problem with Quikclot

[airdog07]

The Case Against QuikClot

UPDATE: This blog post has been very popular since it was first posted in 2012, but I received this additional information from the company that produces this product and thought it only fair to include it in the body of this article:

We came across this review on your blog and we do like your blog! However, the product you mention concerning QuikClot has not been produced since 2009.
Currently, QuikClot products are now in their 3rd generation and are composed of a rayon/polyester gauze impregnated with a mineral called kaolin. Kaolin has been shown to accelerate the body’s natural coagulation cascade and is a naturally-occurring, inorganic mineral that does not contain any botanicals, biological material or shellfish products and does not cause any exothermic reaction or vascular complications. QuikClot is intuitive, with a simple-to-use dressing format, conforms readily to the wound and will not break down or fall apart under pressure. The hemostatic dressing may be left in place for up to 24 hours. To remove, gently remove dressing and thoroughly irrigate wound. Please view our website here for more information: http://goo.gl/c8KbUJ.
Our product is credited with helping thousands of people survive traumatic blood loss every year. It’s used by our military, law enforcement officers, EMS departments and in hospitals throughout the country. We would ask if you could please retract your post or include this amendment. I’d be happy to provide you with additional information if you need it. Thanks again for your help in this,
Z-MEDICA, LLC
203-294-0000 X243 (Office)
203-232-0649 (Mobile)

THE ORIGINAL REVIEW: QuikClot, the product, seems almost too good to be true. Even the slowest prepper on earth can stop a deep wound gushing with blood by simply opening a packet of QuikClot an slapping it into place. Who wouldn’t want this miraculous product in their first-aid kit?


image by tedeytan

Well, doctors and nurses, for one! As it turns out, QuikClot can cause more harm than good, sometimes, and makes life more difficult for the medical professionals who have to deal with the injured patient.
Here is what two professionals told me about this product.
First, from Courtney, an E.R. nurse:
“I work in an emergency room, and I can tell you first hand, QuikClot is AWFUL to get out of a wound.
It definitely will stop you from bleeding to death, but if you are in a situation where hospitals are functioning and the Stuff has NOT hit the fan, and you aren’t at risk of bleeding to death (i.e. haven’t severed a major artery), I would recommend going to the nearest E.R. instead of applying QuikClot. Pressure on the wound is the MOST important thing you can do.
I had a patient who was out fishing, cut his thumb with a fishing hook, and applied a quick clotting agent. He continued to fish for another 4 hours then decided to come to the E.R., where I tried my best to debride the wound. The QuikClot was hard and deeply embedded into the laceration, it took me a half hour just to clean it out. Now, I will admit that it is possible that the extended length of time the product remained in the wound is the culprit. But one thing is for sure, I wouldn’t use QuikClot unless I absolutely had to.”
Next, I asked James Hubbard, The Survival Doctor, for his opinion, and here is his response:
“First there’s the mess that comes with QuikClot.
My experience has been seeing fairly minor wounds treated with QuikClot. If the patient has used the older version of the product, I have to clean and scrub, and still I’m not certain I’ve gotten all the granules out. When this has happened, I can’t help but think that if they had simply applied direct pressure on the wound, I wouldn’t be forced to traumatize the fragile tissue so much more. I understand this is a complaint with emergency-room physicians and trauma surgeons also, except the wounds they see can be much worse, and time can be precious.


