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Federal Agency Reports - Centers for Disease Control (CDC), Food and Drug Administration (FDA), Department of Defense (DoD), Veterans Administration (VA) and Military related reports in response the HCV Disease (hepatitis C) Epidemic

1948 Blood Experiments US Army makes deal to recruit volunteers for hepatitis experiments with Mr. Durnquist, the Attorney General of the State of Minnesota, with respect to the possibility of conducting experimental work on volunteers in the penitentiaries. Mr. Durnquist was favorably inclined to the idea and quite optimistic about its feasibility...

1920-87 Global Disaster Prediction DEADLY NEEDLES Fast Track to Global Disaster- For decades, researchers warned...syringes could transmit ... efforts to defuse the crisis were failed, and today...become an insidious global epidemic, destroying millions of lives every year.
1950's Korean War Blood and Plasma The Blood, Plasma, and Related Programs in the Korean War- A plasma program was also developed which later had to be discontinued because of the risk of serum hepatitis associated with plasma infusions
1960's Vietnam Blood and Plasma Korean War and Vietnam troops given serum gamma globulin- a high risk factor for hepatitis c
1969 DoD Experimental Funding Research and Technology for the Department of Defense project to produce a synthetic biological agent for which humans have not yet acquired a natural immunity
1969 Pharmaceutical Experiments New York Times- many people sickened and some died in an extended series of drug tests and blood plasma experiments
1970 Jetgun Nursing Instructions How to use the jetgun, detailing how the device got contaminated.
1970 NIH Warning NIH Warning- one unit of hepatitis-contaminated plasma could contaminate an entire pool. Diluted 10 million times
1974 FBI Knowledge FDA & FBI allowed high risk plasma- As early as 1974 the FBI and the FDA did investigations into the plasma distribution
1977 Warning Furthermore, the efficacy of the ISG, manufactured in 1944, against apparent type non-A, non-B hepatitis suggests that this overlooked disease has existed from at least that time.
1990 FDA Jetgun Autoclaves Recalled FDA Enforcement Report- Vernitron Majestic Table Top Sterilizers, Models 8080, Recall...The locking hub may detach from the unit at high pressure...compromise of sterility... (note: these autoclaves were used to sterilize the Ped-o-Jet Jetguns used by the military. Sterilization could not be guaranteed.)
1994 CDC Jetgun Recommendations This potential risk for disease transmission would exist if the jet injector nozzle became contaminated with blood during an injection and was not properly cleaned and disinfected before subsequent injections.
1994 Hepatitis C ISG product recall At the end of February 1994, Baxter Healthcare announced the removal of Gammagard from the global market because of plasma used was positive for hepatitis C. In July 1995, the FDA said that as many as 1,000 cases of hepatitis C could have been linked to use of Gammagard.
1995 Experiments Philadelphia Inquirer “On the Trail of Tainted Blood-Gives an in-depth report of our Governments knowledge of Hepatitis transmission. Experiments with human volunteers from the military, prisons and state hospitals were abandoned...plasma-induced hepatitis...scientists, meanwhile, said the products were dangerous
1996 CDC Jetgun Advisory Committee Faulty Design...Various routes of transmission ...documented, including ...blood products, use of jet gun injectors with a design fault that allowed blood to remain inside the equipment, re-use of contaminated needles and syringes, and indirect transfer from contaminated environmental surfaces in haemodialysis units....
1996 FDA Roll The Role of the FDA- What the FDA is doing and what the public thinks it's doing are as different as night and day
1996 WHO Jetgun Warning When tested on animal models the metal cap was found to be contaminated after 1 in 7 injections
1997 Did Shots Cause Hepatitis C? Officials Downplay Concerns- They found the genetic fingerprint in batches used for decades to inoculate soldiers against hepatitis A and B
1997 DoD Jetgun Report Vaccines in the Military- Wide review of Vaccine Policies and Procedures ... says, ...jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed."
1997 WHO Jetgun Statement Safety of Injections-...-Needle-free injectors designed for use with multi-dose vials...should not be used for immunization. These injectors have an inherent risk of bloodborne disease transmission...
1998 CDC Global Disaster OpED Federal heads in the sand:( The Dear Colleague letter written by Acting Deputy Director, Epidemiology and Surveillance Division, National Immunization Program, CDC, and read as follows:
1999 DoD Jetgun Policy Chronology Military discontinues the use of jet guns for mass immunization of military troops U.S. Department of Defense (DoD) needle-free injection policy chronology
1999 Federal Safety Needle Legislation Federal Safety Needle Legislation-"...accidental needlesticks...76%, the highest rate of any device ...million per year...result in the transmission...
1999 Hepatitis C Survives Hepatitis C NOT Killed by Commercial Sterilants and Disinfectants
1999 Military Link Hepatitis C Origin Points to Military...Responses to the request by the Department of Defense indicate that soldiers at major U.S. military training bases during the late 1960s and 1970s were used to test vaccines...
