On-Site Drug Screening An industry perspective
IVD Australia Inc • 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
On-Site Drug Screening a substantial & growing industry segment 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
AS4760 – an industry standard • 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
Issues – Standard/NATA • 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 (continued) • 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
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