Medical Device Evaluation and Testing

Medical Device Evaluation and Testing

With over two decades of experience in medical device evaluation, development and testing, 5D is the ideal partner to undertake studies to determine the physical and chemical performance of a device. Clients request an array of different studies on various types of medical devices, and testing solutions can be developed to suit most medical device technologies. Tests can range from the measurement of a device’s antimicrobial efficacy to evaluating its ability to micro-contour a wound surface.

Devices tested

The following list is not exhaustive, but includes some examples of medical devices we have tested:

  • Lock and lock-flush solutions for intravascular catheters
  • Urinary catheters
  • Bladder washout devices
  • Catheter tubing
  • Catheter bags
  • Point of care (POC) diagnostic devices
  • Negative pressure wound therapy (NPWT) devices
  • Long and short-term implantable medical devices

Standard and bespoke testing

We offer a wide range of bespoke test methodologies, examples of which include:

  • Biofilm forming potential assays of clinical isolates
  • Biofilm prevention assays
  • Biofilm removal assays
  • Biofilm dispersal assays
  • Microbial percentage coverage analysis using confocal laser microscopy
  • Live/dead imaging to determine microbial viability
  • Confocal microscopy studies to evaluate the architecture of biofilms
  • Scanning Electron Microscopy (SEM)
  • Transmission Electron Microscopy (TEM)
  • Antimicrobial efficacy analysis

In addition to bespoke test methods, we also offer a wide range of British, European and International Standards (BS EN ISO) and American standards for Testing and Materials (ASTM) tests. Examples include:

  • BS EN 1616: Sterile urethral catheters for single use
  • ASTM D7907: Standard test methods for determination of bactericidal ecacy on the surface of medical examination gloves
  • WHTM 01-01: Decontamination of medical devices within acute services
  • BS EN ISO 11737-1: Sterilisation of Medical devices –Microbiological Methods – Part 1: Determination of a population of microorganisms on products(Bioburden)
  • ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces

Contact Lenses

To demonstrate the antimicrobial and anti-biofilm efficacy of your contact lens material or lens-care products, we oer testing which includes:

  • Antimicrobial coated lenses
  • Silica lenses
  • Hydrogel lenses
  • Contact lens solutions
  • Surface structure in relation to microbial attachment
  • Protein accumulation on contact lenses in relation to microbial attachment

We offer a range of standard test methodologies including:

  • ISO 14729: Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
  • ISO 14730: Antimicrobial preservative efficacy testing

Wound care

 Chronic wounds are colonised with a polymicrobial community which causes a delay in healing and increases infection risk. Our testing supports global companies which design and develop advanced wound care products.

Our testing experience includes working with:

  • Wound dressings
  • Topical wound agents
  • Dressing removal agents
  • Non-antimicrobial and antimicrobial-based
  • wound-irrigating solutions
  • Negative pressure wound therapy (NPWT) devices
  • Wound dressing speed of kill assays

Our range of bespoke test methodologies includes:

  • EpiDerm™ skin model
  • Direct contact dressings testing
  • Shake-flask assay
  • Bacterial barrier testing
  • Viral/phage barrier testing
  • Centers Disease Control (CDC) biofilm reactor model adapted for testing wound dressings based on ASTM E2871 and ASTM E2562
  • Drip flow reactor model adapted for testing wound dressings based on ASTM E2647
  • Porcine skin explant drip flow model based on ASTM E2647
  • Wicking absorbency
  • MMP modulation testing
  • Dressing material strength testing – wet and dry
  • Peel force testing

We also offer a wide range of British, European and International Standards (BS EN ISO) and ASTM tests, including:

  • AATCC Test Method 100: Antibacterial Finishes on Textile Materials
  • Modified AATCC Test Method 100 AATCC Test Method 147 Antibacterial Activity
  • Assessment of Textile Materials: Parallel Streak Method
  • BS EN ISO 11737-1: Sterilisation of Medical devices.
  • Microbiological Methods. Determination of a population of microorganisms on products (Bioburden)
  • BS EN 13726-1: Test methods for primary wound dressings. Aspects of absorbency: Free swell absorption, fluid retention and absorption under a fixed load
  • BS EN 13726-2: Test methods for primary wound dressings. Moisture vapour transmission rate (MVTR) of permeable film dressings
  • BS EN 13726-3: Test methods for primary wound dressings. Waterproofness
  • BS EN 13726-4: Test methods for primary wound dressings. Conformability 
  • BS EN ISO 20743: Textiles, Determination of antibacterial activity of antibacterial finished products
  • BS EN IS0 20645: Textile fabrics. Determination of antibacterial activity. Agar diffusion plate test
  • ASTM E2149: Standard Test Method for determining the antimicrobial activity of immobilised antimicrobial agents under dynamic contact conditions.

We have listed some examples of the testing we undertake on medical devices, but it’s not practical to list every device we can test or method we can use.

 

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