Ababoneleli be-Orthopedic: Isikhokelo esiSebenzayo soVavanyo lweziFakelo kunye nezixhobo e-US

Ukukhetha ababoneleli ngamathambo akukho nje malunga nexabiso leyunithi. Kubathengisi abathengisa kwizibhedlele zase-US kunye namaziko otyando, isigqibo somthengisi siba sisigqibo somngcipheko: ukulibaziseka kwamaxwebhu kunokubulala iithenda, imiba yokuleyibhile inokuthintela ukuthunyelwa, kunye nezikhewu zokulandela umkhondo zinokujika isikhalazo esincinci sibe yimpendulo epheleleyo yokukhumbula.

Esi sikhokelo sisikhokelo senqanaba lokwazisa: sicacisa ukuba yintoni 'ababoneleli bezinto zamathambo' ngokuqhelekileyo bebhekisa kuko, indlela ikhonkco lonikezelo elisebenza ngayo, zeziphi iziseko zokuthotyelwa kwe-US omele uzazi, kunye noluhlu lokukhangela olusebenzayo onokulusebenzisa ukufaneleka kwababoneleli bokufakelwa kwamathambo kunye nezixhobo.

Izinto eziphambili ezithathwayo

• 'Ababoneleli ngamathambo' bangathetha umenzi, umenzi wekhontrakthi, okanye umsasazi/isiphinda-phinda-cacisa iindima phambi kokuba uvavanye.

• E-US, uya kufuna ukuqonda ukuba lusebenza njani imvume ye-FDA 510(k) kwizifakelo ezininzi ze-orthopedic kunye nendlela yokuqinisekisa iimpawu zokuthobela ezisisiseko.

• Inkqubo eyomeleleyo yesiqinisekiso somthengisi kukubhaliweyo okokuqala: ukulandeleka, ulawulo lotshintsho, ukuvala inzala/ukuqinisekisa ukupakishwa (xa kufanelekile), kunye nokuziphatha kweCAPA kubaluleke ngaphezu kwamabango okuthengisa.

• Ukulandeleka kwe-UDI ayisiyongcombolo yokuleyibhile nje—ngumqolo wokulungela ukukhumbula kunye nokuchaneka kwe-inventri.

Lithetha ukuthini 'ababoneleli ngamathambo' (kwaye kutheni eli gama libhidisa)

Enyanisweni, abantu basebenzisa 'abanikezeli be-orthopedic' njenge-shorthand kuyo nayiphi na inkampani enokuthi ibonelele ngokuqhubekayo i-orthopedic implants kunye nezixhobo-iipleyiti kunye ne-screws, izikhonkwane ze-intramedullary, iinkqubo zokulungisa umgogodla, iinkqubo zokuvuselela ngokubambisana, kunye neeseti zesixhobo ezifunekayo ukuzifakela.

Kodwa igama lifihla inqaku elibalulekileyo: 'umthengisi' kwikhontrakthi yakho inokuba:

• Umenzi osemthethweni / umfaki-mibhalo (iqumrhu elinoxanduva lokulebhelisha, ukungeniswa okusemthethweni, kunye nezibophelelo zasemva kokuthengisa)

• Umenzi wekhontrakthi ovelisa ilebula eyahlukileyo

• Umsasazi umthengisi okanye kwakhona (onokuthi atshintshe uxanduva lolawulo)

Ngaphambi kokuba ufumane amanqaku kumthengisi, cacisa imibuzo emibini:

1. Ngubani umgcini werekhodi wesixhobo oza kusithengisa e-US?

2. Leliphi iqumrhu elingumnini amaxwebhu olawulo kunye nenkqubo yolawulo lotshintsho?

Ezo mpendulo zichaza into onokuthi uyiqinisekise-kwaye ngubani oza kuphendula xa kukho utshintsho.

