Are Heart Rate Monitors used in Wellness Environments considered Medical Devices?

A

andreiafilipaf

#1
Hi
I would like to ask your opinion about heart rate monitors that are not used in medical institutions and not used for diagnosis but just for control. Just as heart rate monitors in running treadmill. These ussually are not classified as medical devices.

Do you consider a system that also read heart rate used not on a medical environment but on a wellness environment, like in a SPA or a recovery center or a senior home facility should be considered a medical device?

Thank you
Andreia
 
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somashekar

Staff member
Super Moderator
#2
Hi
I would like to ask your opinion about heart rate monitors that are not used in medical institutions and not used for diagnosis but just for control. Just as heart rate monitors in running treadmill. These ussually are not classified as medical devices.

Do you consider a system that also read heart rate used not on a medical environment but on a wellness environment, like in a SPA or a recovery center or a senior home facility should be considered a medical device?

Thank you
Andreia
but just for control
Control what ?
Per the MDD definition.,
Is it for diagnostic or therapeutic purpose...? No
Is it for a display or monitoring of disease ...? Display
Is the above the intention of the manufacturer...? Yes
Then it is not a medical device.
Otherwise heart rate monitor is a medical device.
 
Last edited:
A

andreiafilipaf

#3
When I say control, I want to say register the values and show them on a platform, but without any interpretation.
 
M

MIREGMGR

#4
Clearly there's a definitional threshold here.

My interpretation would be that, if the context of use is generally that the users are healthy and they are using the provided information to maintain that good-health state, the product's use is not as a medical device.

If on the other hand the context of use is generally that the users are in questionable health and they are using the provided information to monitor that questionable-health state, the product's use is as a medical device.
 

Ronen E

Problem Solver
Staff member
Moderator
#5
the users are healthy and they are using the provided information to maintain that good-health state
Isn't that the meaning of Prevention?

On another aspect, I tend to think it matters less who finally uses the device and how, and more what is intended by the manufacturer (labeling intended use), i.e. under what definition the device is put onto the market. If a manufacturer clearly excludes a certain use on the labeling, than they can't be held responsible for such use if someone decides to do so in spite of that exclusion, can they?

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#6
When I say control, I want to say register the values and show them on a platform, but without any interpretation.
.... which again per my thinking is display. The heart rate changes from rest state to active state of a person and you are showing up just the heart rate at any state.
Ronen has added more meaning to state that what is a medical device is more from the manufacturer's intention rather than user's way.
 
M

MIREGMGR

#7
Isn't that the meaning of Prevention?
Yes, of course, but that's why it's necessary to explicitly address the definitional threshold. In some respect, practically everything a healthy person uses in activities-of-daily-living is part of that person's prevention-scheme. Certainly the knife and fork I used last night at dinner are important in that regard for me. That however is not a practical way to apply MDD Article I Section 2.

The definitional extension I suggested is one way to manage that boundary. Whatever approach one uses, in my view it should be documented as a memo to file in one's QMS so that an auditor can see evidence of consistent application.

That however is just my view.

If a manufacturer clearly excludes a certain use on the labeling, than they can't be held responsible for such use if someone decides to do so in spite of that exclusion, can they?
Actually that's an interesting legal question. In the US, the answer often is yes. Maybe not so in Europe, though.
 

SilkTie

Starting to get Involved
#8
On another aspect, I tend to think it matters less who finally uses the device and how, and more what is intended by the manufacturer (labeling intended use), i.e. under what definition the device is put onto the market.
Right. Years ago I planned putting a trainer on the market, which could be used either for fitness only or also for rehabilitational use. I discussed this with my NB and he made it clear to me that the intended use is what determines the regulatory status. If I was to market it as a fitness device, it would be according to Directive such-and-so (forgot which one), if as a rehabilitational device it would be according to the MDD.
If a manufacturer clearly excludes a certain use on the labeling, than they can't be held responsible for such use if someone decides to do so in spite of that exclusion, can they?

Cheers,
Ronen.
I sure hope you're right, but ...
Actually that's an interesting legal question. In the US, the answer often is yes. Maybe not so in Europe, though.
... makes me fear that especially in the US you'll have to design your device in such a way that that other use is inherently prevented, a.k.a. made law-suit-trigger-happy-idiot-proof.
 
M

MIREGMGR

#9
It's not so much that the design has to prevent an unintended use, although one can use that tactic.

Rather, in my understanding based on past enforcement actions, a manufacturer cannot avoid FDA responsibility for medical device compliance of a product merely by stating the product to not be a medical device and not intended for use X, if FDA determines that a normal user otherwise would regard the product as suitable and intended for use X and the product's marketing in totality communicates the message that the product is suitable and intended for use X.

Without such a regulatory stance, some manufacturers would put rules-dodging statements on their labels and in their marketing materials, in what's sometimes called "wink-and-nudge" marketing. This particularly has occurred in the past in regard to products that are labeled as non-medical-devices but actually are marketed for consumer-medical-device applications.

In my understanding, the significance of this is that a manufacturer in the US market should look at the uses for which their product will be perceived as suitable based on its design, and assure that it in fact is suitable (including regulatorily) for those uses. A manufacturer cannot hide behind disclaimers.
 
A

andreiafilipaf

#10
I agree with you, but that take us to the example of the running treadmill. It give us the value of the heart rate, it even can draw the line of the variation of the values, some of them even give an alarm when the heart is beating more than a determined treshold. This is monitoring a vital sign, right? And in Europe a system that monitors vital signs are in fact medical devices.
So, should we consider the strap that my running treadmill brings as a medical device?
 
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