FMEA vs. Risk Analysis - What are the differences - Medical Devices

[howste]

My company has been asked to provide training for a medical device company on risk analysis (or risk management) and FMEA. We have on staff a medical device expert who knows risk analysis inside and out, and I have been asked to team with her and focus on the FMEA training. My background in FMEA comes from years in automotive and aerospace companies. Of course, we'll be getting together to prepare for this, but I'd like some help from all of you cove-dwelling brainiacs to get me up to speed on the finer points of applying this to a medical device company.

In the reading that I've done recently, my impression is that FMEA and risk analysis are very similar. My questions are these:

• What does risk analysis (or risk management) require over and above FMEA?
• Are there things in FMEA that are not normally part of risk analysis?
• Is FMEA commonly used in the medical device industry?

Any insight would be most appreciated. TIA!

[Kevin Mader]

FMEA is a Risk Analysis tool. There are several tools that can be used by an organization to perform risk analysis, and the FMEA/FMECA may be the most widely used tool. Your experience with process in the Automotive industry should serve you well.

In the Medical Device industry, the two most broadly used tools for risk assessment are Hazards Analysis and FMEAs. Often times, I've heard it expressed that Hazards Analysis is a top-down approach at risk analysis while the FMEA/FMECA is a bottom-up approach. Either way, its about risk mitigation or how you plan to manage risk.

Design and Process FMEAs are the most widely used approaches in medical device as far as FMEAs go. However, I would do a Systems FMEA also. I can say that while they may have been used by many medical device manufacturers in the past, recent experience indicates a growing movement towards their inclusion into the Design and Design Transfer activities.

In my mind, FMEAs just make good sense no matter what industry you find yourself in. I would even go further to say that folks should be creative in how to apply this Risk Analysis tool. For example, if folks challenged the need to create a procedure/form using this tool, I think many folks out there would have far fewer docs to manage in their Doc Control activities.

Good luck, but I think you prior experience should make this transition simple for you.

Regards,

Kevin

[howste]

Thanks Kevin, I feel a bit more comfortable about it. So, what is required for risk management over and above FMEA? Is there more emphasis on contingency plans and that sort of thing?

[Wes Bucey]

Originally Posted by howste

Thanks Kevin, I feel a bit more comfortable about it. So, what is required for risk management over and above FMEA? Is there more emphasis on contingency plans and that sort of thing?

In an earlier incarnation, I ran an FDA-certified manufacturer of medical devices (bone screws were a tiny part of our high-tech machining operation.) I still keep my hand partly into the trade.

ISO has an entire library of stuff associated with the quality and risk management of medical devices. If you are going to be active in this arena, you should get some or all of the documents. Here's a list:

Quality management and corresponding general aspects for medical devices

ISO 13485:2003 Medical devices -- Quality management systems -- Requirements for regulatory purposes

ISO 13485:1996Quality systems -- Medical devices -- Particular requirements for the application of ISO 9001

ISO 13488:1996Quality systems -- Medical devices -- Particular requirements for the application of ISO 9002

ISO 14969:1999Quality systems -- Medical devices -- Guidance on the application of ISO 13485 and ISO 13488

ISO 14971:2000Medical devices -- Application of risk management to medical devices

ISO 14971:2000/Amd 1:2003Rationale for requirements

ISO 15223:2000Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

ISO 15223:2000/Amd 1:2002 & ISO 15225:2000Nomenclature -- Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange

ISO/TR 16142:1999Medical devices -- Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

ISO/TS 20225:2001Global medical device nomenclature for the purpose of regulatory data exchange

[howste]

A little light reading there... And it looks like there are a few new documents in the works too.

Of course it will help having a member of the TAG to TC 210 to work with in getting ready for this. I already have and am familiar with 13485:2003 & 1996, and I plan to get a copy of ISO 14971 before this happens. Do these sound like the key documents?

[Wes Bucey]

Originally Posted by howste

A little light reading there... And it looks like there are a few new documents in the works too.

Of course it will help having a member of the TAG to TC 210 to work with in getting ready for this. I already have and am familiar with 13485:2003 & 1996, and I plan to get a copy of ISO 14971 before this happens. Do these sound like the key documents?

IMO, your new colleague will be your best guide - maybe you can combine libraries.

[wrodnigg]

Hello howste,

EN ISO 14971 is _the_ key-document for risk management of medical devices in the EC.

It gives a useful introduction and guidance what to do and what are the minimum requirements for risk management of medical devices.

One of the central points in 14971 is the risk assessment, which is quite simple, when you follow the steps.

As Kevin wrote, FMEA is one Risk Analysis tool, which you can use (and it works fine), but there are others, and it depends on the "problem to solve", when you choose a method for finding a solution.

And yes: FMEA is used by our customers (but it is not a must-have).

I had some files, but they are in german...
[If you are still interested, I could translate them during the holidays]

[howste]

Thanks for the offer Gerhard, but the training has been put "on hold," and I'm sure you've got better ways to spend your holidays. I have a copy of 14971 now, and have spent some time reviewing it. If the client decides they want to go ahead with the training, I'll dig in a little more to prepare for it...