Safety checks
The technical safety control (STK) is a periodic safety check prescribed for operators of medical products. In medical technology , the STK is a measure to determine the safety of an active, non-implantable medical product . The aim of this measure is the timely detection of device defects and risks for patients, users or third parties. A STK is mainly carried out by a state-certified medical technician, often also by specially trained electricians or electronics technicians. The special qualification is necessary due to the high liability risks of the auditor and the necessary assessment of technical risks during the audit, taking into account the current legal bases and test specifications.
General
The Medical Devices Operator Ordinance (MPBetreibV) forms the legal basis for the technical safety control, which is described in more detail by § 11 MPBetreibV. According to the MPBetreibV, all active medical products that meet the definition of Annex 1 (MPBetreibV) are subject to STK. The safety checks must be carried out at least every two years.
The manufacturer of a medical device specifies which controls are to be carried out and at what intervals they must be carried out, but since the last amendment the operator is no longer bound by manufacturer specifications, provided the minimum interval of 2 years is observed. According to the law, all devices according to Annex 1 MPBetreibV must be subjected to an STK even if the manufacturer has not explicitly prescribed an STK for them. However, the manufacturer can exclude a STK, which z. B. is usually the case with automated defibrillators .
The prerequisite for carrying out an STK is that the auditor, through training, knowledge and practical work, has experience in properly controlling the device. The testing and measuring instruments required to carry out the inspection must be available and the inspector must not be subject to any instructions with regard to his control activities.
The inspector or technician who carries out the safety inspection must prepare a report "containing the date of execution and the results of the safety inspection, including the measured values determined, the measurement method and other assessment results". The operator must keep this log at least until the next test.
In the case of safety checks, metrological checks (MTK) according to § 14 MPBetreibV may also have to be carried out.
Examples of devices subject to STK
- Defibrillators
- RF devices
- Infusion pumps
- Incubators
- Patient monitors (invasive)
- Stimulation current therapy devices (e.g. Stangerbad )
- Syringe pumps
- external pacemaker
- Ultrasound therapy device
