Medical Device Operators
The following requirements are covered:
- operation in general
- incoming inspection, commissioning, maintenance and application
- periodic safety inspections and metrological checks
- the instruction of the personnel
- the inventory and the device file
- the implant register
- the reprocessing of medical devices
Members of a health profession, persons with a trade licence who are professionally authorised to operate or use a medical device, and technical safety officers of hospitals are obliged to report incidents in accordance with § 70 MPG. In the case of hospitals, except in the case of other imminent danger, these must be carried out uniformly by the medical director.
Medical devices that are suspected of having caused damage to a patient must not be destroyed, but must be subjected to a cause analysis. It is the task of the user or the operator within the meaning of § 72 MPG to take measures to identify and assess risks and, if necessary, to carry out or arrange investigations. In this sense, it may be advisable to hand over a medical device to the manufacturer for a root cause analysis - also in the interest of the patient. Alternatively, in justified individual cases, own investigations can also be carried out or commissioned. It should also be noted that the medical device alone is often not meaningful for a complete root cause analysis and can only lead to a final root cause analysis together with, for example, the patient's medical history, x-rays, etc. The decision as to whether a medical device is to be examined by the hospital, the manufacturer or a third examination facility must be made in each individual case by the responsible physician or the operator. In this context, the health institution is obliged to safeguard the legal position of the patient or any surviving dependants with regard to the significance of the medical device for the enforcement of any liability claims.