Kum 20 13 khan Food and Drug Administration (FDA) chuan dan hnuhnung ber a tichhuak a, chu chuan device identification system danglam tak a siam a, chu chu distribution leh use hmanga devices te chu a dik taka hriat theihna tura duan a ni. Rule hnuhnung ber chuan device labeller-te chuan device label leh package-ah unique device identifier (UDI) an dah tel tur a ni a, chu chu rule-in exception emaw alternative emaw a pekna hmun tih loh chu. UDI tin hi plain-text version leh automatic identification and data capture (AIDC) technology hmanga siam tur a ni. UDI hi vawi khat aia tam hman tur device-ah direct-a mark a ngai bawk ang a, hman apiangin reprocess tura ruahman a ni bawk ang. Device label leh package-a date awmte chu international standard leh international practice nena inmil standard format-a tarlan tur a ni.
UDI chu numeric emaw alphanumeric code danglam tak a ni a, a then hnih a awm a:
device identifier (DI), UDI-a labeler leh device pakhat version emaw model bik hriat theihna tur mandatory, fixed portion, leh
production identifier (PI), UDI-a conditional, variable portion, device label-a dah a nih chuan a hnuaia mi pakhat emaw a aia tam emaw hriat theihna:
device siamna lot emaw batch number emaw;
device bik pakhat serial number;
device bik pakhat expiry date;
hmanrua bik siam a nih ni;
mihring cell, tissue, emaw cellular leh tissue-based product (HCT/P) device anga regulated tana §1271.290(c)-in a phut identification code danglam tak chu.
UDI zawng zawng hi FDA-accredited issuing agency-in a enkawl system hnuaia pek chhuah tur a ni. Rule hian diltuin FDA accreditation a dil theihna tur process a pe a, diltuin FDA hnena a pek tur information a tarlang a, dilna endikna atana FDA-in a hman tur criteria a tarlang bawk.
Exception leh alternative thenkhat chu dan hnuhnung berah tarlan a ni a, chu chuan senso leh phurrit chu a tlem berah dah a ni. UDI system hi stage hrang hrangah hman tan a ni ang a, kum sarih chhungin hman tan a ni ang a, hei hi a taka kalpui a nih theih nan leh a kalpui dan tur senso leh phurrit te chu vawi khata lakluh vek ngai lovin, hun kal zelah a darh zel theih nan a ni ang.
He system kalpui mek zingah hian device labelers te hian FDA enkawl Global Unique Device Identification Database (GUDID)-ah information an thehlut tur a ni. GUDID hian UDI nei device tinte tana basic identifying elements standard set a keng tel ang a, DI CHAUH a awm ang a, chu chu database-a device information hmuh theihna tur key atan a thawk ang. PI te hi GUDID ah hian an tel lo.
FDA hian heng thu tam zawk hi AccessGUDID-ah mipui hnenah a pe chhuak a, National Library of Medicine nena thawhhona hmangin a siam a ni. Medical device hmangtute chuan AccessGUDID hmangin device chungchanga information an zawng thei a, an download thei bawk. UDI hian device hmangtu chungchang, mimal privacy information te pawh tiamin, a tarlang lo va, GUDID database-ah pawh a awm lo vang.
GUDID leh UDI chungchang hrechiang duh tan UDI Resources page en la, chutah chuan education module angkai tak tak, kaihhruaina, leh UDI nena inzawm thil dangte link i hmu ang.
'labeler' chu device pakhata label vuah tir, emaw, device label tihdanglam tirtu, device chu a hnu lama label thlak leh siam danglam ngai lovin sumdawnna atana sem chhuah a nih tumna a ni. Device semtu hming leh a biak theihna tur information dah belh chu, label-a tihdanglamna dang siam lovin, mi pakhat chu labeler a nih leh nih loh hriatna atana siam danglamna a ni lo. A tam zawkah chuan labeler chu device siamtu a ni ang a, mahse labeler chu specification developer, single-use device reprocessor, convenience kit assembler, repackager emaw relabeler emaw a ni thei.
Automatic identification and data capture (AIDC) tih hian UDI emaw device identifier emaw chu automated process hmanga electronic patient record emaw computer system dang emaw-a dah theih tur angin a thlen thei technology eng pawh a huam a ni.
