Medical Device Test Methods

Perfectus Biomed provide a number of both standard and customised medical device test methods. We can help support your research and development into microbial infection control of medical devices. Please click here for more information on our expertise.

Infections relating to medical implants such as catheters, stents and joint prosthesis can result in a number of healthcare problems. These include local and systemic infection, implant replacement, patient pain and discomfort and associated healthcare costs. An improvement in the antimicrobial nature of medical implants therefore helps to improve patient well-being while also minimising healthcare costs.

Please contact Perfectus Biomed to discuss how we can support research and development programmes related to infection control on medical devices.

 

 

Medical Device Test Methods We Offer:

Our testing experience includes working with:

  • Catheter tubing
  • Catheter bags
  • Negative pressure wound therapy devices
  • Implantable medical devices
  • Point of care diagnostic devices
  • 510(k) submission

We offer a range of customised test methodologies which include:

  • Biofilm prevention assays
  • Biofilm removal assays
  • Bacterial percentage coverage analysis
  • LIVE/DEAD imaging
  • Confocal microscopy
  • Scanning Electron Microscopy (SEM)
  • Disinfection efficacy analysis

 

 

We also offer a range of standard test methodologies including:

  • ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
  • BS EN 1616: Sterile urethral catheters for single use
  • 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
  • WHTM 01-01: Decontamination of medical devices within acute services

Our library of test organism includes…

Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates.

Single or mixed species assays containing:

Acinetobacter baumannii
Actinomyces naeslundii
Adenovirus (human)
Aspergillus brasiliensis
Aspergillums niger
Aureobasidium pullulans
Bacillus cereus
Bacillus subtilis
Camplylobacter jejuni
Candida albicans
Clostridium difficile
Corynebacterium minutissimum
Enterobacter cloacae
Enterococcus faecalis
Enterococcus faecium (VRE)
Enterococcus hirae
Escherichia coli
Fusobacterium nucleatum
Haemophilus influenzae
Heliocbacter pylori
Halomonas magadiensis
Klebsiella pneumoniae
Lactobacillus casei
Neisseria gonorrhoeae
Neisseria subflava
Porphyromonas ginigvalis
Prevotella nigrescens
Propionibacterium acnes
Proteus mirabilis
Pseudomonas aeruginosa
Salmonella enteritidis
Shigella dysenteriae
Staphylococcus aureus (MRSA and MSSA)
Staphylococcus epidermidis
Staphylococcus haemolyticus
Stenotrophomonas maltophilia
Streptococcus mutans
Streptococcus oralis
Streptococcus pneumoniae
Streptococcus pyogenes
Streptococcus zooepidemicus
Tannerella forsythia
Trichophyton rubrum
Veillonella dispar
WHO Priority organisms.

Other- please ask.