Using MD on a flight

Junn1992

Quite Involved in Discussions
#1
Hi!

Does anybody know the regulations covering medical devices to be used on board the airplane? Eg: pacemakers

Thanks!
 
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Jen Kirley

Quality and Auditing Expert
Leader
Admin
#2
Hello Junn1992.

I am confused. Pacemakers are used by whom on an airplane?

There are always AEDs though the regulations I have seen are for shipments.

Anyone else have input?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
Once a medical device is sold it becomes personal property. Medical device regulations are for entities that produce, sell, transport for sale or use, but as an owner I am not aware of any legal rule that regulates my personal use of a personal medical device, for example a CPAP.

But there is no need to limit our discussion to what I know when we can research in a place like the International Medical Device Regulators Forum (I have no affiliation).
 

Ronen E

Problem Solver
Moderator
#9
I agree with Jen that from a MedDev regulatory perspective there aren't likely to be any limitations.

I also subscribe to dgrainger's approach that it's best to consult with airlines. If there ARE any applicable MedDev regulatory limitations, most likely the airline will know about them, just as they are likely to know about the relevant FAA (etc.) requirements.
The only problem with this approach is that you'd probably have to consult with each relevant airline - from my little knowledge of airlines I tend to think that this aspect isn't harmonized or standardized, and I doubt that there's a single, reliable, publicly accessible source that collects this info from all/most. I might be wrong on this last point though - I'm from MedDev, not from aviation.

I also tend to think that airlines' concerns would focus on flight safety, security and avoiding legal/medical liability. There would be, I imagine, a big difference between using a knee-replacement, a pacemaker, a band aid (which is also a medical device), a scalpel for an in-flight emergency procedure, or a CPAP device, just to illustrate with examples.
 

Raisin picker

Quite Involved in Discussions
#10
For my personal CPAP device, I received a "patient pass" (German), which contains a "flight certificate", stating it is safe to carry in switched-off mode. It references EN 60601-1-2. There's no statement regarding in-flight use. Since I only have the device for one year, I never got the chance to take it on a plane.
I think it is safe to say that medical implants are no problem. Airport security has labels to remind patients to announce their implants prior to scanning. I've been on flights with patients carrying implanted active devices.
 
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