Regulatory Open Forum

Hello All; 

I have received some questions from a colleague regarding what level of detail one should use when conducting a risk and hazard analysis (Medical Device). I am not quite familiar with creating a risk and hazard myself. Does anyone have any good resources and or do you know of any examples one could use to reference other than the ISO risk standard? Are there any guidance documents about how/if risk cases can be combined? My colleague is creating risk cases for each harm (and subsequently for each harm severity level). Example: a risk case is created for both a minor and a moderate burn when the mitigation and path will likely be the same.

They also asked if they should be considering immediate AND subsequent harms, or just immediate harm; I would expect one would consider immediate harm only, as harm considerations could quickly spiral out of control when thinking of potential subsequent harm. Am I on the right path?

Thank you for your help!

------------------------------
Elizabeth Zak
Quality Engineer
Strongsville OH
United States
------------------------------

​Hi Elizabeth,

IMO, you have zeroed in on the main problems with relying on FMEA to assess clinical risks, which typically occur across a continuum of frequency and severity and at different points in time.

Clinically, it makes no sense to assign a single frequency and severity to a clinical harm, but "that's the way we've always done it."

I would include both immediate and subsequent harms.  I don't think anyone wants to use a device that might injure them in six months or a year much more than one that might injure them tomorrow.  There are many examples of medical devices that did their harm later rather than sooner, with Essure as an example that has been recently in the news.

Where I think FMEA works well is to identify potential clinical harms.  After they have been identified, someone with a clinical background needs to sit down and review them and assess them in much more depth than can be adequately addressed with a number in a spreadsheet.

------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Durham, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
------------------------------

Original Message:
Sent: 21-Jan-2019 16:23
From: Elizabeth Zak
Subject: Risk and Hazard Guidance

Hello All;

I have received some questions from a colleague regarding what level of detail one should use when conducting a risk and hazard analysis (Medical Device). I am not quite familiar with creating a risk and hazard myself. Does anyone have any good resources and or do you know of any examples one could use to reference other than the ISO risk standard? Are there any guidance documents about how/if risk cases can be combined? My colleague is creating risk cases for each harm (and subsequently for each harm severity level). Example: a risk case is created for both a minor and a moderate burn when the mitigation and path will likely be the same.

They also asked if they should be considering immediate AND subsequent harms, or just immediate harm; I would expect one would consider immediate harm only, as harm considerations could quickly spiral out of control when thinking of potential subsequent harm. Am I on the right path?

Thank you for your help!

------------------------------
Elizabeth Zak
Quality Engineer
Strongsville OH
United States
------------------------------

Hi Elizabeth,

I suggest to check ISO 14971 Medical devices -- Application of risk management to medical devices.
It gives you a quite good guidance with the potential hazards and risk throughout the whole life-cycle of the product. It also mentions all the potential methodology you can use.
To me approaching a risk assessment for clinical hazards should not be done in the same way as a risk assessment for e.g. production hazards.

You will hear a lot of different opinions regarding the methodologies. In this case nothing is right or wrong.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 21-Jan-2019 16:23
From: Elizabeth Zak
Subject: Risk and Hazard Guidance

Hello All;

I have received some questions from a colleague regarding what level of detail one should use when conducting a risk and hazard analysis (Medical Device). I am not quite familiar with creating a risk and hazard myself. Does anyone have any good resources and or do you know of any examples one could use to reference other than the ISO risk standard? Are there any guidance documents about how/if risk cases can be combined? My colleague is creating risk cases for each harm (and subsequently for each harm severity level). Example: a risk case is created for both a minor and a moderate burn when the mitigation and path will likely be the same.

They also asked if they should be considering immediate AND subsequent harms, or just immediate harm; I would expect one would consider immediate harm only, as harm considerations could quickly spiral out of control when thinking of potential subsequent harm. Am I on the right path?

Thank you for your help!

------------------------------
Elizabeth Zak
Quality Engineer
Strongsville OH
United States
------------------------------

You can also review ISO TR 24971 which is guidance for ISO 14971 that gives some examples.  Also note that ISO 14971 has a new version being published soon though there appears just to be clarification on most points. And Julie is absolutely right that risk management over the entire lifecycle of the device should be considered - FMEA is just a method of risk analysis.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 22-Jan-2019 02:50
From: Spyros Drivelos
Subject: Risk and Hazard Guidance

Hi Elizabeth,

I suggest to check ISO 14971 Medical devices -- Application of risk management to medical devices.
It gives you a quite good guidance with the potential hazards and risk throughout the whole life-cycle of the product. It also mentions all the potential methodology you can use.
To me approaching a risk assessment for clinical hazards should not be done in the same way as a risk assessment for e.g. production hazards.

You will hear a lot of different opinions regarding the methodologies. In this case nothing is right or wrong.

Hope that helps

------------------------------
Spyros Drivelos
Medical Devices Manager
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 21-Jan-2019 16:23
From: Elizabeth Zak
Subject: Risk and Hazard Guidance

Hello All;

I have received some questions from a colleague regarding what level of detail one should use when conducting a risk and hazard analysis (Medical Device). I am not quite familiar with creating a risk and hazard myself. Does anyone have any good resources and or do you know of any examples one could use to reference other than the ISO risk standard? Are there any guidance documents about how/if risk cases can be combined? My colleague is creating risk cases for each harm (and subsequently for each harm severity level). Example: a risk case is created for both a minor and a moderate burn when the mitigation and path will likely be the same.

They also asked if they should be considering immediate AND subsequent harms, or just immediate harm; I would expect one would consider immediate harm only, as harm considerations could quickly spiral out of control when thinking of potential subsequent harm. Am I on the right path?

Thank you for your help!

------------------------------
Elizabeth Zak
Quality Engineer
Strongsville OH
United States
------------------------------