FMEA vs. Hazard Analysis per FDA interpretation

W

Watchwait

#1
A Hazard Analysis (per FDA interpretation) speaks to health/safety related issues only. This has been further solidified by FDAs recent support of ISO 14971, which absolutely only speaks to health/safety issues. Product functionality is not an issue per ISO 14971. If it doesn't result in a degree of risk to human health or safety, it is not a consideration.

Conversely, an FMEA speaks to both health/safety and functionality. So my question is:

In an FMEA, what is the Severity Level of a failure mode whose impact on health is a 0 & whose impact on functionality is a 10? E.g., if this happens, the device will absolutely not work, but there is absolutely no impact to health or safety?

Or - should an FMEA ignore potential health/safety issues & a seperate Hazard Analysis be developed exclusively for health/safety related issues?
 
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yodon

Staff member
Super Moderator
#2
When we've done FMEAs, we rank the severity in terms of harm (to the patient, etc.). So a failure like you describe is considered failing safe and thus a low severity. Of course, there are cases where failing inoperable is just the opposite! You wouldn't want a heart/lung machine shutting down mid-stream. So in that case, the severity would be quite high.

The FDA really is only concerned about harm (public safety). Everything else is primarily a business concern.
 
W

Watchwait

#3
Still, I wrestle with a failure mode who's impact is such that the customer would be extremely dissatisfied, but relatively unharmed.

E.g., I sell an alarm clock that simply stops working in the middle of the night. Customer is furious but unharmed. Functionality loss is total but customer is at no risk. What is the Severity Level? 10? 5? Zero?

I can't be the 1st bloke whose ever wrestled with this dilemna...
 
M

MIREGMGR

#4
A Hazard Analysis (per FDA interpretation) speaks to health/safety related issues only. This has been further solidified by FDAs recent support of ISO 14971, which absolutely only speaks to health/safety issues. Product functionality is not an issue per ISO 14971. If it doesn't result in a degree of risk to human health or safety, it is not a consideration.
Harm, of course, is realized risk. I think it's important to recognize how the FDA defines patient harm.

Per FDA definition, an object is a medical device if one of three conditions is true:

1. It's listed in the National Formulary or the USP, or their supplements;
2. It's "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man or other animals", or
3. It's intended to affect the structure or any function of the body of man or other animals, and (continuing statement to differentiate from drugs).

My understanding per the above definition is that a device that is intended to support a diagnostic or curative process can harm the patient not only by some active process that causes that harm, but also by failing to effectively perform its intended diagnostic or curative function, thereby leading to harm due to an un- or incorrectly diagnosed medical condition or to an ineffective curative effort. That is, the FDA fundamentally requires medical devices to be both safe and effective, with equal emphasis.

My understanding of the FDA's expectation in regard to risk analysis is that risks related to active lack of safety and risks related to ineffective performance of intended functions, on which patients and care providers might reasonably rely to avoid patient harm, are to be analyzed. If harm can occur through the function or dysfunction of the device, there's a risk.

I've been reading all of the device Warning Letters for the past year or so. As evidence in support of this interpretation, it appears to me that the FDA writes Warning Letters about equally often for ineffectiveness-related potential for harm and for active lack of safety.

I'm not sure that the alarm clock is a very good example. Is your inquiry in regard to a particular device type that in fact could become dysfunctional without affecting a diagnostic or curative process? I can't think of very many device types...particularly not in Class II, of course...for which that could be true.
 
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W

Watchwait

#5
Great analysis of the FDA's interpretation & expectations. Further, relating this understanding to real evidence, e.g. FDA Warning Letters really does help clarify the question.

So when developing a Severity Index, it needs to contain references to both safety & effectiveness. So in my Severity hierarchy it would contain statements similar to:

Level 1: Transparent to user. Customer will not notice the effect of this failure mode and/or poses no risk to user whatsoever.

Level 2: Customer may notice effect of this failure mode and/or risk posed to user is noticeable but inconsequential.

Level 3: Etc.

This same logic would then, of course apply to ANY product, medical device or otherwise.

Another interesting take on this is ISO 14971, which FDA has publicly endorsed as acceptable guidance on risk management. Per ISO 14971:2007:

"It is accepted that the concept of risk has two components:

a) the probability of harm

b) the consequences of that harm"

with "harm" being defined as:

"physical injury or damage to the health of people, or damage to property or the environment".

Clearly, ISO 14971 concerns itself exclusively with "safety" (as opposed to efficacy/effectiveness). To wit, the Severity levels in my above mentioned example would not appear to be appropriate following this ISO model. In this case, only those references to functionality would seem appropriate.

As it happens, we make both medical devices & non-medical products - hence my stubborn pursuit of this clarification...
 
M

MIREGMGR

#6
With regard to 14971, we interpret "physical injury or damage to the health of people, or damage to property or the environment" to include both direct and indirect harm. I'm not sure that that's theoretically correct, but that's what we do.

The downside of that interpretation is that practically any service-availability failure of a diagnostic or curative system element has at least a small likelihood of pretty serious indirect harm, i.e. a fast growing cancer not diagnosed, etc.
 
S

SRavi

#10
Thank you for the link. I have a simple question regarding ISO 14971. If a software / hardware is used in the calibrating medical device, which posses a minor level of risk, can we combine, Device hazard analysis and FMEA (with concentration on the calibration process and sterilization ) in one document or do we need two seperate documents. What's FDA's take on that. please reply soon
 
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