Cov Khoom Siv Orthopedic: Phau Ntawv Qhia Txog Kev Tso Cai Rau Vetting Implants Thiab Instruments hauv Teb Chaws Asmeskas

Xaiv cov chaw muag khoom orthopedic tsis yog hais txog nqi tsev xwb. Rau cov neeg muag khoom muag hauv Asmeskas cov tsev kho mob thiab cov chaw phais mob, qhov kev txiav txim siab ntawm tus neeg muag khoom tau dhau los ua qhov kev txiav txim siab pheej hmoo: cov ntaub ntawv qeeb tuaj yeem tua cov kev sib tw, cov teeb meem ntawm daim ntawv lo tuaj yeem thaiv cov khoom xa tuaj, thiab qhov sib txawv ntawm qhov tsis txaus ntseeg tuaj yeem hloov qhov kev tsis txaus siab me me rau hauv cov lus teb rov qab tag nrho.

Phau ntawv qhia no yog lub hauv paus kev paub txog theem: nws piav qhia txog dab tsi 'orthopedic lwm tus neeg' feem ntau yog hais txog, yuav ua li cas cov saw hlau ua haujlwm, qhov kev ua raws li Teb Chaws Asmeskas cov ntsiab lus koj yuav tsum paub, thiab daim ntawv teev cov tswv yim uas koj tuaj yeem siv kom tsim nyog rau cov neeg muab khoom orthopedic implants thiab cov cuab yeej.

Cov khoom tseem ceeb

• 'cov neeg muab khoom orthopedic' txhais tau tias yog cov chaw tsim khoom, cov chaw tsim khoom cog lus, lossis tus neeg muag khoom / tus neeg sawv cev - qhia meej txog lub luag haujlwm ua ntej koj ntsuas.

• Hauv Teb Chaws Asmeskas, koj yuav xav nkag siab tias FDA 510 (k) kev tshem tawm siv tau li cas rau ntau qhov kev cog hniav orthopedic thiab yuav ua li cas txheeb xyuas cov cim ua raws cai.

• Cov txheej txheem tsim nyog tus neeg muag khoom muaj zog yog cov ntaub ntawv-ua ntej: traceability, kev hloov pauv, kev ua kom tsis muaj menyuam / ntim khoom siv (thaum muaj feem cuam tshuam), thiab CAPA kev qhuab qhia tseem ceeb tshaj li kev thov kev lag luam.

• UDI traceability tsis yog tsuas yog sau npe nthuav dav - nws yog lub hauv paus ntawm kev rov qab los npaj thiab cov khoom raug raug.

Dab tsi 'orthopedic suppliers' txhais tau tias (thiab vim li cas lo lus tsis meej pem)

Hauv kev xyaum, tib neeg siv 'orthopedic lwm tus' ua luv luv rau txhua lub tuam txhab uas tuaj yeem muab cov kev cog hniav orthopedic thiab cov twj paj nruag - cov phaj thiab cov ntsia hlau, cov ntsia hlau intramedullary, cov kab mob txha caj qaum, cov txheej txheem sib koom ua ke, thiab cov twj paj nruag uas xav tau los cog lawv.

Tab sis lo lus zais ib qho tseem ceeb: tus 'tus neeg muab khoom' hauv koj daim ntawv cog lus yuav yog:

• Cov chaw tsim khoom raug cai / daim ntawv lo (lub koom haum muaj lub luag haujlwm rau kev sau npe, kev cai xa ntawv, thiab kev lav phib xaub tom khw)

• Ib daim ntawv cog lus chaw tsim khoom tsim rau cov ntawv sib txawv

• Ib tus neeg faib khoom lossis tus neeg tsim khoom (uas tuaj yeem hloov pauv txoj haujlwm tswj hwm)

Ua ntej koj tau qhab nia tus neeg xa khoom, qhia ob nqe lus nug:

1. Leej twg yog tus sau daim ntawv teev npe rau cov cuab yeej koj yuav muag rau hauv Teb Chaws Asmeskas?

2. Lub koom haum twg yog tus tswv ntawm cov ntaub ntawv tswj hwm thiab cov txheej txheem hloov-tswj?

Cov lus teb no txiav txim siab seb koj tuaj yeem txheeb xyuas qhov twg - thiab leej twg yuav lav ris thaum muaj qee yam hloov.

