SALDA In Vitro Diagnostics in South Africa Welcome 5 November 2014 Portfolio Committee Bill

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 sample Doctor writes script Sample separated and sent to appropriate department Qualified technologist processes sample In vitro tests pre validated in an ISO 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 TECHNOLOGISTS THANK YOU