Safety Assurance Case Report Format

[dore_m]

It seems that the FDA is requiring a Safety Assurance Case for our infusion pump. I've been looking into how to implement this, and think the GSN format is the best.

However, the formatting for GSN format is "flow-charty" and graphical. I cannot imagine how to document this on paper, other than to have a wall sized poster.

Does anyone have experience with reporting a GSN formatted safety case in a 510k submission?

-Dore

 

[yodon]

We supported a client years ago that did a safety assurance case for an infusion pump. Beastly exercise! If I recall, I think they used Visio - broke it up into many layers / chunks (not advocating that approach, just saying what I think was done). I recall it was supplemented with a lengthy text document. Never done anything in GSN format so I can't say one way or the other.

In this presentation, the author outlines a tabular format. Seems scholarly and I have my doubts.

 

[dore_m]

I did see that presentation, and I'm under the impression that that author of that sells a software that can convert between a GSN graphical format to a tabular one.

The Visio project that you mention sounds like GSN or similar to GSN. The key point for me is how to easily transfer from GSN or a graphical format into tabular, or if someone has submitted materials in large "visio" format, that would also be helpful.

Honestly, the infusion pump guidance already has which things to consider, and we've pretty much already considered them. I just need to link everything up in to a safety case, and present it in a proper format for the 510k. That's my thinking anyway. We can then upkeep the safety case moving forward. But I need to choose the right tool first (on a shoestring budget).

-Dore

 

[yodon]

Yeah, I recognized early on when the FDA first published the initiative that wasn't well suited for companies on a shoestring budget.

Your post got me poking around more and found this FDA site. I don't know if any of that would be helpful or not.

Sorry I can't be more help in the mechanics. From what I recall, it was a very labor-intensive, manually-driven process to pull it all together into a submission package.

 

[dore_m]

Actually, that example of a safety case report helps. At least now I have a format to work towards.

If anyone else has advice or links, it would be helpful.

I'm currently considering AdvoCATE, which is an open source software that is made by NASA. I'm just not sure if I can output the correct format for a report.

 

[GoBigRed]

I'd be curious to hear how this came out for you....what format / method of generating this did you settle on?

 

[zoneofindifference]

I think AAMI TIR 38 "Medical Device Safety Assurance Case Guidance" might be helpful in this scenario