Ga ƙungiyoyin sayan asibitoci na EU da Amurka, samar da titunan likita aiki ne na daidaitawa, aminci, da kwanciyar hankali. Jirgin da ba a yarda da shi ba zai iya jinkirta tafiyar da aiki mai mahimmanci, yayin da rashin isasshen kulawar kamuwa da cuta yana ƙara € 15,000-€ 30,000 a farashin kowane kamuwa da asibiti (HAI) . Shigar da takaddun shaida na TS EN ISO 13485 melamine na ƙwayoyin cuta - wanda aka ƙera don saduwa da ƙayyadaddun ingantattun ka'idodin kiwon lafiya yayin da ake magana da wuraren jin zafi kamar ƙaramin tsari da isarwa lokaci. Yayin da asibitoci ke kokawa game da hauhawar farashin sarkar samar da kayayyaki da kuma binciken MDR/FDA, waɗannan trays ɗin suna fitowa azaman mafita wanda ke daidaita ƙa'ida ta ƙayyadaddun ayyuka.
Me yasa Takaddun shaida na ISO 13485 yana da mahimmanci ga tiren asibiti
TS EN ISO 13485: 2016 ba kawai akwati ne mai inganci ba - ma'aunin zinare ne na duniya don Tsarin Gudanar da Ingancin Na'urar Kiwon Lafiya (QMS), wanda aka tsara don tabbatar da amincin haƙuri da bin ka'idoji. Don tiren melamine da aka yi amfani da su wajen isar da magunguna, jigilar kayan aiki, da sabis na abinci na haƙuri, wannan takaddun shaida tana fassara zuwa ingantaccen tsaro wanda hukumomin EU da Amurka suka umarta:
1. Cikakkiyar Kula da Ingancin Kekeken Rayuwa
Ma'auni yana buƙatar ingantaccen tsari na ƙarshe-zuwa-ƙarshe, daga tushen albarkatun ƙasa zuwa gano bayan bayarwa. Tirelolin mu suna amfani da resin melamine na likitanci da aka gwada don ƙarfe mai nauyi ( gubar/cadmium ≤0.01%) da formaldehyde kyauta (≤75mg/kg), tare da kowane tsari da aka ba da wani mai ganowa na musamman da ke da alaƙa da kwanan watan samarwa, sakamakon gwaji, da bayanan masu kaya. Wannan matakin na takaddun ya gamsar da buƙatun Takardun Fasaha na EU MDR da umarni Fayil ɗin Tarihin ƙira na FDA (DHF).
2. Gudanar da Hadarin da aka haɗa a cikin Zane
TS EN ISO 13485 yana ba da umarnin rage haɗarin haɗari - mai mahimmanci ga tire waɗanda ke tuntuɓar kayan aikin da ba su da lafiya da marasa lafiya. Muna gudanar da FMEA (Yanayin Kasawa da Binciken Tasiri) don magance hatsarorin kamar tarwatsewar saman (wanda ke haifar da ƙwayoyin cuta) da leken sinadarai yayin haifuwa. Sakamakon haka: tire mai jurewa mai santsi mai santsi, ƙasa mara fashe wanda ke rage mannewar ƙwayoyin cuta da kashi 68% idan aka kwatanta da daidaitaccen melamine.
3. Ƙofar Kasuwar EU/US
Takaddun shaida na ISO 13485 wani sharadi ne don cikar CE MDR (Annex IX, 1.1) kuma ya dace da FDA ta 21 CFR Sashe na 820 (QSR) ta hanyar shirin MDSAP. Asibitocin da ke amfani da tinkunan mu suna guje wa ƙin yarda da tsada - bayanai sun nuna samfuran da aka tabbatar da ISO 13485 suna da ƙimar wucewa sama da 92% a cikin binciken FDA.
Ayyukan Kwayoyin cuta: Bayan Yarda da Kula da Kamuwa
Asibitoci suna ba da fifikon tire waɗanda ke rage haɗarin HAI da ƙarfi, kuma fasaharmu tana ba da sakamako mai aunawa ta hanyar gwajin ISO 22196:
1. 99.9% Tasirin Bakan Bakan
Infused tare da polyhexamethylene biguanide (PHMB) -wani wakili na antimicrobial marar leaching - trays ɗinmu suna kawar da 99.9% na gram-tabbatacce (Staphylococcus aureus, MRSA) da gram-negative (E. coli, Pseudomonas aeruginosa) kwayoyin cuta a cikin sa'o'i 24. Ba kamar magungunan azurfa-ion da ke rasa ƙarfi a kan lokaci ba, PHMB an haɗa shi da matrix na melamine, yana kiyaye inganci bayan 30+ high-zazzabi sterilizations (121 ° C autoclaving).
2. Tsaro don Muhalli na Clinical
Tsarin kwayoyin cuta ya dace da ka'idodin ISO 10993-5 (cell cytotoxicity), tare da ≥80% iyawar kwayar halitta, kuma ba ta da haushi ga fata. Wannan yana sa kwanon rufin lafiya don tuntuɓar raunuka kai tsaye da magunguna, da kayan aikin kula da jarirai-yana magance babbar damuwa ga rukunin yara da kulawar gaggawa.
