New guidelines have recently been released for the validation of drying cabinets, which have been adopted in France in the last year. These same guidelines are strongly believed will be adopted as the standard here in Ireland. These guidelines outline several different methods to validate that the drying cabinets are operating safely, and keeping endoscopes in sterile conditions.

Medipure Ireland Ltd can offer the following tests, which adhere to the guidelines.

 

Validation of Channels

The channels must have a sterile flow with extremely low moisture content, which should be enough to ensure that any viable bacteria are killed. The guidelines recommend that, at least, log 5.0 reduction is obtained by the channel flush mechanism. This test is provided in the form of our surrogate box devices, which are explained below.

The channel feeds into the box, directly into surrogate tubing which is inoculated with Pseudomonas aeruginosa. This then feeds into a container which prevents leakage of micro-organisms into the cabinet. The air then escapes via a HEPA filter. Inside the box, a control piece is also present, which enables the log reduction of bacteria to be calculated.

Medipure Ireland offers an alternative way of testing the cleanliness of the circulating air inside the endoscope channels, by using a sterile endoscope surrogate.

 

Surface Validation

The inner surfaces of the drying cabinet should be relatively sterile. The standards recommend that the inner surfaces at five different points should be swabbed and tested for viable bacteria and fungi. There should be no significant recovery of fungi and/or bacteria.

 

Air Validation

Circulating air inside the cabinet must meet the manufacturer's specifications relating to viable and non-viable particulate matter. These parameters are determined using settle plates and a particle counting device.