Overview – Purpose of validation

Overview – Purpose of validation

Validation is a documented process used to confirm that all of the reprocessing procedures – including cleaning, disinfection, packaging, and sterilisation – are consistently effective. It provides evidence that reusable medical devices processed in the practice are safe for reuse and meet required standards.

Validation applies to all reprocessing stages and needs to be performed:

• When new equipment is installed
• When existing equipment is repaired, moved, or upgraded
• Annually (as a minimum)
• Whenever a change is made that could affect the sterilisation process

All validation steps and outcomes need to be documented and retained for quality assurance and accreditation.

Validation is undertaken before a process or item of equipment is placed into routine use. Routine monitoring and control only apply once validation has occurred. For this reason, validation is addressed before monitoring and control in this guideline.