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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 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. ____________________________________________________________________________________________
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... ____________________________________________________________________________________________
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 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	Discriptions: 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 ...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 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,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 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 Guidleines	CDC 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. ____________________________________________________________________________________________
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.. ____________________________________________________________________________________________
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 ____________________________________________________________________________________________
Testing for HCV after exposure	Approximately 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 Factors	VA Risk factor for HCV disease. HCVets explain why the source of infection is unknown in so many patients. ____________________________________________________________________________________________
VA OIG Report	VA supply orders not equal to demand... __________________________________________________________________________________________________