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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

1920-87 Global Disaster PredictionDEADLY 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. ____________________________________________________________________________________________
1948 Blood ExperimentsUS 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... ____________________________________________________________________________________________
1950's Korean War Blood and PlasmaThe 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 PlasmaKorean War and Vietnam troops given serum gamma globulin- a high risk factor for hepatitis c ____________________________________________________________________________________________
1969 DoD Experimental FundingResearch 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 ExperimentsNew York Times- many people sickened and some died in an extended series of drug tests and blood plasma experiments ____________________________________________________________________________________________
1970 NIH WarningNIH Warning- one unit of hepatitis-contaminated plasma could contaminate an entire pool. Diluted 10 million times ____________________________________________________________________________________________
1974 FBI KnowledgeFDA & FBI allowed high risk plasma- As early as 1974 the FBI and the FDA did investigations into the plasma distribution ____________________________________________________________________________________________
1977 WarningFurthermore, 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 RecalledFDA 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 recallAt 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 CommitteeFaulty 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 RollThe 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 WarningWhen tested on animal models the metal cap was found to be contaminated after 1 in 7 injections ____________________________________________________________________________________________
1997Did 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 StatementSafety 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 OpEDFederal 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 ChronologyMilitary 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 LegislationFederal 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 LinkHepatitis 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 WarningThe Global Infectious Disease Threat and Its Implications for the United States-John C. Gannon Chairman, National Intelligence Council ____________________________________________________________________________________________
2001 CIA ReportTable ________________________________________________________________________________________________
2001 FDAPublic Hearing to approve Jetgun use
2001 Jetguns Transmit InfectionJet 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 ClaimsIn 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 PatientsOKLAHOMA 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 GuidelinesNosocomial 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 HistoryResearch by the CDC on jetgun history- Needle-Free Jet Injection Bibliography, Device & Manufacturer Roster, and Patent List ____________________________________________________________________________________________
2004 CDC Report Finger Stick Device LancetsCDC 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 InfectionsHealth-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 EventsPersons 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 TroopsDiscriptions: Immunization to Protect the U.S. Armed Forces: Heritage, Current Practice, Prospects from DoD, Office of the Surgeon General, U. S. Army.. ____________________________________________________________________________________________
2005 FDA GuidelinesFDA 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 MeetingDR. FRIEDE: The devices (jetguns) that we have seen ...show 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 EgyptResearchers 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 RequirementsTo 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 Review1998–2008: 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 TestThe study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate).. ____________________________________________________________________________________________
2008 Jet injectors & Bifurcated NeedlesThe 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 VialsRecommended Practices for Multiuse Vials Status and Update to General Chapter 797 Pharmaceutical Compounding – Sterile Preparations ____________________________________________________________________________________________
2008 VA Nevada Exposures VA Office of Inspector General,inspectionefurbished 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 hemodialysis 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 ClinicsKerry urges probe of unsanitary conditions at VA __________________________________________________________________________________________________
2009 GA Med Center EndoscopesColumbia 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 ClinicThe 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 ExposuresHCV 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 strategiesHCV 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 Jetgunshowever, these were found to be unsafe because of the possibility of bloodborne pathogen transmission ____________________________________________________________________________________________
2011 CDC Infection ChecklistOut-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 GuidelinesCDC guidleines 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 guidleines for appropriate vaccine administration ____________________________________________________________________________________________
2012 CDC Report Sites HospitalBased 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 (HCV) Infection: Treatment ConsiderationsChronic Hepatitis C Virus (HCV) Infection: Treatment Considerations Update May 2014 ____________________________________________________________________________________________
Hearing Transcript - House Committee on Veterans' AffairsDr. 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 Support On the Web
Hepatitis C Virus Infection Among Persons Born During 1945–1965Hepatitis 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 ____________________________________________________________________________________________
jetgunstudy
Paris Island Air Force inspectionFull 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 vialsSince 2001, at least 49 outbreaks due to the mishandling of injectable medical products...150,000 patients required notification .. potential exposure to unsafe injections. ____________________________________________________________________________________________
Testing for HCV after exposureApproximately 20%...have symptoms... before the seroconversioN...average time...is approximately 50 days, although it can be as long as nine months ____________________________________________________________________________________________
VA Defines Hepatitis C Risk FactorsVA 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 ReportVA supply orders not equal to demand... __________________________________________________________________________________________________
Vaccine- Department of Defense (DoD) immunization program- Full Report 1997 jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed...

 

 

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