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Staying up to date on regulatory requirements and industry standards can be a challenge with ever-evolving expectations. However, keeping a close eye on changes in standards will insure that your medical device testing stays on track to a successful submission.
Today, we focus on medical textiles—specifically, the newest requirements with AATCC Test Method 100-2019 (TM100). For textile devices that make antimicrobial claims, the U.S. FDA requires manufacturers to provide proof of a certain level of antimicrobial efficacy. TM100 is one of the most commonly used to determine whether a device reaches the minimum threshold. A base-level understanding of the AATCC TM 100-2019 test can help manufacturers achieve regulatory compliance the first time around, conserving costs and time in the regulatory process.
About the test
TM100 provides a quantitative procedure for the evaluation of antimicrobial activity on textiles. The test’s application covers a broad range of products – from implantable medical devices to sportswear. To determine the desired amount of antimicrobial activity, two pieces of textile – one treated with an antimicrobial and one not – are compared to establish the level of antimicrobial activity. Coupled with the controls in the standard, this test continues to be an established method to provide data on antimicrobial activity by way of an in vitro test.
How to find clarity
The purpose behind the 2019 updates to AATCC TM 100-2019 were to remove ambiguity that led to confusion amongst users. The test previously had a loose explanation of how much product the testing required. Before the update, the test was performed on as many fabric swatches as it took to absorb one milliliter of inoculum which left room for many variabilities in interpretation and unclear test article requirements. Now, the standard states that you use swatches that are equal to one gram of material. Additionally, the updated testing requires a viability control using a fabric that does not have any antimicrobial properties to demonstrate that your testing organism has stayed viable throughout the duration of the test.
What it means for medical device manufacturers
The changes in the standard, which result in reduced variability from test to test, allow for a more accurate picture of the antimicrobial efficacy of a textile product. This is an enormous advantage when claiming substantial equivalency to a product in the market. Additionally, using TM100 as a screening test during R&D, as it was originally intended, can assist in planning many aspects of downstream production and regulatory approval.
Consult your testing partner
While testing partners can help you understand what a U.S. FDA reviewer may want to see, opinions among reviewers can always differ. There are two steps to take to stay on the path of success.
First, create a solid testing plan from day one – preferably one that includes a U.S. FDA pre-submission meeting – and there will not be any surprises going into final U.S. FDA review. If you complete a pre-submission, it is highly unlikely that expectations would change upon formal submission.
Second, ensure you are testing to recognized standards throughout the entirety of product development. Your testing partner can work with you early on to determine the best approach with TM100 for your device to avoid any bumps in the road while gaining regulatory approvals. To learn more about TM100 and how it fits into your testing plans, contact us.
