Othandizira Mafupa: Maupangiri Othandiza Powunika Ma Implants Ndi Zida Ku US

Kusankha ogulitsa mafupa sikungotengera mtengo wagawo. Kwa ogulitsa omwe akugulitsa muzipatala zaku US ndi malo opangira opaleshoni, lingaliro laopereka limakhala lingaliro pachiwopsezo: kuchedwa kwa zolemba kumatha kupha ma tender, zolemba zolembera zimatha kuletsa kutumiza, ndipo mipata ya traceability ingasinthe madandaulo ang'onoang'ono kukhala mayankho okumbukira.

Bukhuli ndi gawo lodziwitsa anthu: limafotokoza zomwe 'opereka mafupa' nthawi zambiri amatanthawuza, momwe chain chain imagwirira ntchito, zomwe muyenera kudziwa za US kuti muzitsatira, ndi mndandanda wazomwe mungagwiritse ntchito kuti muyenerere ogulitsa implants ndi zida za mafupa.

Zotengera zofunika

• 'Ogulitsa mafupa' angatanthauze wopanga, wopanga makontrakitala, kapena wogawa/wolemberanso makina—kufotokozerani maudindo musanawunikire.

• Ku US, mudzafuna kumvetsetsa momwe chilolezo cha FDA 510(k) chimagwirira ntchito pamakina ambiri a mafupa ndi momwe mungatsimikizire zizindikiro zoyambira.

• Njira yamphamvu yoyenetsera ogulitsa ndi kulemba-choyamba: kutsata, kuwongolera kusintha, kuletsa / kutsimikizira kuyika (pamene kuli koyenera), ndi kuwongolera kwa CAPA ndikofunikira kuposa zonena zamalonda.

• Kutsatiridwa kwa UDI sikungotengera zolemba - ndi msana wa kukonzekera kukumbukira komanso kulondola kwazinthu.

Kodi 'opereka mafupa' amatanthauza chiyani (ndi chifukwa chiyani mawuwa akusokoneza)

Pochita, anthu amagwiritsa ntchito 'opereka mafupa' monga chidule cha kampani iliyonse yomwe ingapereke implants ndi zida za mafupa nthawi zonse - mbale ndi zomangira, misomali ya intramedullary, makina opangira msana, machitidwe ogwirizanitsa, ndi zida zofunika kuziyika.

Koma mawuwa amabisa mfundo yofunika: 'wopereka' mu mgwirizano wanu angakhale:

• Wopanga zamalamulo / wolemba zilembo (bungwe lomwe limayang'anira zolemba, zowongolera, ndi zomwe zimafunikira pambuyo pa msika)

• akupangira Wopanga makontrakitala cholembera china

• Wogawa relabeler kapena ( yomwe ingasinthe maudindo owongolera)

Musanapereke chindapusa kwa ogulitsa, fotokozani mafunso awiri:

1. Kodi ndi ndani amene amapereka zolembera pa chipangizo chomwe mungagulitse ku US?

2. Ndi bungwe liti lomwe liri ndi zolembedwa zowongolera ndi kusintha kosintha?

Mayankho amenewo amatsimikizira zomwe mungatsimikizire—ndipo ndani amene adzayankha zinthu zikasintha.

Momwe makina opangira mafupa amagwirira ntchito

Kuwoneka kosavuta kumawoneka motere:

1. Zopangira (mwachitsanzo, titaniyamu aloyi, cobalt-chrome, PEEK pazinthu zina)

2. Kupanga + njira zapadera (machining, kumaliza pamwamba, kuyeretsa; kuphatikiza kutsekereza kwa zinthu zosabala)

3. Kupaka + kulemba (kuphatikiza zofunikira zolembera za UDI zikafunika)

4. Zolemba zotulutsa bwino + zotsatiridwa (zowongolera zambiri / gulu, zolemba ngati DHR, zipika zoyendera)

5. Kutumiza kunja / kuitanitsa + kugawa (miyambo, malo osungiramo katundu, zoperekera kuchipatala, katundu)

Kwa ogawa, kudalirika kwa supplychain nthawi zambiri 'kupambana' kapena 'kutaika' m'malo awiri:

• Kachitidwe kabwino : Kodi maulamuliro ndi ma rekodi ndi olimba mokwanira kuti athe kuwunika ndikuwongolera kusintha moyenera?

• Kuwongolera magwiridwe antchito : Kodi nthawi zotsogola, mphamvu, ndi kulumikizana ndizomwe zikuyenera kupewedwa kuti tipewe kuchepa kwa katundu ndi kulephera kwachifundo?

Zofunikira pakutsata zaku US zomwe muyenera kuzimvetsetsa musanalembe mndandanda waothandizira

Simufunikanso kukhala katswiri wazowongolera kuti muyenerere othandizira mafupa - koma muyenera kumvetsetsa zomwe zingatsimikizidwe (ndipo zomwe sizingatsimikizidwe).

