Ensuring that reusable medical devices can be properly cleaned, disinfected, and sterilized is crucial for patient safety and minimizing healthcare-acquired infections, corrective actions, and recalls. Regulatory agencies and healthcare facilities are increasingly concerned about the spread of diseases, a concern that has been amplified by the COVID-19 pandemic. Therefore, having validated cleaning, disinfection, and sterilization instructions in place that comply with current regulatory standards is paramount.
To assist customers in developing and validating reprocessing instructions in an ever-changing regulatory landscape, Nelson Labs has a dedicated team of experts actively serving on relevant ISO and AAMI committees. These experts are capable of guiding customers through every step of the process. Nelson Labs offers a comprehensive range of services, starting from writing appropriate Instructions for Use documents, selecting worst-case devices for validation, and performing the actual validations in ISO17025 and GLP accredited laboratories.
During intake conversations with clients, it becomes clear that determining which regulatory aspects apply to a specific medical device can be challenging. To address this, Nelson Labs has summarized the regulatory guidance available and how it can be applied to specific medical devices. This summary covers a selection of frequently asked questions, although it is not exhaustive and does not cover all aspects related to reprocessing validations.
This presentation is essential for professionals involved in the development, regulatory compliance, and quality assurance of reusable medical devices. By attending, participants will gain valuable insights into the reprocessing validation process, ensuring their products meet stringent safety and regulatory requirements.