image by Parker Michael Knight

Prior to 2008, QuikClot also produced a lot of heat when it reacted with blood, and this can be very painful—even burn flesh. If a granule flew into an eye, ouch!
The more recent version uses a chemical that doesn’t cause as much of a burn reaction, although it can still get hot when it comes in contact with plain water. They’ve also encased it in gauze. Hallelujah!”
QuikClot isn’t a cure-all
He goes on, “But my main concern about QuikClot is that some people think it’s a cure-all.
Certainly it can be a lifesaver in battles, where the wounds are large and potential blood loss is severe. It stops the bleeding long enough for these injured victims to get to surgical care. But the key is getting them the surgical care.
Lay people tend to use QuikClot first-line for every wound. They forget the basics, like direct pressure. If anyone pulls off the QuikClot to actually treat the wound, the clot comes with it, and you’re back to stage one unless there are granules, and then the situation has been made worse.
Remember, QuikClot does nothing to repair the wound. You put this stuff in, and that’s only the beginning. You can’t keep it in forever. It will stop working at some point, and because it’s a foreign body, it will increase the risk for a bad infection. When it’s removed, the bleeding begins anew.
A wound often includes an artery that supplies vital blood to an extremity. If the artery is not surgically repaired fairly quickly, the extremity will die. Gangrene will set in. The QuikClot may have been a lifesaver, but only short-term.
The bottom line is QuikClot in your bug-out-bag is not enough. You need to know when and how to use it. Start by learning how to stop bleeding with direct pressure. Know your pulse points in the arms and legs, and how you can press on them to stop the bleeding. Know how to use a tourniquet for extreme injuries.
Then, watch a few instructional videos on how to properly use QuikClot.”
When would QuikClot be an acceptable remedy?
The Survival Doctor continues, “Okay, I’d use QuikClot in a flash if blood were pouring, and direct pressure or pressure on pulse points wasn’t going to stop the bleeding, and using QuikClot was the only thing I knew to do to save a life—like if a femoral artery were cut so close to the groin a tourniquet wasn’t feasible. Or if I were facing a gusher on the neck and pressure wasn’t helping. I’d try it on a badly bleeding chest or abdominal wound if I couldn’t do anything else, even though I know if the QuikClot doesn’t come in contact with the bleeding blood vessel, it’s not going to help.
After the bleeding had stopped, I’d apply a pressure dressing on the wound and figure out how I was going to get this person some definitive medical help ASAP.
Oh, and if you have the old granule type of QuikClot, replace it with the new gauze type. Whoever ends up repairing the wound will thank you.”
Bottom line:
Only use QuikClot if:

1. Direct pressure over several minutes isn’t stopping the bleeding.
2. The compress becomes saturated with blood quickly and repeatedly. (A sanitary pad is helpful for these types of injury and provides an idea of the level of injury that would cause several of these pads to be soaked through in a matter of minutes.)
3. You are miles and miles from any medical assistance.

The best action to take now is to become better informed and trained in the areas of first aid and medical care. Visit The Survival Doctor’s blog, watch videos on YouTube and locate classes that teach these skills. Someday you might save the life of a friend or loved one.
There may be links in the post above that are “affiliate links.” This means if you click on the link and purchase the item, I will receive an affiliate commission, which does not affect the price you pay for the product. Regardless, I only recommend products or services I use personally and believe will add value to my readers.

[airdog07]

[airdog07]

http://www.fda.gov/ICECI/Enforcement.../ucm203960.htm

Inspections, Compliance, Enforcement, and Criminal Investigations

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Warning Letters
2009

Compliance Actions and Activities

Warning Letters

2009

Z-Medica, LLC 12/3/09

Department of Health and Human Services' logoDepartment of Health and Human Services
Public Health Service
Food and Drug Administration
New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781)596-7896

WARNING LETTER
NWE-09-10W

VIA FEDERAL EXPRESS

December 3, 2009

Mr. Brian Herrman
Chief Executive Officer
Z-Medica Corporation
4 Fairfield Blvd
Wallingford, CT 06492

Dear Mr. Herrman:

During an inspection of your firm located in Wallingford, Connecticut on October 26-28, 2009 and November 3, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices such as haemostatic agents including QuikClot Combat GauzeTM. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321 (h), these products are devices because they are 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.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:

1. Failure to fully validate and approve according to established procedures as required by 21 CFR 820.75 (a).

Specifically, the sterilization validation procedure identifies the sterility validation for the product was done according to ISO 11137-2:2006 Part 2. ISO 11137-2:2006 Part 2 requires that (b)(4) separate lots of product to be used in the validation of the product manufactured on a frequency of more than one lot per quarter. Your firm's procedure labeled as "Initial Sterilization Validation" identifies one lot of product consisting of (b)(4) units is to be used in the validation of the product. In addition, the protocol does not require and your firm does not place dosimeters or biological indicators in routine production runs sent to (b)(4) for gamma sterilization.

