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SALDA In Vitro Diagnostics
in South Africa
Welcome
5 November 2014
Portfolio Committee
Bill 6 2014
In Vitro Diagnostic Tests
A new era of regulatory oversight is welcomed
What are In Vitro Diagnostic Tests?
How do they differ from Medical Devices and Medicines
The current regulatory framework in laboratories
What are the “Point of Care Tests” risks to the patient
What is the Minister’s vision for IVD legislation, regulation and
guidelines
Minister of Health Objectives
BURDEN OF DISEASE
IVDs ARE NOT MEDICAL DEVICES
IVDs ARE NOT USED IN OR ON
THE BODY
IVD STAKEHOLDERS AND
SUPPORTING LEGISLATURE
IVDs WORKING TOGETHER
MINISTERS INITIATIVES
UNIQUE HEALTH NEEDS MET
SOUTH AFRICAN NATIONAL BLOOD SERVICE
I HAVE LIFE
IN VIVO = OUTSIDE THE BODY
IVDs PROVIDE INFORMATION
NOT THERAPIES
TECHNOLOGIST ANALYSIS
EXPERIENCE
Go to
doctor
Doctor
writes
script
Phlebotomist
draws
sample
Doctor
assesses
patient
Patient and
form goes to
laboratory
Need in vitro
diagnostics
Y/N
Complete
request form
Sample
separated
and sent to
appropriate
department
Qualified
technologist
processes
sample
In vitro tests
pre validated in
an ISO 15189
accredited
environment
Doctor
assesses
results
Pathologist
sends
results to
doctor
Pathologist
collates test
results with
clinical
results
IVDs = HEALTH SYSTEM
IVDs ARE EVERYWHERE
NURSES DO IN VIVO DIAGNOSTICS = IN
OR ON THE BODY
IN VIVO IS DIFFERENT TO IN
VITRO DIAGNOSTICS
In Vitro Diagnostic tests are :
•
•
•
•
•
•
•
•
reagent products,
calibrators,
control materials,
kits,
diagnostic instruments,
apparatus, large capital equipment,
software systems or
specimen receptacles;
whether used alone or in combination with other IVDs, intended by the
manufacturer to be used in vitro (outside the body) for the examination of
specimens derived from the human body, animals or the environment, solely
or principally for the purpose of providing information:
•
concerning a physiological or pathological state;
•
concerning a congenital abnormality;
•
concerning the predisposition to a medical condition or a
disease;
•
To determine the safety and compatibility with potential
recipients;
•
To predict treatment response or reactions;
•
To define or monitor therapeutic measures;
•
For the surveillance of materials in the environment for
biological contaminants that would potentially affect public
health;
•
For surveillance for epidemiological purposes;
•
For forensic determination;
An accessory to an in vitro diagnostic test means an article which, whilst
not being an in vitro diagnostic test, is intended by its manufacturer to be
used together with one or several particular in vitro diagnostic tests to
specifically enable or assist the in vitro diagnostic test to be used in
accordance with its/their intended purpose(s);
This excludes IVDs where the intended use is for non-clinical purposes
without any medical or public health objective such as “RUO - Research
use only” In Vitro Diagnostics.
Point Of Care Tests can be classified under the following definitions:
•
In Vitro Diagnostic tests for near-patient testing: These tests
are not for self-testing but could be performed outside the laboratory
setting by a qualified Medical Technologist. This enables quicker
results.
•
Companion In Vitro Diagnostic tests: To define or monitor
therapeutic measures.
•
In Vitro Diagnostic test for self-testing: Rapid Tests done by a
lay person, and are not companion diagnostic tests.
IVD Wi-Fi
COMPANION TESTING
SELF TESTING
THE LABORATORY
EASY TO USE ?
ACCREDITED QUALITY ASSURANCE
SAMPLE INTERGITY
SINGLE TESTING VS BATCH TESTING
IVDs IN THE RAIN
IVDs ON THE ROAD
IVDs FOR FREE
HPCSA REGISTERED
MEDICAL TECHNOLOGISTS
THANK YOU