Orthopaedic Suppliers: Akwankyerɛ a Ɛyɛ Mfaso a Ɛfa Vetting Implants Ne Nnwinnade Ho wɔ U.S.

Nnompe ho nnuruyɛfo a wobɛpaw no nyɛ unit bo kɛkɛ. Wɔ wɔn a wɔkyekyɛ nneɛma a wɔtɔn kɔ U.S. ayaresabea ne mmeae a wɔyɛ oprehyɛn fam no, gyinaesi a wɔn a wɔde nneɛma ma no bɛyɛ asiane ho gyinaesi: nkrataa a wɔkyɛ no betumi akum tender ahorow, nsɛm a ɛfa nkyerɛwde a wɔde kyerɛw nneɛma ho no betumi asiw nneɛma a wɔde mena no kwan, na nsonsonoe a ɛwɔ sɛnea wobetumi ahwehwɛ nneɛma mu no betumi adan anwiinwii ketewaa bi ayɛ mmuae a wɔde bɛkae a edi mũ.

Saa akwankyerɛ yi yɛ nhumu-gyinabea nhyehyɛe: ɛkyerɛkyerɛ nea 'nnompe ho aduruyɛfo' taa kyerɛ, sɛnea nneɛma a wɔde ma no yɛ adwuma, U.S. mmara sodi ho mfitiasesɛm a ɛsɛ sɛ wuhu, ne nhwehwɛmu kratasin a mfaso wɔ so a wubetumi de adi dwuma de ama wɔn a wɔde nnompe a wɔde hyɛ nipadua mu ne nnwinnade ma no afata.

Nneɛma atitiriw a wɔde kɔ

• 'Nnompe ho aduruyɛfoɔ' betumi akyerɛ adwumayɛfoɔ, apam adwumayɛfoɔ, anaa ɔkyekyɛfoɔ/ɔsan kyerɛwfoɔ—ma dwumadie ahodoɔ mu da hɔ ansa na woasɔ ahwɛ.

• Wɔ U.S. no, wobɛpɛ sɛ wote sɛnea FDA 510(k) clearance fa nnompe a wɔde hyɛ nipadua mu pii ho ne sɛnea wobɛhwɛ sɛ mfitiase nsɛnkyerɛnne a ɛkyerɛ sɛ wodi mmara so no ase.

• Adetɔnfoɔ a wɔfata ho nhyehyɛeɛ a emu yɛ den ne nkrataa-di kan: wotumi hwehwɛ, nsakraeɛ sohwɛ, sterilization/packaging validation (bere a ɛfata), ne CAPA nteɛsoɔ ho hia sene aguadi ho nsɛm.

• UDI traceability nyɛ labeling detail kɛkɛ —ɛyɛ akyi dompe a ɛma recall ahoboa ne inventory pɛpɛɛpɛ.

Nea 'orthopaedic suppliers' kyerɛ (ne nea enti a asɛmfua no yɛ basaa) .

Wɔ nneyɛe mu no, nkurɔfo de 'nnompe ho adwumayɛfo' di dwuma sɛ nkyerɛwde tiawa ma adwumakuw biara a ebetumi de nnompe a wɔde hyɛ nipadua mu ne nnwinnade ama bere nyinaa—mprɛte ne nkɔnsɔnkɔnsɔn, nnadewa a ɛwɔ ntini mu, akyi berɛmo a wɔde si hɔ, nhyehyɛe a wɔde san yɛ nkwaa, ne nnwinnade a ehia na wɔde ahyɛ nipadua mu.

Nanso asɛmfua no de asɛm titiriw bi sie: 'supplier' a ɛwɔ wo apam no mu no betumi ayɛ:

• Mmara kwan so adwumayɛfo / labeler (adwumakuw a ɛhwɛ labeling, mmara kwan so nsɛm a wɔde bɛkɔ, ne asɛyɛde ahorow a ɛwɔ gua akyi) .

• A contract manufacturer a ɔyɛ nneɛma ma labeler soronko

• Ɔkyekyɛfo . anaa nea ɔsan de nkyerɛwde foforo (a ebetumi asesa mmara mu asɛyɛde ahorow)

Ansa na wobɛma obi a ɔde nneɛma ma no nkontabuo no, ma nsɛmmisa mmienu mu nna hɔ:

1. Hena ne labeler of record ma device a wobɛtɔn akɔ US no?

2. Adwumakuw bɛn na ɛwɔ mmara ho nkrataa ne nsakrae-hwɛ nhyehyɛe no?

Saa mmuae ahorow no na ɛkyerɛ nea wubetumi agye atom —ne nea obebu akontaa bere a biribi sesa no.

