Why we need medical device regulation in times of crisis

I know we as a community sometimes struggle to understand or get behind the “red tape” associated with regulation. In the field I work in, which is medical devices, this regulation is truly designed to protect us - our community.

It can seem frustrating in times like this when we are facing the coronavirus pandemic. When there is an urgent need to get a product to those who need it most. But it is during these times that we need the regulation to stand behind us and ensure we are safe. 

Being practical in times like these is important, but the system that is in place protects our precious health care workers and the patients they serve. 

Last week, hundreds of thousands of masks were recently recalled from hospitals in the Netherlands as they were defective. They failed a number of the critical quality checks once they were tested. Doctors and nurses across the country were exposed to significant risk, as a result of defective manufacturing processes.

Our nurses and doctors and at-risk people in our community, put these masks on trusting that they will serve the purpose as they are claiming. Assuming they will protect them from inhaling the COVID-19 virus. These people can assume this because we have a robust regulatory framework in Australia that protects us. 

Are we as a society willing to put the lives of our health workers and our community at risk by bypassing regulation? I certainly am not. 

All Personal Protective Equipment (PPE) for health workers is regulated by the Therapeutic Goods Administration (TGA). What that means is that controlled tests need to be done on both the design and the ongoing manufacture of products. The amount of control and work required varies based on the risk that a defective product poses to the user. 

For example, Face Shields that are used in health applications are a Class 1 Device. This is deemed to be a relatively low-risk device. But it still has an inherent risk to the user if it fails. It stops contaminated fluids from making contact with the face and in conjunction with an appropriate mask, it provides additional coverage to the wearer from airborne viral particles.

Can we 3D print these at home for use in health care? Absolutely. Should we? No! Unless you have met the requirements as outlined by our regulators to ensure you have adequately managed the risks, and aren’t inducing any further risks to the user. More info is available at the TGA website https://www.tga.gov.au/medical-devices-regulation-basics

This is not impossible! We can get safe, effective products to market quickly if we band together to make it happen. Partnering with a certified medical device manufacture is one easy way of getting these products to those health care providers who need it most. 

On the COVID-19 Supply Chain Task Force we are working on a project for almost every health care PPE item. We are ensuring they are designed, tested and manufactured to the highest standards to keep our community safe. Many local providers are partnering with us to enable this.