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缇庡浗寤虹珛鐨勫敮涓€鍣ㄦ鏍囪瘑鏄粈涔堬紵

瀹為獙瀹よ祫璁綉鏃堕棿:2019-04-28 鐐瑰嚮: 娆?/span> 鐧惧害鎼滅储

銆愬璇汇€?/strong>浠€涔堟槸鍞竴鍣ㄦ鏍囪瘑锛?鍞竴鍣ㄦ鏍囪瘑锛圲nique Device Identification锛?UDI锛夋槸瀵瑰尰鐤楀櫒姊板湪鍏舵暣涓敓鍛藉懆鏈熻祴浜堢殑韬唤鏍囪瘑锛屾槸鍏跺湪浜у搧渚涘簲閾句腑鐨勫敮涓€韬唤璇併€傚叏鐞冮噰鐢ㄧ粺涓€鐨勩€佹爣鍑嗙殑UDI鏈夊埄浜庢彁楂樹緵搴旈摼閫忔槑搴﹀拰杩愪綔鏁堢巼锛涙湁鍒╀簬闄嶄綆杩愯惀鎴愭湰锛涙湁鍒╀簬瀹炵幇淇℃伅鍏变韩涓庝氦鎹紱鏈夊埄浜庝笉鑹簨浠剁殑鐩戞帶鍜岄棶棰樹骇......
TAG鏍囩锛?缇庡浗 鍖荤枟鍣ㄦ UDI 韬唤璇?/a> 鍞竴鍣ㄦ鏍囪瘑
缇庡浗寤虹珛鐨勫敮涓€鍣ㄦ鏍囪瘑鏄粈涔堬紵

浠€涔堟槸鍞竴鍣ㄦ鏍囪瘑锛?/strong>

鍞竴鍣ㄦ鏍囪瘑锛圲nique Device Identification锛?UDI锛夋槸瀵瑰尰鐤楀櫒姊板湪鍏舵暣涓敓鍛藉懆鏈熻祴浜堢殑韬唤鏍囪瘑锛屾槸鍏跺湪浜у搧渚涘簲閾句腑鐨勫敮涓€“韬唤璇?rdquo;銆傚叏鐞冮噰鐢ㄧ粺涓€鐨勩€佹爣鍑嗙殑UDI鏈夊埄浜庢彁楂樹緵搴旈摼閫忔槑搴﹀拰杩愪綔鏁堢巼锛涙湁鍒╀簬闄嶄綆杩愯惀鎴愭湰锛涙湁鍒╀簬瀹炵幇淇℃伅鍏变韩涓庝氦鎹紱鏈夊埄浜庝笉鑹簨浠剁殑鐩戞帶鍜岄棶棰樹骇鍝佸彫鍥烇紝鎻愰珮鍖荤枟鏈嶅姟璐ㄩ噺锛屼繚闅滄偅鑰呭畨鍏ㄣ€?/p>

缇庡浗鐨勫尰鐤楀櫒姊板敮涓€鏍囪瘑绯荤粺

FDA姝e湪寤虹珛鍞竴鍣ㄦ鏍囪瘑绯荤粺锛屽湪鍒嗛厤鍜屼娇鐢ㄧ幆鑺傚厖鍒嗚瘑鍒尰鐤楀櫒姊般€傝绯荤粺瀹屽叏鎶曞叆瀹炴柦浠ュ悗锛屽ぇ澶氭暟鍖荤枟鍣ㄦ鐨勬爣绛惧皢鍖呭惈浜烘満鍙褰㈠紡鐨刄DI銆傚尰鐤楀櫒姊版爣绛惧晢杩樺繀椤诲悜FDA鐨勫叏鐞冨敮涓€鍣ㄦ鏍囪瘑鏁版嵁搴擄紙Global Unique Device Identification Database 锛?GUDID锛夋彁浜ゆ瘡涓澶囩殑鐗瑰畾淇℃伅銆傚叕浼楀彲浠ュ湪"https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm444831.htm缃戦〉涓殑GUDID鏍忔悳绱㈠拰涓嬭浇淇℃伅銆?/p>

鍞竴鍣ㄦ鏍囪瘑绯荤粺灏嗗湪鍑犲勾鍐呭垎闃舵瀹炴柦锛岄€氳繃灏哢DIs绾冲叆鍖讳繚绯荤粺涓紝鍙互鏇村姞鍏呭垎鍦板疄鐜版煇浜涗紭鍔裤€俇DI鐨勫疄鏂藉皢鏀瑰杽鎮h€呭畨鍏ㄣ€佸疄鐜拌澶囦笂甯傚悗鐩戞帶銆佷績杩涘尰鐤楀櫒姊板垱鏂般€?/p>

