Single Use Devices - Surgeon must have backup in stock, just in case?

[peter_traina]

Has anyone ever experienced this??

We manufacture a Single Use Laproscopic Surgical Device that, if the Surgeon uses incorrectly, can be damaged. The fix is to just grab another one... and the problem is, that if they don't have a backup device, they are unable to finish the procedure! This is a potentially a very serious issue.

So, as the Manufacturer, is there any requirement that we inform them of the need to carry a backup device? Should we place it in our FMEA / Risk Docs?

Hopefully, someone out there has been here?? Thanks!

 

[yodon]

We have a client with a sort-of similar situation. In the risk analysis, we put various causes of risk being that the device failed (in your case, device failure would be from improper use, I would say) and then the mitigation was to have a backup available. We put such a statement in the IFU.

 

[somashekar]

I would rather have it put in bold so that it stands out and helps the cause.

 

[MIREGMGR]

the problem is, that if they don't have a backup device, they are unable to finish the procedure! This is a potentially a very serious issue.

So, as the Manufacturer, is there any requirement that we inform them of the need to carry a backup device? Should we place it in our FMEA / Risk Docs?

"Requirement" as such, i.e. some sort of mandate that you can't buy a single unit because you have to have a spare at all times: no.

But certainly it makes sense for you to inform in a clear manner.

The risk from not informing with sufficient clarity, it seems to me, is less from the point of view of the patient than the risk from the end user using the device incorrectly, thereby resulting in its failure.

 

[RA Guy]

Labeling is of course the last resort in risk mitigation and its effectiveness is arguable when used to communicate pre-emptive measures (i.e., if you don't fully read and take it to heart well prior to use, it will not be effective). Prominence and placement is key to this type of communication.

I would agree adding the reference to a backup may be helpful. At the very least it covers your bases in terms of making the clinicians think about their protocol and including a backup.

The other thing that I would consider (you likely already have) is ensuring that the warning was implemented as a true last resort after a very robust/exhaustive DFMEA that includes as many user driven failure modes as reasonable. Otherwise due diliegence is not complete as you have already recognized use error as a cricital risk. Hopefully you have a number of design based mitigations already in place.

 

[MIREGMGR]

There are limits to analysis of risk, and what we can do to guide clinicians away from risk. I don't think we want to warn them not to use an available medical device solely because medical devices aren't always available.

Many medical device types involve a risk related to non-availability in the event of damage or failure, unless a backup is ready. Think of MRI systems, surgical tables, etc. The list might not be endless, but it's long. Yet many care providers create vast amounts of healthcare benefit using single resources for which no immediate backup exists. For certain medical specialties and at certain times, the doctor him- or herself is a unique resource for which a risk would be created in the event of unplanned unavailability, yet that doesn't keep unique doctors from practicing the medical arts.

It would be a morass to determine via risk analysis that a device presents a risk specifically because its care provision function is uniquely clinically effective and therefore if it should become unavailable, the lack of provision of that care would amount to harm.

 

[peter_traina]

Labeling is of course the last resort in risk mitigation and its effectiveness is arguable when used to communicate pre-emptive measures (i.e., if you don't fully read and take it to heart well prior to use, it will not be effective). Prominence and placement is key to this type of communication.

I would agree adding the reference to a backup may be helpful. At the very least it covers your bases in terms of making the clinicians think about their protocol and including a backup.

The other thing that I would consider (you likely already have) is ensuring that the warning was implemented as a true last resort after a very robust/exhaustive DFMEA that includes as many user driven failure modes as reasonable. Otherwise due diliegence is not complete as you have already recognized use error as a cricital risk. Hopefully you have a number of design based mitigations already in place.

The company governance (the big shots)...
a.) Do not believe in filing MDR's ever...
b.) Understand the risk of not having a backup device but, minimize it totally. We have absolutely nothing in our DFMEA nor in our IFU.

They have no interest in putting it in either, stating that Hospital protocol ensures that they have backups of everything!

A little story about hospitals and Back-Up Devices...
When my 11 lb. son was born, he was stuck in the birth canal long enough for the Doc to be extremely upset and scared...and the reason...

There are two different suction "caps" that they suction onto the baby's head, in order to have a "handle" with which to pull him/her out. One cap is large and blue, the other is smaller and pink! Obviously the blue larger one is for bigger babies (blue is for boys) and the pink smaller one is for girls...
Anyway, when my son was born, all that was 'on the shelf' was a pink cap, no blue! The pink wouldn't fit on the 11 lb. baby and they couldn't get him out of the birth canal!! They finally wound up using the "giant salad tongs", or what they refered to as the foreceps... the same ones they use in abortions. All this because they didn't have a backup on the shelf!!
NOTE: Although he was immediately rushed to the intensive care (Mom didn't even get to hold him) with a heart rate of @ 140 bpm and an Apgar score that was near stillborn, he eventually was fine, although his head was lopsided (from the "giant salad tongs") until he grew out of it @ 4 yrs old...made for some really crummy baby pics!! No, we didn't sue...

 

[peter_traina]

There are limits to analysis of risk, and what we can do to guide clinicians away from risk. I don't think we want to warn them not to use an available medical device solely because medical devices aren't always available.

Many medical device types involve a risk related to non-availability in the event of damage or failure, unless a backup is ready. Think of MRI systems, surgical tables, etc. The list might not be endless, but it's long. Yet many care providers create vast amounts of healthcare benefit using single resources for which no immediate backup exists. For certain medical specialties and at certain times, the doctor him- or herself is a unique resource for which a risk would be created in the event of unplanned unavailability, yet that doesn't keep unique doctors from practicing the medical arts.

It would be a morass to determine via risk analysis that a device presents a risk specifically because its care provision function is uniquely clinically effective and therefore if it should become unavailable, the lack of provision of that care would amount to harm.

Very good!
That is what my first thought was and I agree with you whole heartedly......except...........................

When that failure mode becomes a trend... In other words, if every third procedure, the surgeon was unavailable, then you would need to list, warn and mitigate such a risk... Right??!!
Bottom line, we need to fix the device such that it doesn't fail before, DURING, or after, the procedure!

 

[MIREGMGR]

Bottom line, we need to fix the device such that it doesn't fail before, DURING, or after, the procedure!

Absolutely. I'm not in any way absolving us from trying hard to find ways to keep user mistakes, or any other product, user or environmental characteristic, or "normal" use consequences from creating effects-of-unavailability.

 

[Ronen E]

Has anyone ever experienced this??

We manufacture a Single Use Laproscopic Surgical Device that, if the Surgeon uses incorrectly, can be damaged. The fix is to just grab another one... and the problem is, that if they don't have a backup device, they are unable to finish the procedure! This is a potentially a very serious issue.

So, as the Manufacturer, is there any requirement that we inform them of the need to carry a backup device? Should we place it in our FMEA / Risk Docs?

Hopefully, someone out there has been here?? Thanks!

Hi,

Why limit the discussion to holding a backup and/or warning in the IFU?

IMO, you've identified a risk and now it's time to mitigate it. There are many ways to do so, improving the design and training users are two of them.

Cheers,
Ronen.