Table 1 Overview of the functions of the quality assurance program

Batch documentation

• Recording of the user and endoscope (type, serial number)

• Documentation and archiving of the entire automatic reprocessing procedure

• Precise assignment of the automatic reprocessing procedure to each endoscope

Device manager

• Automatic withholding of the endoscope/medical product if the reprocessing procedure has not been correctly completed

• Automatic withholding of the endoscope/medical product if the set interval (e.g. 5 to 7 days) between reprocessing and use has been exceeded

• Manual withholding of the endoscope/medical product when there are negative hygiene checks or defects

• Automatic recording of the maintenance history and intervals, failures and error messages

Reporting documentation

• Linking of the reporting and batch documentation makes additional patient-related documentation of the correctly reprocessed endoscope unnecessary, as it is automatically recorded in the reporting sheet

Administrator rights

• Authorization of access to the program is graded

• Correctly reprocessed endoscopes/medical products are accessible to all members of staff for inclusion in reporting

• Manual withholding, revocation of withholding, available analyses and statistical data are controlled in a user-defined and password-secured fashion that is therefore also related to individual staff members

Analyses available

• Frequency of use of the washer-disinfector, endoscope, or medical product

• Frequency of errors or failures in the washer-disinfector, endoscope, or medical product

• Maintenance status

• Statistical data