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110 Glover Circle Staunton VA 24401
November, 10, 2003 Board of Veterans' Appeals 810 Vermont Avenue NW Washington DC 20420
VA Regional Office 210 Franklin Road SW Roanoke VA 24011
Subject: Claim#xxx xx xxxxx reference xxxxxxxx
To whom it may concern: Please include the following studies and statements as evidence to my Hepatitis C infection and extra hepatic manifestations as a service related disease. Please include that, I, Gary Lupole, do here by state; "All pneumatic jet gun injections I received were not wiped off or rinsed off beforehand or after the administration of immunizations to me in accordance with compliance protocol for device use.
SHDEPARTMENT OF HEALTH AND HUMAN
SERVICES PUBLIC HEALTH ADMINISTRATION, FOOD AND DRUG
ADMINISTRATION, GENERAL HOSPITAL & PERSONAL USE DEVICES PANEL OPEN
SESSION Kansas City Star Nov. 8,
2003 Quote submitted from Lawrence Deyton MSPH, MD Director/Aids/Hepatitis US Dept. Veterans Affairs Washington DC that said in part " it's possible the devices could transmit hepatitis C: "I am sure that, with the right degree of misuse, the devices could become contaminated."
Statement by from Federal
Laboratory Community online paper
June 2003 excerpts
Jet
Gun Injection updates Though syringe jet injectors have been in use for almost 50 years, current designs still suffer from inconsistent performance….. Results from these two investigations are useful for design modification of the jet injector to achieve desired pressure-time profiles at the orifice. Control of pressure-time profiles may help to achieve a more consistent and effective injection process.
Potential for cross-contamination
from use of a needleless injector.
CONCLUSION: This study demonstrated that needleless injectors become contaminated during in vitro use and direct contact with contaminated surfaces and that needless injectors carry over the contamination to subsequent sites of release. The replacement of the injector's rubber cap with a new one after initial discharge or the removal of an exposed rubber cap and immersion of the head of the injector in 2% glutaraldehyde followed by a rinse of the head in sterile water, as recommended by one injector manufacturer, can minimize or eliminate the carryover. UI - 98388286 AU - Weintraub AM AU - Ponce de Leon MP IN - Office of Clinic Management and Patient Services, University of Pennsylvania School of Dental Medicine, Philadelphia 19104-6003, USA. TI - SO - American Journal of Infection Control 1998 Aug;26(4):442-5 AB INFO: Potential for Cross-Contamination From Use of a Needleless Injector. The in vitro fluorescein indicator tests conducted in this study clearly show that needleless injectors become contaminated on use. The contact of the injector’s discharge orifice, head, and rubber cap with surfaces simulating body tissues and fluids during the in vitro tests generally resulted in the contamination of these 3 sites on the device. World Health Organization Statements on Jet Gun Injection and Transmission of Blood Born Pathogens WHO recommended policy Draft: Revision October 1998 GLOBAL PROGRAMME FOR VACCINES AND IMMUNIZATION EXPANDED PROGRAMME ON IMMUNIZATION the metal cap was found to be contaminated after 1 in 7 injections PATH is a nonprofit, nongovernmental, international organization. PATH’s mission is to improve health........ The (new) injector utilizes disposable protector caps that prevent retrograde passage of infectious material to the jet-injector nozzle. This is a novel and effective approach to eliminating cross contamination between injections….. http://www.path.org/files/htup-JetInjector.pdf+safety+of+multi-dose+jet+injection&hl=en&ie=UTF-8
PREVENTION AND CONTROL
OF HEPATITIS B IN CENTRAL AND EASTERN EUROPE AND THE NEWLY INDEPENDENT
STATES
Transmission of hepatitis B, hepatitis C and human immunodeficiency
viruses through unsafe injections in the developing world: model-based
regional estimates Hepatitis C (HCV) = six times the rate of infection than HIV in Sub Saharan Africa. http://www.who.int/docstore/bulletin/pdf/issue10/kane.pdf
The Answer is "no universal precautions' and 'jet gun injections" http://hcvets.com/images/who%20infection%20rates%20for%20hcv.jpg
CDC
Military's
Hepatitis C Risk Low, But DoD Still Concerned (corrected copy)
By Douglas J. Gillert Hepatitis C infections drop from a reported 242,000 infections to less than 40,000 a year once universal precautions and stricter blood standards were implemented! In 1988 the CDC developed universal precautions …. These recommendations stress that blood is the most important source …… control efforts should focus on the prevention of exposures to blood as well as the receipt of HBV immunizations.
