Reprocessing of Reusable Medical Devices: Case studies overview to meet regulatory challanges

Medical device designer and manufacturer are recently facing new requirements, updates and challenges in the reprocessing of medical devices field.

Official guidance documents such as AAMI TIR12, AAMI TIR30, AAMI ST-98 and the FDA’s Reprocessing Medical Devices in Health Care Setting (2015, Annex E updated on 2017), provide indications underlying the most critical aspects. However, depending on the medical device complexity, classifications and clinical applications, is it possible to experience uncertainty about the multiple reprocessing options.

With this webinar, our experts will present various aspects of cleaning disinfection and sterilisation validation testing: overall considerations, selection of artificial test soil, soiling challenge sites and contact time, chemicals, requirements and acceptance criteria. It will also cover life cycle considerations and challenges in the design of an appropriate validation study.