If a manufacturer provides specific information on when a device should no longer be used
If a manufacturer provides specific information on when a device should no longer be used, it can't be established when a device should no longer be re-used in order to safeguard patient safety.
This exposes the hospital to potentially large risks: a hospital has a legal obligation to have a procedure in place that results in compliant devices.
Working with our products in combination with endoscopemanager.com allows for more precise testing control and proof of re-use cycles, making achieving compliance easier.
In the EU, the MDR 2017/745 forces hospitals to think about this. Here's a guidance document on the impact of this regulation.