As a member of the Coronavirus Industry Roundtable which is meeting regularly to discuss and address supply chain issues, MTAA has been asked by the Federal Government to lead the industry effort to coordinate the supply of essential medical equipment.
MTAA is coordinating with medical equipment suppliers and manufacturers, including non-members of MTAA, and other relevant industry associations to identify sources of supply and also to provide advice to Government regarding any constraints or obstacles to securing and maintaining supply. This includes identifying current stock, likely quantities that can be obtained through existing supply channels, new sources of supply and potential quantities, and opportunities to increase domestic manufacturing.
These groups will all be focused on providing the Federal Government with advice around supply chain and logistics issues, as well as working directly with state governments to gauge supply and the potential for shortages.
As part of maintaining the supply chain, MTAA is working directly with individual state governments to ensure that medical device services, including technical support and training, are able to continue to operate.
We are also working to ensure that vital technical support services, including service/maintenance/repairs and intraoperative technical support, can still be provided by technicians during medical procedures.
“We are incredibly grateful to the many medical technology companies dedicating significant resources to the effort at a time when their own companies are under an extreme amount of stress,” said Ian Burgess, MTAA CEO.
“The medical devices industry is 100% focused on helping to ensure the continued supply and distribution of vital medical supplies and maintaining Australia’s healthcare system,” Mr Burgess said.
The medical technology industry has also been working closely with the TGA to enable faster access to life-saving medical equipment. A number of exemptions and fast-tracking processes have now been put in place:
- On 22 March 2020, an exemption was enacted to enable faster access to PPE. This will facilitate necessary access to certain kinds of medical devices that are used for the prevention, monitoring, treatment or alleviation of COVID-19. (In practice, disposable face masks, disposable gloves, disposable gowns, and protective eye wear in the form of goggles, glasses or visors, which are designed to be worn by individuals to prevent the transmission of organisms.)
- A new emergency exemption, Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020, has been made to allow rapid supply of COVID-19 diagnostic tests to all Australian accredited pathology laboratories. In practice this emergency exemption allows COVID-19 diagnostic tests to be immediately supplied to accredited pathology laboratories approved under the Health Insurance Act 1973, while the TGA continues to expedite the regulatory assessment process for these devices.
- The TGA is currently undertaking an expedited assessment process based on the information and performance data currently available at the time of application for inclusion on the ARTG. All COVID-19 tests that are included on the ARTG based on this expedited assessment process are subject to additional non-standard conditions, which makes it easier for the TGA to perform additional post market assessments as experience and knowledge around COVID-19 diagnostic testing grows. The conditions require that additional evidence to support the ongoing safety and performance of the devices be provided to the TGA within 12 months of approval.
ACCC INTERIM AUTHORISATION TO SHARE INFORMATION
The ACCC has granted interim authorisation to MTAA to allow its members and other groups, such as suppliers or distributors of medical equipment, to share information between each other, co-ordinate orders and supply requests, prioritise requests, and jointly tender to supply COVID-19 medical equipment.
The interim authorisation will allow MTAA members and others to coordinate the manufacture and supply of equipment, and exchange information so that potential supply shortages can be addressed more quickly.
It will also allow industry to keep Federal Government, State and Territory Governments and relevant health agencies up to date on supply issues.