VacioPak for Endoscopy

The VacioPak for Endoscopy system is a storage and transportation vehicle which allows any full-cycle reprocessed and dried endoscope to be transported safely, while maintaining the endoscope’s conditioned state for a defined period without deterioration of the microbiological quality of the endoscope.

The VacioPak system is not an additional means of decontamination, nor does it replace any part of the requirements of the standards ISO 15883-4 and EN 16442.

A Standard Operational Procedures (SOP) for storage and transport should be in place to ensure compliance with the risk assessment process as stated for example within e.g. HTM 01-06 Sections 4.22, 7.28, 7.29, 8.105, and Table 3. 

It is recognised that not all Automated Endoscope Reprocessors (AER) are routinely as effective as they should be at reducing bacterial loads, but the dryers may make the whole process more effective at reducing the contamination.  Conversely, the AER may have done a good job, but the process to and in the dryer may have introduced cross-contamination. Reprocessing departments frequently have AERs and dryers sourced from different companies, and they will not have been tested as a complete system (the BESTest* has been introduced as a means to test a complete process in these circumstances).

We also believe strongly that type testing of an original product in factory conditions is not appropriate for accepting that that piece of equipment will work effectively within a local environment.  Therefore, just as the AER, for example, will have gone through IQ, OQ, and PQ processes at installation, and then undergone regular Q and A processes, the ancillary processes, such as packaging and transportation should undergo the same rigours.

Therefore, we require that use of VacioPak for Endoscopy is only used in a safe process for the patient, and that the longer term storage and transportation does not introduce or propagate a risk.

Thus, before endoscopes in their transport systems are introduced to the VacioPak for Endoscopy transportation process, we will carry out a test procedure to ensure that a microbiologically loaded surrogate passes through a complete decontamination reprocessing cycle and then a drying cycle, following which test bacteria have been reduced to the levels indicated in ISO 15883-1  and ISO 15883, and in EN 16442, before and after the prescribed storage period within the VacioPak for Endoscopy system.