Taking the Stress out of the FDA s UDI Labelling Regulations

Transcription

1 Taking the Stress ut f the FDA s UDI Labelling Regulatins With the applicatin f the FDA s final ruling n medical devices Unique Device Identificatin (UDI) system in September 2013 there are nw new regulatins in frce which means that medical device manufacturers will be cmpelled t implement imprtant labelling changes ver the frthcming years. This will invlve investment in labelling and prduct marking accmpanied by restructuring manufacturing practices and supprting IT systems. By 2018 all medical devices (Class I-III) will be required t bare identifying infrmatin which is cmpliant with the standard, and by 2020 all devices (even with previus exemptins) will be frced t cmply. The higher classificatin devices (Class III & II) will be required t achieve this standard f new regulatins much sner, sme cming int frce by the end f DraniX integrated printing slutins has the expertise and experience t supply a full printing and labelling facility in rder t take the stress ut f adapting t these identificatin changes. Labelling Requirements: In rder t cnfrm t regulatry requirements, it will becme mandatry fr all medical devices t exhibit a labelling system n bth primary and secndary packaging which will include a Device Identifier (DI) and a Prduct Identifier (PI). The end utcme f the FDA s insistence f a UDI practice is t ensure that a barcding system will in the near future ensure tracking and traceability f devices thrughut their life cycle. This is set t ensure ptimizatin f patient safety and enhance ease f prduce recalls and safety warnings in the ccurrence f Adverse Events. The DI must present infrmatin abut the Labeller and specific mdel f device. The PI must include (but nt be limited t) the fllwing: Lt r batch number within which a device was manufactured Serial number f the specific device Expiry date f the specific device Date f manufacture Distinct Identificatin Cde required by (c) fr a human cell, tissue, r cellular and tissue-based prducts (HCT/P) regulated as a medical device.

2 Due t the fact that each label fr a specific device must be uniquely different this has direct implicatins n printing fr every individual device, cvering bth primary and secndary packaging. This being the case, the mst sensible apprach wuld seemingly be t emply the practice f Variable Data Printing, using emerging technlgy t individualize labels in an rganized and reliable manner. Variable Data Printing: Variable Data Printing (VDP) als knwn as Variable Infrmatin Printing (VIP) is the prcess whereby using digital print mechanisms, all elements f the print, including data, graphics and images may be altered autmatically frm ne piece t the next withut interfering with the printing prcess. It als means that data cllated frm databases and external filing systems may be merged int the printing prcess, individualizing each piece withut slwing r delaying the run. VDP has been used in recent years fr direct marketing and advertising hwever it seems that it will nw becme a cre factr in achieving medical device UDI cmpliance. VDP sftware which facilitates file merging and data cleansing is nw widely available and which autmate data preparatin fr the printing prcess. Taking int cnsideratin that medical devices encmpass a huge spectrum f prducts with varying uses, the requirements fr VDP n them will clearly differ t. Fr example, an implantable device (such as an artificial hip cmpnent r breast implant) will require applicatin directly t the material. Etching is mst cmmnly used fr metallic prducts, hwever VDP may be applied t printable material - dispsable packaging such as stmy puches will cmmand this t. In cntrast ther devices such as insulin injectr pens, inhalers r bld glucse meters will be suitable fr labelling prir t secndary (r structural) packaging and in these cases adhesive labelling culd be deemed entirely apprpriate. Fr this reasn when prcuring VDP services the labelling requirements including device classificatin, materials and packaging prcess must be taken int cnsideratin. Device Identifier (DI) Prduct Identifier (PI)

3 Fig 1: Illustratin f an example f UDI cmpliant labelling incrprating VDP t facilitate individualizatin. VDP printing directly nt secndary packaging such as cut card sheets, puches, fil, lids and bags is mre cnvenient and time cnserving fr the manufacturer. This is als a primary cnsideratin when determining the printing partner. DraniX Printing Services: DraniX is a US based Glbal designer, manufacturer and supplier f highly specialized printing slutins suitable fr a wide range f applicatins. As a cmpany we have invested substantially in designing and develping ur new range f direct-t-prduct printing range the ThermaPrint64. This innvative range f printers takes ur printing facilities t a new level, prviding us with the capacity t ffer labelling applicatins t a wide range f materials including primary and secndary medical packaging. The ThermaPrint64 range f printers are an innvative step frward frm the riginal ThermaPrint series, ffering advanced cnnectivity capabilities (USB and Ethernet), and therefre increased, yet simple, imprved cnnectivity capabilities. As utlined abve this new innvative range f printers was designed with the capability t cpe with a large spectrum f packaging materials. These include puches and bags (direct-t-prduct) r alternatively card, cartns and cut sheets, all f which are cmmn in the medical packaging envirnment. Anther distinct advantage f the ThermaPrint64 range is the ability t print directly nt Tyvek puches and Tyvek lids; this enhances the cnvenience f the whle packaging prcess. It is pssible t print directly t blister back packaging, tags and ther flat packaging materials. This whle prcess eliminates the hassle f label printing, hwever where this is nt feasibly pssible, the Label-Printing-Applicatrs are a perfect ptin fr heavy duty table tp label preparatin. Further t this, as the ThermaPrint64 Series was created intentinally t undertake high-vlume VDP batches, it is perfect fr creating labels and identificatin systems that adhere t all the stipulated requirements recently intrduced by the FDA regulatin. The bar-cding ptins and graphical capabilities prvide the manufacturer with utstanding flexibility allwing the ptin f creating packaging prir t labelling and printing directly t pre-prepared packaging, r alternatively prducing a full packaging printing preparatin including lg and branding, alngside fulfilling UDI regulatry requirements.

4 Fig 2: DraniX ThermaPrint 64 Direct-t-Prduct printing system Ultimately in the near future medical device manufacturers will be required t ensure that all devices are adequately labelled and identifiable within the cnstraints f the newly applied FDA UDI guidelines. Any prcurement decisins relating t labelling needs must be supprted by prven and technlgically sund printing slutins, incrprating the specificity f the class f device and current stage f identificatin in rder t achieve regulatry apprval. At DraniX, we believe that we are an excellent chice f partner fr all VDP requirements ffering an unrivalled level f service cmbined substantiated by utstanding experience within the medical packaging sectr. Our team are able t ffer supprt and technical expertise alngside educated advice and persnal cntact. We truly believe that we are the leading prvider in innvative prduct identificatin and bar cding prducts, and we d have the capability t take the stress ut f the UDI labelling headache fr medical devices.

5 Fig 3: DraniX VDP print example nt Tyvek puch Fig 4: DraniX VDP print example incrprating bar cding and QR cde

6 Fig 5: DraniX VPD print example illustrating differential labelling t accmmdate packaging shape Please cntact ur ffice t have a persnal cnsultatin and request a qutatin: Dranix Genesee Trail Rad, Unit 50 Glden, CO Tel: Fax: Tll Free: 855-DORANIX ( ) E: inf@dranix.cm