Unacceptable risk and information for safety

MrTetris

Involved In Discussions
#11
Hi,
I`m hopping on the re-design train, hope it didn`t leave already.... ;-)

We solved a similar problem (treatment planning) by having users sign off with their password, once they wanted to make a change. This was also stored in the audit trail.
We had different roles who could plan the treatment, and also a kind of busy use environment (nurses, doctors, techs..). But someone in charge had to sign off all changes.
Honestly, from a usability perspective: not cool. workflows were often interrupted by the password dialogue.
From a risk perspective: probably quite good.
Totally agree with your view about usability and risk... that is the reason why it is not an acceptable solution :)
 
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MrTetris

Involved In Discussions
#12
Do you know how the Occurrence, Severity and Detectability levels were established?
Not properly, in my opinion, and for sure qualitatively. Considering the environment in which our sw are used, I believe that attributing 3 to the occurrence is far too conservative.
 

Watchcat

Trusted Information Resource
#15
Not in a position to have an opinion on occurrence. On severity, is it a certainty that an undetected (and therefore implemented, I think?) wrong surgical plan can't end up killing the patient? At the very least, I hope this isn't how the failure is detected...
 

MrTetris

Involved In Discussions
#16
Not in a position to have an opinion on occurrence. On severity, is it a certainty that an undetected (and therefore implemented, I think?) wrong surgical plan can't end up killing the patient? At the very least, I hope this isn't how the failure is detected...
No, no death or serious permanent impairment are possible.
 
#17
@MrTetris
Are you doing this in pursuit of MDR compliance? MDD? Other?
This is a never-ending (sad) story.

Similar to the requirement to inform users about the residual risks in § A.2 of Annex I to the MDD, the MDR CHAPTER III paragraph 23.1(g) specifies that "Residual risks which are required to be communicated to the user and/or other person shall be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer."
As you correctly noted, GSPR 4(c) in ANNEX I CHAPTER I of the MDR stipulates that the last in the order of risk control options is to "provide information for safety (warnings/precautions/contra-indications) and, where appropriate, training to users."

This prompts a conclusion that residual risks=information for safety.

BUT, paragraph 23.4(g) of the same CHAPTER III requires that the instructions for use shall contain, among other particulars, "any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard."

So, now residual risks are separated from contra-indications with a comma?
I am just curious, is it just me or other people have issues with accepting MDR as their native language?

Now to the standards...

ISO 14971:2019 has been published and received an EU designation as EN ISO 14971:2019, though is yet to be published in the Official Journal of the European Union. Importantly, Article 8(1) of the Regulation 2017/745 of the European Parliament and of the Council (Medical Devices Regulation; MDR) states that:

Devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.

The first subparagraph shall also apply to system or process requirements to be fulfilled in accordance with this Regulation by economic operators or sponsors, including those relating to quality management systems, risk management, post-market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow-up (‘PMCF’).

References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union.

Since EN ISO 14971:2019 is yet to be harmonized in the European Union, the analysis, at this time, would have have to account for the harmonized edition of the standard (EN ISO 14971:2012) and content deviations addressed in its Annex ZA establishing relationship between this European standard and the MDD requirements. Still, ISO 14971:2019 has already received recognition of the United States Food and Drug Administration (FR Recognition Number 5-125), while a notification under Article 12 of Regulation (EU) No 1025/2012 issued on June 26, 2019 requests the 2012 (2nd) edition of the standard be revised. To put icing on the cake, the result of an independent review of the informative Annexes submitted with the draft ISO 14971:2019 can only be interpreted as a bird to whoever wrote these Annexes (rumor has it, eventually, there won't be any).

How very cute of the EU legislators to have the chip on their shoulders carried by someone else (bad manufacturer, angry manufacturer).

As an outcome, the 2019 (3rd) edition of the standard is being considered for benefit-risk analysis purposes, as the current state-of-the-art standard. But this was not enough. We have also been given a gift of the latest revision of ISO/TR 24971:XXXX Medical devices — Guidance on the application of ISO 14971. Why XXXX? Because it has not been published yet. But the circulating draft is an ode to joy.

Annex D of the draft ISO/TR 24971 clarifies that information for safety is a risk control measure is to be used only after the manufacturer has determined that (further) risk reduction by other measures is not practicable, whereas Annex C of the this standard defines practicability (being practicable; viable or reasonable) as the ability of a manufacturer to reduce the risk, and should not be confused with practicality (being practical), which refers to measures that are useful or convenient. The latter Annex further clarifies that economic practicability should not be used as a rationale for the acceptance of unnecessary risk.

Logically, after reading all the above and scratching off the last signs of haircut, similar to the clarification provided in content deviation #7 in Annex ZA of EN ISO 14971:2012, the residual risks may not be further reduced using information for safety to users?

A disclosure is in order: I am not a QA professional. My part is clinical affairs. Still, the long-due ISO/FDIS 11455 update is upon us and, judging by the circulated draft, ISO 14971 will play a major part in it.
 
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