UDI: History and Players US Congress mandates FDA GHTF recognizes global relevance www.ghtf.org GHTF ad-hoc WG for guidance preparation 2007 ‘ensure global harmonisation’ 2008 ad-hoc WG2008 - 2010 Europe North America Asia - Pacific • EU Commission • US FDA • China FDA •MoH Germany •Health Canada • JFMDA •Eucomed •AdvaMed • AHWP • EDMA
UDI: Rational, Purpose and ScopeRationalA common, worldwide system for product identification should eliminatedifferences between jurisdictions and offer significant benefits tomanufacturers, users and/or patients, and Regulatory Authorities.PurposeImprove patient safety by :• facilitating traceability of devices• enhancing the identification of devices in case of adverse events• assisting in the event of a field safety correctionIt is anticipated that a UDI System may facilitate the reduction of medical errors.ScopeAll products placed on the market that fall within the definition of amedical device that appears within the GHTF document :‘Information Document Concerning the Definition of the Term MEDICAL DEVICE’
Packaging Level Hierarchy Important Definitions!Hierarchy example :• Device itself The Device Identifier (DI) of the lowest- without packaging packaging level(*1) which is marked with• Primary pack an AIDC carrier is the UDI which serves- e.g. pack with 1 unit as the Primary Key of the UDI Database.• Secondary pack- e.g. shelf pack with 10 primary packs (*1) can also be the device itself• Tertiary pack- e.g. case with 50 secondary packs The Identifiers of higher or lowerOut of scope in terms of UDI packaging levels (independent of AIDC• Pallet marking) are Alternative Keys.- e.g. with 200 tertiary packs
UDI Database: Data Elements• Packaging Hierarchy (unlimited no.), per pack. level • Device Identifier / Unit of Measure / Quantity• Manufacturer Name• Manufacturer Contact Information (address, email, phone)• Nomenclature (e.g. GMDN code)• Nomenclature Term (e.g. GMDN term) Intention• Trade Name• Device Model Number (REF No./Catalog No.) Collection of information• Controlled by (e.g. expiry date, manuf. date, lot no. serial no., …) with Medical Device• Size/Volume/Length/Gauge… (clinically relevant characteristics) •identification• Product Description (additional clinically relevant info.) • and labelling• Special Storage/Handling Conditions•Labelled as ‘single use’ ‘global core elements’• Sterility / Package sterile• Need to be sterilized before use• Restricted number of reuses• Containing Natural Rubber Latex• Authorized Representatives (list of countries and addresses)• License / Marketing Authorization (e.g. registration no.)• URL for additional information• Critical warnings or contraindications FDA statement (Dec 2010): data elements will change and grow over time (e.g. DEHP, but no specific plan)
UDI Carrier + Placement Classes B – D DI + PI mandatory (techn. feasibility prerequisited)
Reusable Products, Kits, Multiple Part Products Reusable products have to be marked directly on the device • e.g. laser etched, dot peen, labelled, inkjet, … • AIDC carrier readable throughout MD lifetime • AIDC carrier should be accessible / visible Kits / multiple part products are seen as ONE product • item with the highest risk-class defines the risk-class of the kit / assembled product • only one UDI • only one database entry • only one AIDC carrier Out of scope or open issues : • Spare parts / replacement components • Software • …
Implementation General agreements :The UDI - System shall be implemented stepwise. stepwise.Starting with highest risk class first, lowest risk class last. first, • according GHTF risk-classes (A, B, C, D) risk-Between the steps time to review • analyze achieved results, experiences, etc. • make system adjustments if necessaryIntroduction shall allow sufficient implementation time formanufacturers to maintain compliance with quality system requirements.Risk-based implementation of Unique Device Identification (UDI) ETF Position Paper June 2009:www.eucomed.be/~/media/45B95BF4CBEB400D94EE229E821D87A8.ashx
Milestones – Timelines (1)Milestones US Congress US FDA EU Commission US FDA going to release mandates FDA to going to consider 1. pilot UDI legislation develop a UDI UDI at UDI-DB (draft) guidance MDD recast in cooperation with GHX + GS1 Sept Oct Sept Nov Mar May - Sept Nov Dec Q1 Apr 2007 2008 2009 2009 2010 2010 2010 2010 2011 2011GHTF SC GHTF SC end of GHTF AHWG : GHTF SCestablished UDI published • comments GHTF AHWG end of public public publishesAHWG goal = 1. UDI review presents UDI comments comments UDI‘global •‘UDI guidance guidance discussion period guidance period draft’ draft to GHTF SCharmonization’ paper draft (5 months) comments from : Eucomed, AdvaMed, JFMDA, EDMA, COCIR, GS1, …. (40+) AHWG closed new WG: ‘impl. issues’
Milestones – Timelines (2)Implementation Schedule (expected)US : US : Implementation US : Implementation US : ImplementationUDI legislation deadline for Class 3 deadline for Class 2 deadline for Class 1becomes a law products products products Q2 (3?) Q3 Q3 Q3 2012 2013 2015 2017 …….… 2011 2016 EU : EU : EU : ??? 2 years at least 3 years other MDD recast legislation transition period for regions UDI legislation process implementation on (2012-2013) national level world- (2014 – 2016) wide???
Eucomed’s PositionUDI will bring great benefits for: PATIENT SAFETY IMPROVED VIGILANCE & MARKET SURVEILLANCE GLOBAL TRADEBUT it is essential that A pragmatic (risk-based) approach is adopted Healthcare providers are fully resourced to respond Regional authorities co-operate to ensure a truly GLOBAL and HARMONISED UDI approach otherwise much time and resources would be waisted!
Thank you very much for your attention! Marjolein Engelen Email: email@example.com Phone: 013-5944342