1) FDA 510 (k): chomwe chiri komanso chifukwa chake chili chofunikira

Ma implants ambiri a mafupa amayendetsedwa ngati zida zamankhwala ku US, ndipo mitundu yambiri yazida imalowa mumsika kudzera panjira ya FDA's 510(k) (chidziwitso choyambirira).

FDA imalongosola mitundu ingapo yotumizira 510 (k) ndikulemba kuti, pamitundu ina yazida zomveka bwino, Njira Yotetezedwa ndi Magwiridwe Antchito ingagwiritsidwe ntchito mkati mwa 510 (k) chimango-kumene otumiza amadalira njira zogwirira ntchito zozindikiritsidwa ndi FDA m'malo moyesa kuyezetsa mwachindunji nthawi zina. Mwaona FDA's Safety and Performance Based Pathway pazopereka 510(k)..

Zoyenera kuchita ngati wogawa: funsani wopereka wanuyo manambala oyenerera a 510(k) pazida zomwe mukufuna kugawa, ndipo sungani mbiri yoyang'anira kuti ndi manambala ati omwe amalola kuloledwa.

2) Tsimikizirani kulembetsa kukhazikitsidwa ndi mindandanda yazida (koma mvetsetsa zomwe sizikutanthauza)

FDA imapangitsa kulembetsa kukhazikitsidwa ndi mindandanda yazida kupezeka kudzera pazida zaboma, kuphatikiza Tsamba la FDA's Search Registration and Listing (lomwe limalumikizana ndi nkhokwe yosakira).

Izi ndizothandiza pakutsimikizira kuti bungwe lili m'dongosololi komanso kuti ntchito/zida ziti zandandalikidwa—koma kulembetsa/kulemba pakhakha kuyenera kuonedwa ngati umboni wa mtundu wa malonda.

3) UDI traceability: dziwa zoyambira

FDA idapanga dongosolo la UDI kuti lizindikire zida pogawa ndikugwiritsa ntchito. Chiyambi chabwino ndi chilankhulo chosavuta FDA UDI Basics (DI ndi PI).

Pamlingo wapamwamba:

• DI (Device Identifier) ​​imazindikiritsa mtundu/mtundu wa chipangizocho.

• PI (Production Identifier) ​​ingaphatikizepo lot/batch, serial number, ndi data ina yopanga.

Chifukwa chomwe ogawa akuyenera kusamala: UDI ndiye msana wothandiza pakukumbukira, kulondola kwazinthu, komanso zoyembekeza zotsatiridwa kutsika (zipatala ndi makina ogulira magulu amayembekezera mochulukira kusuntha kwa data kwa UDI).

Mndandanda wa ziyeneretso zothandiza kwa ogulitsa mafupa

Ili ndi gawo lomwe matimu ambiri amalakalaka akadakhala nalo tsiku lomaliza la ma tender lisanafike.

A. Zolemba zomwe muyenera kuzifunsa musanachite china chilichonse

Khalani ndi cholinga chophatikiza 'paketi yofunikira kwa ogulitsa ' yomwe mungagwiritsenso ntchito pamatenda onse:

• Zitsimikizo zamtundu (mwachitsanzo, kukula kwa ISO 13485, bungwe lotulutsa, masiku ovomerezeka)

• Zolemba zamalamulo zogwirizana ndi njira yanu yolowera msika (mwachitsanzo, chilolezo cha zida ngati kuli kotheka)

• Kuwunikira mwachidule (zowongolera zambiri/magulu, kulemba zilembo, momwe UDI imayendetsedwa)

• Chidule chotsimikizira kutsekereza (kwa ma implants osabala/zida)

• Chidule chotsimikizira pakuyika (chotchinga chotchinga kukhulupirika ndi kuyesa kugawa)

• Sinthani ndondomeko yowongolera (momwe amadziwitsira makasitomala, zomwe zimayambitsa kutsimikizika)

• Kusamalira madandaulo + mwachidule CAPA (momwe nkhani zimafufuzidwa ndi kupewedwa)

Chotengera Chofunikira : Ngati wogulitsa sangakupatseni paketi yoyera, yowerengeka, mudzalipira pambuyo pake-mukuchedwetsa, kusungitsa katundu, kapena zowawa mmbuyo ndi mtsogolo panthawi yofufuza.

B. Audit madera (zoyenera kuyang'ana pamalo kapena pakuwunika kwakutali)

Mukawunika (kapena kutumiza kafukufuku), yang'anani pa zowongolera zomwe zimalosera kusasinthika:

• Traceability drills : 'Ndiwonetseni momwe mumalondolera SKU iyi kuchokera kuzinthu zopangira mpaka kutumizidwa.''

• Chilango chotsimikizira ndondomeko : njira zapadera monga kutsekereza ndi kulongedza ziyenera kukhala ndi umboni wotsimikizirika.

• Nonconformance ndi CAPA : angawonetse malingaliro oyambitsa mizu ndi njira zodzitetezera zomwe zimakhazikika?

