Reusable Device Testing Services

Consulting and testing services for medical device cleaning, disinfection and sterilization

Medical devices are widely used in clinical practice to include surgical, therapeutic, diagnostic, supportive and life-sustaining functions. They can be single use or reusable depending on their design and intended use. Devices range from complex, critical devices that come into contact with sterile areas of the body to more simple, non-critical devices that only touch the skin.

Regardless of its complexity and criticality, it is important to ensure that a medical device designed to be reusable is safe for both patient and hospital staff by routinely processing according to defined instructions for use (IFU). Processing (or reprocessing) can include cleaning, disinfection, and sterilization depending on the risks associated with the use of the device. The manufacturer is required to provide specific validated instructions to ensure that device processing can be safely and effectively conducted in compliance with national and international standards.

STERIS supports manufacturers in the design, final development and validation testing of their reusable medical devices and instructions for use. Our reusable device testing services include:

Consultation and Support

  • Reprocessing expertise
  • Troubleshooting problems or complaints
  • Instructions for use development
  • USA and international requirements
  • Device design or redesign for processing
  • Human factors consideration in processing
  • Regulatory support
  • Risk analysis

Verification and Validation Testing

  • Cleaning (manual and automated methods)
  • Vaporized hydrogen peroxide sterilization
  • Thermal and chemical disinfection (high, intermediate and low-level)
  • Packaging
  • Liquid chemical sterilization
  • Moist heat (steam) sterilization

Laboratory Testing

  • Microbiology
  • Total organic carbon (TOC)
  • Endotoxin
  • Cytotoxicity
  • Protein
  • Chemical residual testing (EO, ECH, EG and H202)

Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.