The legislator demands in the medical devices operator regulation (MPBetreibV) in §8(2) for the dressing of medical instruments that the success of the cleaning, disinfection or sterilization must be comprehensibly ensured.
The reprocessing of medical devices ends with the documented release for reuse or storage. Before the thermal disinfector or washer-disinfector is put into operation for the first time during the day, a few routine checks must be carried out and documented.
The RDG diary offers the possibility to document 1000 individual batch releases on 125 pre-filled forms. In addition, the microbiological checks can be filed here, so that all relevant data for reprocessing are clearly available in a folder.
The routine checks carried out every working day include an assessment
These general checks are recorded in the RDG diary so that they can be verified at any time.
The most important and indispensable step of the batch control is the visual inspection of the instruments and the cleaning indicator (Wash-Checks) after removal from the washer-disinfector (RDG). It is also essential to check the instrument display and, if the washer-disinfector is technically equipped accordingly, to check the relevant process parameters.
The final batch control must be documented. Release decisions may only be made by persons authorized to release. They must be named in writing by the operator. This is also done in the RDG diary. The release of the batch is only correctly documented with the signature of these employees.
With the documented release of the batches in the RDG diary, you have fulfilled the requirements of the Medical Devices Operator Ordinance (§8  MPBetreibV) as well as the duty of documentation within the scope of your quality management.