1. MEDICAL DEVICE
SAFETY

2. Medical Device Safety
 Absolute Safety.
 Risk Management Issue.
 Effectiveness/Performance.
 Throughout the life span.
 Shared responsibility.

3. MEDICAL DEVICE SAFTEY
Essential Elements
Absolute safety cannot be guaranteed
• It is a risk management issue.
• It is closely aligned with device
effectiveness/performance.
• It must be considered throughout the life span of the
device.
• It requires shared responsibility among the stakeholders.

4. Medical Device Safety and Risk Management
• All Devices carry a certain degree of risk.
• Extensive market experience is needed.
• Estimate the potential of a device becoming a hazard.
 Risk assessment.
 Risk analysis.
 Risk evaluation.
Potential areas of Hazard
– Degree of invasiveness.
– Duration of contact.
– The body system affected.
– Local versus systemic effects.

5. Principles of Safety and Performance
Medical devices should be designed and manufactured in such
a way that, when used under the conditions and for the
purposes intended and, where applicable, by virtue of the
technical knowledge, experience, education or training of
intended users, they will not compromise the clinical condition
or the safety of patients, or the safety and health of users or,
where applicable, other persons, provided that any risks which
may be associated with their use constituted acceptable risks
when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety.
The goal, therefore is to maximize benefit and minimize risk.

6. Effectiveness/performance of Medical
devices
• A device is clinically effective when it produces the
effect intended by the manufacturer relative to the
medical condition.
• Clinical effectiveness is a good indicator of device
performance.
• Performance, however, may include technical functions
on addition to clinical effectiveness.
• Performance is closely linked to safety.
• The role of the regulatory authority is to ensure that
the manufacturer has effectively implemented the risk
management.

7. Role of each participant/stakeholder
1.The manufacturer-
Must ensure that it is manufactured to meet or exceed the required standards of safety and
performance.
Human factor engineering of principles in design.
1.The vendor –
Between the product and the user.
Careful to avoid misleading or fraudulent claims.
Provide after-sale service. Make training a condition. Post market surveillance.
3. The user –
Proper use and maintenance of the device.
Qualifications and training.
It is crucial that experience gained be shared with other users.
Reporting any incidents.
Ensure proper maintenance.
4. The public –
Putting “customer pressure.
5. The Government –
Policies and Regulations.

8. Phases in the life span of a Medical Device
1. Conception and Development.
2. Manufacture.
3. Packaging and Labeling.
4. Advertising and sale.
5. Uses.
6. Disposal.

9. Shared responsibility for medical device safety
and performance
Ideal conditions for ensuring the safety and performance of medical devices
SHARED
RESPONSIBILITY
COMMUNICATION
PARTICIPATION
EDUCATION
RISK/COST
ASSESSMENT
MANUFACTURER
GOVERNMENT
PUBLIC/PATIENTUSER
VENDOR

10. Shared responsibility for medical device safety
and performance
Ideal conditions for ensuring the safety and performance of medical devices
SHARED
RESPONSIBILITY
COMMUNICATION
PARTICIPATION
EDUCATION
RISK/COST
ASSESSMENT
MANUFACTURER
GOVERNMENT
PUBLIC/PATIENTUSER
VENDOR