King LTS-D

[tniuqs]

Flyin dutch makes a good point about evidence based literature and what is currently available is limited and biased because of manufacturer support. I do know of several studies that will soon be published that demonstrated subjects with minimal medical training can quickly place the King in a mannequin. Also, the latest edition of Prehospital Emergency Care is supposed to have an article about the King but I haven't seen it as of yet.

Spock So just what happened AFTER you handed over care ? A point of debate to follow.

I don't mean to beat a dead Horse here, the point I am pushing IS there any research being done AFTER the Resusitation. This is why I am so skeptical about handing these devices "carte blanche" to every Tom, Dick or Mary. Just saying from a historical perspective with the EOA and we all jumped on that bandwagon, because we did NOT have ANY Paramedics .... to find out later that "higher than unexpected complications" and have them shelved, I still have the 20+ research documents identifying the complications in my files.

Its well established that insertion is so easy a Caveman can do it, as an RRT my choice is always the ETT, and in over 24 years I think I have missed one or two, not bragging here just practice makes perfect. Sad commentary: I do see a new reliance / excuse (s) to use these, for whatever reason. :evil:

All the other devices LMA, Combi/ King LTare just RESCUE ONLY and as in the example above used in difficult situations, so please send "buddy" Paramedic to the OR or to polish his skills period ! Airway Adjuncts are just that, NOT to be used as a Primary Airway as this is just a stopgap, perhaps leading one to believe that it is mandatory that a more educated and practiced provider be on car to provide improved Airway Management and care.

I hate having to change a combitube in the ER and would much rather change a King. Most of our ER docs don't want to deal with it so they call anesthesia to change the things if the patient has survived to the point where they are admitted. If either a King or combitube is in a cardiac arrest patient they leave it alone as long as they are ventilating easily.

YOU TOO ? :wink: But if they are resusitated then its back to the ETT. Thing is you don't have to change out if an ETT is placed correctly from the get go. 8) And my point exactly, fewer possible complications .... see where I going with this ?

I agree, too--in a perfect world, everyone WOULD have paramedics and we wouldn't be having this discussion . . . but as we all know, this isn't a perfect world. Many of the places I fly have only a clinic with maybe an MD but most of the time a PA-C or NP is the highest level of provider. And then to expect that same community to be staffed with paramedics? It's not going to happen!

Statement: If you continue to think the way you have always thought, you will continue to get what you have always got.

Question 1 : Is it enough :?:

Quoting it's not a perfect world crap is just self defeating plain and simple.

Question 2: Why, Oh, Why, in EMS do we just drop off that patient then wash our hands and never do the follow up research ? This is our biggest flaw and I believe that we can be the forefathers of the future, if we just would try, mindset has to change first I suspect.

cheers

thats all I have to say about that ... F.Gump.

[Dustdevil]

Many of the places I fly have only a clinic with maybe an MD but most of the time a PA-C or NP is the highest level of provider. And then to expect that same community to be staffed with paramedics? It's not going to happen!

Ummm... you just did a good job of explaining why they should have medics, not why they do not. And, of course, your explanation is completely irrelevant. It is not a function of your tax dollars to provide doctors. They should however, provide professional EMS. Especially if you have no doctors or hospitals.

[CBEMT]

Just saying from a historical perspective with the EOA and we all jumped on that bandwagon, because we did NOT have ANY Paramedics .... to find out later that "higher than unexpected complications" and have them shelved, I still have the 20+ research documents identifying the complications in my files.

Feel like sharing? EOA is still state-required equipment here, and even with NREMT you can't get licensed here without taking a class on how to use it unless you can demonstrate you already were. I'd love to be rid of it.

[firemedic37]

Okay sorry for not following this closer and putting up the link when I first put this topic on here. I since have lost the link for this study and have not been able to find my hard copy of it. I think it may be on the University of Iowa Hospitals and Clinic website, where at on there I don't have a clue. I was given this information in Paramedic school, it was used as a tool to educate us on being aware of our time and the other options that we had other than the ET when securing an airway for our patients.

