Saturday, April 07, 2007

HEPATITIS "C" FROM INJECTIONS

Hepatitis C from
JET GUN INJECTIONS

Boot Camp, Paris Island 1968


Hepatitis C is a result of receiving immunizations in service by means of a multi-use jet gun injector.CONCLUSION OF LAW Hepatitis C was incurred in service. 38 U.S.C.A. § 1131 (West 2002); 38 C.F.R. § 3.102, 3.303 (2005).ADD TO YOUR CLAIM!
Vaccine WeeklyAugust 03, 2001 by N.R. Saltmarsh, staff medical writer -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, say researchers working in England.The injectors, which are needleless systems that penetrate skin with high-pressure fluid, have potential advantages over needles and syringes, but P.N. Hoffman and associates at the Laboratory of Hospital Infection, London, sought to determine whether they might have a major disadvantage as well.They used a highly sensitive enzyme-linked immunosorbent assay (ELISA) to detect whether small amounts of blood and fluid remained in the jet injector after injecting inert buffer into calves.All four injectors tested - two with reusable heads and direct skin contact, one with single-use injector heads, and one with an injector head that discharged at a distance from the skin - contained at least 10 pl of blood, enough to transmit hepatitis B infection, reported Hoffman and coworkers ("A model to assess the infection potential of jet injectors used in mass immunization," Vaccine, July 2001;19(28-29):4020-4027)."The source of the contamination was consistent with contamination by efflux of injected fluid and blood from the pressurized pocket in tissue that is formed during injection," reported Hoffman and coauthors. "This insight should inform the design of safe jet injectors."For more information about this study contact P.N. Hoffman, Laboratory of Hospital Infection, Central Public Health Laboratory, 61 Colindale Ave., London NW9 5HT, UK.Key points reported in this study include: * Needleless jet injector systems are potentially beneficial for mass immunization programs, but they may transfer blood-borne viruses * Researchers used a highly sensitive ELISA to evaluate whether small volumes of blood remained in the jet injectors after injecting calves with a buffer solution * All four injector models tested transmitted more than 10 pl of blood, the minimum amount required for hepatitis B transmission, and the quality of the blood was consistent with efflux from the pressurized pocket created by the jet injectorThis article was prepared by Vaccine Weekly editors from staff and other reports.Follow uphttp://cphl.phls.org.uk/divisions/nsi/lhi/highlights.htm (if this link no longer works, click heretransmission of hepatitis c by jet gun injections exists)
The Central Public Health Laboratory (CPHL) is the national reference centre for medical microbiology in the UK. CPHL provides specialist expertise and advice to the Regional PHLS laboratories, NHS hospital laboratories, consultants in communicable disease control, community and hospital physicians, environmental health officers, government and industry.
Public Health Highlights Interventions LHI in their reflective practitioner role receive many requests for advice on the prevention and control of infection and outbreaks. These cover infection control in hospitals and other, wider aspects of healthcare. One example of this was recently generated in the Infection Control Unit and concerns the transmission of blood borne infectious agents by jet injectors. These injectors use a high-pressure focussed jet of fluid to provide a needleless mechanism for penetrating skin. They have great potential in mass immunisation campaigns in areas of limited resources and allow high immunisation delivery rates. They would eliminate many logistical problems such as the shipping of single-use syringes and needles, accidental contaminated needlestick injuries to immunisation staff, and the burden of safe disposal of sharps clinical waste.
At the request of the World Health Organization, we developed a laboratory model of jet injection safety that could test the capacity of jet injectors to transmit blood between injection recipients. Hepatitis B is thought transmissible in volumes of blood as low as 10 picolitres, so a novel immunoassay (developed in conjunction with Kings College, University of London) was used that could detect these extremely low levels. Results from the use of this model indicated jet injectors can regularly transmit relevant volumes of blood. Use of this model under field conditions in Brazil (in conjunction with WHO and the Brazilian Ministry of Health) confirmed the laboratory model as valid. As a result of this work, WHO and other major users of jet injectors have reconsidered their use. A more positive outcome of this work has been an understanding of previously unsuspected contamination mechanisms, which is enabling design of new generations of jet injector whose safety can be assessed in our model. View Study
