BioPharma Services >> Technical Consulting >> Cleaning and Disinfection (Sterilisation) Validation of Reusable Medical Devices

Cleaning and Disinfection (Sterilisation) Validation of Reusable Medical Devices

Sidebar Image

Eurofins | ams has been testing medical devices for over 18 years and during that time, has witnessed the significant evolution in the design of reusable medical devices. While such advances bring great benefits to patients, they can also present challenges for optimal cleaning, disinfection and sterilization of the devices.

We are often approached by companies to validate the cleaning and disinfection (sterilisation) processes for their reusable medical devices. The challenges involved are to ensure the test conditions are adequate and the test methods appropriate for each device. The selection of the test soil (artificial contaminant) is vital as it must adequately simulate the worst case conditions likely to occur in a clinical setting after use.

To date, Eurofins | ams has validated the cleaning and disinfection (sterilisation) processes for a number of reusable medical devices such as, surgical instruments, anaesthesia equipment, wash bowls, dishes, infant feeding bottles, bedpans, urine bottles and flexible endoscopes. As such, we have built up a strong and comprehensive knowledge on designing and completing such validation studies.

Validations can be performed according to test protocols provided by device manufacturers. Alternatively, in the absence of such test protocols, our Eurofins | ams consultants can help companies to develop protocols specifically for their products based on known international standards such as ISO 15883, ASTM 2314, BS 2745, AAMI-TIR 30 or any other agreed test method/standard. Test protocols should include:

  1. Suitable test soils and test organisms.
  2. Number of replicates.
  3. Tests required verifying cleaning efficacy.
  4. Acceptance criteria.

Detailed GLP reports are provided by Eurofins | ams for each these studies.