Re: Do we need to remove the King Airways?

December 4, 2009

I imagine that the complaining company provided plenty of Internet (and

hard copy) references so that the FDA investigator didn't have to scour,

merely confirm...

ck

In a message dated 12/4/2009 08:20:19 Central Standard Time,

phillipsdo@... writes:

I imagine that another company manufacturing a similar device, but labeled

for that use complained to FDA. I doubt the FDA is scouring the internet

looking for wrong labeling.

December 4, 2009

I do not plan to alter our use. OK, it is an off label use. We do this quite

often. I can't come up with any current examples, but off label uses are common

within medicine. OK, here's one: dosing of vecuronium. In my residency, the

high dose vecuronium for induction to avoid fasiculations. Still lasts soooo

long, but that was an off label use. Many of us were using zofran in kids

before labeling for peds use.

As I see it, the problem is that the company cannot promote use other than as

labeled. When a company takes a drug or device for FDA approval, it tells how

it will be labeled. More uses, more labeling, more costs!

My service also uses the mini-trach II for surgical airways. The label does not

say can be used for retrograde intubations, but there was a trial in anesthesia

literature where was used that way. It is an off label use, but I have it in my

protocol.

I imagine that another company manufacturing a similar device, but labeled for

that use complained to FDA. I doubt the FDA is scouring the internet looking

for wrong labeling.

>

> How are others treating this recent FDA warning letter regarding the King

> Airway?

>

> Most on the NEMSMA list where it has been discussed most of the agree no

> change in practice is needed and we can continue to use them just another

> example of the FDA not having any idea what they are doing.

>

>

> Jim<

>

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