Clearification on who can insert this airway. This is who it is in Iowa, even if you don't agree with it. EMS First Responder (NREMT-FR), EMT-Basic (NREMT-, EMT-Inermediate (NREMT-I/85), EMT-Paramedic (NREMT-I/99), Paramedic Specialist (NREMT-P/98) and RN/PA exception. And yes even the ER doctors don't understand the different levels that we have.

I understand that EMS levels differs state to state and that's why I put the NREMT level that is required for certification in the State of Iowa. And yes Iowa is a Registry State.

Training is required to be completed by someone who has been trained and aprroved by the services Medical Director. For my service we help a mandatory course and went through our local Community College and completed the Airway Refresher in the 24 hour DOT Refresher to include the King airway and a mandatory lab to follow the lecture. This way we all got hours for recertification and the colege also has a record of who took the course.

Hope this helps, even though it is late.

[JPINFV]

Since this got bumped, anyone who is using the King LT(s)-D airway needs to check the status of approval with the manufactuer. I don't know exactly how this get's played out in terms of consumer use of the product (i.e. ambulance companies), however King recently got hit by the FDA for mismarketing the LT(s)-D for emergencies.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm191860.htm

[Richard B the EMT]

OK, I have never even handled, in classes, a combi or King, but wish to comment on that 70 seconds.

An instructor in EMT refresher once taught, when suctioning a patient, that we should hold our own breath, as the patient needs to breath. If you are uncomfortable, imagine how the patient feels! Therefore, never suction for more than 15 seconds at a time.

We now return you to the ongoing discussion on Combitube versus King versus other manufacturer's products for similar usage.

[joesph]

Well this has been fun it started with a discussion on the king airway but because a basic brought it that point fell out to the old traditional paramedics rule basics drool argument. but I would still like to know dust do you think the king is a good device. Also there was some pending problems with the king airway and the FDA, how did that come out. As far as the age old basic verse paramedic argument if we throw money out of the equation and did strictly what was best for the patient we would have a ER doc and nurse plus a basic for a driver on ever call in every state but this is the real world know what?

[chbare]

OK, I have never even handled, in classes, a combi or King, but wish to comment on that 70 seconds.

An instructor in EMT refresher once taught, when suctioning a patient, that we should hold our own breath, as the patient needs to breath. If you are uncomfortable, imagine how the patient feels! Therefore, never suction for more than 15 seconds at a time.

We now return you to the ongoing discussion on Combitube versus King versus other manufacturer's products for similar usage.

We need to ensure adequate oxygenation and we need to ensure a patent airway. If aggressive suctioning is required, so be it. We also need to remember that the urge to breath when holding your breath is not because you are hypoxemic or hypoxic. In fact, most people have a primary respiratory drive that responds to PH changes well before responding to hypoxemia. Therefore, I tend not to use breath holding or a set time in seconds so much as assessing the patient for any indications of hypoxia as an end point to suctioning. However, many sources do use 10-15 seconds as a recommended suction time.

Take care,

chbare.

Well this has been fun it started with a discussion on the king airway but because a basic brought it that point fell out to the old traditional paramedics rule basics drool argument. but I would still like to know dust do you think the king is a good device. Also there was some pending problems with the king airway and the FDA, how did that come out. As far as the age old basic verse paramedic argument if we throw money out of the equation and did strictly what was best for the patient we would have a ER doc and nurse plus a basic for a driver on ever call in every state but this is the real world know what?

Joseph, you need to read through JPINFV's link.The King is not technically approved to be marketed as a rescue device for EMS. While it can be used as such, the FDA has not approved the King to be marketed for this role. I believe at one time only two devices could be marketed as such and they included the Combitube and LMA. These were the only two devices to have the AHA "alternative to endotracheal intubation" seal of approval as well. This may have changed with recent changes, however.

