FDA Approval For EP Lab iPad Medical Application

Question

FDA Approval For EP Lab iPad Medical Application

Hello,

I have created one iPad medical application for EP lab (Electrophysiology Lab) that will communicate with my other EP lab windows application via WiFi.

I have few questions regarding FDA approval . I would like to get the technical details like how does Wi-FI on iPad works and is there any data, study or solid proof to show that it does not interfere with current EP lab equipments like fluoroscopy,cardio-lab.

Also I would to know some existing EP lab iPad application names which uses WiFi communication and approved by FDA.

Any help on this is appreciated.

Thanks.

iPad, iOS 6

Posted on Jun 5, 2013 9:17 AM

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Answer 1

varjak paw

Level 10

182,668 points

Jun 5, 2013 9:30 AM in response to shamsudheenfromkerala

I would like to get the technical details like how does Wi-FI on iPad works

The WiFi in the iPad works just as it does in any other WiFi-equipped device. The iPad follows the industry standards for 802.11a/b/g/n Wi‑Fi (802.11n 2.4GHz and 5GHz), so data for those standards would probably suffice. If the FDA asks for specific additional information, you can then look for that information.

and is there any data, study or solid proof to show that it does not interfere with current EP lab equipments like fluoroscopy,cardio-lab.

That would again be something that would apply to any WIFi device, so I'd suggest you look for any studies or measurements for WiFi interference with said lab equipment. The manufacturers of the lab equipment would be most likely to be able to provide that sort of information and may well have it readily available, particularly if the equipment is particularly sensitive to EM interference.

Regards.

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Answer 2

Jun 5, 2013 12:21 PM in response to varjak paw

Thanks for the insightful information and I will get back to you after discussions with EP lab staffs.

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Answer 3

Jun 6, 2013 3:19 AM in response to shamsudheenfromkerala

As the cat wrote above, the WiFi facilities in iPads are completely standard and anything written about current standards for 802.11 applies. It's also worth noting that iPads have Bluetooth facilities, with the versions of Bluetooth supported depending on the model of iPad. So you may want to check out emission and interference standards relating to Bluetooth too.

However, the iPad is FDA approved and in wide use by doctors in all areas of medicine, including inside Intensive Care Units with all their delicate monitoring equipment. The only places nobody uses them are near NMR machines, for reasons left to the student. You're not going to catch me making a medical safety assertion here, but nobody much is more worried about iPads than they are mobile phones.

You might like to know about the Association for the Advancement of Medical Instrumentation which deals with this stuff for the USA:

http://www.aami.org

They may be able to help you, or at least point you in appropriate directions. I am not 'plugged in' to the US scene so I don't know what the reputation of this organisation is among professionals. Could be a highly respected organisation; might be a thinly-veiled marketing organisation.

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