We acknowledge your written response dated November 20, 2009 which provided your proposed corrective actions for this deficiency. Your response appears inadequate. Your response to this deviation states in part "To meet the requirement the revised Sterilization Validation procedure we will re-validate the sterilization of Combat Gauze using three lots. This will be completed by December 31, 2009."Please provide us with a copy of the sterilization re-validated data for our review.

2. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met as required by 21 CFR 820.75 (b).

For example, your firm's procedure for process validation of your sealing machine (b)(4) lacks documentation of monitoring of periodic burst testing of in process or finished product during periodic manufacturing. Your firm used a burst strength finished specification of (b)(4) as a baseline test marker for the finished product specification, while the validation protocol testing met the validation requirements there is no formal program to monitor (e.g. annually, weekly, daily) daily production to assure the (b)(4) sealer meets the finished product specification for the seal integrity. In 2008, your firm changed the testing for seal integrity from burst testing to a peel test performed for you by (b)(4) a contract vendor. Your management stated the recommendation for changing from the burst test to the peel test was based on a recommendation from the contract vendor, however, there is no formal approved protocol changing the test procedure from the burst test to the peel test documenting the validation of the sealer for the Combat Gauze and identifying the frequency of testing to assure the sealer maintains the finished product peel test parameter.

We received your firm's written response dated November 20, 2009 in which you provided your proposed corrective action to this deviation. Your response appears to be inadequate. Your response to this deviation states in part "We have drafted procedure (b)(4) to formally require a sampling plan for package integrity testing, and to require the results to be part of DHR. All effected employees will be trained on the procedure and the procedure will be fully implemented on or before Dec. 4, 2009." Please provide us for our review a copy of the approved procedure (b)(4) and evidence that all employees have been trained on this procedure.

3. Failure to review, evaluate, and investigate a complaint involving the possible failure of a device, labeling or packaging to meet any of its specification as required per 21 CFR 820.198 (c).

Specifically, three complaints received by your firm concerning the vacuum packaging of the finished product were investigated by placing the returned products in (b)(4) with unknown time/temperature and observing them for package shrink around the product. Your conclusion on all three investigations was that the packaging did shrink and the final conclusion was that the vacuum packaging was adequate.The (b)(4) test is not a formally approved test procedure for any of your products and is not validated or documented as equivalent to your finished product test procedure for finished product packaging. In addition review of complaint (b)(4) noted 15 samples were returned to Z-Medica for what was termed a "'loose" condition of packaging (indicating loss of vacuum). The investigation consisted of a visual inspection of the packages by the investigating individual who indicated the term" loose" was subjective and the seals were not tested by either the burst or peel methodology used by your firm to assure packaging meets the finished product specification validated in the process validation procedure.

We acknowledge your written response dated November 20, 2009 which provided your proposed corrective actions for this deficiency. Your response for this deviation appears to be inadequate. Your response in part states "By November 27, 2009, we will revise the complaint handling procedure, train our personnel, and implement the revised procedure. In addition, for the complaints on packaging cited by investigator, we will perform peel and leak tests on the packaging to provide objective supporting data toward complaint resolution. " Please provide us for our review a copy of the revised approved complaint handling procedure, and evidence that your employees have been trained on this revised document.

4. Failure to conduct management reviews at defined intervals as required by 21 CFR 820.20 (c).

For example, your Product Development Review Meetings that are routinely conducted by the company do not fully satisfy your Management Review Policy identified as (b)(4). When your management was asked if the firm had conducted a documented formal Management Review at any time in the past, management responded that they had not.

Your written response dated November 20, 2009 provided your proposed corrective action for this deficiency. Your response appears adequate. We will assess the full adequacy of this corrective action during our next inspection of your firm.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to: Maren Forsyth,Food & Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact Ms. Forsyth at (781) 596-7769.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely,

John R. Marzilli
District Director
New England District

[airdog07]

http://www.expeditionportal.com/foru...uze-Quick-Clot

every one should have in there med kit QuikClot Advanced Clotting Sponge, but only for last resort.