More excerpts (in italics) from the FDA public hearing on jet-guns 8/9/05
FDA Presenter: Jason Lipman. Lead Reviewer. General Hospital Devices Branch.
Definition?
“These devices typically have a large medicinal vial that fills an injection chamber after each subsequent injection. Reusable fluid path injectors are also known as multi-Use Nozzle Jet injectors or MUNJIs, for short.”
How do they work?
“Jet injectors must create high pressure, usually by the use of springs or compressive gas. This high pressure forces the medicinal product out of an injection chamber through an orifice and into the body.”
Let’s skip to the disadvantages of MUNJI-use.
“The focus of our presentation today is the first one, the potential for blood cross-contamination or disease transmission. The second is the potential for laceration injury from improper technique. And this can occur since the jet stream has such a high velocity of jet stream that if you were to actually lift it off the skin prematurely, you could lacerate the skin from that high velocity jet.
There has been one documented case of cross-contamination. This was in California in 1985 at a weight loss clinic. It resulted in a hepatitis B outbreak. In addition to that outbreak, there have been in vivo animal studies and bench laboratory studies that also link these devices to disease transmission.
Just one case of cross-contamination? Quite remarkable when considering that thousands of Veterans have documented HCV infections. And only one common denominator–MUNJI vaccinations.
“So I want to talk about how the cross-contamination occurs. It can occur, as we heard before, about blood actually the skin contacting surface on the injector or that blood or serum can actually go up into the fluid path. And there are a couple of theories as to how that can actually occur.
One is splash-back. Again, the high velocity jet can actually bounce back off the body and back through the small orifice. Or there’s also a thought that the injection, the pocket of fluid in the body is pressurized and pressurizes the tissues…”
Was that a tremble in your weasel-voice? Can or does blood splash back? Are we finally getting some facts? What about the new “improved” jet guns?
“Manufacturers have attempted to mitigate that risk of cross-contamination. The primary design of the mitigations are single-use patient contacting components, such as caps, spacers or sheaths. But there have been no validated methods to assess the effectiveness of these components.
So the challenge of evaluating the potential for disease transmission exists because there’s no consensus on the amount of blood contamination that can potentially transmit disease, and there’s no validated test method for detecting blood cross-contamination....There is global concern about using these devices, the new devices as well, the new MUNJIs. The World Health Organization recommends against MUNJIs use.”
A senseless and abrupt ending:
“I just want to talk a little bit about the purpose of today’s meeting. We’re here to discuss the cross-contamination risk associated with MUNJIs and to discuss the methods that might be used to assess this risk. This concludes my presentation.”
Did he say that no MUNJI-testing at the FDA took place, and if not, why not, given WHO’s position alone? Or just that there was no validated test method–a nod and semi-admission to MUNJI-testing.
Miscellaneous accidental strokes of bad luck? Or dirty medical devices? Where does the evidence massively point?
asknod
Bethanie Spangenberg
kcraveiro
robinhoodesqvetsatty
Wesley McCauley
Veterans Claims Help 
Robert, SquidlyOne, and Randy, you speak for the thousands of HCV-infected patients, civilian and military, who had vaccinations via jet-guns. I am a firm believer in vaccinations. The evidence shows that they save lives. But medical devices among other things (organic or inorganic), with surfaces, spread infections. We deserve answers and we’re going to get them.
In my case “my evidence” shows I have HCV, Cirrhosis, Head/Neck Cancer,Thyroidectomy,Grade 1 varices, ED, Arthritis, probable PCT, and uncontrollable flashbacks of IFN symptoms of suicidal thoughts and memory loss. YES I deserve answers but my life is running out. WE all deserve answers not DENIALS.
Ongoing denial keeps them employed and the VA gets another pass year after year. They all know damned good and well that we were exposed and contracted the disease from the guns and lack of sterile conditions but hey what the heck if a couple of troops are infected right? Wish it was hunting season because I could get some satisfaction out of shooting something.
After the “backfire” of the 2004 Fast Letter, The VA hasn’t touched jetguns with a ten foot pole! In some of the BVA jetgun wins that I have seen, that Fast Letter of 2004 was cited as being “biologically plausible”. The recent “baby boomer” recommendation by the CDC left the public wondering why now? What could have caused all of these HCV infections that are now 25-35 years of age? The CDC has tried to push to the public that 800,000 cases could be identified. I do suspect however that the CDC is playing the numbers game as that is less than half as many as the VA knows to be infected. That leaves us with the majority of the “baby boomers” who are infected, just happen to be Vietnam, Post-Vietnam and Gulf War Vets. Follow the the nose, the VA knows!
Why doesn’t the VA do these kind of studies so they can skew or ignore the results? So many HCV cases and they do not acknowledge the common factor? Everywhere I went in the army a MUNJI device was used. Except at the dentist at my ETS discharge physical, etc. Oh yes and those enemas from eating mess hall slop. I was doomed coming and going…