建立医疗器械唯一标识（UDI）编码规则的实践与思考

摘要/Abstract

摘要： 为规范医疗器械唯一标识(unique device identification，UDI)系统建设，加强医疗器械全生命周期管理，国家药品监督管理局制定发布了《医疗器械唯一标识系统规则》，并于2019年10月1日起正式施行。创建UDI，需建立符合各利益相关方管理需求的UDI编码规则。本文采用内容分析法，综合分析了现行法规、标准对UDI编码的要求，并结合医疗器械产品生命周期内各方的管理需求，对如何进行UDI编码进行了阐述，并就编码过程中发现的问题，以及所收集到的现有市场上出现的UDI编码问题进行了讨论。建议相关企业应尽快学习UDI系统规则和标准，给产品赋予合规、合理的UDI编码，各UDI应用方应正确使用UDI编码，切实提升医疗器械识别的准确性，提升医疗器械管理的精细化程度，优化医疗器械供应链效率。

关键词: 医疗器械唯一标识（UDI）, 产品标识, 生产标识, GS1

Abstract: In order to standardize the construction of the unique device identification（UDI）system and strengthen the life cycle management of medical devices， the National Medical Products Administration(NMPA) has issued the Rules for the Unique Device Identification System， which is officially implemented from October 1， 2019.To creat UDI，it is necessary to establish a UDI code rules that meets the management needs of various stakeholders. This paper uses content analysis method to comprehensively analyze the requirements of current regulations and standards for UDI coding， and explains how to carry out UDI coding in combination with the management needs of all parties in the life cycle of medical device products. At the same time， this paper discusses the problems found in the coding process， as well as the UDI coding problems that have emerged in the existing market. It is recommended that relevant enterprises should learn UDI rules and standards as soon as possible， and give products a compliant and reasonable UDI code. UDI applications should correctly use UDI codes to improve the accuracy of medical device identification and improve the level of medical device management， and optimize the efficiency of the medical device supply chain.

Key words: Unique device identification（UDI）, Device identifier, Production identifier, GS1

. 建立医疗器械唯一标识（UDI）编码规则的实践与思考[J]. 中国医药导刊, 2019, 21(9): 529-532.