Indlela ikhonkco lobonelelo lokufakelwa kwamathambo olusebenza ngokuqhelekileyo

Umbono owenziwe lula ujongeka ngolu hlobo:

1. Imathiriyeli ekrwada (umzekelo, i-titanium alloy, i-cobalt-chrome, iPEEK yamalungu athile)

2. Ukuvelisa + iinkqubo ezikhethekileyo (umatshini, ukugqiba umphezulu, ukucocwa; kunye nokuvala inzala kwiimveliso ezingenazintsholongwane)

3. Ukupakishwa + ukuleyibheli (kubandakanya iimfuno zokuleyibheli ze-UDI xa kufanelekile)

4. Ukukhutshwa komgangatho + iirekhodi zokulandela umkhondo (ulawulo oluninzi / lwebhetshi, iirekhodi ezifana ne-DHR, iilogi zokuhlola)

5. Ukuthumela ngaphandle / ukuthumela ngaphandle + ukuhanjiswa (izithethe, indawo yokugcina impahla, ukuhanjiswa kwesibhedlele, ukuthunyelwa)

Kubasasazi, ukuthembeka kwekhonkco lonikezelo ngokuqhelekileyo 'kungaphumeleli' okanye 'kulahlekile' kwiindawo ezimbini:

• Iisistim zomgangatho : Ngaba ulawulo kunye neerekhodi zomelele ngokwaneleyo ukuba ziphumelele uphicotho kunye nokusingatha utshintsho ngokufanelekileyo?

• Ukuziphatha ngendlela yokusebenza : Ngaba amaxesha okukhokela, amandla, kunye nonxibelelwano lunokuxelwa kwangaphambili ngokwaneleyo ukunqanda ukuphela kwamayeza kunye nokusilela kweethenda?

Iziseko zokuthotyelwa kwe-US zifanele ukuqondwa phambi kokuba wenze uluhlu olufutshane lwababoneleli

Akuyomfuneko ukuba ube yingcaphephe yemicimbi yolawulo ukuze ulungele ukuba ngababoneleli ngamathambo-kodwa udinga ukuqonda okusebenzayo malunga nokuba yintoni (kwaye ayinakuqinisekiswa).

1) I-FDA 510(k): yintoni kwaye kutheni ibalulekile

Ukufakelwa kwamathambo amaninzi alawulwa njengezixhobo zonyango e-US, kwaye iintlobo ezininzi zezixhobo zingena kwimarike ngendlela ye-FDA's 510(k) (isaziso sentengiso).

I-FDA ichaza iindidi ezininzi zokungeniswa kwe-510 (k) kwaye iphawula ukuba, kwiintlobo ezithile zesixhobo eziqondwa kakuhle, iNdlela yoKhuseleko kunye neNtsebenzo eSekwe kwiNtsebenzo ingasetyenziswa ngaphakathi kwe-510 (k) isakhelo-apho abahambisi baxhomekeke kwiikhrayitheriya zokusebenza ezichongiweyo ze-FDA kunokuvavanya ngokuthe ngqo ukuthelekisa kwezinye iimeko. 'Yabona Ukhuseleko lwe-FDA kunye neNdlela eSekwe kuMsebenzi ye-510(k) yokungeniswa.

Yintoni omawuyenze njengomthengisi: cela umboneleli wakho ngeenombolo ezifanelekileyo ze-510(k) zezixhobo ezithile oceba ukuzihambisa, kwaye ugcine irekhodi elawulwayo yokuba yeyiphi imephu yeenombolo zeemephu zeziphi iindawo zokukhutshwa.

2) Qinisekisa ubhaliso lokusekwa kunye noluhlu lwesixhobo (kodwa uqonde ukuba ayithethi ntoni)

I-FDA yenza ubhaliso lokusekwa kunye nolwazi loluhlu lwesixhobo lufumaneka ngezixhobo zoluntu, kubandakanywa Iphepha le-FDA's Search Registration kunye noLuhlu (elinxibelelanisa kwisiseko sedatha esikhangelekayo).

Oku kuluncedo ekuqinisekiseni ukuba iziko likwisistim kwaye yeyiphi imisebenzi/izixhobo ezidwelisiweyo—kodwa ubhaliso/uluhlu kuphela akufunekanga luthathwe njengobungqina bomgangatho wemveliso.

3) Ukulandeleka kwe-UDI: yazi iziseko

I-FDA yenza isakhelo se-UDI ukuchonga izixhobo ngokusasazwa kunye nokusetyenziswa. Isiqalo esihle kulwimi olulula Iziseko ze-FDA UDI (DI kunye ne-PI).

Kwinqanaba eliphezulu:

• DI (Isichongi seSixhobo) sichonga imodeli/uguqulelo lwesixhobo.

• I-PI (I-Identifier yeMveliso) inokubandakanya iqashiso / ibhetshi, inombolo ye-serial, kunye nezinye iinkcukacha zemveliso.