Yuav ua li cas cov orthopedic implant mov saw feem ntau ua haujlwm

Ib qho yooj yim saib zoo li no:

1. Cov ntaub ntawv raw (xws li, titanium alloy, cobalt-chrome, PEEK rau qee yam khoom)

2. Kev tsim khoom + cov txheej txheem tshwj xeeb (machining, nto tiav, tu; ntxiv rau kom tsis muaj menyuam rau cov khoom tsis muaj menyuam)

3. Ntim + daim ntawv lo (xws li UDI daim ntawv lo yuav tsum yog thaum muaj)

4. Kev tso tawm zoo + cov ntaub ntawv taug qab (ntau / batch tswj, DHR-zoo li cov ntaub ntawv, tshuaj xyuas cov cav)

5. Export / ntshuam + tis (kev lis kev cai, warehousing, tsev kho mob, xa khoom)

Rau cov neeg xa khoom, kev ntseeg tau ntawm cov saw hlau feem ntau yog 'won' lossis 'poob' nyob rau hauv ob qhov chaw:

• Cov Txheej Txheem Zoo : Puas yog kev tswj hwm thiab cov ntaub ntawv muaj zog txaus kom dhau kev tshuaj xyuas thiab tswj kev hloov pauv lub luag haujlwm?

• Kev qhuab qhia kev ua haujlwm : Puas yog lub sijhawm ua haujlwm, lub peev xwm, thiab kev sib txuas lus tuaj yeem ua tau txaus kom tsis txhob muaj cov khoom lag luam thiab kev sib tw?

Teb Chaws Asmeskas kev ua raws li cov hauv paus tsim nyog nkag siab ua ntej koj xaiv cov neeg muag khoom luv

Koj tsis tas yuav yog tus kws tshaj lij kev tswj hwm kev tswj hwm kom tsim nyog rau cov neeg muab khoom orthopedic - tab sis koj xav tau kev nkag siab ua haujlwm ntawm dab tsi tuaj yeem (thiab tsis tuaj yeem) txheeb xyuas.

1) FDA 510 (k): nws yog dab tsi thiab vim li cas nws tseem ceeb

Ntau yam orthopedic implants raug tswj raws li cov cuab yeej kho mob hauv Teb Chaws Asmeskas, thiab ntau hom cuab yeej nkag mus rau hauv kev ua lag luam ntawm FDA's 510 (k) txoj hauv kev (kev ceeb toom ua ntej).

FDA piav qhia txog ntau yam 510(k) xa ntawv thiab sau tseg tias, rau qee yam kev nkag siab zoo ntawm cov cuab yeej, Txoj Kev Nyab Xeeb thiab Kev Ua Haujlwm Raws Li Txoj Cai yuav raug siv nyob rau hauv 510 (k) lub moj khaum - qhov twg cov neeg xa khoom cia siab rau FDA- txheeb xyuas cov txheej txheem ua haujlwm es tsis yog kev sib piv ncaj qha rau qee kis. Saib FDA's Safety and Performance Based Pathway rau 510 (k) xa.

Yuav ua li cas los ua tus neeg faib khoom: nug koj tus neeg xa khoom rau tus lej 510 (k) uas cuam tshuam rau cov khoom tshwj xeeb uas koj npaj yuav faib, thiab khaws cov ntaub ntawv tswj hwm ntawm cov lej ntawm daim ntawv qhia txog qhov kev tshem tawm.

2) Txheeb xyuas cov ntawv sau npe thiab cov khoom siv (tab sis nkag siab tias nws tsis txhais li cas)

FDA ua rau kev tso npe tsim khoom thiab cov ntaub ntawv teev cov cuab yeej muaj los ntawm cov cuab yeej siv pej xeem, suav nrog FDA's Search Registration and Listing page (uas txuas mus rau cov ntaub ntawv tshawb nrhiav tau).

Qhov no yog qhov muaj txiaj ntsig zoo rau kev txheeb xyuas qhov chaw nyob hauv qhov system thiab cov haujlwm / cov khoom siv twg tau teev tseg - tab sis kev sau npe / npe ib leeg yuav tsum tsis txhob ua pov thawj ntawm cov khoom zoo.

3) UDI traceability: paub cov hauv paus

FDA tsim UDI lub moj khaum los txheeb xyuas cov khoom siv los ntawm kev faib khoom thiab siv. Ib qho pib zoo yog cov lus yooj yim FDA UDI Basics (DI thiab PI).

Nyob rau theem siab:

• DI (Device Identifier) ​​txheeb xyuas tus qauv / version ntawm lub cuab yeej.

