Mandatory register of all active non-implantable medical devices at a facility, with type, serial number, manufacturer and location.
The inventory register (Bestandsverzeichnis) is mandatory for every operator under § 14 MPBetreibV: it must keep a register of all active non-implantable devices at the facility. For each device, the entry must give the designation, kind and type, lot code or serial number, and year of acquisition. Also required are the name or company and address of the manufacturer or authorized representative or, failing both, of the importer, the internal identification number where one exists, and the location and organizational assignment. Any data medium is allowed if the information can be made readable within a reasonable time.
The register has to be told apart from a related document. The medical device log is kept by the operator only for devices in Annexes 1 and 2. It additionally holds, among other things, the instruction given, the inspections with deadlines and results, maintenance, malfunctions and incident reports (§ 13). After the device is taken out of service, it must be kept for five years. The inventory register, by contrast, covers all active non-implantable devices but has less content. Entering the device in a register kept under other rules is allowed, for example in the technical department's asset management system.
For cost, liability and deadlines, the register is the basis for planning. It shows which devices need an STK or MTK, when they were put into operation and which deadlines are running. If a device is missing from the register, it is often missing from the deadline list and the maintenance contract too. For quotes and invoices from service companies, the serial number helps you match services to the right device and spot duplicate line items. When devices are retired or moved, the entry should be updated promptly, so inspections are not looked for in the wrong place or paid for on a device that has been taken out of use.
What matters
- Check that all active non-implantable devices are recorded, including devices used only occasionally.
- Take type, serial number and manufacturer from the nameplate and compare them with the invoice and the service report.
- Update location and assignment after every move.
- Link each device to its STK and MTK deadlines.
Suppose two wards are merged and devices are moved around. The technical department compares the inventory register with the nameplates on site, finds one device with no entry and two entries for devices that no longer exist, and cleans up the deadline list.
In the original wording
“The operator must keep an inventory register for all active non-implantable devices at the respective facility.”
Unofficial translation
“The following information must be entered in the inventory register for each device under paragraph 1, sentence 1: […] designation, kind and type, lot code or serial number, year of acquisition of the device […]”
Unofficial translation