Cleaning validation requirements for reusable medical devices according to AAMI TIR30 did not distinguish between non-critical devices on the one hand and semi-critical or critical devices on the other. Only general recommendations were formulated, which resulted in one validation approach being applied to all types of medical devices, regardless of contamination and patient risk. Now that AAMI TIR30 has recently been replaced by ANSI/AAMI ST98, specific exemptions are mentioned for non-critical devices. According to ANSI/AAMI ST98 non-critical devices are generally allowed to be tested using a less rigorous approach as compared to semi-critical or critical devices. These changes are summarized in the infographic below.
One particular challenge reusable medical device manufacturers will be facing is the determination of an appropriate sample size for testing. Our Expert Advisory Services team can help you perform sample size justifications, leveraging our experience in validation testing and knowledge of how device complexity relates to cleanability.