Take care,

chbare.

[fireflymedic]

I'm not one to complain. The King airway is much simpler to use, meant for an easier insertion, does a fairly decent job of getting the job done, and much less airway trauma than a combitube produces. Plus it's almost impossible to screw it up. I'd go for it over almost any other alternative airway for basics. They are catching on across the state here (yeah we were a bit slow) finally and more and more services are utilizing them which I'm excited about. Plus you have a pedi size which you really don't for combi tube (you've got SA but that's it). Whereas with King you do have pedi size. It's been popular with anesthesia for quite a while being chosen over LMA on several occasions for simplicity - meant to follow right along roof of mouth and just inflate and seat. Perfect ! I don't think one could really complain. Plus reduces risk of aspiration more than LMA. Definitely a favorite of mine (but then again, I may just be partial.) I've used it a few times and in my experience, have no complaints. Only possibility I see for a screw up is either trying to put it in the trachea which it is not meant to be or choosing the wrong size. Other than that, no biggie ! Great option for BLS services !

[tniuqs]

Keepin' Up in EMS

FDA Warns King Airway to Cease Dissemination

By

Dec 3, 2009, 16:20

Courtesy the EMS House of DeFrancehttp://www.defrance.org

King Systems Corp. 10/26/09

Department of Health and Human Services Public Health Service

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

OCT 26 2009

WARNING LETTER

VIA FEDERAL EXPRESS

Flois Burrow

Owner/Chief Executive Officer

King Systems Corporation

15011 Herriman Blvd.

Noblesville, Indiana 46060-4253

RE: King LT(S)-D™ Oropharyngeal Airway

Refer to GEN0900697 when replying to this letter

Dear Ms. Burrow:

The Food and Drug Administration (FDA) has learned that your firm is marketing in the United States the King LT(S)-D oropharyngeal airway for uses that have not received marketing clearance or approval. in violation of the Federal Food, Drug, and Cosmetic Act (the Act).

The Office of Compliance in the Center for Devices and Radiological Health (CDRH) reviewed your website, http:www.kingsystems.com, for the King LT(S)-D™ oropharyngeal airway product. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

Your firm has obtained 510(k) clearance for the following products and intended uses: King LT oropharyngeal airway (K021634), intended for use in adult patients for controlled ventilation during anesthesia for procedures of short duration, when the patient is considered to have a low risk of aspiration of stomach contents; and the King LT-D disposable oropharyngeal airway (K033186) and King LTS oropharyngeal airway (K033189), both intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. King LT(S)-D™ Airway - Instructions For Use available on your website states that the "KING LTS-D is intended for airway management in patients over 4ft in height for controlled (30 cm H²0 or higher) or spontaneous ventilation. It is also indicated for difficult and emergent airway cases and is

well suited for ambulatory and office-based anesthesia." This represents a major change or modification in the cleared intended use of the device and requires a new 510(k).

The device is adulterated under section 501(f)(1)( of the Act, 21 U.S.C. § 351(f)(1)(, because you do not have approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or approved applications for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by sections 510(k) of the Act, 21 U.S.C. § 360(k), in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at

http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

The Office of Compliance requests that King Systems immediately cease the dissemination of promotional materials for the King LT(S)-D Oropharyngeal Airway the same as or similar to those described above. You should take prompt action to correct these violation(s). Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.

Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for the King LT(S)-D™ Oropharyngeal Airway the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to the Food and Drug Administration, Jennifer R. Medicus, Chief, Radiology, Anesthesiology, and Neurology Devices Branch, Office of Compliance, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO66/2626, Silver Spring, MD 20993, facsimile at 301-847-8128. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the King LT(S)-D™ Oropharyngeal Airway comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,

/S/

Timothy A. Ulatowski

Director

Office of Compliance

Center for Devices and

Radiological Health