1999 OSHA Preambles OSHA Preambles -  Bloodborne Pathogens (29 CFR 1910.1030)Revision Date: Jul 30 1999 Most healthcare workers who have transmitted to patients have several factors in common):  (1) The dentists and surgeons were chronic... had high titers...were unaware that they were infected. 
2000 CIA Warning The Global Infectious Disease Threat and Its Implications for the United States-John C. Gannon Chairman, National Intelligence Council
2001 CIA Report Table
2001 FDA Public Hearing to approve Jetgun use
2001 Jetguns Transmit Infection Jet Injectors Capable of Transmitting Blood-Borne Pathogens-Jet injectors may be ideal for mass immunization programs but not until design refinements eliminate their capacity to transmit blood-borne infections....
2001 VBA Fast Letter Boost Hepatitis C Claims In the Fast Track letter, Carolyn F. Hunt, Acting Director, for Compensation and Pension Service states: "..needles (and other objects that puncture the skin) are contaminated with HCV infected blood and are then used by others, HCV can be transmitted.
2003 Anesthetist-transmission to Patients OKLAHOMA CITY — The Oklahoma Board of Nursing unanimously approved...revoking nurse anesthetist... license... regularly engaged in the practice of reusing the same needle and syringe... such as Versed, Fentanyl and Propofol, to patients through their existing heparin locks …”
2003 NIH Guidelines Nosocomial transmission of bloodborne viruses from infected health care workers to patients...some occupations ... higher risk ... rate of HCV in oral surgeons
2003 Risk of EMG Needles “Platinum single fiber electrodes ... including the use of disposable NCS electrodes, .. with patients.. with agents ...Hepatitis C virus, Creutzfeldt-Jakob disease, and human immunodeficiency virus”.
2004 CDC Jetgun History Research by the CDC on jetgun history- Needle-Free Jet Injection Bibliography, Device & Manufacturer Roster, and Patent List
2004 CDC Report Finger Stick Device Lancets CDC and the Food and Drug Administration (FDA) have recommended since 1990 that fingerstick devices be restricted to individual use
2004 CDC Risk Factors Position-Any percutaneous exposure has the potential for transferring infectious blood and potentially transmitting bloodborne pathogens (e.g., HBV, HCV, or HIV); however, no data exist
2004 Transfusions- Fatal Bacterial Infections Health-care providers should be aware of the new standard and the need for bacterial testing of platelets to improve transfusion safety.
2005 CDC Mass-Casualty Events Persons wounded during such events or in conjunction with hepatitis c... blood, body fluids, or tissue from injured and at risk for bloodborne infections.
2005 DoD List Vaccines Given to All Troops Descriptions: Immunization to Protect the U.S. Armed Forces: Heritage, Current Practice, Prospects from DoD, Office of the Surgeon General, U. S. Army..
2005 FDA Guidelines FDA Guidelines for Infection Control and Safe Injection Practices- Current good manufacturing practice (Note to reader- the following guidelines ...injections of vaccines were not followed by the military.
2005 FDA Safety of Jetguns Advisory Meeting DR. FRIEDE: The devices (jetguns) that we have seen that frequent contamination...was clearly of a level of blood that we are convinced can carry disease. So the devices which do not have a protection cap which are to be used for giving intramuscular injection we are convinced that these carry a significant risk.
2005 Global Burden Egypt Researchers at the University of Maryland School of Medicine... high prevalence of hepatitis C ...traced to mass treatment ... fight a common illness ...decades ago.
2006 DoD-USCG Jetgun Defects ... due to safety concerns...use of the same unsterile nozzle and fluid pathway to inject consecutive patients ... were usually refilled quickly from attached multidose vaccine vials...2–8. Jet–injection immunization devices
2008 CDC Infection Control Requirements To avoid contamination and potential spread of infection... medications and solutions must be handled using proper infection control precautions as described in CDC guidelines and now mandated through the new CMS
2008 CDC Review 1998–2008: Nonhospital Health Care–Associated Hepatitis ...these recognized outbreaks indicate a wider and growing problem as health care is increasingly provided in outpatient settings in which infection control training and oversight may be inadequate.
2008 CDC- Jetguns (PCNIF) Fail Safety Test The study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate)..
2008 Jet injectors & Bifurcated Needles The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods B. G. Weniger..
2008 NV State Investigation UPDATE So Nevada Hepatitis C Investigation UPDATE: "Patients were put at risk, health officials say, when a syringe would be reused on an infected patient and then used to draw anesthesia from vials intended for just one patient. The vials would then be used on other patients, potentially spreading disease."