• PI (Production Identifier) ​​tuaj yeem suav nrog ntau ntau / batch, serial tooj, thiab lwm yam ntaub ntawv ntau lawm.

Vim li cas cov neeg faib khoom yuav tsum saib xyuas: UDI yog lub hauv paus tseem ceeb ntawm kev rov qab ua tiav, cov khoom tsim nyog, thiab kev cia siab rau kev taug qab (cov tsev kho mob thiab pab pawg kev yuav khoom nce siab dua UDI-phooj ywg cov ntaub ntawv ntws).

Ib daim ntawv teev kev tsim nyog rau cov neeg muab khoom orthopedic

Qhov no yog ntu feem ntau pab pawg xav kom lawv muaj ua ntej hnub kawg ntawm kev sib tw thawj zaug.

A. Cov ntaub ntawv koj yuav tsum thov ua ntej lwm yam

Lub hom phiaj los sib sau ua ke ntawm 'cov khoom xa tawm vim kev mob siab rau' uas koj tuaj yeem siv rov qab los ntawm kev sib tw:

• Cov ntawv pov thawj zoo (xws li ISO 13485 Scope, muab lub cev, hnub siv tau)

• Cov ntaub ntawv tswj hwm txoj cai muaj feem xyuam rau koj lub tswv yim kev lag luam nkag (piv txwv li, cov cuab yeej tshem tawm qhov tsim nyog)

• Traceability txheej txheem cej luam (ntau / batch tswj, sau npe, yuav ua li cas UDI tswj)

• Sterilization validation summary (rau sterile implants/instruments)

• Ntim validation summary (sterile barrier integrity and distribution testing)

• Hloov txoj cai tswj hwm (yuav ua li cas lawv ceeb toom cov neeg siv khoom, dab tsi ua rau rov siv tau)

• Kev tuav pov hwm kev tsis txaus siab + CAPA txheej txheem txheej txheem (yuav ua li cas cov teeb meem raug tshawb xyuas thiab tiv thaiv)

Key Takeaway : Yog tias tus neeg muag khoom tsis tuaj yeem muab cov ntaub ntawv pov thawj huv, tshawb xyuas tau, koj yuav them rau nws tom qab - hauv kev sib tw qeeb, kev xa khoom thauj, lossis mob rov qab los thaum kuaj xyuas.

B. Kev soj ntsuam xyuas thaj chaw (dab tsi yuav nrhiav rau ntawm qhov chaw lossis hauv kev tshawb xyuas qhov tob tob)

Thaum koj tshawb xyuas (lossis ua haujlwm rau kev tshuaj xyuas), tsom mus rau kev tswj hwm uas kwv yees qhov sib xws:

• Traceability drills : 'Qhia kuv li cas koj taug qab SKU no los ntawm raw khoom mus rau kev xa khoom.'

• Txheej txheem validation kev qhuab qhia : cov txheej txheem tshwj xeeb xws li kom tsis muaj menyuam thiab ntim khoom yuav tsum muaj pov thawj tseeb tseeb.

• Kev tsis sib haum xeeb thiab CAPA : lawv puas tuaj yeem pom cov hauv paus kev xav thiab kev tiv thaiv uas ua rau?

• Kev cob qhia thiab kev muaj peev xwm : leej twg tau tso cai tso tawm cov khoom, pom zoo sib txawv, thiab tswj kev hloov pauv?

• Kev tswj hwm tus neeg muab khoom : lawv ua li cas tsim nyog thiab saib xyuas lawv tus kheej cov khoom lag luam tseem ceeb?

C. Cov txheej txheem kev ua haujlwm uas cuam tshuam rau lub ntiaj teb kev cia siab rau khoom

Rau cov neeg xa khoom, 'zoo' tsis yog engineering xwb - nws tseem yog tus neeg muag khoom tuaj yeem khaws koj hauv Tshuag.

Nug kom ntsuas tau cov lus cog tseg thiab meej meej ntawm:

• Lead-time txhais (tus qauv vs. non-standard SKUs)

• Kev txwv tsis pub muaj peev xwm (dab tsi tshwm sim thaum xav tau nce?)