Kutheni abasasazi kufuneka bakhathalele: I-UDI ngumqolo osebenzayo wokwenziwa kokukhumbula, ukuchaneka kwe-inventri, kunye nokulindela ukulandelelwa phantsi komsinga (izibhedlele kunye neenkqubo zokuthengwa kweqela zilindele ngakumbi ukuhamba kwedatha ye-UDI-friendly).

Uluhlu lokuqinisekisa isiqinisekiso esisebenzayo sababoneleli ngamathambo

Eli licandelo uninzi lwamaqela anqwenela ukuba nalo ngaphambi komhla wokugqibela wethenda.

A. Amaxwebhu kufuneka uwacele ngaphambi kwayo nayiphi na enye into

Injongo yokuhlanganisa 'ipakethe yenkuthalo yomthengisi' onokuphinda uyisebenzise kuzo zonke iithenda:

• Iziqinisekiso zomgangatho (umzekelo, ububanzi be-ISO 13485, umzimba okhuphayo, imihla yokuqinisekisa)

• Amaxwebhu esimo solawulo afanelekileyo kwisicwangciso sakho sokungena kwimarike (umzekelo, ukucocwa kwesixhobo apho kufanelekileyo)

• Ujongo lokulandelelwa (iqashiso/ulawulo lwebhetshi, ukulebhile, indlela i-UDI elawulwa ngayo)

• Isishwankathelo soqinisekiso lokuqinisekisa (ufakelo oluyinyumba/izixhobo)

• Isishwankathelo sokuqinisekiswa kokupakishwa (ingqibelelo yesithintelo esingenazintsholongwane kunye novavanyo lokusasaza)

• Guqula umgaqo-nkqubo wolawulo (indlela abazisa ngayo abathengi, yintoni ebangela ukuqinisekiswa kwakhona)

• Ukuphathwa kwezikhalazo + isishwankathelo seCAPA (indlela imiba ephandwa ngayo kwaye ithintelwe)

I-Key Takeaway : Ukuba umboneleli akakwazi ukubonelela ngepakethi ecocekileyo, ephicothiweyo yamaxwebhu, uya kuyihlawulela kamva-ngolibaziseko lwethenda, ukubamba ukuthunyelwa, okanye ukubuyisela emva-na-phambili ngexesha lophicotho.

B. Iinkalo ekugxilwe kuzo kuphicotho-zincwadi (yintoni omawuyijonge kwisiza okanye kuphicotho olude kakhulu)

Xa uphicotha (okanye ugunyazisa uphicotho), gxila kulawulo oluqikelela ukuhambelana:

• Traceability drills : 'Ndibonise indlela olanda ngayo le SKU ukusuka kwimathiriyeli ekrwada ukuya ekuhanjisweni.'

• Inkqubo yokuqinisekisa inkqubo : iinkqubo ezikhethekileyo ezifana nokuvala inzala kunye nokupakishwa kufuneka zibe nobungqina obucacileyo bokuqinisekisa.

• I-Nonconformance kunye ne-CAPA : ngaba banokubonisa ukucinga kwengcambu kunye nesenzo sokuthintela esibambelelayo?

• Uqeqesho kunye nobuchule : ngubani ogunyazisiweyo ukuba akhulule imveliso, avume ukutenxa, nokulawula utshintsho?

• Ulawulo lwababoneleli : bafaneleka njani kwaye babeke iliso kubaxhasi babo ababalulekileyo ababalulekileyo?

C. Iikhrayitheriya zokusebenza ezichaphazela ukuthembeka kokubonelela ngehlabathi lokwenene

Kubasasazi, 'umgangatho' ayisiyobunjineli kuphela—ikwanokuba umthengisi unokukugcina kwisitokhwe.

Cela izibophelelo ezilinganisekayo kunye nokucaciswa koku:

• Iinkcazo zexesha eliphambili (esemgangathweni vs. ii-SKU ezingekho mgangathweni)

• Izithintelo zomthamo (kwenzeka ntoni ngexesha lokunyuka kwemfuno?)

