Commercial tablet as an "accessory" for a medical device

MedicalResp

Starting to get Involved
#1
Hi all,

We are developing a wearable device that measures single vital sign.
It is basically a small box with sensors that the patient wear.
The device communicates with a tablet via low energy Bluetooth (BLE).
Inside the tablet we have our app that is used to present the measured data and log it.

The device intended environment is hospitals and is intended to the European market and therefore will be evaluated by a notified body.

The wearable device is considered a medical device and shall comply with IEC 60601-1, IEC 60601-1-2.
The SW/app for presenting and logging the data is also considered a medical device and shall comply to IEC 62304 and the relevant clauses in IEC 60601.

However, we would like to include a commercial tablet (e.g. Samsung) with our system on which our app would be installed. This tablet does not comply with IEC 60601, but with IEC 60950 (TLE).
As part of our risk management we decide to replace the tablets' charger with an IEC 60601 approved charger and define that the tablet will be placed outside (>1.6m) from the patient environment

Does anyone familiar with a similar situation?
Should I expect any issues with the notified body?
How should we address/define the tablet during the IEC 60601 tests? it is not rea

Hope to be able to use your experience.

Thanks in advance.
 
Elsmar Forum Sponsor
#2
re: Commercial tablet as an "accessory" for a medical device

If you include a tablet with your (wearable) medical device and medical software, with your name on it, it then must be thought of as a medical device itself - with the consequent need for 60601-1 and -1-2 testing.

When your supplier (Samsung or other) updates the tablet (every year or even less) you will have to repeat all of the qualifications - expensive!

I would strongly suggest that you only supply a 'generic tablet' that is, any tablet running Android 7+ (say). Or do not supply the tablet at all - just the minimum specification for what is required.
 

MedicalResp

Starting to get Involved
#3
re: Commercial tablet as an "accessory" for a medical device

Thanks for the quick reply.
Just to clarify, we will not put our logo on the tablet. We will provide the tablet as-is to our customers as an accessory, with our SW preinstalled and an SD CARD for saving the data.

Can you please elaborate on what do you mean by :

"I would strongly suggest that you only supply a 'generic tablet' that is, any tablet running Android 7+ (say). Or do not supply the tablet at all - just the minimum specification for what is required."
I understand that in practice, if we act according your suggestion, we will have to declare the tablet minimal specifications in the IFU.

However, i would appreciate if you can direct me with the following:
1. how should we address this issue during the V&V of the software (e.g. how do we prove that the device/SW will work with any type of tablet ? )
2. how should we address this issue during the IEC 60601 tests ?
3. How to address cyber-security requirements/risks ?
 
#4
1. I guess you could do tests with 3 or 4 different tablets, perhaps with differing chip-sets etc.

2. Risk assessment. Actually, few of the applicable clauses of 60601 would be impacted by which tablet was in use.

3. Operating system dependant. Again, Risk management should provide you your answers.
 

VinceTech

Involved In Discussions
#5
Just my opinion, please advice if not correct.

It's very important to know if the data presented in the tablet can lead to harm? If so, the risk control has to be implemented to prevent the failure of the tablet or sufficient verification shall be done for tablet (hardware / software) to ensure the tablet is reliable.
Think about what risk will be introduced if tablet is faulty?

There maybe not necessary to replace with IEC 60601-1 compliance power supply. If the Tablet is only device used by operator the genuine double insulated power supply shall be sufficient.
 

Peter Selvey

Staff member
Super Moderator
#6
Looking at the thread, there are a couple of legal points to make clear:

If the tablet retains the original labelling (manufacturer's name, model etc) including the instructions for use, it is not a medical device and not subject to any medical standards. This applies whether or not you provide the tablet. The key point is whether the labelling is modified.

If the tablet is placed on the market with a specified charger then it this also should not be replaced (legally). If the tablet is placed on the market with generic power supply (e.g. USB Type C) then the risk should be acceptable to use any IEC 60950 power supply, since there is no contact with the patient (only BT comms). Changing to a IEC 60601-1 power supply seems to be overkill, noting the users will probably continue to use other power supplies anyway.

The software (app) is a medical device. But installing it on the tablet does not make the tablet a medical device.

From a risk perspective, I agree with MedicalResp, it makes sense to use a specified tablet so that V&V can be done with a particular operating system.

My experience with companies jumping on the Bluetooth bandwagon is three basic points:
- the intended purpose is not well defined. Yes, monitoring, but what for - diagnostics, alarms, other? This feeds into many (many) decision in the risk management, design and even the regulatory path so it has to be clarified fairly early in the process (or if not, at least write up the various options and keep in mind the impact of the decision)
- the requirements for alarms are not well understood or considered, partly again due to lack of clarity in the intended purpose i.e. whether the alarms are important or not.
- the sensor performance is often terrible: the company has expertise BT comms and app software, but have no idea about the technology associated with normal patient monitoring. It does not matter how good the app is, if the source patient data is garbage ...
 
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