What Norms and Standards for Auto-Disable (AD) Syringes ?

1
What Norms and Standards for Auto-Disable (AD)
Syringes ?

• Gerald Verollet
• World Health Organization

2
Preliminary questions

• What are AD syringes
• Introducing curative AD syringes
• Appropriate use of AD syringes
• Forum of AD syringe Manufacturers

3
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

4
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

5
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

6
Existing options

• Nothing specific for AD syringes except WHO spec.
  for EPI
• Manufacturers consensus on AD syringe
  specifications
• International standards

7
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
Pre-market
Post-market
On-market
8
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
Norms and Standards
9
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.

10
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

11
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 gt ISO

12
Development of International Standards

• Principle
• Consensus
• Industry-wide
• Voluntary

• Actors
• Manufacturers
• Users
• National standard bodies
• Specialists
• WHO ?

13
ISO Standards for Quality and Environment

• ISO 9000
• Quality management
• ISO 14000
• Environmental management
• Systematic approach reduces cost of waste
  generated

14
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

15
AD Syringes Manufacturers

• Assurance that syringes meet / exceed standards
• Concept and design
• Manufacturing
• Packaging and labelling
• Technical collaboration to improve standards and
  safety

16
Users of AD Syringes

• Users should be qualified and trained
• Growing consumer demand for safe injections
• Awareness regarding risks associated with reuse

17
Implementation of International Standards

• Principle
• Information
• Authority
• Harmonization

• Actors
• National regulatory authorities
• Global Harmonization Task Force (GHTF)
• WHO ?

18
National Regulatory Authorities

• Responsibility to ensure syringes safety and
  effectiveness
• Periodic review of policies and regulations
• Export / manufacturers certificate

19
Control Authorities

• Manufacturers declarations
• Private testing laboratories
• E.g., Notified body for CE mark products
• E.g., TUV in Germany
• Each country could have its own
• Auditing

20
Global Harmonization Task Forcehttp//www.ghtf.or
g

• Forum for
• National regulatory authorities
• Industry representatives
• Objectives
• Convergence of national regulations
• Promotion of technological innovation
• Facilitation of international trade

21
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

22
World Health Organization

• Co-ordination of post-market surveillance
• Arbitration on export certification
• Ethical assurance
• Independent review of field evaluation results
• Contacts with Ministries of Health

23
Actors of the Quality System

• Norms and standards providers
• Global Harmonization Task Force (GHTF)
• National regulatory authorities
• AD syringes manufacturers
• Users
• WHO
• Control authorities

24
Communication Between the Actors
AD syringes manufacturers
Nal Reg A
Users
ISO
GHTF
WHO
25
Communication Between the Actors
AD Syringe Manufacturers
Nal Reg A
Users
ISO
GHTF
WHO
26
Questions for the AudienceWhat NS 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?

27
The Good AD Syringe definitionThe Worlds
Perspective

• Manufactured according to international standards
  
• Used only once
• Safe and easy to dispose

28
Questions for the AudienceWhat NS 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?

29
Forum for AD Syringes Manufacturers

• 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,..)

30
Questions for the AudienceWhat NS 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?

31
AnswerYes, 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
• ...

32
Is it a SIGN Objective...

• Specific
• International
• Guarantee on
• Norms Standards
• ... for AD Syringes

33
AD Syringe Market,a Healthcare challenge

• Reduction of unsafe infection
• Reduction of contamination with waste
• Healthcare industry leading the safe and clean
  products campaign
• gtgtgt Safe injection / No waste