3. Tattalin Arziki daga Rage Cututtuka
Wani bincike na 2025 na asibitoci 50 na EU ya gano cewa canzawa zuwa tiren ƙwayoyin cuta ya yanke HAI masu alaƙa da 41% . Don asibitin Amurka mai gadaje 500, wannan yana fassara zuwa $280,000 a cikin tanadi na shekara-shekara daga farashin jiyya da aka guje wa da ɗan gajeren zaman haƙuri.
Sayayyar Jumla An Ƙirƙira don Buƙatun Asibiti
Siyan asibitocin EU da Amurka suna fuskantar ƙalubale na musamman: matsananciyar kasafin kuɗi, sauye-sauyen buƙatu, da tsauraran lokutan isarwa. Samfurin mu na jumlolin mu yana magance waɗannan tare da fasalulluka guda uku masu ɗaure kai:
1. MOQ mai sauƙi: 3,000 Pieces don Scalability
Ba kamar masu fafatawa da ke buƙatar ƙaramin yanki 5,000+ ba, MOQ ɗin mu guda 3,000 yana ɗaukar buƙatu iri-iri-daga ƙananan asibitocin da ke gwada sabbin kayayyaki zuwa manyan asibitocin da ke cike kaya. Misali, kwanan nan wani asibitin Jamus ya ba da umarnin tire guda 3,000 don reshen sa na ciwon daji, yana guje wa wuce gona da iri yayin cimma burin magance kamuwa da cuta.
2. Kwanaki 60, Isar da Batch 3 don Sarrafa Kuɗi
Asibitoci sukan kokawa da yawan haihuwa da ake ɗaure jari. Jadawalin tsarin mu (33% a ranar 15, 33% a ranar 30, 34% a ranar 60) ya yi daidai da tsarin sayayya kowane wata. Asibitin Florida da ke amfani da wannan ƙirar ya rage kashe kuɗin gaba da kashi 67 cikin ɗari yayin da ke tabbatar da daidaiton hannun jari ga sashen sa na gaggawa.
3. Kunshin Shirye-shiryen Biyayya
Kowane odar jumloli ya haɗa da keɓaɓɓen kayan yarda: ISO 13485 takardar shaidar, Sanarwa na Daidaitawa, FDA 21 CFR Sashe na 177 yarda da hulɗar abinci, rahotannin gwajin ƙwayoyin cuta (ISO 22196), da takaddar bayanan aminci (SDS). Wannan yana yanke aikin gudanarwa da kashi 40% idan aka kwatanta da samo samfuran da ba a tantance ba.
Nazarin Harka: Canjin Nasara na Asibitin Dutch
Ziekenhuis Gelderse Vallei, asibiti mai gadaje 600 a cikin Netherlands, ya canza zuwa trays ɗinmu na ISO 13485 da aka tabbatar a cikin Q1 2025 don biyan sabbin buƙatun MDR. Sakamakonsu:
Yarda: Ya wuce EU Sanarwa Jiki duba tare da sifili non-conformities, guje wa m € 20,000 fine.Infection Control: Tray-related MRSA lokuta ya ragu daga 8 zuwa 3 a cikin watanni 6. Cost Efficiency: Phased bayarwa rage kaya riko halin kaka da €3,200 da wata-wata. "A hade da sauki, da kuma m isar da maganin kashe kwayoyin cuta, ya ce asibiti mai sassaucin ra'ayi, isarwa mai sassaucin ra'ayi. manaja. "Ba za mu ƙara zaɓar tsakanin aminci da kasafin kuɗi ba."
Yadda Ake Tsare Sallar Kuɗi
Samo tiren mu yana biye da tsari mai sauƙi, mai dacewa da asibiti:
Ƙimar Bukatun: Raba girman tire ɗinku (misali 30x40cm ko al'ada), buƙatun rikodin launi (don ƙungiyar sashe), da jadawalin isarwa.
Bita Bita: Muna ba da samfurin riga-kafi tare da cikakkun takaddun gwaji don amincewar ƙungiyar ku mai inganci.
Ƙarshen kwangila: Ƙirƙirar sharuɗɗan ciki har da kwanakin tsari da matakan biyan kuɗi (net-30 don asibitocin EU/US).
Bayarwa & Tallafawa: Kowane tsari ya ƙunshi lambar QR mai haɗawa zuwa bayanan gano ainihin lokaci; ƙungiyarmu tana ba da jagorar sake tabbatarwa kyauta bayan shekaru 2.
Ga asibitocin EU da Amurka, TS EN ISO 13485 ƙwararrun tarkacen melamine na ƙwayoyin cuta suna wakiltar fiye da kayan wadata - su ne dabarun saka hannun jari a amincin haƙuri da ingantaccen aiki. Tare da ingancin ƙwayar cuta 99.9%, tabbataccen tsari, da sassauƙan sharuddan siyarwa, waɗannan trays ɗin suna warware manyan abubuwan zafi a cikin siyan kayan aikin likita.
Kamar yadda masu kula da kiwon lafiya ke ƙarfafa ma'auni kuma farashin sarrafa kamuwa da cuta ya tashi, tambayar ba idan za a canza zuwa ƙwararrun tiren ƙwayoyin cuta ba - amma ta yaya sauri za ku iya samun abin dogaro. Tuntuɓi ƙungiyarmu a yau don neman samfurin kuma tsara tsarin isar da ku na kwanaki 60.
Game da Mu
Lokacin aikawa: Oktoba-29-2025