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Biofilm Testing for Medical Devices


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NAMSA’s Biofilm Testing At A Glance

Microorganisms like bacteria, fungi and yeast can exist as free-floating planktonic entities or attach to a surface — or one another — to form microbial biofilms. These biofilms can form anywhere — including on medical devices, which introduces risks to both patient health and treatment efficacy.


Standard microbiological testing focuses almost exclusively on planktonic bacteria. As such, current standard testing often underestimates the quantity of active agents required to effectively remove a microbial biofilm. At NAMSA, we understand the significance of biofilms as a worldwide health issue, which is why we prioritize biofilm test models with ISO 17025 accreditation to ensure the reliability, accuracy and competence of all our biofilm testing


While no longer accredited, we also still offer reliable Drip Flow Biofilm Reactor and Single Tube Method biofilm tests for medical device manufacturers that need them.


What ISO 17025 Accreditation Means for MedTech Biofilm Testing

Alongside ISO 17025 accredited methods we also offer the Drip Flow Biofilm Reactor and Single Tube method biofilm tests. We have extensive experience in designing and developing biofilm testing methods to support efficacy and safety claims for medical device manufacturers.


Accredited methods offer:

  • Additional assurance that the test has been carried out to a high standard
  • Highly repeatable data between tests, scientists and laboratories
  • Guarantee that study measurements are taken with instruments that have been maintained and calibrated to traceable international standards
  • A seal of quality that’s respected and recognized around the world


ISO 17025 Accredited Biofilm Test Methods

Minimum Biofilm Eradication Concentration (MBEC) 

The Minimum Biofilm Eradication Concentration (MBEC) assay is a high throughput screening model. The MBEC assay evaluates biofilm grown under batch conditions with no flow of nutrients into or out of an individual well. The testing model can be used to determine the efficacy of multiple antimicrobial products simultaneously at multiple concentrations against pre-formed biofilms.


CDC Biofilm Reactor

The CDC Biofilm Reactor test model develops reproducible biofilms on 24 individual coupon surfaces under flow. The coupon materials used in the model are interchangeable and can be chosen to help simulate the use of a product. Examples include polycarbonate, copper, ceramic, stainless steel and glass. The reactor can be tested in a batch system or can include the addition of fresh nutrients during incubation to simulate real-world environments in which biofilms develop.


Ex vivo Burn Wound Model

The ex vivo Burn Wound Model is used for growing repeatable single-organism Pseudomonas aeruginosa and Staphylococcus aureus biofilms on the surface of individual porcine skin burn wounds. This model can be used to enable the pre-clinical efficacy testing of antimicrobial agents such as antibiotics and dressings. Similar tests are not currently commercially available to UKAS 17025 standards for testing dressings against simulated infected burn wounds.