Help with ISO 14971: Benefit-Risk Analysis

[KSto33]

Hello All,
Thanks in advance for any help with this. We are developing a device that has been determined through our FMEAs to have relatively low overall risk. In building out our quality system, we know we need to have an established procedure for Risk Mgmt including how to conduct a BRA. While we have gone through the FDA's guidance documents on conducting a BRA, are there any templates/procedures/documents that can tell you exactly what you need to do to make them happy? Specifically what needs to be put to paper and attached as part of a RMF? Is there some sort of form we can fill out or do we just list any risk we have identified per the FMEA as "high", then list any risk controls measures and define a "benefit" to leave the risk as-is then move on? We are confused on what exactly to do on paper for the FDA submission.

While there is lots of information on factors to consider, we need establish a written process or form that tells you exactly what you need to document and how to add to our submission.

Thanks again in advance for any thoughts you may have!

 

[Tidge]

You have asked several complicated questions, each with a diversity of possible avenues of exploration and many possible resolutions. I'm not a fan of the Socratic approach to forum participation when questions are earnestly asked, so I will try to offer some points to consider as you try to solve your particular problem in a (perhaps) holistic manner. Cutting and pasting follows.

Specifically what needs to be put to paper and attached as part of a RMF?
<snip> ...we need establish a written process or form that tells you exactly what you need to document and how to add to our submission.

It would benefit your company to have an established Risk Management process, but for submission purposes you probably can get quite far with a (reasonably robust) Risk Management Plan for the specific device. Ultimately, the RMP will reinforce your commitment to make a safe and effective medical device by outlining your specific strategies and requisite activities to demonstrate such a thing has been achieved.

While we have gone through the FDA's guidance documents on conducting a BRA, are there any templates/procedures/documents that can tell you exactly what you need to do to make them happy? Specifically what needs to be put to paper and attached as part of a RMF?

Regulatory reviewer "happiness" isn't quite what you should be focusing on, but I think I know what you mean One key element that you will need to have clearly defined is the Essential Performance of the device... to first order: this is what the actual medical benefit of the device is to the patients and users. To second order, Essential Performance also requires that the device not present unacceptable risks to patients and users (there may be other stakeholders, but focus on the patients and users). The Benefits-Risk analysis ought to conclude that the benefits outweigh the risks, per the Risk Management Plan.

Sidebar 1a: Essential Performance (to first order) was decided on VERY early in your development process. The (second order) effects were analyzed during the Risk Management activities of your development process.

Sidebar 1b: My advice is to not oversell your Essential Performance. Almost all medical devices, no matter how complicated (electrical or not, software included or not), fundamentally have a very limited Essential Performance.

Sidebar 2: Failure Modes Effects and Analyses are generally recognized as an incomplete method of doing Risk Analysis for medical devices, as failure modes do not actually explore risks. For example: There is a risk of a surgeon cutting herself (or someone else) with a scalpel, even though "cutting" is the essential performance of a scalpel. Any attempt to rely on FMEA as "top level" risk analysis documents, no matter how sincere or thorough (e.g. highly detailed Use Cases and corresponding Use FMEA), relying on FMEA only is something of a red flag.

The (well-established) current paradigm is to have a Hazard Analysis as the top level document for consideration of risks. The Benefit-Risk Analysis will be the partner of the Hazard Analysis as you transition into the marketing phase of your product life-cycle. Each is a "living" document.

 

[yodon]

Good feedback from @Tidge (as usual). This was posted in the 14971 forum so I presume you have that? FDA recognizes it as a consensus standard so following that is the recommended (overall) approach for risk management. Since you asked about the benefit-risk analysis, I would point you to section 7.4 of the Guidance on Application of ISO 14971 (ISO/TR 24971). It provides a good explanation and example approaches.

 

[Gemayel12]

Hello All,
Thanks in advance for any help with this. We are developing a device that has been determined through our FMEAs to have relatively low overall risk. In building out our quality system, we know we need to have an established procedure for Risk Mgmt including how to conduct a BRA. While we have gone through the FDA's guidance documents on conducting a BRA, are there any templates/procedures/documents that can tell you exactly what you need to do to make them happy? Specifically what needs to be put to paper and attached as part of a RMF? Is there some sort of form we can fill out or do we just list any risk we have identified per the FMEA as "high", then list any risk controls measures and define a "benefit" to leave the risk as-is then move on? We are confused on what exactly to do on paper for the FDA submission.

While there is lots of information on factors to consider, we need establish a written process or form that tells you exactly what you need to document and how to add to our submission.

Thanks again in advance for any thoughts you may have!

Word of caution;
You should not rely solely on FMEA to assess the risk for medical device, but FMEA should be part of your overall Risk Management File (RMF).
Keep in mind, FMEA is more of a reliability tool than it is a risk management tool. FMEA is helpful tool to the deign team upstream to evaluate material, component and system failure modes.
A Medical device doesn't necessarily have to fail in order to cause risk that can potentially lead to a Hazardous Situation.

Word of advice;
Your company should want to invest in adoption of ISO 14971 for medical device risk assessment.
The latest edition (ISO 14971:2019 and companion document ISO/TR 24971:2020).
The standard is straightforward and will guide you step by step thru developing the risk management plan for the device, including developing and documenting RBA with objective evidence and/or rational to demonstrate why benefits outweigh the remining, unacceptable risk.
The companion document to the standard (ISO/TR 24971:2020) serves as work instructions to further simplify and interpret the standard requirements.