• Imigaqo yoqikelelo kunye nolwabiwo

• Uthutho / ukhetho lweVMI (ukuba luyanikezelwa)

• I-cadence yonxibelelwano: indlela oza kwaziswa ngayo malunga nokulibaziseka okanye utshintsho

Iiflegi ezibomvu ezixela kwangaphambili ukukhunjulwa kwexesha elizayo, ukulibaziseka, okanye ukungaphumeleli kwethenda

Sebenzisa ezi njengoluhlu 'misa uphande' olusebenzayo:

• Izatifikethi ngaphandle komda ocacileyo (zibandakanya umsebenzi wokurhweba kodwa hayi iinkqubo zokuvelisa)

• 'Sinayo yonke into' amabango ngaphandle kobungqina besixhobo-ngesixhobo (ukucoca, iirekhodi zokulandeleka)

• Akukho nkqubo yokwazisa yotshintsho ebhaliweyo (okanye akukho mizekelo yonxibelelwano oludlulileyo)

• Amabango emveliso oyinyumba ngaphandle kwesishwankathelo sokuqinisekisa onokuthi ujonge kwakhona

• Ukungacaci okuzingileyo malunga nokuba ngubani umleyibheli/umenzi werekhodi

Isicwangciso esilula seentsuku ezingama-30 sokukhuthala

Ukuba uqala ku-zero, olu lulandelelwano lwenyani olugcina umsebenzi ucwangcisiwe.

Iintsuku 1–7: Ukucaca kwendima + ipakethe yamaxwebhu

• Qinisekisa ukuba ngubani umleyibheli/umenzi werekhodi kusapho ngalunye lwesixhobo.

• Cela ipakethe yokunyameka (iziqinisekiso, uphononongo lokulandelelwa, izishwankathelo zokuqinisekisa).

• Imephu ejolise kwii-SKUs kwizichongi zazo ezilawulayo (apho kufanelekileyo).

Iintsuku 8-21: Ukuqinisekiswa + ukulungiswa kophicotho

• Qinisekisa imiqondiso kawonke-wonke (ubhaliso/uluhlu apho kufanelekileyo; qinisekisa izazisi zesixhobo).

• Yakha uluhlu lwakho lophicotho-zincwadi malunga nethenda yakho kunye neemfuno zesibhedlele.

• Gqiba ngokuba uphicothe ngokuthe ngqo okanye usebenzise umntu wesithathu oneziqinisekiso.

Iintsuku ezingama-22-30: Umyalelo wokulinga + uphononongo lokusebenza

• Qala ngomyalelo wokulinga olawulwayo.

• Landela ukuthembeka konikezelo, ukugqibelela kwamaxwebhu, umgangatho wokupakishwa, kunye nokuphendula.

• Bhala oko ukufundileyo-uze wenze isigqibo malunga nokukala.

Ividiyo: Iziseko ze-UDI ngaphantsi kwemizuzu emi-3

Ngezantsi inkcazo emfutshane enokunceda ukulungelelanisa ukuthengisa, i-ops, kunye namaqela e-QA malunga nokuba kutheni i-UDI ibalulekile ekulandeleni umkhondo.

Ividiyo: 'IiMfuno ze-FDA zesiXhobo esiSahlukileyo (i-UDI)' (iRegistrar Corp)

Amanyathelo alandelayo

Ukuba ufuna isiqalo sovandlakanyo lomboneleli, jika uluhlu lokutshekisha olungentla lube kwiphepha elinye lamanqaku kwaye ulisebenzise ngokungatshintshiyo kumgqatswa ngamnye.

Ukuba ufuna nomzekelo wehlabathi lokwenyani wendlela umenzi anikezela ngayo ubungakanani bepotfoliyo kunye namabango okuzaliseka, unokuphonononga ulwazi loluntu I-XC Medico (umzekelo, iindidi zemveliso ezidwelisiweyo, uluhlu lwempahla kunye neengxelo zokuthumela), isishwankathelo senkampani XC Medico Malunga Nathi iphepha , kwaye-ukuba i-OEM/ODM yinxalenye yemodeli yakho-i Isikhokelo sokugqibela se-Orthopedic OEM kunye ne-ODM yokuFumana . Phatha iiwebhusayithi zababoneleli njengesiqalo-uze uqinisekise amaxwebhu kunye nokulandeleka kwinkqubo yakho yesiqinisekiso.

Ukuziphendulela: Eli nqaku lenzelwe iinjongo zolwazi kuphela kwaye alibandakanyi isiluleko solawulo okanye somthetho. Iimfuno ziyahluka ngohlobo lwesixhobo kunye nolawulo.