What Norms and Standards for AutoDisable (AD) Syringes ?
Gerald Verollet
World Health Organization
Preliminary questions
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What are AD syringes
Introducing curative AD syringes
Appropriate use of AD syringes
Forum of AD syringe Manufacturers
Do we need N&S for AD syringes ?
• Reference to medical devices N&S
• Reference to disposable syringes N&S
• Specific N&S for AD syringes for which application ?
– Immunization
– curative application
Addressing Safety Needs in the
Immunization AD Syringe market
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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
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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
Conception
and Design
Manufacture
Pre-market
Packaging
Labelling
Advertising
Sale
On-market
Use
Disposal
Post-market
Life Cycle of a Medical Device
Conception
and Design
Manufacture
Norms and
Standards
Packaging
Labelling
Advertising
Sale
Use
Disposal
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
……….
• N&S 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 Standards
• ISO 9001 and 9002
– General application for products and services
• ISO 13485 and 13488
– Medical device industry with or without design control
requirement
• ISO 7886-1
– Sterile hypodermic syringes for single use
• part 1: Syringes for manual use
• ISO ????
– AD Syringes
AD Syringes Manufacturers
• Assurance that syringes meet / exceed standards
– Concept and design
– Manufacturing
– Packaging and labelling
• Technical collaboration to improve standards and
safety
Users of AD Syringes
• Users should be qualified and trained
• Growing consumer demand for safe injections
• Awareness regarding risks associated with reuse
Implementation of International
Standards
• Actors
– National regulatory
authorities
– Global Harmonization
Task Force (GHTF)
– WHO ?
• Principle
– Information
– Authority
– Harmonization
National Regulatory Authorities
• Responsibility to ensure syringes safety and
effectiveness
• Periodic review of policies and regulations
• Export / manufacturer’s certificate
Control Authorities
• Manufacturer’s declarations
• Private testing laboratories
– E.g., “Notified body” for CE mark products
• E.g., TUV in Germany
• Each country could have its own
• Auditing
Global Harmonization Task Force
http://www.ghtf.org
• Forum for:
– National regulatory authorities
– Industry representatives
• Objectives:
– Convergence of national regulations
– Promotion of technological innovation
– Facilitation of international trade
Global Harmonization Task Force
Study Groups
1- Regulatory requirements / pre-market review
2- Medical device vigilance / post-market surveillance
3- Quality system requirements and guidance
– Collaboration with ISO
4- Auditing
World Health Organization
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Co-ordination of post-market surveillance
Arbitration on export certification
Ethical assurance
Independent review of field evaluation results
Contacts with Ministries of Health
Actors of the Quality System
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Norms and standards providers
Global Harmonization Task Force (GHTF)
National regulatory authorities
AD syringes manufacturers
Users
WHO
Control authorities
Communication Between the Actors
AD syringes
manufacturers
Nal Reg A
ISO
Users
GHTF
WHO
Communication Between the Actors
AD Syringe
Manufacturers
Nal Reg A
ISO
Users
GHTF
WHO
Questions for the Audience
What N&S for AD syringes ?
• What definition for an AD syringe ?
• How can we collaborate on a global quality and
safety policy for AD and other syringes ?
• Do we need a specific ISO standard for AD syringes?
The Good AD Syringe definition:
The World’s Perspective
• Manufactured according to international standards
• Used only once
• Safe and easy to dispose
Questions for the Audience
What N&S for AD syringes ?
• What definition for an AD syringe ?
• How can we collaborate on a global quality and
safety policy for AD and other syringes ?
• Do we need a specific ISO standard for AD syringes?
Forum for AD Syringes Manufacturers
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Consensus on waste management
Training strategy for user
Co-ordination of AD syringes field evaluation
Exchange of information
One voice for negotiation with ISO, GHTF, and WHO
Relation with the Healthcare Industry Manufacturer
Associations (EUCOMED, ADVAMED,..)
Questions for the Audience
What N&S for AD syringes ?
• What definition for an AD syringe ?
• How can we collaborate on a global quality and
safety policy for AD and other syringes ?
• Do we need a specific ISO standard for AD syringes?
Answer:
Yes, A specific International standard
for AD syringes is recommended
• First step : Preparation of a proposal prepared by
the forum of AD syringe manufacturers
• second step : Presentation of the proposal to the
ISO /TC 84
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Is it a SIGN Objective...
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Specific
International
Guarantee on
Norms & Standards
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for AD Syringes
AD Syringe Market,
a Healthcare challenge
• Reduction of unsafe infection
• Reduction of contamination with waste
• Healthcare industry leading the safe and clean
products campaign
>>>
Safe injection / No waste