Risk Analysis of Class IIb Disinfectant

[RAlille1400]

Dear all,

firstly, let me say that I really enjoy this cove as a reader. I learnt a lot of things reading post from each of you.
Here is a new issue for me (i'm really novice inrisk assessment):
drawing a risk analysis report for an unsual medical device : a disinfectant classified as class IIb. this is for a CE marking.
It's a really new discipline for me. I read ISO 14971, go through annexes... Annex C is quite useless, since i could answer 'No' to all questions.... The other annexes are just completely confusing and uninformative for me...
how shall I construct my excel sheet ? which column heads ? how quantify the risk ?
Has anyone already done the same analysis? could anyone share any template ?

I already thank every answer or comment !
all the best,

 

[Stijloor]

A Quick Bump!

Can someone help??

Thank you very much!!

 

[yodon]

Hmm... according to your description, it's curious that it's considered a medical device. Regardless, that doesn't solve your problem so let's see what we can do. Can't let a first post go un-responded.

Many do consider 14971 (esp. the annexes) to be a template and for most devices, that's not a bad idea. If you take a more abstract view, it's really just guiding you through the process. Identify the hazards, identify what could cause the hazards, determine how 'big' the risk is (i.e., severity * likelihood), identify the controls to mitigate the risk, and then re-assess how big the risk is. Use that information to determine if you have a product sufficiently safe for its intended use.

Annex C is merely intended to be a thought-stimulator to identify the hazards associated with the device. Annex D describes how to characterize the risks. Annex E is another thought-stimulator for the source of the hazards.

How can your product cause harm to:
* intended users (patients)
* other people (care givers, etc.)
* the environment

Do what makes sense to characterize the hazards with your product and identify how you control those risks.

 

[planB]

Generally, you would have to follow this process:

http://medicaldevicequality.blogspot.co.at/2013/05/risk-management-flowchart-per-mdd-and.html (kudos to Sam Lazzara, where you find lots of other interesting stuff)

Here is an example of a risk assessment for a disinfectant:

http://www.brighthygiene.co.uk/brig...angro-pine-disinfectant-cossh-risk-assessment

HTH,

Gerhard

 

[pkost]

Here are some questions to help get you started:

• Can a resistance be developed to your disinfectant?
• What happens if the microbiological composition of the devices you clean changes?
• Is your disinfectant for all products or a specific one..e.g. contact lenses?
• Does the disinfectant have any chance of damaging the device it is disinfecting?
• What are the long term effects of multiple resuses on the device being disinfected?
• What happens if there is residual disinfectant on the device? could it harm the patient?
• Could the disinfectant react with any other chemical being used?

Annex C should only be seen as a prompt/aide-memoire, not as a definitive list of questions (although this is how most people treat it)

If you need more questions, I would suggest contacting the intended users of your product for their experience

 

[RAlille1400]

Thank a lot !
your 3 answers are helpfull !
Thanks for the questionning and links... things are progressing...
I'm far from the end, but, will manage the bloody Risk Assessment !

 

[Peterseb]

Hi,

Also do remember that it will generally expected that you have training in risk management and records of it if you are the one doing the risk assessment (the good thing is that it also makes it easier

/Peter