In general, a device can be shown to meet the minimum standards of its kind by demonstrating conformity with a relevant and recent technical standard. However, as new risks are identified or specific claims are being made that are not covered by the respective standard, additional relevant tests may be required to verify and ensure that conformity and all Essential Principles are met.
Guidelines for disinfectants products with anti-virus or anti-microbial claims - although the claim guidance being primarily intended for disinfectants – are transferable to medical devices.
TGA has specified that evidence from the relevant clinical or laboratory studies to support the claims made by the manufacturer are critical. More importantly, evidence from testing is required to be specific to the product itself, instead of a proof of concept. In short, the testing protocol such as the time of action, actual operation and final product should be taken into consideration.
A few examples:
- • Studies on the final product of the mask, instead of its fabric or additive, for cell culture;
- • Consideration of continuous passage of air through the facemask, instead of static cell culture;
- • Consideration of in vivo immune response conditions and biofilm/capsule formation to the microenvironment where the implant is placed;
- • For face mask applications, clinical literature indicates the infectious period is ~8-17 min. Reduction timeframes over 15 minutes may not provide appreciable benefits to the user.
In addition, the following standards and additional sources should also be taken into consideration when planning the testing for evidence, such as:
- • TGA guidance and website;
- • Relevant international standards;
- • Overseas regulatory guidance;
- • Reviewing the latest relevant information/studies in state of the art and identify the gap in between.
Including the worst-case scenario, appropriate sample size, sampling plan, sampling timeframe and batch repeat, if necessary. For instance, a sample size of 3 is not sufficient especially if the uncertainty is high.
Besides, if the product may be introduced to new risks, such as, introduction of compounds, addition of pharmaceutical/pharmacological ingredients, incorrect or improper use, the risk assessment of the overall risks is necessary to be conducted, and to be minimised by the manufacturer in the proper risk management standard, e.g. ISO 14971:2019. Failing to have a comprehensive appropriate risk management and adequate evidence would cause a rejection from the Australian Health Authorities TGA.
Lastly, the manufacturer is required to include the evidence and documentation into the Design Dossier/Design History File/Technical documentation, which should contain all testing reports, relevant risk management or risk assessment report, release records, post-market surveillance (PMS), complaint procedures, as well as adverse event procedures. All related documents will need to be kept on file and well maintained with the historical and latest versions.