Cleaning Indicator Systems

Processing of reusable medical devices must be documented to prove that it was done and done successfully. There are two approaches to documentation. One is verification and the other validation. The optimum situation lies in between the two and uses the best aspects of both.

Per AAMI/ISO TS11139:

• Verification: the provision of objective evidence that the specified requirements have been fulfilled.
• Validation: (a) confirmation process through providing objective evidence that the requirements for a specific intended use or application have been fulfilled.

What’s the difference?

Verification generally means that you assume nothing about the general capability of the processing equipment and verify the efficacy of the process using indicators, visual inspection, or augmented visual inspection (borescopes, magnifiers), and review of cycle records (if available). It is a retrospective process to evaluate success of a processing step after the fact for the process just run.

For sterilization, biological and chemical indicators are used plus review of the cycle tape. These indicators tell you that the instance of the process in which they were processed was successful or unsuccessful at the location of the indicator.

Cleaning indicators tell a similar story but tend not to be run as often as sterilization indicators. Leaving you wondering (at best) if the cycles since the last cleaning indicator was run ran as well as the last one in which you ran the cleaning indicators.

Validation proves that the processing equipment WILL execute the required task using independent means of process evaluation on worst-case loads. It provides the knowledge that the process SHOULD be successful or not. It measures the ability of the processing equipment to execute the process it is designed to do and prove that it can do it reliably. It also uses a comprehensive review of the machine, its capabilities, its consumables (detergent, for example), and utilities fed to it to ensure that the needed operations are done with the machine working with supplies that are within the tolerances established by its manufacturer. Validation removes doubt from the process. Which is a very desirable thing.

• Verification looks back. Validation looks forward.
• Verification answers the question, “What happened?”. Validation tells you that you can expect the process to work.

Validation lets you reduce the amount of time and effort spent on verification since you routinely ensure performance. And, you can spend less time and money on consumables to verify that the process ran correctly.

If you validate cleaning, should you verify it too? Unfortunately, yes. Periodic testing is needed because cleaning is a complex, relatively uncontrolled process. But validation shows you that the expectations of properly cleaned devices are realistic in your facility, with YOUR equipment, YOUR utilities and YOUR consumables. Periodic routine testing demonstrates that the performance of the process remains within the limits established during validation. The difference from normal practice is that a validated system will not require daily or weekly testing as long as proper attention is given to making sure that the machine’s condition is as it should be (where it was at validation) when in use.

Our validation and cycle optimization services help you to get to a place of trust where your equipment is validated to meet or exceed the requirements of the worst-case instruments you process. We help you and your team to become informed masters of your own destinies for these processes. We provide these services for both healthcare SPD clients and industrial (medical devices) clients. Please contact us for more information.

For washer/disinfectors, our work is guided by the German Guidelines for washer/disinfector validation, please see the Publications . For sterilization, we are guided by the validation procedures of AAMI/ISO 17665-1, Sterilization Of Health Care Products – Moist Heat – Part 1 for steam sterilization and AAMI/ISO 14937, Sterilization Of Health Care Products — General Requirements For Characterization Of A Sterilizing Agent And The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices.