Identifying Hazards - Risk management process

[mf389]

I have a question as it related to the risk management process.

For instance,

Say I have a sequence of events which results in harm. (we include not being able to use the device as harm)

The sequence of events is:

(1) User applies heat to device in order to reshape it (normal use)
(2) user accidentally applies heat for too long

Hazardous Situation:

The device melts and is damaged

Harm: The user is prevented from effectively using the medical device to achieve its intended purpose

My QUESTION is:

What would be the appropriate hazard here? What is the true source of the harm? The use error is what results in the device not being functional but without the heat, the Use error cannot happen?

(1) Energy Hazards/ Thermal Energy: High Temperatures
(2) Operational Hazards / Use Error: Attention Based Failure

 

[Hemanth Kumar]

The appropriate hazard would be operational Hazards / Use Error: Attention Based Failure. Energy Hazards is a byproduct of the use error. You would normally define a risk control to cut out the heating mechanism at certain temperatures.

 

[mf389]

Thank you!

 

[mf389]

Are you looking at the hazards that lead to harm to the patient AND the hazards that lead to harm to the device (damage)?

 

[yodon]

It's always helpful for me to refer back to the definitions. Per 14971:

harm - physical injury or damage to the health of people, or damage to property or the environment

You could include damage to the device but it seems like, in your case, the focus would be on the patient and the device not being available. The control, as @Hemanth Kumar points out, might be to prevent melting the device - which would cover both the patient harm (unavailability) and the device harm.

 

[Ronen E]

I look at that scenario in this way:

Hazard = potential source of harm. At the most basic level it is the need to reshape the device. Maybe that's part of the intended use and nothing can be done about it, but we don't know because we have very limited information here. One of the prerequisites for effective risk management is full access to design information (including the design input). At the next level, the hazard can be seen as the need to reshape the device through application of heat. Is there a design alternative to achieve the same without applying heat? That would be an elimination of the hazard (potential source of harm) - Inherently Safe Design (ISD). Next up, the hazard can be seen as the material being sensitive to the duration of heating (i.e. requires a certain duration, tolerates an extra t1 without damage, irreversibly destroyed after t2). An ISD in that frame of thinking would be a different material that doesn't have such a sensitivity at all. Etc. etc.

Everything and anything to do with use errors in the presence of the hazard (i.e. the potential source of harm is not eliminated) is Protective Measures (PM), which is a less favourable course of action. Any PM that would break an identified chain / combination of events / circumstances is worth considering as a risk control.

 

[Tidge]

Say I have a sequence of events which results in harm. (we include not being able to use the device as harm)

"Not being able to use a device" is not a harm. In some circumstances it could possibly lead to a harm, but no one is being harmed right now by not using your device.