Validation of Cleaning Process for Reusable Medical Devices
Publish time 2025-07-14 17:17
FDA Guidance for industry and Food and Drug Administration Staff AAMI TIR 12: 2020 AAMI TIR 30: 2011/(R)2016 ISO 15883-1 ISO 15883-2 ISO 15883-5 ISO 17664: 2017 YY/T 0802-2020 WS/T 367-2012 WS 310.1-2016 WS 310.2-2016 WS 310.3-2016
Manufacturers of reusable medical devices must provide instructions on how to reprocess their devices before next use. Three types of risks are associated with the reuse of a medical device: (a) the risk of disease transmission from one patient to another or from environmental sources to a patient; (b) the risk of inadequate or unacceptable device performance following reprocessing; and (c) the risk of occupational exposure to bloodborne pathogens and other potentially infectious materials. Reprocessing involves several steps, including cleaning, testing for device performance, disinfection, and/or sterilization.
Cleaning a device is the critical first step in reprocessing any device after it has been used on a patient. Failure to remove foreign material (e.g., soil, lubricants, microorganisms, organic and inorganic materials) from both the outside and the inside of the device can interfere with the effectiveness of subsequent disinfection and/or sterilization.
Cleaning validation process:
Referred Standards:
Ø FDA Guidance for industry and Food and Drug Administration Staff
