Antimicrobial Efficacy Testing
Antimicrobial Efficacy Testing
Antimicrobial efficacy testing helps evaluate the effectiveness of antimicrobials/preservatives that are added for preventing the growth of microorganisms in your medical device. WuXi AppTec Medical Device Testing experts can tailor a testing program to the specific needs of your device or application. Talk to us today about your project needs.
Evaluate Antimicrobial Efficacy for Your Medical Device
Need to assess the effectiveness of antimicrobial efficacy in your device? WuXi AppTec is an experienced preclinical testing partner for device manufacturers. We offer everything from package testing to complete chemical characterization and everything in between. This ensures you collect the right data to advance your device to the next development stage.
To ensure proper evaluation, our experts adhere to a variety of testing standards utilized in antimicrobial efficacy testing.
The general chapter USP<51> Antimicrobial Effectiveness Testing established by the United States Pharmacopeia (USP), pertains to the antimicrobial efficacy testing of medical devices, pharmaceutical products, and sterile multidose units. It outlines the guidelines and procedures for evaluating the effectiveness of antimicrobial agents or materials incorporated into pharmaceutical products and medical devices.
This standard is crucial because it ensures that medical devices with antimicrobial properties are tested and validated for their ability to inhibit or kill microorganisms effectively. By following the USP-51 standard, manufacturers can demonstrate the antimicrobial efficacy of their products, providing healthcare professionals and patients with assurance regarding their safety and effectiveness in preventing or reducing the risk of infections associated with medical device use.
ASTM E2180 is a standard test method titled “Standard Test Method for Determining the Activity of Incorporated Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials.” This method provides a procedure for evaluating the antimicrobial effectiveness of antimicrobial agents incorporated into or onto polymeric or hydrophobic surfaces.
ASTM E2180 is commonly used in the medical device industry to evaluate the antimicrobial properties of materials used in the manufacture of medical devices. It helps determine the effectiveness of antimicrobial treatments or additives in preventing the growth of microorganisms on the surfaces of medical devices. The procedure also permits determination of “shelf-life” or long-term durability of antimicrobial treatment which can be achieved through testing both non-washed and washed samples over a time span.
ASTM E2315 is a standard test method titled “Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure.” This standard provides guidelines to measures the changes in the aerobic microbial population within a specified sampling time when antimicrobial agents are present in liquid or solid disinfectants, antiseptics, and other materials.
ASTM E2315 is commonly used in the field of microbiology and in industries where evaluating the effectiveness of antimicrobial products is important, such as healthcare, pharmaceuticals, and consumer products. It provides a standardized approach to assess the ability of antimicrobial agents to kill or inhibit the growth of microorganisms.
AATCC Test Method 100
AATCC (American Association of Textile Chemists and Colorists) Test Method 100 is a widely recognized standard used to assess the antimicrobial activity of textile materials. It is titled, “AATCC TM100-2019, Test Method for Antibacterial Finishes on Textile Materials: Assessment of” and provides guidelines for evaluating the effectiveness of antibacterial treatments on textiles.
This test is a quantitative test for assessing the ability of fabrics and textiles to inhibit the growth of microorganisms, which is important in applications where textiles come into contact with the skin or are used in environments where bacterial growth is a concern, such as healthcare facilities, sports apparel, medical dressing, and personal protective equipment.
ISO 22196 is an international standard titled “Measurement of Antibacterial Activity on Plastics and Other Non-Porous Surfaces.” It provides a standardized method for evaluating the antibacterial activity of surfaces that are non-porous, such as plastics, ceramics, and metals.
The results obtained from the ISO 22196 test provide information on the antibacterial effectiveness of the tested surface material. It allows for a comparison of different materials’ ability to inhibit bacterial growth and helps assess their potential in applications where antibacterial properties are desired, such as in healthcare settings, food processing, or consumer products.
ISO 21702:2019 is indeed a valid standard titled “Plastics — Measurement of antibacterial activity on plastics surfaces.” This standard provides guidelines and a standardized method for evaluating the antibacterial activity of plastic surfaces.
The results obtained from the ISO 21702:2019 test provide information on the antibacterial effectiveness of the tested plastic surface. The standard allows for comparisons of different plastics’ ability to inhibit bacterial growth and assesses their potential in applications where antibacterial properties are desired, such as in healthcare settings or food contact materials.
FDA-accepted animal models (developed by WuXi AppTec) test the efficacy of antimicrobial components of medical devices in an infectious agent-challenge study. Each antimicrobial efficacy (AME) study is custom designed, using clinically relevant bacterial strains and several implant and infection-delivery methodologies to produce a consistent and non-lethal in-vivo device infection. Analyses of infection at device explant include assessment of remaining bacteria from device and surrounding tissue, imaging, and identification of viable bacterial strain from the resulting infection.
Our library of bacterial strains continues to expand. The bacterial strains most commonly administered during in-vivo device infection studies include:
– Acinetobacter baumannii
– Escherichia coli
– Methicillin-resistant Staphylococcus aureus (MRSA)
– Pseudomonas aeruginosa
– Staphylococcus aureus
– Staphylococcus capitis
– Staphylococcus epidermidis
– Vancomycin-resistant Enterococcus faecium/faecalis (VRE)
– Other isolates suggested or provided by the Sponsor
– In vitro antimicrobial tests, including Zone of Inhibition
– Histopathology to assess local response, microscopic evidence of bacterial infection,
device characteristics, etc.
– Biochemical and/or DNA identification of recovered bacterial strains
– Hematology and clinical chemistry analyses to assess disease progression
– Chemistry / drug elutions analysis of serum and tissue samples
Antimicrobial Efficacy Testing FAQ
What is antimicrobial efficacy testing?
