Medical Device Cleaning, Disinfection & Reprocessing Validation
Reusable devices need validated reprocessing instructions. Laboratories simulate clinical use with test soils, apply the manufacturer's instructions, then measure residual markers (such as protein, carbohydrate, haemoglobin or TOC) and test disinfection or sterilization efficacy. FDA's reprocessing guidance and AAMI TIR12/TIR30 and ST98 are common references.
What does it measure?
- Residual soil markers after cleaning
- Disinfection and sterilization efficacy
- Repeated-cycle durability and functional performance
- Cleaning-agent residues
When is it used?
- New reusable devices and instructions for use
- Design changes affecting cleanability
- Changes to recommended detergents or equipment
Sample considerations
- Provide the draft reprocessing instructions and worst-case device configurations.
- Specify the detergents and equipment named in the instructions.
Laboratories with relevant capabilities
- Nelson Labs Europe (Leuven, Flemish Brabant) — Extractables & Leachables, Biocompatibility, Chemical Analysis