参考文献

[1]World Health Organization.Hypertension[EB/OL].(2015-07-31)
http://www.who.int/topics/hypertension/en/. Accessed 31 July 2015.
[2]刘力生,中国高血压防治指南修订委员会.中国高血压防治指南（2010年修订版）[J].中国医学前沿杂志,2011,3(5):42-93.
[3]Watts C,Cairncross S.Should the GBD risk factor rankings be used to guide policy?[J] Lancet,2012,380(9859):2060-2061.
[4]Field MJ,Lohr KN.Guidelines for clinical practice: from development to use[M].National Academies Press:Washington, D.C,1992.
[5]Boluyt N,Lincke CR,Offringa M. Quality of evidence-based pediatric guidelines[J].Pediatrics, 2005,115(5):1378-1391.
[6]Ward JE, Grieco V.Why we need guidelines for guidelines: astudy of the quality of clinical practice guidelines in Australia[J].Med J Aust,1996,165(10):574-576.
[7]Woolf SH,Grol R,Hutchinson A,et al.Clinical guidelines: potential benefits,limitations,and harms ofclinical guidelines[J].BMJ,1999,318(7182):527-530.
[8]Graham ID,Beardall S,Carter AO,et al.What is the qualityof drug therapy clinical practice guidelines in Canada?[J]CMAJ,2001,165(2):157-163.
[9]Fretheim A,Williams JW Jr,Oxman AD,et al.The relationbetween methods and recommendations in clinical practiceguidelines for hypertension and hyperlipidemia[J].J Fam Pract,2002,51(11):963-968.
[10]Vlayen J,Aertgeerts B,Hannes K,et al.Asystematic review of appraisal tools for clinical practice guidelines:multiple similarities and one common deficit[J].Int J QualHealth. C,2005,17(3):235-242.
[11]Zhang Z, Guo J, Su G,et al.Evaluation of the quality of guidelines for myasthenia gravis with the AGREE II instrument[J].PLoS One,2014,9(11):e111796.
[12]Harris KC,Benoit G,Dionne J,et al. Hypertension Canada’s 2016 CHEP Guidelines for Blood Pressure Measurement,Diagnosis and Assessment of Risk of Pediatric Hypertension[J].Can J Cardiol,2016,32(5):589-597.
[13]Clinical Practice Guidelines and Protocols in British Columbia.Hypertension–Diagnosis and Management.[EB/OL].(2015-03-31)http://www2.gov.bc.ca/gov/content/health/practitioner-professional-resources/bc-guidelines/hypertension
[14]Lurbe E,Agabiti-Rosei E,Cruickshank JK,et al.2016 European Society ofHypertension guidelines forthemanagement of high blood pressure in childrenand adolescents[J].J Hypertens,2016,34(10):1887-1920.
[15]Gabb GM,Mangoni AA,Anderson CS,et al. Guideline for the diagnosis and managementof hypertension in adults-2016[J].Med J Aust,2016,205 (2):85-89.
[16]Queensland Clinical Guidelines Steering Committee. Hypertensive disorders of pregnancy. 2016. [EB/OL].(2016-03-31)http://www.health.qld.gov.au/qcg
[17]Qaseem A,Wilt TJ,Rich R,Humphrey LL,et al.Pharmacologic Treatment of Hypertension in Adults Aged 60 Years orOlder to Higher Versus Lower Blood Pressure Targets: A ClinicalPractice Guideline From the American College of Physicians and theAmerican Academy of Family Physicians[J].Ann Intern Med,2017,166(6):430-437.
[18]中华医学会器官移植分会,中国医师协会器官移植医师分会.中国器官移植受者的高血压诊疗指南（2015版）[J].实用器官移植电子杂志,2016,(5):258-265.
[19]中华医学会妇产科学分会妊娠期高血压疾病学组.妊娠期高血压疾病诊治指南(2015)[J].中华妇产科杂志,2015,50(10):721-728.
[20]Tranquilli AL, Dekker G, Magee L, et al. The classification, diagnosis andmanagement of the hypertensivedisorders of pregnancy: A revised statement from the ISSHP[J].Pregnancy Hypertens,2014,4(2):97-104.
[21]国家卫生计生委合理用药专家委员会,中国医师协会高血.高血压合理用药指南[J].中国医学前沿杂志（电子版）,2015,(6):22-64.
[22]Magee LA, Helewa M, Rey E, et al.Diagnosis, Evaluation, and Managementof the Hypertensive Disorders of Pregnancy:Executive Summary[J].J Obstet Gynaecol Can,2014,36(5):416-438.
[23]González-Juanatey JR, Ramos PM, Arcos FS, et al. 2003 Update of the Guidelines of the Spanish Societyof Cardiology on High Blood Pressure[J].Rev Esp Cardiol,2003,56(5):487-497.
[24]Mancia G,Fagard R,Narkiewicz K, et al.2013 ESH/ESC Guidelines for themanagement ofarterial hypertension[J].Blood Press,2014,23(1):3-16.
[25]中国高血压防治指南修订委员会.中国高血压防治指南2010[J].中华心血管病杂志,2011, 39(7):701-708
