Medical devices; monitoring of operators

The trade supervisory authorities inspect the operation of medical-technical devices.

It is the task of the trade supervisory offices of the governments to ensure that neither users nor patients are endangered by the use of medical devices.

The trade supervisory authorities

• monitors the proper cleaning, disinfection and sterilization of used instruments and devices before they are used again.
• monitors the performance of technical inspections (safety inspections) of certain "active" (energy-operated) medical devices (e.g. mechanical ventilators, magnetic resonance devices).
• monitors the performance of metrological checks on certain medical devices with a measurement function (e.g. blood pressure monitors) to ensure that the measurement accuracy is within specified error limits.
• monitors the documentation obligations of operators, such as keeping an inventory or medical device books.