ESSENTIAL TRAVELLER UPDATE
We are currently working to expedite a more coordinated national approach to ensuring that specialist medical equipment technicians can move in and out of jurisdictions, but in the mean-time, please see updated contact details below and on the MTAA website. Please note the removal of John Heslop from this list, as he is no longer the correct contact.
We have been asked by a number of companies to provide a letter confirming MTAA membership and completion of OTP course and a template letter to assist with identification purposes for staff of member companies. Please contact Peter Tustin for further assistance: ptustin@mtaa.org.au.
MEMBER NEWS
- Overnight Medtronic announced they are publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. Read more.
- Local success story: the US FDA has approved Abbott Labs five-minute “rapid coronavirus test” – this machine was developed in Melbourne and for the first few years of its life was exclusively manufactured in Dandenong by SRX. The machine, IDNow, was originally developed for Alere and production was moved from SRX after Alere was purchased by Abbott. Read more.
- MTAA member Gelworks is setting up to start manufacturing hand sanitiser to help out with the local shortage. Read more.
If you have any updates you would like to share with MTAA members, please contact Rachel Fry: rfry@mtaa.org.au.
REGULATORY UPDATES
- TGA COVID-19 information for clinicians on ventilators and alternative strategies when in short supply. Read more.
- TGA issues warning about illegal advertising relating to COVID-19. Read more.
- MedTech Europe Statement on EU Commission intention to postpone MDR deadline. Read here.
3DMEDITECH AVAILABLE FOR LOCAL DEVICE, PART AND COMPONENT COLLABORATIONS
We are all aware that the ongoing Coronavirus (COVID-19) global health emergency has resulted in acute shortages of key medical devices and component parts. These shortages could be caused by unprecedented demand, logistics constraints or even export controls in the jurisdiction of manufacture.
Early reports from Europe and North America indicate that 3D Printing is uniquely capable of rapid local deployment to assist in preventing these shortages. However, when doing so, ensuring that the highest levels of clinical, engineering, regulatory and supply certainty are met is essential.
Based in Melbourne, 3DMEDiTech operates one of the only – and certainly the largest – ISO13485 certified medical 3DPrinting manufacturing facilities in Australia. Read more.
FUMIGATION OF TESTING KITS
We have been advised that any Customs Broker or Importer that has a consignment that contains COVID-19 diagnostic kits or related goods for Coronavirus that is subject to Brown marmorated stink bug (BMSB) may contact the Seasonal Pest Policy team at SPP@agriculture.gov.au and they will manage the consignment on a case by case basis.
MEDIA RELEASE – CLINICAL TRIALS ARE CRITICAL IN COVID-19 FIGHT
In support of the clinical trials sector during the COVID-19 pandemic, a position statement has been developed by the Research and Development TaskForce (RDTF), sponsored by AusBiotech, Medicines Australia, and the Medical Technology Association of Australia, together with respective memberships. Read more.
REQUEST FOR MEMBER INFORMATION - FREIGHT
If you are experiencing difficulties with securing freight routes please contact Rachel Fry: rfry@mtaa.org.au. We are in the process of compiling information on this to escalate to government.