Safety inspection (sicherheitstechnische Kontrolle) under the German Medical Devices Operator Ordinance. For devices listed in Annex 1, every two years at the latest.
The safety inspection (sicherheitstechnische Kontrolle, STK) is, under § 12 MPBetreibV, a mandatory check for the medical devices listed in Annex 1. These include defibrillators, ventilators, infant incubators and MRI scanners. The operator must carry it out, or have it carried out, according to the generally recognized rules of technology, at the latest every two years, counted from the end of the month in which the device was put into operation or last inspected. If, because of the conditions of use and the environment, defects are to be expected sooner, the inspection has to take place sooner. The STK includes the measuring functions.
Whoever performs the STK must meet the requirements of § 5. The result is recorded in a report with the date, measured values, measuring methods and other assessment results. After a successful inspection, the device gets a mark showing the year and month of the next STK and who performed it. The operator keeps the report until the next STK (§ 12(3)). Deadlines, date and result also go into the medical device log (§ 13). For self-testing defibrillators intended for lay use, § 12(2) provides an exemption under conditions.
The STK differs from servicing in its purpose: servicing keeps a device in good condition, while the STK determines whether it is safe. Often both services are done in one visit. Make sure the STK appears in the quote and on the invoice as a separate service, because only it meets the legal deadline and triggers the mark on the device. A missed STK is a violation of the operator's duty.
What matters
- Track the month of the next STK for each device and schedule it before the two years run out.
- Check that the company doing the work meets the requirements of § 5, and get that confirmed.
- Get the report and the device mark, and file the report in the device record.
- Enter date and result in the medical device log.
Suppose a hospital has several ventilators with different commissioning months. The technical department tracks, for each device, the month of the last and next STK. One device shows irregularities in use, so the department moves its STK forward instead of waiting until the end of the two years.
In the original wording
“The safety inspections must be carried out at the latest every two years, at the end of the month in which the device was put into operation or the last safety inspection was carried out.”
Unofficial translation
“to mark the device, after successful safety inspections, with a mark that clearly and traceably shows the year and month of the next safety inspection and the person who carried out the safety inspection”
Unofficial translation
Related regulations
In vi
- Deadlines & calendar: Every inspection, every maintenance, every cancellation has a date