Where does this all end?
How far do I need to go in reducing risks is a question manufactures often ask? To take the principle of not using economic justification for reducing to its logical conclusion, I could ensure that my device is free particulate by having it built in space. As I cannot state that it would not be economically feasible to do so, how am I to proceed? You are not expected to go to the Nth degree but are expected to adhere to the ‘generally acknowledged state of the art’ as required by the MDDs. The MDDs do not define state of the art, but ISO 14971 does define sate of the art as follows:
“State of the art” is used here to mean what is currently and generally accepted as good practice. Various methods can be used to determine "state of the art" for a particular medical device. Examples are:
⎯ standards used for the same or similar devices;
⎯ best practices as used in other devices of the same or similar type;
⎯ results of accepted scientific research.
State of the art does not necessarily mean the most technologically advanced solution.
As there is no content deviation in EN ISO 14971: 2012 relating to state of the art it can be concluded that this definition is valid for compliance with the MDDs. As long as your designs and controls are state of the art you can justify that you have reduced the risk as far as possible.
For example: To have a line of six inspectors each checking the previous inspector has not missed a defect is not the state of the art; however, to have a vision system checking for defects which are associated with a high severity harm for the patient is state of the art, while to have a vision systems to check for every possible defect irrespective of the harm that it could cause is not state of the art.
Manufacturers must be aware that the state of the art changes over time and that they must keep up with the state of the art. Consideration of how current designs and controls compare to the state of the art should form part of the periodic review of risk conducted by top management as required by ISO 14971.
This leaves the following possible justification available for not reducing risk further:
The risk has been eliminated.
The designs and controls are state of the art.
Improved design or further controls are not technically feasible (as opposed to economically feasible) taking into account the current state of the art.
The existing design (or controls) have reduced the risk to the same level as the proposed new design.
Additional designs or controls would conflict with the existing design or controls thereby resulting in a risk that is equal to worse than the current situation.
The design or control introduces a new hazard that presents a risk that is equal to worse than the current situation.
How to Address Deviation No. 3
In order to address content deviation No. 3 your risk management team will need to change the risk management process to remove the ALARP risk category and the use of economic justification for not reducing risk. These will need to be replaced with requirements to reduce risk as far as possible given the state of the art and a requirement to clearly state that all risks have been reduced as far as possible. The risk review process will need to be updated to ensure that it contains a requirement that the designs and controls be kept up to date with the current state to the art.
Your team will need to review risk management documents such as dFMEAs and pFMEAs to remove all reference to ALARP and to ensure that all risks have been reduced as far as possible. Where this is the case a clear justification should be added to state that risks have been reduced as far as possible given the state of the art. Where this is not the case, redesigns and or improved controls will have to be developed in order to bring the device safety up to the state of the art. A project plan to achieve this should be embedded in your Quality System and kept up to date.
Finally communication with your Notified Body is vital to ensure that they are on side with your programme for compliance with content deviation No. 3.
* Content Deviation: During the process of making ISO 14971 an EN standard (a process known as harmonisation), it became apparent that the standard did not comply with all the requirements of the Medical Devices European Directives, namely 90/385/EEC, 93/42/EEC and 98/79/EC. The differences between EN 14971: 2012 and the medical devices directives are known as Content Deviations.
The seven Content Deviations are:
Treatment of Negligible Risk
Risk Acceptability Assessment
Risk Reduction Economic Considerations
Risk-Benefit Analysis Not Optional
Risk Control Options
First Risk Control Option
Labelling Information Cannot Influence Residual Risk