The two pillars of safety in automatic washing.

In the automatic washing of medical devices, it is often taken for granted that a cycle completed without errors is, in itself, a guarantee of effectiveness.

In reality, this is not the case.

To verify process effectiveness and confirm its declared performance, a washer-disinfector must comply with two fundamental phases that form the basis of process control, traceability and risk prevention.

In this article you will discover:

• how to monitor every cycle and ensure process traceability;
• why periodic validation is essential to verify process effectiveness;
• which critical issues may go unnoticed during routine checks;
• how these activities improve safety and efficiency.

Monitoring: everyday process control

Monitoring consists of the continuous analysis of process parameters during every cycle. It is the daily activity that answers a fundamental question:

“Did the completed cycle comply with the defined parameters?”

For every washing cycle, the following should be monitored:

• cycle duration;
• actual temperatures reached;
• achieved A₀ value;
• completion of the different programme phases;
• any alarms or anomalies.

Modern washer-disinfectors make this information available through electronic records, while supervision systems such as AT-Vision by AT-OS enable the collection and centralization of these data, facilitating cycle control and the status monitoring of washer-disinfectors.

The objective is simple: to immediately identify any deviation from the expected process before it can turn into an operational issue.

Validation: demonstrating that the process really works

Monitoring checks the individual cycle.

Validation, on the other hand, verifies that the entire process is actually capable of delivering the expected result.

It therefore answers a different question:

“Is this washer-disinfector, installed in this operating environment and used under these conditions, actually capable of cleaning and disinfecting medical devices correctly?”

It is a periodic technical activity, essential for confirming the maintenance of the expected performance.

To scientifically validate a process, it is not enough to rely on the machine display; external verification tools must also be used:

• soiling tests, which simulate controlled contamination conditions using artificially contaminated plates or objects;
• chemical or biological indicators, which react only when the process reaches the required conditions;
• sensors placed inside the load, to verify temperature, pressure and effective water penetration.

Validation must be carried out during initial installation, after significant technical interventions and periodically thereafter, at a frequency defined according to the criticality of the operating environment.

What can go wrong?

Many critical issues are not immediately visible, even when the cycle ends without errors. For example:

• the cycle finishes regularly, but the A₀ value does not reach the required level (as discussed in our previous article);
• some instruments receive insufficient mechanical action;
• partially clogged filters reduce water circulation;
• improperly calibrated probes provide data that appear correct but do not reflect actual conditions.

Validation is precisely what makes it possible to identify these issues before they affect process safety.

Cycle compliance does not always coincide with process effectiveness: only independent verification can demonstrate that the process is actually performing as intended.

The value of process control for the organization

Monitoring and validation are not simply documentation requirements, but essential tools for managing the reprocessing process.

A properly monitored and validated system enables organizations to:

• reduce the risk of residual contamination;
• face audits and inspections with objective and verifiable data;
• improve operator training;
• identify anomalies and trends early, before they become critical issues.

In other words, they transform control from a reactive activity into a preventive tool.