Nelson Labs Europe is pleased to announce that we have recently expanded our ISO17025 accreditation for our healthcare reprocessing services. Reusable medical devices must be properly cleaned, disinfected, and/or sterilized. One of the services that Nelson Labs offers is to assist manufacturers of reusable medical devices validate their reprocessing instructions. This includes writing appropriate instructions for use (IFU), selecting worst-case devices that should be validated, and performing the validations in an ISO17025-accredited lab.
The recent expansion of our ISO17025 accreditation has two key parts. First, we have added ANSI/AAMI ST98 to our accreditation for cleaning validations of reusable medical devices, replacing AAMI TIR30. In August of 2022 one of the applicable guidelines for cleaning reusable medical devices, AAMI TIR30: 2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, was retired and replaced by ANSI/AAMI ST98: 2022 Cleaning validations of health care products – requirements for development and validation of a cleaning process for medical devices. Therefore, we have updated our ISO17025 accreditation to reflect this change. In addition to using ANSI/AAMI ST98, our cleaning validations are also ISO17025 accredited according to ISO17664 and ISO 15883-5.
Second, we have expanded our disinfection-validation services with thermal-disinfection validations according to the A0 method. According to ISO17664, having a thermal-disinfection step as part of an automated washer-disinfector program is required unless the device cannot withstand such a process. In Europe validations for these automated thermal-disinfection processes are typically conducted by measuring temperatures to calculate whether the desired accumulated-lethality value, or A0 value, is met. Nelson Labs Europe has acquired a system that utilizes flexible real-time temperature data loggers to perform temperature measurements and associated A0 value calculations, and we have expanded our ISO17025 accreditation to include this service.