Paris Island Air Force inspectionJet injector nozzles were frequently contaminated with blood
click here Vaccines in the Military Department of Defense- Wide review of Vaccine Policies and Procedures Read excerpt- Page 60 in particular says, "Of note is that the AFEB made a site visit to the MTF at Parris Island and directly observed high volume recruit immunization using jet injectors. It was noted that jet injector nozzles were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed." View complete report at http://www.ha.osd.mil/afeb/reports/vaccines.pdf
Military discontinues the use of jet guns for mass immunization of military troops U.S. Department of Defense (DoD) needle-free injection policy chronology
(1997-11-20) Ped-O-Jet® manufacturer (Keystone Industries, Cherry Hill, NJ) notifies Defense Supply Center Philadelphia (DSCP) (Defense Logistics Agency) of intent to withdraw as device supplier over liability concern for bloodborne disease transmission from multiple-use-nozzle design.
(1997-12-07) DSCP issues Medical Products Quality Control System (MPQCS) device alert (DSCP 970147) as "cautionary measure", while noting the absence of bloodborne disease transmission case reports over 35 years of military use (followup MMQC-98-1019 dated 1998-Jan-30).
(1998-01-09) Armed Forces Epidemiological Board (AFEB) concurs with withdrawal of Ped-O-Jet® for "routine immunization", but availability for "public health emergency". AFEB recommends use of "newer technology" devices with disposable parts for skin contact.
(1998-04-20) Navy Bureau of Medicine and Surgery updates via BUMED notice 6230 its Immunization Requirements And Recommendations document (3.6Mb .pdf) prohibiting jet injector use until otherwise directed.
(1998-04-28) AFEB recommends DoD formulate new needle-free injector specifications and support device research and development.
(1998-07-09) Letter from Dr. Sue Bailey, Assistant Secretary of Defense, Health Affairs, to United States Representative Alan B. Mollohan (D-WV), explaining DoD policy on jet injectors in response to the concerns of a constituent of the Congressman.
(1998-1999) Manufacturer discontinuation of large multi-dose vials for yellow fever, meningococcal, and tetanus-diphtheria vaccines because of military withdrawal of Ped-O-Jets® capable of using them (MMQC-99-1248 dated 1998-Nov-03 and MMQC-99-1251 dated 1999-Aug-12).
Current DoD policies and information available at the Military Immunization Information Source http://www.cdc.gov/nip/dev/jetinject.htm
(((Thanks Roger))))
This reads as a tacit admission, problems existed with the jet injectors. . NOVEMBER 1998 http://www-nehc.med.navy.mil/prevmed/epi/BUMED25NOV98.txtSUBJ/MEDICAL JET INJECTOR USE FOR IMMUNIZATIONS, UPDATE//REF/A/DOC/BUMEDNOTE 6230/20APR98//REF/B/MSG/NAVMEDLOGCOM FORT DETRICK MD/081300ZDEC97/NOTAL//
NARR/REF A IS BUMED IMMUNIZATION REQUIREMENTS ANDRECOMMENDATIONS NOTICE. REF B IS NAVMEDLOGCOM DRUG RECALLNUMBER 97-75, DOD-MMQC-97-1169
AUTOMATIC JET HYPODERMIC INJECTION UNITS/WITHDRAWAL (DPSC 970147).//POC/MCBRIDE/CDR,MC,USN/MED-24B/WASHINGTON DC/TEL:COM (202)762-3495/TEL:DSN: 762-3495//
RMKS/1. THIS MESSAGE HAS BEEN COORDINATED WITH THE COMMANDANT OF THE MARINE CORPS (CMC). THE COMMANDANT HAS AUTHORIZED TRANSMISSION TO MARINE CORPS ACTIVITIES.2. PURPOSE: UPDATE GUIDANCE IN REFS A AND B ON USING COMMERCIAL JET INJECTORS FOR ADMINISTERING IMMUNIZATIONS.3. BACKGROUND: SINCE ISSUING REFS A AND B, SEVERAL ACTIVITIES EXPRESSED INTEREST IN USING A NEW TRANSCUTANEOUS, CO2 POWERED IMMUNIZATION DEVICE MANUFACTURED BY BIOJECT, INC. THIS DEVICE, MARKETED AS "BIOJECTOR 2000 INJECTION MANAGEMENT SYSTEM", IS THE ONLY FOOD AND DRUG ADMINISTRATION (FDA) LICENSED HYPODERMIC JET INJECTOR. IT AVOIDS RISKS OF BLOOD-BORNE PATHOGEN TRANSMISSION AND NEEDLE-STICK INJURY ASSOCIATED WITH PREVIOUSLY USED JET INJECTOR GUNS.4. GUIDANCE:
