔdziwo kple ƒuƒoƒo ƒe nuƒleɖoɖowo le mɔ kpɔm na nyatakakawo ƒe sisi si sɔ na UDI geɖe wu).

Dzesidede ƒe ɖaseɖigbalẽ si ŋudɔ woate ŋu awɔ na ƒumeŋutinunyalawo

Esiae nye akpa si ƒuƒoƒo akpa gãtɔ adi be yewoanɔ yewo si hafi tender gbãtɔ naɖo.

A. Nuŋlɔɖi siwo wòle be nàbia hafi nàwɔ nu bubu ɖesiaɖe

Taɖodzinu be yeaƒo 'supplier due diligence packet' si nàte ŋu azã ake le tenderwo katã me nu ƒu:

• Dzedzeme ƒe ɖaseɖigbalẽwo (le kpɔɖeŋu me, ISO 13485 ƒe kekeme, dɔwɔƒe si na, ŋkeke siwo dzi woawɔ dɔ)

• Sedziwɔwɔ ƒe nɔnɔme ŋuti nuŋlɔɖi siwo sɔ ɖe wò asi me yiyi ƒe aɖaŋu nu (le kpɔɖeŋu me, mɔ̃a ƒe mɔɖeɖewo le afisi wòsɔ le) .

• Traceability ƒe wɔwɔfia (lot/batch controls, labeling, alesi wokpɔa UDI dzii)

• Vidzidzi ƒe kpeɖodzi kpuie (na dɔlékuiwutike siwo wotsɔ dea ame me/dɔwɔnuwo) .

• Packaging validation summary (sterile mɔxenu ƒe blibonyenye kple mama dodokpɔ) .

• Trɔ dziɖuɖu ƒe ɖoɖo (alesi wonaa nyanya asisiwo, nusi hea gbugbɔgaɖoanyi vɛ)

• Nyatoƒoetotowo gbɔ kpɔkpɔ + CAPA ƒe wɔwɔfia (alesi wokua nyawo me hexea mɔ ɖe wo nu) .

Key Takeaway : Ne nudzrala la mete ŋu na nuŋlɔɖigbalẽvi dzadzɛ si woate ŋu adzro eme o la, àxe fe ɖe eta emegbe—le tender ƒe megbetsitsi, agbalẽɖoɖoɖa ƒe mɔxexe, alo vevesese ƒe yiyi kple megbe le agbalẽdzikpɔkpɔɣiwo me.

B. Dɔwɔƒe siwo ŋu wotsia dzi ɖo le agbalẽdzikpɔkpɔdɔa me (nusi woadi le teƒea alo le agbalẽdzikpɔkpɔ si le didiƒe ʋĩ me) .

Ne èle agbalẽdzikpɔkpɔdɔ wɔm (alo de dɔ asi na wò be nàwɔ agbalẽdzikpɔkpɔdɔ) la, lé fɔ ɖe nusiwo dzi woaɖu siwo gblɔa nusiwo sɔ ɖe enu ɖi ŋu:

• Traceability drills : 'Fia alesi nèle SKU sia yome tso raw material dzi va ɖo shipment dzi.'

• Dɔwɔwɔ ƒe kpeɖodzinana ƒe amehehe : ele be dɔwɔwɔ tɔxɛwo abe dɔlékuiwutikewo kple nubablɛwo ene nakpɔ kpeɖodzi si me kɔ.

• Nonconformance kple CAPA : ɖe woate ŋu aɖe nuŋububu si tso ke gbɔ kple mɔxexeɖedɔléle nu ƒe afɔɖeɖe si léna ɖe ame ŋu afia?

• Hehenana kple ŋutete : amekae woɖe mɔ na be wòaɖe adzɔnu ɖe ​​go, ada asi ɖe deviations dzi, eye wòakpɔ tɔtrɔwo gbɔ?

• Supplier controls : aleke wowɔna dzena heléa ŋku ɖe woawo ŋutɔ ƒe sub-suppliers veviwo ŋu?

C. Dɔwɔna ƒe dzidzenu siwo kpɔa ŋusẽ ɖe xexeame ŋutɔŋutɔ ƒe nuzazãwo ƒe kakaɖedzi dzi

Le mamalawo gome la, 'quality' menye mɔ̃ɖaŋudɔwɔwɔ ɖeɖeko o—enye nenye be nudzrala ate ŋu adzra wò ɖo le nudzraɖoƒe hã.

Bia ŋugbedodo siwo woate ŋu adzidze eye eme nakɔ le:

• Lead-time ƒe gɔmesesewo (SKU siwo woɖo ɖi vs. SKU siwo mele ɖoɖo nu o) .

• Ŋutete ƒe mɔxenuwo (nukae dzɔna le didi ƒe dzidziɖedzi me?)

• Nyagblɔɖi kple mama ƒe sewo

• Consignment / VMI tiatia (ne wotsɔe na) .

• Kadodo ƒe cadence: alesi woana nànya tso heheɖemegbe alo tɔtrɔwo ŋu

Aflaga dzĩ siwo gblɔa nuwo yɔyɔ le etsɔme, heheɖemegbe, alo tender ƒe kpododonu ɖi

Zã esiawo abe 'tɔ eye nàku nu me' ƒe xexlẽdzesi si wɔa dɔ ene:

• Ðaseɖigbalẽ siwo ƒe lolome me kɔ o (eku ɖe asitsatsa ƒe dɔwɔnawo ŋu gake menye adzɔnuwo wɔwɔ ƒe ɖoɖowo ŋu o) .