Sɛnea nnompe a wɔde hyɛ nipadua mu no taa yɛ adwuma

Adwene a wɔayɛ no mmerɛw no te sɛ eyi:

1. Nneɛma a wɔde yɛ (sɛ nhwɛso no, titanium a wɔde afra, cobalt-chrome, PEEK ma nneɛma bi) .

2. Nneɛma a wɔyɛ + akwan titiriw (mfiri, ɔfasu a wɔde wie, ahotew; ne sterilization a wɔde yɛ nneɛma a wɔmfa nnuru nni dwuma wom)

3. Packaging + labeling (a UDI labeling ahwehwɛde ka ho bere a ɛfata) .

4. Quality release + traceability kyerɛwtohɔ (lot/batch controls, DHR-te sɛ kyerɛwtohɔ, nhwehwɛmu kyerɛwtohɔ) .

5. Export/import + distribution (amammerɛ, adekoradan, ayaresabea a wɔde kɔ, nneɛma a wɔde kɔ) .

Wɔ wɔn a wɔkyekyɛ nneɛma fam no, supply-chain ahotoso taa yɛ 'won' anaa 'lost' wɔ mmeae abien:

• Quality systems : So controls ne kyerɛwtohɔ ahorow no mu yɛ den sɛnea ɛbɛyɛ a wobetumi atwam audits na wɔadi nsakrae ho dwuma wɔ asɛyɛde mu?

• Adwumayɛ mu nteɛso : So wotumi hyɛ bere a wɔde bɛkɔ, tumi, ne nkitahodi ho nkɔm sɛnea ɛbɛyɛ a wɔbɛkwati stockouts ne tender huammɔdi?

US mmara sodi mfitiasesɛm a ɛfata sɛ wote ase ansa na woakyerɛw wɔn a wɔde nneɛma ma no tiawa

Ɛho nhia sɛ woyɛ mmara ho ɔbenfo na ama wɔn a wɔde nnompe ho nnuru ma no afata —nanso wuhia ntease a ɛyɛ adwuma wɔ nea wobetumi (ne wontumi) agye atom no ho.

1) FDA 510(k): nea ɛyɛ ne nea enti a ɛho hia

Wɔahyɛ nnompe a wɔde hyɛ nipadua mu pii ho mmara sɛ nnuruyɛ mfiri wɔ U.S., na mfiri ahorow pii nam FDA 510(k) kwan (premarket notification) so na ɛba gua so.

FDA kyerɛkyerɛ 510(k) a wɔde mena ahorow pii mu na ɛhyɛ no nsow sɛ, wɔ mfiri ahorow bi a wɔate ase yiye ho no, wobetumi de Ɔkwan a Egyina Ahobammɔ ne Adwumayɛ so adi dwuma wɔ 510(k) nhyehyɛe no mu —baabi a wɔn a wɔde mena no de wɔn ho to adwumayɛ ho gyinapɛn ahorow a FDA ahu so sen sɛ wɔde ntotoho sɔhwɛ tẽẽ bedi dwuma wɔ nsɛm bi mu. Hwɛ FDA Ahobammɔ ne Adwumayɛ a Egyina Ɔkwan a wɔfa so ma 510(k) nsɛm a wɔde kɔma.

Nea ɛsɛ sɛ woyɛ sɛ obi a ɔkyekyɛ nneɛma: bisa nea ɔde nneɛma ma wo no 510(k) nɔma a ɛfata ma mfiri pɔtee a woayɛ w’adwene sɛ wobɛkyekyɛ no, na yɛ kyerɛwtohɔ a wɔahyɛ so a ɛkyerɛ sɛ ɔfã nɔma ahorow bɛn na ɛkyerɛ kwan a wɔfa so gyae nneɛma.

2) Hwɛ sɛ establishment registration ne device listing (nanso te nea ɛnkyerɛ ase) .

FDA ma wonya nsɛm a ɛfa establishment registration ne device listing ho denam ɔmanfo nnwinnade so, a nea ɛka ho ne FDA’s Search Registration and Listing krataafa (a ɛkɔ database a wotumi hwehwɛ mu no so).

Eyi ho wɔ mfaso ma hwɛ sɛ adwumakuw bi wɔ nhyehyɛe no mu ne dwumadi/mfiri a wɔakyerɛw din wom—nanso ɛnsɛ sɛ wobu dinkyerɛw/kyerɛwtohɔ nkutoo sɛ adanse a ɛkyerɛ sɛ nneɛma no yɛ papa.

3) UDI traceability: nim mfitiaseɛ no

FDA yɛɛ UDI nhyehyeɛ a wɔde bɛhunu mfiri denam nkyekyɛmu ne dwumadie so. Ade pa a yebetumi afi ase ne kasa a emu da hɔ FDA UDI mfitiasesɛm (DI ne PI) ..

Wɔ ɔfã a ɛkorɔn mu no:

• DI (Device Identifier) ​​kyerɛ afiri no mfonini/nkyerɛase.

