Cleaning is an essential step to ensure the safe processing of reusable medical devices. In recent years, national and international standards and guidelines have matured to define scientifically sound analytical requirements to define endpoints for cleaning. Although these requirements can be based on what is practically achievable in clinical practice, it is important to ensure that cleaning endpoints are scientifically based to ensure patient safety. The impact of protein cleaning endpoint concentrations at or greater than 6.4 μg/cm2, the current recommended cleaning level, in posing a toxicity or immune risk to patients has not previously been evaluated.
This study investigated the impact of residual protein levels on patient toxicity and concluded that an acceptable level of protein in cleaning efficacy studies to be in the 3-6.4 μg/cm2 range.
Authors: T.A. Kremer, A. Patel, C. Summers, M. Quin, K. Lemons, G. McDonnell