• Kev kwv yees thiab kev faib cov cai

• Kev xa khoom / VMI kev xaiv (yog tias muaj)

• Kev sib txuas lus cadence: yuav ua li cas koj thiaj paub txog kev ncua lossis kev hloov pauv

Cov chij liab uas kwv yees kev rov qab los yav tom ntej, ncua sijhawm, lossis kev sib tw ua tsis tiav

Siv cov no los ua ib daim ntawv teev npe 'tshem thiab tshawb xyuas':

• Cov ntawv pov thawj uas tsis muaj qhov meej meej (nrog rau kev ua lag luam tab sis tsis tsim cov txheej txheem)

• 'Peb muaj txhua yam' thov yam tsis muaj ntaub ntawv pov thawj ntawm cov khoom siv (kev tshem tawm, cov ntaub ntawv taug qab)

• Tsis muaj ntaub ntawv qhia txog kev hloov pauv (lossis tsis muaj piv txwv ntawm kev sib txuas lus yav dhau los)

• Sterile cov khoom thov tsis muaj cov ntsiab lus tseeb uas koj tuaj yeem tshuaj xyuas

• Tsis pom tseeb tsis meej txog leej twg yog tus sau npe / tus tsim cov ntaub ntawv

Ib qho yooj yim 30-hnub kev mob siab rau txoj kev npaj

Yog tias koj pib los ntawm xoom, qhov no yog qhov tseeb ib ntus uas ua rau kev ua haujlwm zoo.

Hnub 1–7: Lub luag hauj lwm clarity + ntaub ntawv pob ntawv

• Paub meej tias leej twg yog tus sau / tus tsim cov ntaub ntawv rau txhua tsev neeg.

• Thov daim ntawv pov thawj ntawm kev mob siab rau (cov ntawv pov thawj, kev saib xyuas kev taug qab, cov ntsiab lus siv tau).

• Daim ntawv qhia npaj SKUs rau lawv cov kev cai tswj xyuas (qhov twg siv tau).

Hnub 8–21: Kev Tshawb Fawb + kev tshuaj xyuas kev npaj

• Txheeb xyuas cov teeb liab rau pej xeem (sau npe / npe qhov twg muaj feem cuam tshuam; paub meej tias cov cim qhia ntaus ntawv).

• Tsim koj daim ntawv txheeb xyuas nyob ib ncig ntawm koj qhov kev sib tw thiab tsev kho mob xav tau.

• Txiav txim siab seb puas yuav tshuaj xyuas ncaj qha lossis siv tus neeg thib peb tsim nyog.

Hnub 22-30: Pilot order + kev tshuaj xyuas

• Pib nrog kev tswj xyuas kev tsav tsheb.

• Taug qab kev cia siab rau kev xa khoom, kev ua tiav cov ntaub ntawv, ntim khoom zoo, thiab kev ua haujlwm.

• Cov ntaub ntawv koj tau kawm - ces txiav txim siab seb puas yuav ntsuas.

Video: UDI cov hauv paus hauv qab 3 feeb

Hauv qab no yog cov lus piav qhia luv luv uas tuaj yeem pab txhim kho kev muag khoom, ops, thiab QA pab pawg vim li cas UDI tseem ceeb rau kev taug qab.

Video: 'FDA Unique Device Identifier (UDI) Requirements' (Registrar Corp)

Cov kauj ruam tom ntej

Yog tias koj xav tau qhov chaw pib rau kev ntsuam xyuas tus neeg muag khoom, tig daim ntawv teev npe saum toj no rau hauv ib nplooj ntawv qhab nia thiab siv nws tsis tu ncua hla txhua tus neeg sib tw.

Yog tias koj tseem xav tau qhov piv txwv ntawm lub ntiaj teb tiag tiag ntawm yuav ua li cas lub chaw tsim khoom nthuav qhia cov peev txheej thiab cov lus thov ua tiav, koj tuaj yeem tshuaj xyuas cov ntaub ntawv pej xeem ntawm XC Medico (piv txwv li, teev cov khoom lag luam, cov lus nug thiab xa tawm), lub tuam txhab saib xyuas ntawm XC Medico Txog Peb nplooj ntawv , thiab-yog tias OEM / ODM yog ib feem ntawm koj tus qauv-tus Qhov kawg Qhia rau Orthopedic OEM & ODM Kev Muag Khoom . Kho cov chaw muag khoom lub vev xaib raws li qhov chaw pib - tom qab ntawd txheeb xyuas cov ntaub ntawv thiab kev taug qab hauv koj tus kheej txoj kev tsim nyog.

Disclaimer: Tsab ntawv xov xwm no yog rau cov ntaub ntawv xov xwm nkaus xwb thiab tsis suav nrog kev tswj hwm lossis kev tawm tswv yim kev cai lij choj. Cov kev xav tau sib txawv raws li hom khoom siv thiab kev txiav txim.