German STK (?6 MPBetreibV) Requirements

[Burgmeister]

German STK (§6 MPBetreibV) Requirements

Hi again all. Just a quick question. I have been asked about the German STK (§6 MPBetreibV) requirements and, unfortunately, my German language skills are not really up to deciphering the answers Google came up with (even after Google Translate has had a go at it!). Can anyone on here tell me what is required of a manufacturer to meet these requirments?

Thanks

 

[anmael]

Re: German STK (§6 MPBetreibV) Requirements

Hi Burgmeister,

the MPBetreibV (Medical Devices Operator Ordinance) is mainly aimed at the operator of a medical device. §6 contains the requirements for safety-related checks ("STK") for active medical devices. IMHO it is relevant for manufacturers only if they require such a check in their instructions for use AND are the ones carrying it out (otherwise the requirements are addressed to operators only). The requirements concern documentation (draw up a protocol containing the date and results of the STK including the determined measurement values, the measuring procedures and the evaluation results) and qualification (STKs may only be carried out by staff with skills that guarantee a proper execution, that is free from directives, and has suitable testing/measuring equipment at its disposal).

The main purpose of §6 MPBetreibV, however, is to make sure that operators perform STKs (or engage someone qualified to do so) according to the indications of the manufacturer and the generally recognised codes of practice within the stated period. If the manufacturer does not require any safety-related checks (n.b. this refers to the devices listed in Annex 1 only) and has not explicitly excluded them either, the operator has to carry out STKs including the measurement functions according to the generally recognised codes of practice within periods that allow the timely identification of defects, but every 2 years at the latest.

Regards, Angelika.

 

[MIREGMGR]

Re: German STK (§6 MPBetreibV) Requirements

Good response. Thanks, could be useful.

 

[Burgmeister]

Re: German STK (§6 MPBetreibV) Requirements

Thanks Angelika. Presumably it would be required by the manufacturer to supply a list of values that the device should conform to in these checks? Would the manufacturer also be required to define what should be tested?

 

[anmael]

Re: German STK (§6 MPBetreibV) Requirements

Hi Burgmeister,

the manufacturer specifies in the instructions for use which STKs are to be performed in which intervals. STKs are mandatory for Annex 1 devices only (with the option of an exception provision by the manufacturer), but it is up to the manufacturer to make provisions independent from legal requirements, and if the device is active the operator has to comply (violations can be fined up to 25.000 Euro, even if the device never posed any danger). So this is actually a money printing machine for manufacturers, if the operator's staff is not sufficiently qualified and/or equipped.

The level of detail of STK requirements varies widely. Some manufacturers refer to device-specific standards, some provide detailed forms or checklists. The focus is to provide objective evidence on electrical safety and essential performance, of course. If the STK is carried out by the manufacturer, the protocol has to be handed over to the operator, as (another provision of §6 MPBetreibV) it has to be kept there until the next STK at least. Comparable requirements for medical devices with a measuring function ("MTK", metrological control) can be found in §11 MPBetreibV.

Regards, Angelika.

 

[Burgmeister]

Re: German STK (§6 MPBetreibV) Requirements

So, if we wished purely to comply with the regulations, could it be just an electrical safety test or would there need to be some kind of performance test as well? Sorry for the continued questions Angelika but I am trying to get this straight in my head!

Thanks very much for your help and patience in this matter!

 

[anmael]

Re: German STK (§6 MPBetreibV) Requirements

Hi Burgmeister,

the STK specified by the manufacturer should be suited to assess the safety of the device with the intent to timely recognize potentially hazardous defects. It usually comes down to visual and functional check, electrical safety check and check of device-specific parameters (e.g. energy release, safety discharge and synchronization time for a defibrillator, or feed rate, end alarm and shutdown pressure for an infusion pump). It lies in the responsibility and competency of the manufacturer to decide which checks are suitable and required for a particular device to timely recognize potentially hazardous defects.

Regards, Angelika.

 

[Brain]

I have another question relating to the STK requirements in Germany?
How often does this STK have to be performed? I have a figure of every 2 years bu cannot seem to locate any evidence as to this. Is there a document stating the duration between STK checks fro Germany?
thank you

 

[anmael]

As already stated on 16th April 2012, ?6 MPBetreibV says that the STK has to be carried out according to the manufacturer instructions (IFU) and the recognized rules of engineering within the indicated periods. It also says that if the manufacturer has neither specified an STK nor explicitly excluded it, the operator has to carry out an STK according to the recognized rules of engineering within periods that allow the timely identification of defects, but every 2 years at the latest.

So the document is either the IFU or the MPBetreibV (the 2 years are expressly mentioned in ?6 Abs. 1 Satz 3). In the latter case, it is the responsibility of the operator to determine an appropriate period <= 2 years.