Mhla zingama-21 kuNhlangulana 2017, i-FDA yaseShayina yamemezela i-14^thisaziso sekhwalithi yamadivayisi ezokwelapha kanye nokuphathwa kwekhwalithi okushicilelwe kanye nesimo sokuhlolwa kwesampula sezigaba ezi-3 amasethi angu-247 imikhiqizo efana namashubhu e-tracheal alahlwayo, i-thermometer yezokwelapha kagesi njll.

Amasampula ahlolwe ngokungahleliwe angahlangabezani nezindinganiso zemishini yezokwelapha ehilela izigaba ezi-3 amasethi ama-4 imikhiqizo ekhiqizwe abakhiqizi bemishini yezokwelapha aba-4; izinto ezihloliwe njengokuhlonza amalebula, izincwajana njll. ezingahlangabezani nezindinganiso ziyisigaba esi-1 amasethi amasethi ama-2 imishini yezokwelapha ekhiqizwe abakhiqizi bemishini yezokwelapha aba-2; izigaba ezi-3 amasethi angama-241 imishini yezokwelapha ekhiqizwe abakhiqizi bemishini yezokwelapha abangama-92 bahlangabezana nezindinganiso ezifanele zazo zonke izinto ezihloliwe.

Njengamanje, i-Food and Drug Administration kazwelonke isivele icele iminyango yendawo yokuphatha ukudla nezidakamizwa ukuthi iphenye futhi ibhekane namabhizinisi afanele, futhi icele iminyango efanele yokuphatha ukudla nezidakamizwa esifundazweni ukuthi imemezele ukuxazulula lesi simo emphakathini.

Ukuze kuqiniswe ukubhekwa nokuphathwa kwekhwalithi kwemishini yezokwelapha nokuqinisekisa ukusetshenziswa okuphephile nokuphumelelayo kwemishini yezokwelapha, i-FDA yethu kazwelonke muva nje yenza ukubhekwa nokuthathwa kwesampula kwekhwalithi ngokuhambisana nemvamisa ebangeni eliphakathi izikhathi ezimbili ngenyanga. Lokhu kubonisa ngokugcwele ukukhathazeka kukahulumeni ngemishini yezokwelapha, kuyadingeka ukuthi umelane nokuhlolwa kwemakethe uma ufuna ukuqhubeka nale ndlela.

I-Shenzhen Med-link Medical Electronics Co., Ltd. ihlala ifuna ukuthi yonke imikhiqizo ihlangabezane nezindinganiso zakamuva zikazwelonke nezamazwe ngamazwe. Njengoba yasungulwa ngo-2004, ngemva konyaka owodwa wokuhlela, iqembu lokuqala lezintambo zekhebula ze-ECG kanye nezintambo ze-lead ze-Med-link liphumelele ukubhaliswa kwe-CFDA ngempumelelo, kuyisiqalo esihle futhi kuwubufakazi obuhle kakhulu bemizamo yethu.

Ngemva kocwaningo olusha lweminyaka eyi-13 emkhakheni wemishini yezokwelapha ngo-2017, i-probe yokushisa ye-Med-link eyakhe ngokuzimela, inzwa ye-SpO₂ ephinde isetshenziswe, ipensela ye-ESU elahlwayo, ikhebula lesandiso se-pulse SpO₂, i-electrode yobuchopho engangenisi, ikhebula le-IBP njll., yonke le mikhiqizo iqinisekiswe ngokugunyaziwe yizinhlangano zomhlaba wonke ezifana ne-CFDA, i-FDA, i-CE njll.

Njengoba sinolwazi olude oluvivinywe emakethe yemishini yezokwelapha, ngeke sizitike esikhathini esidlule, futhi ngeke simane nje sithathe isinyathelo ngesinyathelo. Njengoba sizivumelanisa nemakethe yemishini yezokwelapha eshintsha njalo, sihlangabezana nezidingo zakamuva zamaqembu ahlukene, i-Med-link Medical izohlala iphishekela amazinga aphezulu kanye nobuchwepheshe obuphezulu, futhi ibonise amandla ethu ngekhwalithi yomkhiqizo.

Ukuxhumanisa ukunakekelwa kokuphila nokunakekelwa, kwenza abasebenzi bezokwelapha babe lula, abantu babe nempilo enhle!