• 'Nusianu le mía si' ƒe nyagbɔgblɔ siwo me kpeɖodzi aɖeke mele mɔ̃ ɖesiaɖe dzi o (kɔkɔwo, traceability records) .

• Tɔtrɔwo ŋuti nyatakakawo nana ƒe ɖoɖo aɖeke si woŋlɔ ɖi o (alo tɔtrɔwo ŋuti kadodo si va yi ƒe kpɔɖeŋu aɖeke meli o) .

• Sterile product claims si me kpeɖodzi kpui aɖeke mele o si nàte ŋu ato

• Nya siwo me mekɔ o si nɔa anyi ɖaa le amesi nye nuŋlɔɖiwɔla/amesi wɔe ŋu

Ŋkeke 30 ƒe veviedodonu ƒe ɖoɖo bɔbɔe aɖe

Ne èle egɔme dzem tso zero dzi la, esia nye ɖoɖo ŋutɔŋutɔ si nana dɔa nɔa ɖoɖo nu.

Ŋkeke 1–7: Akpa si me kɔ + nuŋlɔɖiwo ƒe agbalẽvi

• Ðo kpe amesi nye nuŋlɔɖiwɔla/wɔla si ŋlɔa mɔ̃a ƒe ƒome ɖesiaɖe dzi.

• Bia veviedodonu si sɔ ƒe agbalẽvi (ɖaseɖiɖiwo, traceability ƒe wɔwɔfia, kpeɖodzinyawo ƒe kpukpuiwo).

• Ma SKU siwo woɖo be woawɔ la ɖe woƒe ɖoɖowɔɖi ƒe dzesidenuwo dzi (afisi wòsɔ le).

Ŋkeke 8–21: Kpeɖodzi + agbalẽdzikpɔkpɔ ƒe dzadzraɖo

• Kpɔ dutoƒo dzesiwo ɖa (ŋlɔ ŋkɔ ŋɔŋlɔ/ŋlɔɖi le afisi wòsɔ le; ɖo kpe mɔ̃a ƒe dzesidenuwo dzi).

• Tu wò agbalẽdzikpɔkpɔ ƒe ɖaseɖigbalẽa ɖe wò tender kple kɔdzi ƒe nudidiwo dzi.

• Tso nya me nenye be yeawɔ agbalẽdzikpɔkpɔdɔa tẽ alo azã ame etɔ̃lia si dze.

Ŋkeke 22–30: Yameʋukulawo ƒe ɖoɖo + dɔwɔwɔ me toto

• Dze egɔme kple yameʋukulawo ƒe sedede si dzi wokpɔna.

• Kpɔ kakaɖedzi si le nudɔdɔwo gbɔ, nuŋlɔɖiwo ƒe blibonyenye, nubablɛwo ƒe nyonyome, kple alesi wowɔa dɔe ŋu.

• Ŋlɔ nusi nèsrɔ̃ la ɖi—emegbe nàtso nya me nenye be yeadzidzee.

Video: UDI gɔmedzenuwo le miniti 3 teti me

Le ete la, numeɖela kpui aɖe si ateŋu akpeɖe ŋu be woawɔ ɖeka kple nudzadzra, ops, kple QA ƒuƒoƒowo le nusita UDI le vevie na traceability ŋu.

Video: 'FDA ƒe Mɔ̃ Tɔxɛ Dzesidede (UDI) ƒe Nudidiwo' (Registrar Corp)

Afɔɖeɖe siwo kplɔe ɖo

Ne èdi be yeadze gɔmedzeƒe na nudzralawo ƒe numekuku la, trɔ ɖaseɖigbalẽ si le etame la wòazu axa ɖeka ƒe dzesidegbalẽvi eye nàzãe ɣesiaɣi le ame ɖesiaɖe si di be yeaxɔ dɔa me.

Ne èhiã xexeame ŋutɔŋutɔ ƒe kpɔɖeŋu si ku ɖe alesi adzɔnuwɔƒe aɖe tsɔa gaxɔgbalẽvi ƒe lolome kple edziwɔwɔ ƒe nyawo ɖoa ŋkume hã la, àte ŋu ato dutoƒonyatakaka siwo le XC Medico (le kpɔɖeŋu me, adzɔnuwo ƒe hatsotso siwo woŋlɔ ɖi, nudzraɖoƒewo kple dɔdɔ ŋuti nyatakakawo), dɔwɔƒea ƒe numedzodzro le... XC Medico About Us page , eye—ne OEM/ODM nye wò kpɔɖeŋua ƒe akpa aɖe—la... Mɔfiame Mlɔetɔ na Ƒumeŋutinunya OEM & ODM Nuƒle . Bu nudzralawo ƒe nyatakakadzraɖoƒewo abe gɔmedzedze ene—emegbe nàɖo kpe nuŋlɔɖiwo kple wo yometiti dzi le wò ŋutɔ wò dzedze ƒe ɖoɖoa me.

Adzɔgbeɖeɖe: Nyatakakawo ɖeɖeko tae nyati sia nye eye menye aɖaŋuɖoɖo alo senyawo ŋuti aɖaŋuɖoɖo o. Nudidiwo toa vovo le mɔ̃ ƒomevi kple ʋɔnudrɔ̃ƒe ƒe ŋusẽ nu.