Medical Device Cleaning Validation

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来源: | 作者:admin | Date: 2025-06-26 | 27 views | Share:

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.