Antimicrobial efficacy testing is a process used to evaluate the effectiveness of antimicrobial agents or coatings applied to pharmaceutical products and medical devices in reducing or eliminating the growth of microorganisms. Pharmaceutical products, such as aqueous-based oral, multiple-dose topical, ophthalmic, nasal, irrigation, dialysis fluids; and medical devices, such as catheters, implants, surgical instruments, or wound dressings, can be prone to colonization by harmful bacteria, fungi, or other microorganisms. These microorganisms can lead to infections and complications in patients.
What is the purpose of antimicrobial efficacy testing?
The purpose of antimicrobial efficacy testing is to assess the ability of a pharmaceutical products and medical device’s antimicrobial component to inhibit the growth of microorganisms or to kill them outright. It involves subjecting the device to laboratory testing methods that simulate conditions encountered during actual use. The tests are designed to determine the device’s effectiveness against specific microorganisms and measure its antimicrobial properties.
What testing methods are involved in antimicrobial efficacy testing?
Common methods used in antimicrobial efficacy testing include:
Agar diffusion test: This method involves placing the medical device onto a solid agar medium inoculated with the test microorganisms. The device’s antimicrobial agent diffuses into the agar, creating a zone of inhibition around the device, which indicates the agent’s effectiveness.
Time-kill kinetics: In this test, the medical device is exposed to a known concentration of microorganisms over a specific duration. Samples are taken at different time intervals to determine the antimicrobial agent’s ability to kill or inhibit the growth of microorganisms over time.
Zone of inhibition test: This method involves placing the medical device onto a solid agar medium inoculated with the test microorganisms. After incubation, the presence of a clear zone around the device indicates the antimicrobial agent’s effectiveness.
Microbial Challenge and Plate-count Method: this method involved spiking of known concentration of challenge organisms generally based on likely contaminant to a drug product or medical device. After incubation, log reduction in the recovery of challenge microorganisms demonstrates the effectiveness of antimicrobial agents present in the container or unit.
How do testing results help manufacturers?
The results of antimicrobial efficacy testing help manufacturers determine the appropriate use and labeling claims for their medical devices. These tests are an essential part of ensuring the safety and effectiveness of antimicrobial-coated or treated medical devices in preventing healthcare-associated infections. Why is antimicrobial efficacy testing important?
Antimicrobial efficacy testing of medical devices is crucial for several reasons:
1. Patient safety: Medical devices that come into contact with the human body, such as catheters or implants, have the potential to introduce or promote the growth of harmful microorganisms. Antimicrobial efficacy testing helps ensure that these devices effectively prevent or reduce microbial colonization, thus minimizing the risk of infections and associated complications in patients.
2. Infection prevention: Healthcare-associated infections (HAIs) are a significant concern in medical settings and can lead to prolonged hospital stays, increased healthcare costs, and even patient mortality. Antimicrobial efficacy testing helps evaluate the ability of medical devices to inhibit the growth of microorganisms, reducing the risk of HAIs and improving patient outcomes.
3. Regulatory compliance: Regulatory authorities, such as the U.S. Food and Drug Administration (FDA), require antimicrobial efficacy data for medical devices that make antimicrobial claims. Manufacturers must provide evidence of the device’s effectiveness through appropriate testing methods to obtain regulatory approval and ensure compliance with relevant standards and guidelines.
4. Product development and improvement: Antimicrobial efficacy testing allows manufacturers to assess the effectiveness of different antimicrobial agents, coatings, or materials applied to medical devices. This information helps guide product development, allowing for the selection of optimal antimicrobial strategies and continuous improvement of device design to enhance patient safety and reduce the risk of infections. It helps in determining the effectiveness of antimicrobials during the product shelf life and extends the shelf life for certain products.
5. Quality assurance: Antimicrobial efficacy testing serves as a quality control measure for medical device manufacturers. It ensures that the antimicrobial properties of the devices are consistent and meet the specified performance criteria. By conducting regular testing, manufacturers can identify any issues or variations in the antimicrobial efficacy and take corrective actions to maintain product quality.
Overall, antimicrobial efficacy testing plays a vital role in safeguarding patient health, preventing infections, complying with regulations, determining shelf life of product, and supporting the development and quality assurance of antimicrobial-coated or treated medical devices.
What are the regulatory requirements for antimicrobial efficacy testing?
Regulatory requirements for antimicrobial efficacy testing of medical devices vary depending on the country or region. For example, in the United States the FDA’s Center for Devices and Radiological Health (CDRH) provides guidance on antimicrobial device submissions, including recommendations for testing. The FDA expects manufacturers to demonstrate the safety and effectiveness of antimicrobial devices through appropriate laboratory testing, including antimicrobial efficacy testing. In the European Union (EU), the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) set out requirements for medical devices. The MDR and IVDR do not provide specific testing guidelines but emphasize that devices should be designed and manufactured to minimize infection risks. Manufacturers should consider relevant harmonized standards, such as ISO 22196 for quantifying antimicrobial activity on plastic surfaces or consult notified bodies for specific testing requirements.
It’s important for medical device manufacturers to consult the regulatory guidelines and requirements specific to their target market and engage with regulatory authorities or notified bodies to ensure compliance. These regulations are subject to change, so staying updated on the latest requirements is crucial.
What products can be tested?
- Medical devices, such as catheters, implants, surgical instruments, or wound dressings
- Pharmaceutical products, such as aqueous-based oral, multiple-dose topical, ophthalmic, nasal, irrigation, dialysis fluids etc.