Seeking advice regarding use of off-the-shelf (OTS) batteries

Mark Meer

Trusted Information Resource
#1
I'm wondering if anyone has any advice from experience regarding supplying off-the-shelf (OTS) batteries with a medical device. For example devices powered by replaceable AA, 9V, or coin-cells.

From a design & risk standpoint, I presume you'd want to at least consider the variety of possible chemistries, and whether batteries are rechargeable or not. Such considerations would be part of the design/risk documentation, and any minimum specifications relayed to the user in accompanying documents. Assume, however, that they are all compatible (device can accept voltage variations due to different chemistries) - the only difference being the capacity mileage you'd get, and that this doesn't result in any hazardous situation.

I'm wondering more about any legal/regulatory considerations. For example, if the device is powered by a standard 9V, is it permissible to simply purchase an off-the-shelf brand-name 9V, and include it with the device?
 
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yodon

Staff member
Super Moderator
#2
We worked on a device years ago that was powered by OTS batteries. If I recall, I think use of rechargeable batteries was considered in risk analysis and the uncertainties around such batteries was sufficient to put a note in the IFU saying rechargeable batteries shouldn't be used. No specific hazard was identified but they felt it might lead to a bad user experience.

Pretty sure they didn't deliver the device with batteries but I don't know if it was for legal / regulatory reasons or cost.
 

Mark Meer

Trusted Information Resource
#3
...If I recall, I think use of rechargeable batteries was considered in risk analysis and the uncertainties around such batteries was sufficient to put a note in the IFU saying rechargeable batteries shouldn't be used. No specific hazard was identified but they felt it might lead to a bad user experience.
Thanks for the input @yodon. I presume the uncertainties just related to capacity? i.e. uncertainty in expected mileage from batteries that have been recharged a lot versus a fresh primary battery. How about specifying battery chemistry for the non-rechargeables? Did you also deem it necessary to specify Alkaline, Zinc-Carbon, or Li-FeS2?

In my experience these days most battery-operated (consumer) devices often come with an initial set of batteries, and as a consumer I certainly appreciate it when they do. As such, it be nice to toss in an OTS set into the package....but again, I'm not sure if there are any regulatory or legal hurdles to this practice. :unsure:
 

yodon

Staff member
Super Moderator
#4
Yes, uncertainties due to capacity, but also there was some question of spikes / surges when rechargeable batteries neared depletion.

They didn't test with anything but alkaline so they only recommended those in the IFU. (Maybe even going so far as to saying the device performance has not been evaluated with other battery types; basically trying to absolve themselves.) This was > 10 years ago so I don't know how well all that would fly these days.
 
#5
Batteries can vary in size and output. I would recommend a specification for your OTS batteries and verification testing at the upper and lower limits of the specified voltage, etc. Through experience, the size of a AA battery in the US can be different than the size of one manufactured elsewhere. If the battery box dimensions are too tight, you could run into issues. Also, you should have a battery indicator so that it shows the battery as "dead" if it does not have enough remaining power to operate your device - meaning, what risk is associated with the device functioning at a subpar level with a low battery? If rechargables are not to be used, state that explicitly in the IFU.
 
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