SALDA In Vitro Diagnosticsin South Africa

Welcome

5 November 2014Portfolio 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 assesses patient

Need in vitro diagnostics

Y/N

Complete request form

Patient and form goes to

laboratory

Phlebotomist draws

sampleDoctor writes script

Sample separated

and sent to appropriate department

Qualified technologist

processes sample

In vitro tests pre validated in

an ISO 15189 accredited

environment

Pathologist collates test results with

clinical results

Pathologist sends

results to doctor

Doctor assesses 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 TECHNOLOGISTSTHANK YOU