• PI (Production Identifier) ​​betumi de lot/batch, serial number, ne production data afoforo aka ho.

Nea enti a ɛsɛ sɛ wɔn a wɔkyekyɛ nneɛma no hwɛ yiye: UDI ne akyi dompe a mfaso wɔ so a ɛma wɔkae nneɛma a wɔakae, nneɛma a wɔakora so pɛpɛɛpɛ, ne akwanhwɛ a wɔhwɛ kwan sɛ wobetumi ahwehwɛ wɔ nsu no ase (ayaresabea ne kuw adetɔ nhyehyɛe ahorow hwɛ kwan kɛse sɛ UDI-adamfofa data bɛsen).

Ahwehwɛde ho nhwehwɛmu a mfaso wɔ so ma wɔn a wɔde nnompe ho nnuru ma no

Eyi ne ɔfã a akuw dodow no ara pɛ sɛ wonya ansa na tender bere a edi kan no aba.

A. Documentation a ɛsɛ sɛ wobisa ansa na woayɛ biribi foforo biara

Fa botaeɛ ne sɛ wobɛboaboa 'supplier due diligence packet' a wobɛtumi asan de adi dwuma wɔ tender ahodoɔ nyinaa mu:

• Adansedie a ɛfa su pa ho (sɛ nhwɛsoɔ no, ISO 13485 scope, kuo a ɛde ma, nna a ɛdi mu) .

• Mmara tebea ho nkrataa a ɛfa wo gua so hyɛn ho nhyehyɛe ho (sɛ nhwɛso no, mfiri a wɔma ho kwan wɔ baabi a ɛfata) .

• Traceability nsusuwii (lot/batch controls, labeling, sɛnea wɔhwɛ UDI so) .

• Sterilization validation nsɛm tiawa (ma sterile implants/nnwinnade) .

• Packaging validation summary (sterile akwanside nokwaredi ne nkyekyɛmu sɔhwɛ) .

• Sesa control policy (sɛnea wɔbɔ adetɔfo amanneɛ, nea ɛkanyan revalidation) .

• Anwiinwii ho dwumadie + CAPA nsusuiɛ (sɛdeɛ wɔhwehwɛ nsɛm mu na wɔsiw ano) .

Key Takeaway : Sɛ nea ɔde nneɛma ma no ntumi mfa nkrataa packet a ɛho tew na wotumi susuw ho mma a, wubetua ho ka akyiri yi —wɔ tender a ɛkyɛ, shipment holds, anaasɛ ɛyaw akyi-ne-akyi bere a audits.

B. Mmeae a wɔde wɔn adwene si akontabuo so (deɛ ɛsɛ sɛ wɔhwehwɛ wɔ beaeɛ hɔ anaa wɔ akyirikyiri akontabuo a emu dɔ mu) .

Sɛ woreyɛ akontabuo (anaasɛ wohyɛ sɛ wɔnyɛ akontabuo) a, fa w’adwene si controls a ɛkyerɛ sɛ ɛbɛkɔ so pɛpɛɛpɛ so:

• Traceability drills : 'Kyerɛ me sɛnea wohwehwɛ SKU yi mu fi raw material so kosi shipment so.'

• Process validation discipline : ɛsɛ sɛ akwan titiriw te sɛ sterilization ne packaging nya validation adanse a emu da hɔ.

• Nonconformance ne CAPA : so wobetumi ada ntini mu nsusuwii ne adeyɛ a wɔde siw ano a ɛbata ho adi?

• Ntetee ne ahokokwaw : hena na wɔama no tumi sɛ onyi ade no adi, pene deviations so, na ɔhwɛ nsakrae so?

• Supplier controls : ɔkwan bɛn so na wɔfata na wɔhwɛ wɔn ankasa sub-suppliers a ɛho hia so?

C. Adwumayɛ ho gyinapɛn a ɛka wiase ankasa mu nneɛma a wɔde ma ho ahotoso

Wɔ wɔn a wɔkyekyɛ nneɛma fam no, 'quality' nyɛ engineering nko ara—ɛyɛ nso sɛ ebia nea ɔde nneɛma ma no betumi de wo asie wɔ stock mu anaa.

Bisa bɔhyɛ ahorow a wobetumi asusuw ne nea emu da hɔ wɔ:

• Nkyerɛaseɛ a ɛfa bere a wɔde di dwuma ho (SKU a ɛyɛ gyinapɛn vs. nea ɛnyɛ gyinapɛn) .

• Tumi anohyeto (dɛn na ɛba bere a ahwehwɛde no kɔ soro?) .

• Nkɔmhyɛ ne nkyekyɛmu ho mmara

• Consignment / VMI options (sɛ wɔde ma a) .

