In the instructions for use (IFU) there are references to inspection procedures.
These are not suitable for adequately confirming that re-use is or isn't possible. This puts hospitals at risk because they cannot confirm if the device is safe to be re-used.
As a result, patient safety is potentially jeopardized and claims can be directed to manufacturers, hospitals and repair facilities if patients are harmed.
Because it is the obligation of the hospital to only use safe and compliant devices on patients, it is incumbent on the hospital to monitor quality, the decline of quality, when a device needs to be replaced or repaired and to validate a quality process based on a reproducible process based on empirical data.
With our products, endoscopes are tested under the same conditions and preset specifications every time.