鍏ㄧ悆UDI鏁版嵁搴擄紙GUDID锛?/strong>

鍏ㄧ悆鍞竴鍣ㄦ鏍囪瘑鏁版嵁搴擄紙GUDID锛夌敱FDA绠$悊锛屽寘鍚墍鏈夊叿鏈夊敮涓€鏍囪瘑鐨勫尰鐤楀櫒姊般€?/p>

鏍规嵁UDI瑙勫垯锛屾爣鏈塙DI鐨勬瘡涓尰鐤楀櫒姊扮殑鏍囩鍟嗗繀椤诲皢鏈夊叧璇ヨ澶囩殑淇℃伅鎻愪氦缁橤UDID锛岄櫎闈炴湁璞佸厤鎴栨浛浠f柟娉曘€?/p>

鏍规嵁UDI瑙勫垯锛?ldquo;鏍囩鍟嗘槸鍦ㄥ尰鐤楀櫒姊颁笂璐存爣绛炬垨杩涜鏍囩淇敼鐨勪汉锛屾棬鍦ㄥ皢鍖荤枟鍣ㄦ寮曞叆宸為檯璐告槗涓紝鑰屾棤闇€鍚庣画鏇存崲鎴栦慨鏀规爣绛撅紱鍦ㄥぇ澶氭暟鎯呭喌涓嬶紝鏍囩鍟嗕负鍖荤枟鍣ㄦ鍒堕€犲晢锛屼絾鏍囩鍟嗕篃鍙互鏄鏄庝功缂栧啓浜哄憳锛坰pecification developer锛夛紝涓€娆℃€у尰鐤楀櫒姊板啀澶勭悊鍟嗭紙single-use device reprocessor锛夛紝渚垮埄濂椾欢缁勮鍟嗭紙convenience kit assembler锛夛紝閲嶆柊鍖呰鍟嗭紙repackager锛夋垨閲嶆柊璐存爣绛惧晢锛坮elabeler锛夈€?rdquo;

鏍规嵁涓嶶DI瑙勫垯涓€璧峰彂甯冪殑鍚堣鏃堕棿琛紝GUDID姝e湪琛ュ厖鏈夊叧鍖荤枟鍣ㄦ鐨勬暟鎹€侴UDID鍙寘鍚尰鐤楀櫒姊扮紪鐮侊紙DI锛夛紝瀹冧富瑕佺敤浜庝粠鏁版嵁搴撲腑鑾峰彇鍣ㄦ鍏抽敭淇℃伅銆傜敓浜х紪鐮侊紙PIs锛変笉闇€鎻愪氦鎴栧瓨鍌ㄥ湪GUDID涓紝浣咷UDID涓寘鍚玃I鏍囧織锛岀敤浜庢寚绀鸿澶囨爣绛句笂鐨凱I灞炴€с€?/p>

GUDID鎻愪緵涓ょ鎻愪氦鍖荤枟鍣ㄦ璇嗗埆淇℃伅鐨勬柟寮忥細

1銆丟UDID Web鐣岄潰 - 灏嗗尰鐤楀櫒姊颁俊鎭殑涓€娆℃€х粨鏋勫寲杈撳叆锛屼綔涓轰竴娆I璁板綍銆?/p>

2銆丠L7 SPL鎻愪氦 -灏嗗尰鐤楀櫒姊颁俊鎭彁浜や负xml鏂囦欢

涓や釜鎻愪氦閫夐」閮介渶瑕佸缓绔婫UDID甯愭埛銆?鐩墠鍦ㄧ編鍥介攢鍞殑鍚勭被璁惧鐨勬爣绛惧晢鍙互鑾峰緱GUDID甯愭埛銆?/p>

GS1鍏ㄧ悆缁熶竴鏍囪瘑绯荤粺

鐩墠锛孎DA鎺堟潈浜嗕笁澶ф満鏋凣S1銆丠IBCC鍜孖CCBBA鏉ヨ礋璐e彂琛岋嫉锛わ缉鐮併€傚浗闄呯墿鍝佺紪鐮佸崗浼氾紙GS1锛夋槸閫氳繃缇庡浗FDA璁ゅ彲鐨刄DI鍙戠爜鏈烘瀯锛屼腑鍥界墿鍝佺紪鐮佷腑蹇冿紙GS1 China锛変綔涓篏S1鍦ㄤ腑鍥界殑鎴愬憳缁勭粐锛屽悓鏍锋槸寰楀埌璁ゅ彲鐨刄DI鍙戠爜鏈烘瀯銆?/p>

