Can a power Supply be an accessory to a medical device, if it is an 'off-the-shelf' product.

Hi All, I have an off the shelf AC/DC adapter to power an induction loop charger for a wearable medical device. the Micro USB plugs into the charging unit with an internal Battery. The AC/DC adapter plugs received the USB connection to the Changing unit plugs into the wall. the charger unit is not used when the device is used for it's intended purpose and purely serves as a means to charge the device at the end of each day. Can this be classified as an acessory, or other means to abdicate the AC/DC adapter as part of the medical device system? The device comes under the home healthcare category
 

Peter Selvey

Leader
Super Moderator
Starting point is the labelling. If the labelling manufacturer placed the device on the market as a general device, then it's not a medical device, even if it ends up being used for a medical purpose. For example if a ruler was used to make a measurement on a diagnostic chart, it is being used for a medical purpose. But if the ruler came from the local office supplies store, it's not a medical device, as the manufacturer of the ruler never stated that as an intended purpose.

If an entity places a group of devices or items on the market as a "set", that principle still applies. Lets say the entity is company "X".

If there are items in the set that are not labelled by X, then X should make sure that for each item:
- the original labelling, IFU and possibly packaging (if needed for compliance) are preserved
- some effort to check approvals etc are all in order for the country of sale (e.g. normal safety/EMC for an ac/dc adaptor)
{this is to avoid that X knowingly imports and distributes an item not meeting local regulations, general responsibility}

For medical regulations X should consider compatibility issues and risks arising from the set, which should be documented in the risk management file. Since this is wireless charging only, there's not much to consider. An example of a criteria may come out of a risk analysis is that the power supply should have no more than 15W output (5V/3A), in order to avoid flammability requirements in the charging unit. Another example to consider might be if the user connects to another USB supply (might be no significant risk). And so on.

In the EU, it's required to draw up a declaration to the above.

Not sure if I made it too confusing? But anyway it all makes sense if you think about it.
 

yodon

Leader
Super Moderator
...purely serves as a means to charge the device at the end of each day

When I read that, I take it that it's necessary to have the charger as part of the "system." The "system" cannot function if the charger is not provided. So to me, this makes it a component in the system and, as @Peter Selvey points out it has to meet the requirements for the countries in which you distribute.
 

Peter Selvey

Leader
Super Moderator
Just to clarify, for the parts in the system, the responsibility for regulatory compliance remains with the labelling manufacturer (with some back up responsibility on the importer, if applicable).

So if "X" puts together a system using items that are already legally sold in a particular country there is no direct or formal obligation to verify compliance. There is just general negligence/liability. For example if you used a CE marked power supply from no-name brand from a region in the world that is known for fake stuff, it's really cheap and purchased it all on Amazon, and that power supply turns out to burn down someone's house, then negligence is in play.

But if the power supply is a well known brand, has certification marks (TUV, UL etc.), bought direct via a reputable distributor and at a reasonable price, I wouldn't dig into it. Actually, it's not really practical to take responsibility for compliance without signed contracts and agreed information exchange, which would not make sense for every item in a system or set. So it's really just a background check to make sure it's not something dodgy you are including in the system.
 

Koubito824

Registered
Hello,
With ecological considerations (and business too!) is it possible in the case of Allana to not sell/supply the wallmount charger with the overall system?
And let the customers using their owns wallmount chargers?
 
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mr9000

Starting to get Involved
I think in that case your charging system must be safety-proof for all different kinds of inputs. What if the customer has a very exotic charger (which does not have to exist in real life, but just imagine) which just passes the supply mains? Is the medical device still safe? Is the medical device still safe in case of a single fault condition of the charger?
There are many manufacturers providing 60601-1 proof SMPS. From the business-side, why abandon the possibility to sell this along with the product? Stating in the instructions that only the power supply which you sell may be used can spare a lot of hassle, although from risk management you still need to consider what happens if another power supply is used.
 

Peter Selvey

Leader
Super Moderator
I think K's question is for a specific but recently a common case: a battery operated device that is charged while in standby (not connected to the patient for function), using a charging system that is powered by a generic USB power supply via a Type A connector, using 5V <3A.

Even if the manufacturer includes a wallmount "charger" (it's not really a charger, it is just a power supply for the charger), the end user can plug it in to any number of these USB outlets which are likely to be around the house or office. These days, even power boards have a couple of USB A outlets built in. I would not be surprised if new hospitals have them built into the panel behind the bed.

The question: is it ecological to bring more USB power supplies into the environment when there should already be plenty available?

Obviously no, but the business side could be wary of complaints. That said, I'm a bike rider and noted that re-chargeable bike lights don't come with a USB supply. I didn't think about it, totally reasonable.
 

ChrisM

Quite Involved in Discussions
There are so many medically certified Mains PSU's with USB outputs available for just a few dollars each that if you do feel the need to supply this item as part of your product, just make sure that you are buying an off-the-shelf PSU with the relevant certification, and ask for a copy of the Test Reports, Certificates etc as part of your purchasing conditions. It's what we do......
 

cklarson2

Registered
There are so many medically certified Mains PSU's with USB outputs available for just a few dollars each that if you do feel the need to supply this item as part of your product, just make sure that you are buying an off-the-shelf PSU with the relevant certification, and ask for a copy of the Test Reports, Certificates etc as part of your purchasing conditions. It's what we do......

I'm curious if you have found any that are certified Mains PSUs with USB outputs that are also certified to 606061-1-11 for home use, which would require them to also be IP21? I've found a couple out there (Friwo Fox6 w/ a special adapter for example) but they run upwards of $30. We included a medically certified Mains PSU with USB output in our device kit specifically for this reason. Now getting pushback on the IP Certification of it. . .
 

ChrisM

Quite Involved in Discussions
^
An interesting question. No we did not check to see if the PSUs we buy are compliant to IEC 60601-1-11 since they are designed to be used by Medical Professionals in their "business premises". I believe that there are two classes of testing in 60601-1-2, one for use in professional premises and one for use by "travelling professionals" for example if they may visit a care home or home of someone with limited mobility who may required professional services whilst they remain in their own home, and this can be addressed through the normal testing route.
If you are designing a medical device used in the home healthcare environment alone, that would seem to be to be the only situation when you would want it certified to 60601-1-11 and not 60601-1-2; and if you were aiming for the home-use market would it not be more practical to market the device as non a medical device but "merely" an electrical product such that you would only have to meet consumer legislation? In principal you could get the PSU re-tested and re-certified against the requirements of 60601-1-11 in conjunction with the supplier, if you cannot find one off-the-shelf where this has already been done
 
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