The OPA Method: Precision in Medical Device Cleaning
The purity of medical devices is imperative! Therefore, it is indispensable for us to continuously ensure their effectiveness. To satisfy this requirement, we employ a modified method to ensure that our in-house cleaning processes adhere to the leading standards. This procedure is known as the OPA method (ortho-phthalaldehyde) and is an essential part of our quality commitment.
What is the OPA Method?
The OPA method is a biochemical method conducted in our S2 hygiene laboratory. Its purpose is to ensure that hygiene measures adhere to the leading standards. We verify the effectiveness of our cleaning processes by examining each luminal catheter for protein residues. Particularly in cases where visual inspection cannot be implemented, such as with lumen instruments, the modified OPA method validates itself as extremely useful. It is based on ISO 15883-5, Annex C, “Performance requirements and criteria for test methods to demonstrate cleaning effectiveness,” and is the reference method.
How Does the OPA Method Work?
Following the OPA methodology, the medical device is rinsed with sodium dodecyl sulfate (SDS) solution. This solution effectively breaks down any potential contaminants present as residual proteins. Subsequently, a sample of this SDS solution is collected and transported to our laboratory to quantitatively measure the free amino groups of the dissolved proteins using specific chemicals with low detection limit in the micromolar range. This sensitivity ensures the detection of the tiniest traces of contaminants. The procedure is regularly validated and provides the utmost trust concerning linearity, robustness, reproducibility, and sensitivity.
Why is the OPA Method Important?
The primary objective of the OPA method was to minimize the risk of transmissible spongiform encephalopathies, neurodegenerative diseases in animals and humans. Today, it is used in production alongside flushable ablation catheters. This quantitative laboratory method allows precise measurement of amino groups in proteins, peptides, and amino acids, ensuring that our medical devices meet the highest quality standards. The modified OPA method is so sensitive that it can even detect traces of proteins lef.