The Operator

The manufacturer or the operator can at any time to carry out checks, if there is reason to do so. Test types are used in surgeries every day many different devices. On the one hand, there are technical equipment used directly for medical purposes, such as examinations, treatments or therapies used. On the other hand require all other electrical devices in a doctor’s Office of a periodic review. Depending on factors such as device properties, their use area and manufacturer is one or more of these checks: safety metrological control VDE-approved according Berufsgenossenschaftlicher regulations BGV A3 security technical niche control (PCs) safety inspections must according to the medical products operator directive (MPBetreibV) held on non-implantable medical devices at a minimum of 2 years. Target controls is the prevention of accidents for patients, users or third parties through early detection and, if necessary, address deficiencies. The risk for a failure by medical technology should be reduced in this way. The content and scope of the audit is provided in most cases by the manufacturers and also depends on the recognised rules of technology.

The device must be functional and in a proper condition at the time of the audit. The question of whether the medical equipment control is still free from defects up to the next technical safety, must also be answered. PCs-liable devices are listed in Appendix 1 of the medical devices operator Ordinance in detail. An excerpt of medical devices which undergo a safety inspection must be, you will find the following: defibrillators RF devices infusion pumps incubators Ultrasound patient monitors (invasive) syringe pumps to ensure external pacemaker ECG devices tens therapy ultrasound therapy device, laser and dialysis machines to the performance and the reliability of these devices must be observed certain inspection specifications. The PCs is representative, circumstances testing must match the normal state. This means all wear parts, products or other accessories used in the daily use of medical technology, need to find use also in testing.

Author: Jackie