鍏ㄧ悆缁熶竴鏍囪瘑绯荤粺锛圙S1绯荤粺锛夋槸涓€绉嶅紑鏀剧殑銆佸鐜妭銆佸棰嗗煙搴旂敤鐨勫叏鐞冪粺涓€鍟嗗姟璇█锛岀敱鍥介檯鐗╁搧缂栫爜鍗忎細鍒跺畾锛屾槸鏈嶅姟浜庣墿娴併€佷緵搴旈摼绠$悊鐨勫紑鏀剧殑鏍囧噯浣撶郴锛岀洰鍓嶅湪鍏ㄧ悆150澶氫釜鍥藉锛堝湴鍖猴級鐨勪竴鐧惧涓囧浼佷笟寰楀埌骞挎硾搴旂敤銆侴S1绯荤粺浠ュ晢鍝佹潯鐮佺郴缁熶负鏍稿績锛屽寘鍚紪鐮佷綋绯汇€佹暟鎹浇浣撱€佺數瀛愭暟鎹氦鎹㈢瓑鍐呭銆?/p>

GS1绯荤粺涓嶶DI缂栧埗瀵瑰簲鍏崇郴

鏍规嵁鍖荤枟鍣ㄦ鐨勪娇鐢ㄩ闄╃瓑绾у強杩芥函瑕佹眰锛屽敮涓€鏍囪瘑鐨勭粍鎴愬涓嬪浘锛?/p>

缇庡浗寤虹珛鐨勫敮涓€鍣ㄦ鏍囪瘑鏄粈涔堬紵

UDI绯荤粺鐨勪紭鍔?/strong>

褰揢DI绯荤粺瀹屽叏瀹炴柦鍚庯紝鍞竴鍣ㄦ鏍囪瘑绯荤粺灏嗛€氳繃浠ヤ笅鏂瑰紡涓哄尰鑽涓氥€丗DA銆佹秷璐硅€呫€佸尰鐤椾繚鍋ユ満鏋勫拰鍖荤枟淇濆仴绯荤粺鎻愪緵涓€绯诲垪鐩婂锛?/p>

鈻?鍏佽鏇村噯纭湴鎶ュ憡銆佸鏌ュ拰鍒嗘瀽涓嶈壇浜嬩欢鎶ュ憡锛屼互渚挎洿蹇湴璇嗗埆鍜屾暣鏀规湁闂鍖荤枟鍣ㄦ銆?/p>

鈻?浣垮尰鐤椾繚鍋ヤ笓涓氫汉鍛樺拰鍏朵粬浜鸿兘澶熸洿蹇€熴€佸噯纭湴璇嗗埆鍖荤枟鍣ㄦ骞惰幏鍙栨湁鍏冲櫒姊扮壒鎬х殑閲嶈淇℃伅锛屽噺灏戝尰鐤楅敊璇€?/p>

鈻?閫氳繃鎻愪緵鏍囧噯鍜屾竻鏅扮殑鐢靛瓙鍋ュ悍璁板綍銆佷复搴婁俊鎭郴缁熴€佺储璧旀暟鎹潵婧愬拰娉ㄥ唽琛ㄧ殑鏂瑰紡鏉ヨ褰曡澶囦娇鐢ㄦ儏鍐碉紝鍔犲己瀵瑰競鍦轰笂鍖荤枟鍣ㄦ鐨勫垎鏋愩€傝繕鍙互鍒╃敤鏇村姞寮哄ぇ鐨勪笂甯傚悗鐩戞帶绯荤粺鏉ユ敮鎸佷笂甯傚墠鎵瑰噯銆佷笉浜堟壒鍑嗘柊鐨勫尰鐤楀櫒姊版垨鍙栨秷褰撳墠閿€鍞櫒姊扮殑鏂扮敤閫斻€?/p>

