SW Classification - Documentation software for steam sterilizer devices. class I, IIA or not even a MDSW?

[AlexisRuiz2772]

Hello everyone!

I'm dealing with the classification of a software that documents the sterilization results of steam sterilizers.

Mainly a PC with the software(possibly MDSW) is connected to the sterilizer. The sterilizer sends all related data of the sterilization cycle to the software.

Then the software shows the results of the sterilization cycle, graphs of the physical parameters (temperature and pressure), number of cycle, etc, in a nicer interface, giving the possibility of printing a report.

From my POV, the software is only transmitting and documenting data, therefore, it should not be a MDSW, BUT, the user uses the report generated by the software to diagnose if the batch of the sterilizer can be released/approved or not, then, it might fall under the definition of "software driving or influencig a device" of the MDCG 2019-11. Steam sterilizers falls under class IIA.

Note: Data shown via the software is not modified or used for other purposes. It is only to watch it through a PC instead of the usual ticket of the thermomagnetic printer. The objective is to quit the printer and use the software.

Its very fuzzy this case, even the software could fall under class I because the software could be considered as an accessory of the steam sterilizer, assisting the sterilization by offering the results (HMI interface) to the user; now that the MDR covers the sterilizer devices within the medical device definition, rule 11 may apply for class I....

I hope this is an interesting topic to discuss and to have feedback from your side.
Thanks!

 

[yodon]

I got a bit lost. Can the sterilizer be operated without the software? What are the consequences if the software fails?

If your user is relying on the output to make quality (and safety) decisions, then you're going to want to ensure the software is operating as expected and following 62304 (class B, probably) is, for the most part, just good software engineering so regardless of whether it's classified as a device or not, compliance would put you in a good position.

 

[AlexisRuiz2772]

Hi! thanks yodon for your answer.

Essentially, yes, the sterilizer can still sterilize properly and is also able to show the results and graph of parameters as required in standard EN285.

However, the software as well show the same results, being the possibility that the user take a decision of approving or not a sterilized batch based on the software, just because it displays exactly the same information but in a nicer interface and with the possibility to print the results in a report with a header of the hospital.

Maybe it can be classified just as "normal" software (not MDSW) that must follow the GSPR 14.5 in order to ensure the interoperability between the sterilizer and the software, and a correct transfer of data.

Following this path, then is not directly the software giving the results for taking the decision of approve or not the reprocessed batch within the sterilizer, but is the sterilizer per se which is offering the results but in more than one interface (the sterilizer screen and the software interface). looking it by this way, the software would not be classified as a software driving or influencing the use of a device...

Yes, I agree to follow IEC 62304, even now the IEC 81001-5-1 to ensure that there is no tampering or other issues concerning the transmitted data between the sterilizer device and the software. The real deal is if the software falls under class IIA (due to the software driving or influencig a device definition=same class as the device) it requires authorization from a notified body in Europe, which is a big deal...

I hope now it is more clear?

Thanks a lot again!

 

[dgrainger]

Is it on the market as an accessory to the sterilizer?

(2) ‘accessory for a medical device’ means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s);

It would need the steriliser's manufacturer to document that the software was required to qualify as an accessory. If it is changing the intended use of the sterilizer beyond its intended use then the new combination may be a new device.

 

[AlexisRuiz2772]

The software works very similar as a biological indicator for steam sterilizer, but instead of a biologic reactions, the software displays the values of the physical parameters (temperature and pressure). Attention: only displays, the sw does not measure or calculate the values. The sw just receive data in .xml from sterilizer and display it in a nicer UI.

In the case of a biological indicator, it is not stablished that it is required in the intended use of a steam sterilizer, however, still it is considered as an accessory of a medical device now due to the new Medical device definition of the MDR.

On which class (I or IIA) would you classify the biological indicator? would it be different for the software just becauseit is a SW ? (and it maybe fits in more definitions i.e. "software driving or influencing a device")?

Thanks in advance and i hope I clarify more my concerns
Thanks!

 

[dgrainger]

MDD Borderlines manual entry might be of use:

"7.4. Sterilization indicators
- Background
The sterilization procedure is monitored routinely by using chemical and biological indicators to evaluate the sterilizing conditions and indirectly the microbiologic status of the processed items.
- Outcome
Sterilization indicators monitor the performance of the sterilizer. They do not affect the sterilization procedure and only provide additional information to the user.
Sterilization indicators do not fulfil either the definition of a medical device laid down in Article 1(2)a of Directive 93/42/EEC or the definition of an accessory laid down in Article 1(2)b of Directive 93/42/EEC as they are not intended specifically to be used together with a device to enable it to be used in accordance with its stated use."

 

[AlexisRuiz27]

Thanks for the insight!

Not sure is the correct to mix MDD with MDR bibliography, however, now is our best path to move straightforward, until MDSW is clearer from the regulatory POV.

Thanks a lot

 

[DanMann]

Hello everyone!

I'm dealing with the classification of a software that documents the sterilization results of steam sterilizers.

Mainly a PC with the software(possibly MDSW) is connected to the sterilizer. The sterilizer sends all related data of the sterilization cycle to the software.

Then the software shows the results of the sterilization cycle, graphs of the physical parameters (temperature and pressure), number of cycle, etc, in a nicer interface, giving the possibility of printing a report.

From my POV, the software is only transmitting and documenting data, therefore, it should not be a MDSW, BUT, the user uses the report generated by the software to diagnose if the batch of the sterilizer can be released/approved or not, then, it might fall under the definition of "software driving or influencig a device" of the MDCG 2019-11. Steam sterilizers falls under class IIA.

Note: Data shown via the software is not modified or used for other purposes. It is only to watch it through a PC instead of the usual ticket of the thermomagnetic printer. The objective is to quit the printer and use the software.

Its very fuzzy this case, even the software could fall under class I because the software could be considered as an accessory of the steam sterilizer, assisting the sterilization by offering the results (HMI interface) to the user; now that the MDR covers the sterilizer devices within the medical device definition, rule 11 may apply for class I....

I hope this is an interesting topic to discuss and to have feedback from your side.
Thanks!

Is the steam steriliser used by the customer or by the manufacturer for sterilisation?

 

[AlexisRuiz2772]

Is the steam steriliser used by the customer or by the manufacturer for sterilisation?

It is used by the customer at the CSSD.