Life cycle of medical devices

1
Life cycle of medical devices

• Gerald Verollet
• World Health Organization
• 3rd SIGN Meeting - New Delhi

2
The risk/benefit nature of medical devices

• The goal is to maximize benefit and to
  minimize risk

3
Definition of medical device

• Article, instrument, apparatus or machine
• for
• Diagnosis, treatment or prevention of disease
• or for
• detecting, measuring, restoring, correcting or
  modifying

4
Risk management in medical device

• Degree of risk
• Risk assessment of devices
• Risk management

5
Critical factors for medical device safety and
effectiveness

• PRODUCT
• Pre-market review

• USE
• Post-market surveillance

• Presentation of product to user

6
The different phases of medical device

• From Conception to disposal

7
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal

• 1 2 3 4
  5 6 7

8
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
Pre-market
Post-market
On-market
9
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
Pre-Market
10
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
On-Market
11
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
Post-Market
12
The role of each participant/stakeholder
Manufacturer
Importer/ Vendor
Government
User
Public
13
Life Cycle of a Medical Device
Conception and Design
Manufacture
Packaging Labelling
Advertising
Sale
Use
Disposal
MANUFACTURER
USER
VENDOR
14
The safety and effectiveness of medical devices
demands co-operation among stakeholders

• The Manufacturer
• The vendor
• The users
• The Public
• The Governnent

15
The nature of medical device safety

• A risk management issue
• tied with device effectiveness/performance
• Throughout the life cycle of the device

16
Communication Between the Actors
Manufacturer
Importer/ Vendor
Government

• Shared
• Responsibility

User
Public