鈻?鎻愪緵鏍囧噯鍖栫紪鐮侊紝浣垮埗閫犲晢锛屽垎閿€鍟嗗拰鍖荤枟淇濆仴鏈烘瀯鏇存湁鏁堝湴绠$悊鍖荤枟鍣ㄦ鍙洖宸ヤ綔銆?/p>

鈻?涓哄叏鐞冨寲鐨勫畨鍏ㄩ攢鍞摼濂犲畾鍩虹锛屽府鍔╄В鍐冲櫒姊板亣鍐掑拰杞Щ闂锛屾彁鍓嶄负鍖荤枟绱ф€ユ儏鍐典綔鍑嗗銆?/p>

鈻?寮曢涓栫晫鍏鐨勫尰鐤楀櫒姊拌瘑鍒郴缁熺殑鍙戝睍銆?/p>

绾冲叆鍖讳繚绯荤粺

鏈€缁堢殑UDI瑙勫垯涓哄尰鐤楀櫒姊拌涓氬疄鏂経DI绯荤粺鎻愪緵浜嗙洃绠℃鏋躲€傝绯荤粺鎵€甯︽潵鐨勫埄鐩婂彧鏈夊湪鍒堕€犲晢銆佸垎閿€鍟嗐€佷粯娆句汉銆佷緵搴斿晢銆佸尰淇濅綋绯荤瓑鍏朵粬鍒╃泭鐩稿叧鏂瑰厖鍒嗛噰绾冲苟浣跨敤UDI鐨勬儏鍐典笅鎵嶈兘瀹炵幇锛岃繖浜涘埄鐩婄浉鍏虫柟鍦ㄦ暣涓尰鐤楀櫒姊扮敓鍛藉懆鏈熶腑灏嗗彂鎸ラ噸瑕佷綔鐢ㄣ€?/p>

瀹炵幇杩欎簺鍒╃泭鐨勯渶瑕佷笌鑱旈偊鍐呴儴鍚堜綔浼欎即鍜屽叾浠栧閮ㄥ埄鐩婄浉鍏虫柟鍚堜綔锛屼粠鑰屽皢UDI绾冲叆鐢靛瓙鍋ュ悍淇℃伅銆侳DA杩樻鍦ㄤ笌鎭╂牸浼牸甯冮瞾閲戞柉鍖荤枟淇濆仴鏀归潻涓績锛坱he Engelberg Center for Health Care Reform at Brookings锛夊悎浣滐紝甯屾湜鑳藉湪鏁翠釜鍖荤枟浣撶郴涓垚鍔熷簲鐢ㄥ拰瀹炴柦UDI鍒跺畾璺嚎鍥撅紝璇ヤ妇鎺皢浼犺揪UDI瀹炴柦鐨勪环鍊硷紝寮曞鍒╃泭鐩稿叧鏂硅В鍐冲叧閿寫鎴橈紝骞朵綔涓烘敮鎸乁DI绾冲叆鍖讳繚鐨勬斂绛栧熀纭€銆?/p>

鍦?012骞村拰2013骞达紝FDA鏀寔寮€灞曚簡涓嶮ercy鍚堜綔鐨勪负鏈?8涓湀鐨勭ず鑼冮」鐩紝Mercy鏄編鍥界殑澶у瀷鍖荤枟淇濆仴绯荤粺锛屾秹鍙婁复搴婄幆澧冧腑閲囩敤鐨刄DI銆傝椤圭洰鍖呮嫭涓変釜鐩爣锛?/p>

鈻?鍦ㄥ鍖婚櫌绯荤粺鐨勭數瀛愬仴搴疯褰曪紙electronic health record 锛孍HR锛変腑瀹炴柦鍩轰簬UDI鐨勭殑鍐犵姸鍔ㄨ剦鏀灦鐩戞帶绯荤粺銆?/p>

鈻?纭畾鍒跺畾UDI璺嚎鍥剧殑闅滅锛屽苟鎻忚堪涓哄厠鏈嶉殰纰嶉噰鍙栫殑骞查鎺柦鐨勬湁鏁堟€с€?/p>

鈻?璇勪及浠嶦HR鑾峰緱鐨勬暟鎹殑鏈夋晥鎬у拰鏁堢敤浠峰€硷紝骞跺皢UDI鐢ㄤ簬涓婂競鍚庣洃绠°€?/p>

涓嬫湡鎴戜滑灏嗕細涓烘偍璇︾粏浠嬬粛鏈夊叧鍞竴鍣ㄦ鏍囪瘑锛圲DI锛夌殑缂栧埗瑙勮寖銆?/p>

鏂囩珷鏉ユ簮

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