[26]Hsu CH,Ho WJ,Huang WH,et al.2014 Guidelines of Taiwan Society of Cardiology(TSOC) for the Management of PulmonaryArterial Hypertension[J].Acta Cardiol Sin, 2014,30:401-444
[27]James PA,Oparil S,Cushman WC,et al.2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee(JNC 8)[J].JAMA,2014,311(5):507-520.
[28]El-Deeb, Sulaiman KJ, Al-Riyami AA,et al.2015 Oman Heart Association Guidelines for the Managementof Hypertension[J].High Blood Press Cardiovasc Prev,2015,22(1):83-97.
[29]Shammas NW,Sica DA,Toth PP. A Guide to the Management of Blood Pressurein the Diabetic Hypertensive Patient[J].Am J Cardiovasc Drugs,2009,9 (3):149-162.
[30]Volpe M,Trimarco M,Battistoni A,et al. Clinical Management of Coronary Heart Disease in Hypertension[J].High Blood Press Cardiovasc Prev,2013,20:129-134.
[31]Weber MA,Schiffrin EL,White WB,et al.Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension[J].J Clin Hypertens (Greenwich),2014,16(1):14-26.
[32]Dionne JM.Evidence-based guidelines for the management of hypertensionin children with chronic kidney disease[J]. Pediatr Nephrol,2015,30:1919-1927
[33]Williams B,Poulter NR,Brown MJ,et al.Guidelines for management ofhypertension:report of the fourth workingparty of the British Hypertension Society,2004-BHS IV[J].J Hum Hypertens,2004,18(3):139-185.
[34]Ogihara T,Hiwada K,Morimoto S,et al.Guidelines for treatment of hypertension in the elderly--2002 revised version[J].Hypertens Res,26(1):1-36.
[35]National Clinical Guideline Centre. The clinical management of primary hypertension inadults（2011）.
[36]Jr DM,MachadoCA,GomesMAM,et al.IV Brazilian Guidelinesin Arterial Hypertension[J].
Arquivos Brasileiros De Cardiologia,2004,82(suplemento 4):S7-22.
[37]Lobo MD,de Belder MA,Cleveland T,et al.Joint UK societies’2014 consensus statement onrenal denervation for resistant hypertension[J]. Heart,2015,101(1):10-16.
[38]Sanchez RA,Ayala M,Baglivo H,et al.Latin American guidelines on hypertension[J].J Hypertens,2009,27(5):905-922.
[39]McCormack T,Krause T,O’Flynn N.Management of hypertension in adults inprimary care: NICE guideline[J].Br J Gen Pract,2012,62(596):163-164.
[40]Watson RE.Management of Hypertension in Patients With Ischemic HeartDisease:New Guidelines[J].J Cardiometab Syndr,2007,2(3):213-216.
[41]Taylor AT,Blaufox MD,Dubovsky EV,et al.Society of Nuclear MedicineProcedure Guideline forDiagnosis of Renovascular Hypertension[J].J Nucl Med,1998,39(7):1297-1302.
[42]Seedat YK,Rayner BL,Veriava Y.South African hypertension practice guideline2014[J]. Cardiovasc J Afr,2014,25(6):288-294.
[43]Dasgupta K,Quinn RR,Zarnke KB,et al.The 2014 Canadian Hypertension Education ProgramRecommendations for Blood Pressure Measurement,Diagnosis, Assessment of Risk, Prevention, andTreatment of Hypertension[J].Can J Cardiol,2014,30(5):485-501.
[44]Ibrahim MM.The Egyptian Hypertension Society:EGYPTIAN HYPERTENSION GUIDELINES[J].Egyptian Heart Journal,2014,66(2):79-132.
[45]Noohi F,Sarrafzadegan N,Khosravi A,et al.The first Iranian recommendations on prevention, evaluation and management ofhigh blood pressure[J].ARYA Atherosclerosis Journal,2012,8(3):97-118.
[46]Lowe SA,Bowyer L,McMahon LP,et al.The SOMANZ Guideline for the Management of Hypertensive Disorders of Pregnancy 2014[J].Aust N Z J Obstet Gynaecol,2015,55(5): e1-29.
[47]Lim W,Arnold DM,Bachanova V,et al.Evidence-based guidelines-anintroduction[J]. Hematology,2008,13:26-30.
[48]Lexchin J,Bero LA,Djulbegovic B,et al.Pharmaceuticalindustry sponsorship and research outcome and quality: systematic review[J]. Brit Med J,2003,326:1167-1170.
[49]Hurwitz B.Clinical guidelines:legal and political considerationsof clinical practice guidelines[J].Brit Med J,1999,318:661.
[50]Al-Ansary LA,Tricco AC,Adi Y,et al. A systematicreview of recent clinical practice guidelines on the diagnosis,assessment and management of hypertension[J].PLoS One,2013,8(1):e53744.

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