2008 USP Policy Change-Multiuse Vials Recommended Practices for Multiuse Vials Status and Update to General Chapter 797 Pharmaceutical Compounding – Sterile Preparations
2008 VA Nevada Exposures VA Office of Inspector General, inspection refurbished scopes were purchased and a scope broke... GI providers reused syringes...contaminated medication from vials...contracts were awarded to the GI provider group or that senior managers received kickbacks.
2009 CDC Report- Hemodialysis Unit Hepatitis C Virus Transmission at an Outpatient Hemodialysis Unit --- New York, 2001--2008 -...  negative to anti-HCV positive in a New York City hemadialysis unit Supervisory staff members failed to address these breaches. Many of the direct care staff members were unaware of ...unit's written infection control policies, including those pertaining to cleaning and disinfection. Investigators also noted the lack of a separate clean area for... has 8% risk factor
2009 Congressional Probe - VA Clinics Kerry urges probe of unsanitary conditions at VA
2009 GA Med Center Endoscopes Columbia County Medical Center In Hot Water-GA officials.. look at a local medical center. Workers... not have followed proper cleaning procedures. ..1,300 patients... received this letter...concerns over the sterilization process of endoscopes
2009 GA VA Ear, Nose and Throat Clinic The fact that it took five years for them to catch a mistake like that....nose and throat clinic at the VA Medical Center ...that they may have been exposed...
2010 CDC Report- Mulitple Exposures HCV quasispecies sequences from the patients were nearly identical (96.9%–100%) to those from source patients with chronic viral hepatitis. All affected patients in both clinics received
2010 HCV screening strategies HCV testing was performed in 3803. Of these, 11.5% were positive, prevalence of HCV infection of 7.7%, 5 times higher than the estimated...40% of HCV-positive persons were unaware of their status.
2011 CDC Advisory Committee on Jetguns however, these were found to be unsafe because of the possibility of bloodborne pathogen transmission
2011 CDC Infection Checklist Out-Patient Settings-Certain infection control lapses e.g., re-use of syringes ; re-use of lancets can result in bloodborne pathogen transmission and should be halted immediately.
2011- CDC Vaccine Guidelines CDC guidelines for appropriate vaccine administration. the following guidelines for standard practices during injections of vaccines were not followed by the military during the height of the hepatitis epidemic. Needles, syringes and vials were commonly reused.
2011- CDC Vaccine Guidleines CDC guidelines for appropriate vaccine administration
2012 CDC Report Sites Hospital Based on record review interview, and review of CDC and AORN national standards it was determined that the hospital failed to provide a sanitary environment, and avoid sources of transmission of potential infections by not..
Chronic Hepatitis C Virus Treatment Considerations Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations Update May 2014
Federal response to Veterans with Hepatitis C "You've got a demon on your hands," he said. "You'd better find out where that's coming from if you can."
Hearing Transcript - House Committee on Veterans' Affairs Dr. PETZEL.  Well, Mr. Chairman, are you implying that we can't do an unbiased investigation? The CHAIRMAN.  I'm not implying.  I'm saying it.  You said you wanted an independent investigation.  Now I find out that it's VA employees that are going to do it. 
Hepatitis C by Airgun was related to active service The Board finds that these physician's opinions express support for the proposition that the Veteran's hepatitis Hepatitis C was related to active service, specifically air gun immunizations therein.
Hepatitis C Support On the Web  
Hepatitis C Virus Infection Among Persons Born During 1945–1965 Hepatitis C Virus Infection Among Persons Born During 1945–1965... The prevalence of anti-HCV among persons born during 1945–1965 is 3.25% (3), five times higher than among adults born in other years. The high prevalence of HCV among persons in this birth cohort reflects the substantial number of incident infections
Jet injection History and Applications  
Paris Island Air Force inspection Full Report 1997... noted that jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed...
Preventing infection from the misuse of vials Since 2001, at least 49 outbreaks due to the mishandling of injectable medical products...150,000 patients required notification .. potential exposure to unsafe injections.
Sen Sanders Tells VA Use Emergency Power Override Hep C Drug Patents Veterans told to wait until the liver is completely diseased before qualifying for the new "miracle" drugs... Read More
Testing for HCV after exposure Approximately 20%...have symptoms... before the seroconversioN...average approximately 50 days, although it can be as long as nine months
VA Defines Hepatitis C Risk Factors VA Risk factor for HCV disease. HCVets explain why the source of infection is unknown in so many patients.
VA HCV Prevalence VS Therapy The prevalence of hepatitis C virus (HCV) infection among VA patients is 3x higher than in the general population. Recent VA data indicate that only about 14% of all HCV-infected VA patients have ever received antiviral therapy.
VA OIG Report VA supply orders not equal to demand...
Vaccine- Department of Defense (DoD) immunization program- Vaccines in the Military- Wide review of Vaccine Policies and Procedures ... says, ...jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed."


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