[TECH LETTER] Reprocessing of Medical Devices

Reusable medical devices are devices that healthcare professionals can reprocess and reuse on multiple patients. Inadequate reprocessing between patient uses can result in accumulation of chemical and biological debris. Chemical residues can lead to pyrogenicity issues. Biological debris can lead to microbial proliferation even after cleaning, disinfection and / or sterilization processes. Hence, reprocessing is a critical step to guarantee patient safety and, as such, it is covered in the different regulatory frameworks.
 
This Tech Letter gives an overview of the reprocessing processes within the US regulatory framework and addresses the importance of adequate reprocessing of medical devices, mentioning the letter issued by FDA regarding the change in reprocessing methods for certain urological endoscopes.
 
GET THE TECH LETTER