WhatNormsandStandardsforAuto-Disable(AD)Syringes.pptVIP

What Norms and Standards for Auto-Disable (AD) Syringes ? Gerald Verollet World Health Organization Preliminary questions What are AD syringes Introducing curative AD syringes Appropriate use of AD syringes Forum of AD syringe Manufacturers Do we need NS for AD syringes ? Reference to medical devices NS Reference to disposable syringes NS Specific NS for AD syringes for which application ? Immunization curative application Addressing Safety Needs in the Immunization AD Syringe market Limited market Well defined users Existing specifications WHO/UNICEF policy for use of AD syringes in immunization Addressing Safety Needs in the Curative AD Syringe Market Major market Multiple user profiles Absence of norms and standards Absence of evidence regarding prevention effectiveness Existing options Nothing specific for AD syringes except WHO spec. for EPI Manufacturers consensus on AD syringe specifications International standards Life Cycle of a Medical Device Life Cycle of a Medical Device Standard: Definition Documented agreements For consistent use as: Rules Guidelines Definitions of characteristics To ensure that materials, products, processes, and services are fit for their purpose. Importance of Norms and Standards Norms and standards guarantee effectiveness Norms and standards ensure quality Definition of quality Control of quality Norms and standards provide safety ………. NS create a market Norms and Standards Providers National standardization National standard body : e.g., AFNOR Regional standardization Regional standard organization : e.g., European Norm (CEN) International standardization forum of national standard bodies ISO Development of International Standards Actors Manufacturers Users National standard bodies Specialists WHO ? Principle Consensus Industry-wide Voluntary ISO Standards for Quality and Environment ISO 9000 Quality management ISO 14000 Environmental management Systematic approach reduces cost of waste generated ISO Standa