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This guidance was written prior to the February 27, 1997, implementation of FDA's Good Guidance Practices, GAP's. It does not create or confer rights for or on any person and does not operate to bind
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What is automated endoscope washers washerdisinfectors?
Automated endoscope washers washerdisinfectors are medical devices used to clean and disinfect endoscopes after each use.
Who is required to file automated endoscope washers washerdisinfectors?
Healthcare facilities and medical centers that use endoscopes are required to file automated endoscope washers washerdisinfectors.
How to fill out automated endoscope washers washerdisinfectors?
Automated endoscope washers washerdisinfectors must be filled out with information about the cleaning and disinfection process of endoscopes, including the type of solution used and the duration of the cycle.
What is the purpose of automated endoscope washers washerdisinfectors?
The purpose of automated endoscope washers washerdisinfectors is to ensure that endoscopes are properly cleaned and disinfected to prevent the spread of infections.
What information must be reported on automated endoscope washers washerdisinfectors?
Information such as the date and time of each cycle, the serial number of the endoscope, and any maintenance or repairs performed must be reported on automated endoscope washers washerdisinfectors.
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