• Nkitahodi cadence: sɛnea wɔbɛbɔ wo amanneɛ wɔ akyɛde anaa nsakrae ho

Frɛmfrɛm kɔkɔɔ a ɛkyerɛ sɛ wɔbɛkae daakye, wɔbɛkyɛ, anaasɛ tender huammɔdi

Fa eyinom di dwuma sɛ 'gyina na hwehwɛ' list a mfaso wɔ so:

• Adansedi nkrataa a enni baabi a ɛda adi pefee (ɛka aguadi dwumadi ho asɛm nanso ɛnyɛ nneɛma a wɔyɛ ho nhyehyɛe) .

• 'Yɛwɔ biribiara' nsɛm a wɔka a enni mfiri biara ho adanse (clearances, traceability records) .

• Nsakrae ho amanneɛbɔ nhyehyɛe a wɔakyerɛw ato hɔ biara nni hɔ (anaasɛ nsakrae nkitahodi a atwam ho nhwɛso biara nni hɔ) .

• Sterile product claims a enni validation summary a wubetumi ahwɛ mu

• Ambiguity a ɛkɔ so wɔ hɔ a ɛfa onii a ɔyɛ labeler/manufacturer of record ho

Nnafua 30 nhwehwɛmu a ɛfata ho nhyehyɛe a ɛnyɛ den

Sɛ worefi ase afi zero a, eyi yɛ nnidiso nnidiso ankasa a ɛma adwuma no kɔ so yɛ nhyehyɛe.

Nna 1–7: Dwuma a ɛda adi pefee + nkrataa packet

• Si so dua sɛ hena na ɔyɛ labeler/manufacturer of record ma device abusua biara.

• Bisa due diligence packet (adansedi ahorow, traceability nsusuwii, validation nsɛm a wɔaboaboa ano).

• Map SKUs a wɔahyɛ da ayɛ no kɔ wɔn mmara kwan so nkyerɛkyerɛmu (baabi a ɛfata).

Nna 8–21: Nhwehwɛmu + akontabuo ahosiesie

• Hwɛ ɔmanfoɔ nsɛnkyerɛnneɛ (kyerɛwtohɔ/kyerɛwtohɔ wɔ baabi a ɛfata; si mfiri a wɔde kyerɛ nneɛma so dua).

• Yɛ wo audit checklist no twa wo tender ne ayaresabea ahwehwɛdeɛ ho hyia.

• Si gyinae sɛ ebia wobɛyɛ akontaabu tẽẽ anaasɛ wode obi foforo a ɔfata bedi dwuma.

Nna 22–30: Pilot order + adwumayɛ nhwehwɛmu

• Fi ase de wimhyɛnkafo ahyɛde a wɔahyɛ so.

• Track delivery ahotoso, nkrataa a edi mũ, packaging quality, ne mmuae.

• Kyerɛw nea wusuae no—afei si gyinae sɛ wobɛkari pɛ anaa.

Video: UDI mfitiasesɛm wɔ nea ennu simma 3 mu

Ase hɔ no yɛ nkyerɛkyerɛmu tiawa a ɛbɛtumi aboa ama adetɔn, ops, ne QA akuo ahyia wɔ deɛ enti a UDI ho hia ma traceability.

Video: 'FDA Mfiri soronko a Wɔde Kyerɛkyerɛ (UDI) Ahwehwɛde' (Registrar Corp)

Anamɔn a edi hɔ a ɛsɛ sɛ woyɛ

Sɛ wopɛ sɛ wufi ase yɛ adetɔnfo nhwehwɛmu a, dannan nhwehwɛmu a ɛwɔ atifi hɔ no ma ɛnyɛ kratafa biako nkontabuo krataa na fa di dwuma daa wɔ obiara a ɔpɛ sɛ ɔyɛ ɔkannifoɔ no nyinaa mu.

Sɛ wo nso hia wiase ankasa nhwɛsoɔ a ɛkyerɛ sɛdeɛ adwinnan bi de portfolio scope ne mmamu ho nsɛm kyerɛ a, wobɛtumi ahwɛ ɔmanfoɔ nsɛm a ɛfa ho no mu XC Medico (sɛ nhwɛso no, listed product categories, inventory ne dispatch statements), adwumakuw no nsusuwii wɔ XC Medico About Us page , na—sɛ OEM/ODM yɛ wo mfonini no fã a—a Akwankyerɛ a Etwa To a Ɛfa Nnompe OEM & ODM Adetɔ Ho . Fa nneɛma a wɔde ma no wɛbsaet ahorow sɛ nea wubefi ase —afei hwɛ sɛ nkrataa ne nea wotumi hwehwɛ mu wɔ w’ankasa wo ahwehwɛde nhyehyɛe mu.

Asɛm a Wɔka: Saa asɛm yi yɛ nsɛm a wɔde bɛma nkutoo na ɛnyɛ mmara anaa mmara ho afotu. Ɛsono nea wɔhwehwɛ wɔ mfiri no su ne tumidi mu.