On-Site Drug Screening An industry perspective IVD Australia Inc - - PowerPoint PPT Presentation

On-Site Drug Screening

An industry perspective

• An ASIC registered incorporated company with a

board of directors a CEO operating with a constitution & Code of Conduct

• Industry Peak body representing >50 companies
• In drug testing market segment companies

represented include: Abbott Diagnostics, Alere, MCG Biotech, MP Biomedicals, Perkin Elmer, Randox, Roche Diagnostics, R-Biopharm, Siemens, ThermoFisher

• This represents >90% of all on-site drug test kits

sold and used in Australia

IVD Australia Inc

Industry Aim/Objective

• Products and services that enhance and support

a safer workplace

• Product that is ‘Fit for Purpose’
• Used in field/not a replacement for labs
• On-site service providers are not laboratories
• Provide world class expertise in drug testing
• World best practice with available technologies
• Australian requirements needs to be aligned

with worldwide requirements

On-Site Drug Screening

a substantial & growing industry segment

• Consultation is key across all sectors
• Need appropriate representation on the

Committees reflecting all stakeholders

– Requires holistic industry representation

• The process of creating/changing the Standard

needs to be transparent and open

• Have achievable outcomes

IVD Australia needs to be on the Committees when deciding on the Standard

AS4760 – an industry standard

• Development of a clear and workable

Standard that supports the users purpose

• Accept that there will be compromises required

by all parties for achievable outcomes

• Accreditation criteria needs to be applied

consistently

– across all assessors & all sites

• Ensure there are no arbitrary decisions made

without industry wide consultation

Issues – Standard/NATA

• Product verification

– In line with standard manufacturing for lateral flow devices

• Availability of viable controls & QAP

– Levels suitable for lateral flow devices

• Transition period to implement any changes
• The Australian market represents approximately

2% of the total worldwide market

– Australian requirements needs to be consistent with worldwide requirements

Issues – Standard/NATA (continued)