Hi All,
Looking for some thoughts on assessing risks where harms are indirect, or a fault with the device in question causes another device to cause harm, with the specific example being low-pressure hose for medical gases.
There are numerous risks where the harm is direct with these types of devices - if there are contaminants in the hose it can cause harm, if the hose bursts it can cause harm, it can be a trip hazard if too long and cause harm, etc. etc. these are relatively straight forward.
However, the hoses are generic in that they connect to a terminal unit or regulated outlet and then the other end connects to a device that performs a medical function. There are no limits on what devices can be connected - if the device requiring gas is designed to take air from a terminal outlet (in accordance ISO 9170-1), then the hose can do it, based on its compliance with ISO 5359 which specifies performance requirements for low-pressure hoses.
One of the risks is that if the hose is too long the pressure drop will be too much and the device will not function.
As a control there are limits on the length of hose that the customer can order as a part of the quality system documentation for the hoses, verified through evidence that hoses at the max length meet the pressure drop requirements of ISO 5359.
Where the connected device could be an oxygen therapy system, an anaesthesia machine, a bone saw, or any other number of non-specified devices - how would you document a harm for this within the risk file?
Cheers,
TS.
Looking for some thoughts on assessing risks where harms are indirect, or a fault with the device in question causes another device to cause harm, with the specific example being low-pressure hose for medical gases.
There are numerous risks where the harm is direct with these types of devices - if there are contaminants in the hose it can cause harm, if the hose bursts it can cause harm, it can be a trip hazard if too long and cause harm, etc. etc. these are relatively straight forward.
However, the hoses are generic in that they connect to a terminal unit or regulated outlet and then the other end connects to a device that performs a medical function. There are no limits on what devices can be connected - if the device requiring gas is designed to take air from a terminal outlet (in accordance ISO 9170-1), then the hose can do it, based on its compliance with ISO 5359 which specifies performance requirements for low-pressure hoses.
One of the risks is that if the hose is too long the pressure drop will be too much and the device will not function.
As a control there are limits on the length of hose that the customer can order as a part of the quality system documentation for the hoses, verified through evidence that hoses at the max length meet the pressure drop requirements of ISO 5359.
Where the connected device could be an oxygen therapy system, an anaesthesia machine, a bone saw, or any other number of non-specified devices - how would you document a harm for this within the risk file?
Cheers,
TS.