• Maphunziro ndi luso : ndani ali ndi chilolezo chotulutsa malonda, kuvomereza zopotoka, ndikuwongolera zosintha?

• Kuwongolera kwa ma Supplier : Kodi amayenerera bwanji ndikuwunika omwe amawathandizira?

C. Njira zogwirira ntchito zomwe zimakhudza kudalirika kwapadziko lonse lapansi

Kwa ogawa, 'ubwino' si uinjiniya wokha komanso ngati woperekayo atha kukusungani.

Funsani malonjezano oyezeka ndi kumveka bwino pa:

• Matanthauzo anthawi yotsogola (yofanana ndi ma SKU osakhazikika)

• Zolepheretsa mphamvu (chimachitika ndi chiyani pakufunika?)

• Zolosera ndi kagawidwe malamulo

• Zosankha zotumizira / VMI (ngati zilipo)

• Communication cadence: momwe mungadziwitsidwe za kuchedwa kapena kusintha

Mbendera zofiira zomwe zimalosera kukumbukira mtsogolo, kuchedwa, kapena kulephera kwachikondi

Gwiritsani ntchito izi ngati mndandanda wa 'yimani ndi kufufuza':

• Ziphaso zopanda malire omveka bwino (zimagwira ntchito zamalonda koma osati njira zopangira)

• 'Tili ndi chilichonse' zonena popanda umboni wa chipangizo ndi chipangizo (zovomerezeka, zolemba zowunikira)

• Palibe zidziwitso zosinthidwa (kapena palibe zitsanzo zamalankhulidwe am'mbuyomu)

• Zomangamanga zamalonda popanda chidule chotsimikizira mutha kuwunikanso

• Kusamveka kosalekeza kokhudza yemwe ndi wolemba / wopanga zolemba

Dongosolo losavuta la masiku 30 lokonzekera mwachangu

Ngati mukuyamba pa ziro, iyi ndi ndondomeko yeniyeni yomwe imapangitsa kuti ntchitoyi ikhale yokhazikika.

Masiku 1-7: Kumveka bwino kwa ntchito + paketi yolemba

• Tsimikizirani kuti ndani amene ali wolemba/wopanga zojambulira pagulu lililonse la chipangizocho.

• Funsani paketi yolimbikira (zitsimikizo, kuwunika mwachidule, chidule chotsimikizira).

• Mapu amapangira ma SKU ku zowazindikiritsa (ngati kuli kotheka).

Masiku 8-21: Kutsimikizira + kukonza zowerengera

• Tsimikizirani zidziwitso za anthu onse (kulembetsa/mndandanda ngati kuli koyenera; tsimikizirani zozindikiritsa zida).

• Pangani mndandanda wanu wowunika molingana ndi zomwe mukufuna komanso zachipatala.

• Sankhani ngati mufufuze mwachindunji kapena mugwiritse ntchito munthu wina woyenerera.

Masiku 22-30: Kuwongolera koyendetsa + kuwunika magwiridwe antchito

• Yambani ndi dongosolo loyendetsa ndege.

• Tsatani kudalirika kwa kutumiza, kukwanira kwa zolembedwa, mtundu wapaketi, komanso kuyankha.

• Lembani zomwe mwaphunzira, ndiyeno ganizirani ngati mukulitsa.

Kanema: Zoyambira za UDI mkati mwa mphindi zitatu

Pansipa pali chofotokozera chachifupi chomwe chingathandize kugwirizanitsa malonda, ops, ndi magulu a QA pachifukwa chiyani UDI ikufunika kuti ifufuze.

Kanema: 'Zofunikira za FDA Unique Device Identifier (UDI)' (Registrar Corp)

Masitepe otsatira

Ngati mukufuna poyambira kuunika kwa ogulitsa, sinthani mndandanda womwe uli pamwambapa kukhala tsamba limodzi la zigoli ndipo mugwiritseni ntchito mosalekeza kwa aliyense.

Ngati mukufunikiranso chitsanzo chenicheni cha momwe wopanga amaperekera kuchuluka kwa mbiri yanu ndi zomwe akufuna kukwaniritsa, mutha kuwonanso zambiri zapagulu pa XC Medico (mwachitsanzo, magulu azinthu zolembedwa, zowerengera ndi zotumiza), chiwongolero chamakampani XC Medico About Us tsamba , ndipo—ngati OEM/ODM ndi gawo lachitsanzo chanu—the Ultimate Guide to Orthopedic OEM & ODM Procurement . Chitani mawebusayiti ngati poyambira—kenako tsimikizirani zolembedwa ndi kutsatiridwa pakuyenerera kwanu.

Chodzikanira: Nkhaniyi ndi yongodziwa zambiri zokha ndipo sipanga upangiri wamalamulo kapena zamalamulo. Zofunikira zimasiyana malinga ndi mtundu wa chipangizocho komanso mphamvu zake.