Centers for Disease Control.
1987. Recommendations for prevention of HIV transmission in health-care
settings. Morbid. Mortal. Weekly Rep. 36(2S):1S-18S. The U.S. Centers for Disease Control and Prevention reports that approximately 28 percent of new AIDS cases in the United States in 2002 were from the use of shared needles by IDUs. WebMed reports 90% of those will be infected with HCV.
Centers for Disease
Control & Prevention report AIDS
Cases & Deaths through 12/31/01 24,855 cases were diagnose resulting in less than seven thousand HIV infection attributed to IDUs Multiplied by 90% of those stated to become infected with HCV by IDUs = 6300 new HCV infection attributed to IDUs.
Highest reported year for HIV Diagnoses 1988 242,000 HCV infections reported annually during the 1980's. Since 1989, the annual number of new infections has declined by more than 80 percent to approximately 41,000 by 1998. http://www.cdc.gov/ncidod/diseases/hepatitis/c/plan/HCV_infection.htm. 1988 35,508 HIV cases report
Something much more far-reaching than drug use caused this enormous decline in HCV infections. Drug use has not declined; in fact, IDU has risen since with the serge of amphetamine injection. These figures prove the risk of service truly out weighs any lifestyle presented by the Veterans Administration in defense for denying claims. ~All jet guns tested transmit hepatitis~ "... All injectors tested transmitted significant, more than 10 pl of blood, the minimum amount required for hepatitis....."
P.N.
Hoffman, Laboratory of Hospital Infection, Central Public Health
Laboratory, 61 Colindale Ave., London NW9 5HT, UK.,
http://cphl.phls.org.uk/divisions/nsi/lhi/highlights.htm
A
rating decision dated Aug 5, 2003
fro the Tiger Team of the Cleveland, Ohio Regional Office awarded a
Vietnam Veteran service connected disability for Hep C as a direct
result of the "JET INJECTOR". The claim was on remand from the BVA
and resulted in an award amount of 10%.
Bacterial Spores Survive Treatment with Commercial Sterilants and Disinfectants Jose-Luis Sagripanti* and Aylin Bonifacino Molecular Biology Branch (HFZ-113), Division
of Life Sciences, Office of Science and Technology, Center for Devices and
Radiological Health, Food and Drug Administration, Rockville, Maryland
Hepatitis C Survives Treatment with Commercial
Sterilants and Disinfectants 2001 SAFETEC SANIZIDE PLUSTM Germicidal Solution SaniZide PlusTM is a ready-to-use, hospital grade, hard surface disinfectant/deodorizer. Our Quaternary Ammonium, alcohol free formulation is non-flammable making SaniZide PlusTM safe to ship, as well as, non-corrosive. Choosing SaniZide PlusTM helps you to comply with the OSHA Bloodborne Pathogens Standard, which requires the use of an "appropriate disinfectant" that is tuberculocidal and virucidal against HIV-1 and HBV. For use on: glass, porcelain, ceramic, metal, polyethylene, polypropylene, vinyl, polyester, rubber, bakelite, and many more hard surfaces. For use in: industrial, institutional, commercial, medical and residential facilities, equipment and vehicles. EPA Registered. Now effective against Hepatitis C Virus (HCV)!
I would also like to add, the small pox bifurcated (two-pronged) needle, dipped into the vaccine solution then rinsed in alcohol, was also used on others previously and after immunizing me. Alcohol does not kill HCV. Vaccins et vaccination dans le monde, n°5, November 1997, p.2. WHO journal, pp. 2-4: "We must act now and take advantage of the new mass vaccination campaigns that are soon to be launched, to improve injection safety. If we fail, we will not only have a catastrophe on our hands, but we will have missed a golden opportunity to resolve this problem". The problem of dangerous injections had already been raised at the Yamoussoukro meeting in 1994, which in turn followed those of Bamako in 1974, Dakar in 1981, Niamey in 1987. Cf. Marchés tropicaux, n°628, 1 April 1994, p.628 Respectfully,
Gary Lupole
Robert H. Roswell, MD Lawrence Deyton MSPH,
MD
U.S. Department of Defense (DoD) needle-free injection policy chronology
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