HELP NEEDED ! Risk Management Exercise

#1
Hi All - Can anyone help me, I am trying to fill out the exercise attached and I am struggling, I did my company training a while ago, however was then off sick and cannot find my notes ! Any help would be appreciated. The example is relating to a hospital setting, I work for a respiratory device company
 

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Jim Wynne

Staff member
Admin
#2
Welcome to the Cove. :bigwave: If you could be more specific and tell us what you're struggling with, you'll get better answers.
 
#3
Hi Jim, Thank you for the welcome !

Im worried I am thinking along the wrong lines when filling out the exercise table, My initial thought on the questions for the first scenario are the following,

So, I need to evaluate the scenario of a product recall.

RISK
(identify)
- A recalled product could be used in a clinical environment

RISK
(to who)
- Patient or clinician

Assess
(impact/likelihood)
X
(1-5)


- Here I am a little confused, is there a scale within ISO14971 ?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Welcome Jessicawabbit!

I think you have made it through the first two steps, unless your group wants more detail. (An internally used or externally used product? An accessory or a finished medical device? Maybe you should cite an example product)

As for Assessment Impact/likelihood X (1-5), your organization should have a procedure for identifying that. Under no circumstances should you be required to guess or even estimate.

As for control, there are multiple considerations: preventing product from reaching the clinician, recall process and end users' awareness to prevent inadvertent use. The end user should always be included in considerations for medical devices.

How to monitor/evaluate is not a one-size-fits-all concept. Advice based on ISO 14971 is available here, also here.

I hope this helps.

I am not affiliated with Clever Compliance or San Jose State University.
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#7
I am assuming this is more of a training or classroom exercise than real-world, or is what we referred to as a pre-mortem. The risk may be the recall is not broadcast well, so there for someone uses the recalled device for XYZ. Now the risk - we have to look at how good are our recall practices. Do we know who exactly purchased all devices and can track them down. What if they were resold? We also need to ask - is it a given that a recall has happened, or do we want to say - this is how we avoid needing to do a recall. So we identify what makes up the likelihood. Then comes the severity of the event. If we have a faulty unit out there, that the recall doesn't reach, will it cause a death of a patient? Serious injury? Are there built in safeguards that should mitigate an issue with the unit? I'm bringing in some FMEA thoughts here, but if the point of the exercise is to identify the risk (probability and impact) then this is the general route one would take.
 
#8
Hi Steve,
Yes, this is a classroom activity, The product is a Nasal High Flow humidifier, used in various clinical settings within hospitals.

In this scenario, what would advise the hazard would be ?

Thank you for your very informative and detailed response, I appreciate the time you have taken to respond to me.

Thank
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
Jessicawabbit, was FMEA covered in your class? What about PHA?

Here in the Cove we are not well prepared to provide details from training we were not present for. You did say this was about product recall, so I found this site for you, also this site.
 

Steve Prevette

Deming Disciple
Staff member
Super Moderator
#10
Must admit I don't know what a nasal high flow humidifier is, but you have to ask yourself (at least as a bounding question) - what is the worst malfunction that can happen? I suppose it could overheat and send scalding steam into your sinuses. If you say - well no that can't happen because . .. then what is the worst that can happen?
 
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