ISO 14971:2007 Risk Management - Class I A Sterile Medical Device

[medwise]

Dear all,

This is my first thread and I would really appreciate your help.I am very new to my job and have no experience apart from university and my internship.

In my new job I have been told to do the risk management of a medical device. The device is class I A sterile and is used for laproscopic surguries especially hysterctomy.

After reviewing the technical file I realised that since this document was produced another version of ISO14971 has been published which is in 2007. While reading that I saw significant differences between the old and the new one. In the new risk management document which I am working on I have included Potential Hazards, Foreseeable Sequences of Events, Hazardous Situations, Harm, Impact and Likelihood, Risk Rating as part of my risk assessment.

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events? And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.

Thank you,
Regards

Romit Singh

 

[Marcelo]

Re: ISO 14971:2007 Risk Management

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events?

I´m not sure i understood your question, could you give some example? Are you talking root cause here?

Generally, the cause is included in the sequence of events because, as you describe what happened (or can pottentially happen), one or more of the steps are done wrong (fault) which led to the harm. This is not always true because there´s really no need to a fault (you can do everything ok and still produce harm). This shows that the "root cause" is not always clear and may need more study to be defined.

Also, it´s always better to act on the root cause to prevent the problem, but this is not always feasible.

And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.

The ones you cited are the "general" detailed hazards used in table E.1. This example taxonomy was created to have a lot of sub-hazards as shown in the table, but are not exhaustive. Anyway, i would not advise on expanding this too much because you can easily get lost - for example, some hazards might fit into more than one category - usability is and example - and in this case the root cause might be needed for the correct classification (is this the reason why you´re asking about the "cause?)

There´s lot of source of possible ramifications of this hazard list. Some are:

- list of essential requirements (MDD annex I, GHTF) - a lot of examples.

- product requirements - it might be interesting to use the taxonomy of product requirements in conjunction with the hazard requirements. This would facilitate the reporting of adverse events and the linking of the problems with the design requirements. An example of these can bee seen, for example, in ISO/TS 19218:2005 - Medical devices -- Coding structure for adverse event type and cause (which is in revisions at the moment).

 

[sagai]

Yes, MDD Annex I is really great start to create a list of hazards, but also not to forget to check each Articles if there is a relevant one to your device.
And not to forget to use the corresponding MDD according to your device
When you have a list add detailed about:
- Hazard Category
- Hazardous situation description
- Potential effect/harm
- Severity, frequency, probability, acceptability before risk control
- Risk mitigation
- Severity, frequency, probability, acceptability after applying risk control
- Rational
- Risk Control traceability

Yes, not as simple as you might thought but not rocket science for sure.
And not to forget to supply your risk management with corresponding SOPs.

I have a draft template for IDV Class II devices if you need, but I am not sure this one the thing u need.

hi
Sz.

 

[jeszar]

Dear all,

This is my first thread and I would really appreciate your help.I am very new to my job and have no experience apart from university and my internship.

In my new job I have been told to do the risk management of a medical device. The device is class I A sterile and is used for laproscopic surguries especially hysterctomy.

After reviewing the technical file I realised that since this document was produced another version of ISO14971 has been published which is in 2007. While reading that I saw significant differences between the old and the new one. In the new risk management document which I am working on I have included Potential Hazards, Foreseeable Sequences of Events, Hazardous Situations, Harm, Impact and Likelihood, Risk Rating as part of my risk assessment.

So the query is do I have to describe or mention causes of potential hazards as well or causes are considered as the part of foreseeable sequences of events? And I would also like to gain your views regarding the types of potential hazards apart from energy, bio hazards, chemical, operational and informational hazards.

Thank you,
Regards

Romit Singh

There is a new standard in Europe: EN ISO 14971: 2009, but it is exactly the same. Open the attached file. It is in Sapnish, but is easy to understand

Regards, Jeszar

 

[arios]

Gracias Jeszar.
Buen resumen! Nice summary!
Saludos