A. BIOJECTOR 2000 INJECTION MANAGEMENT SYSTEM IS AUTHORIZED FOR USE IN NAVY AND MARINE CORPS ACTIVITES FOR IMMUNIZATION ADMINISTRATION TO SERVICE MEMBERS AND OTHER BENEFICIARIES. AT THIS TIME, NO OTHER HYPODERMIC JET INJECTOR SYSTEM IS FDA APPROVED-THIS IS REQUIRED PRIOR TO CONSIDERATION FOR BUMED AUTHORIZATION.B. USE OF HYPODERMIC JET INJECTOR APPARATUS LISTED IN REF B REMAINS UNAUTHORIZED.C. WITH BIOJECTOR 2000, ESTIMATED COST PER INJECTION AND MECHANICS OF PREPARATION FOR EACH INJECTION MAY LIMIT COST AND PAGE 03 RUENMED3162 UNCLAS EFFICIENCY BENEFITS. HOWEVER, THESE CONCERNS MAY BE OFFSET BY SAFETY ENHANCEMENT THROUGH AVOIDANCE OF BLOOD-BORNE PATHOGEN EXPOSURE AND ELIMINATION OF POSSIBLE NEEDLE-STICK INJURY TO BOTH PATIENTS AND THOSE ADMINISTERING IMMUNIZATIONS. ALSO, SHARPS DISPOSAL IS NOT NECESSARY.5. POINTS OF CONTACT:A. PROCUREMENT: NAVMEDLOGCOM, FORT DETRICK, MD-LT WILLIAMS, TEL: (301)619-3086; DSN 343-3086 OR HM1SPICER, TEL: (301)619-7118; DSN 343-7118.B. BUMED-24: CDR MCBRIDE, (AS ABOVE)EMAIL: WZMCBRIDE@US.MED.NAVY.MIL.//RTAUZYUW RUENMED3162 3291800-UUUU--RUCOFAE.ZNR UUUUURUCKMEA T CG II MEFRUWICBD T CG FIRST FSSGRUWICBE T CG I MEFR 251800Z NOV 98 ZYB PSN 895734I36FM BUMED WASHINGTON DC//24//TO AIG SEVEN SEVEN EIGHT THREEAIG SIX NINE FOUR SEVENINFO AIG ONE THREE SEVEN SEVEN SIXBTUNCLAS //N06230//MSGID/GENADMIN/BUMED//
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. View
Safety Testing of Needle Free, Jet Injection Devices to Detect Contamination with Blood and Other Tissue Fluids JAMES M. SWEATa,b, et.al
"Five different procedures were used to administer injections to calves and pigs: (1) following compliance protocol (device nozzle is swabbed with alcohol between vaccinates)",.............."It was interesting to note that the amount of backsplash resulting from injection using a disposable plastic nozzle was slightly less than that from the metal type"......"If albumin is detected in test samples (at more than 10 pL/mL), the conclusion is that the device is responsible for transmitting volumes of blood sufficient to contain pathogenic agents." View study
June 2003 excerpts from Federal Laboratory Community online paper
"The challenge was to solve the pathogen transfer problem while retaining the advantages of the needle-free injector system.The technology transfer of a Russian-designed protector cap was the missing link needed to improve the safety found in this needle-free injector system. This protector cap provides three separate challenges to any pathogen transfer between patients. Each cap is packaged in a sterile container and exposed only immediately before injection. The cap is then disposed of after each use in a biohazard bag."http://www.federallabs.org/ContentObjects/News/NewsLink/NewsLinkJune2003.pdf
SHDEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH ADMINISTRATION, FOOD AND DRUG ADMINISTRATION
GENERAL HOSPITAL & PERSONAL USE DEVICES PANEL
OPEN SESSION
Monday, August 2, 1999
Jet Guns were always cleaned between injections of the Military troops! Quote: It = jet gun injectors MR. HARRINGTON: Not necessarily. It was used by the Army for 35 years and it was always wiped. Never had an issue. Good tracking system. And there's nothing recorded in the world that says that it wasn't wiped. It's in a study that was presented using a method that isn't approved, it was not wiped and it said oh, we can contaminate 31 out of 100...
....What I'm saying to you is we believe that there are situations--the U.S. military for 35 years used the product appropriately. There was never an indicated transmission of hepatitis. Certainly they follow cases of hepatitis in the U.S. military.


PREVENTION AND CONTROL OF HEPATITIS B IN CENTRAL AND EASTERN EUROPE AND THE NEWLY INDEPENDENT STATES Click here jet gun injectors with a design fault that allowed blood to remain inside the equipment
Cost of tetanus toxoid injection using a jet-injector (Imule) in collective immunization in Senegal: comparison with injection using a syringe and resterilizable needle]
Needle-less jet injectors were developed by the US army after World War II. Their principal use, however, has been in the administration of lyophilized vaccines from multidose vials to at-risk populations in developing countries. In 1983, a hepatitis B epidemic occurred among customers of a beauty clinic in California (USA) following the use of jet-injectors, demonstrating a clear risk of cross-contamination associated with this technique. As a result, the WHO and UNICEF stopped recommending jet-injectors for collective immunizations in developing countries View study
Breaches in safe-injection practices CDC recommendations. How many were not practiced on you?...Fourteen patients reported breaches in safe-injection practices by the practitioner, including 1) failure to practice hand hygiene, 2) failure to prepare the skin with an antiseptic, 3) failure to wipe vials with alcohol before injection, and 4) failure to wear gloves. Of 11 patients who could recall, all reported use of a new needle; however, nine patients reported use of a multidose vial.


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