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Hepatitis C from

JET GUN  INJECTIONS

Boot Camp, Paris Island  1968

The study ended early because the protector cap needle-free injector (PCNFI) failed to prevent contamination in the first batch tested (8.2% failure rate).

Vaccine. 2008 Mar 4;26(10):1344-52. Epub 2008 Jan 18. Links

Preventing contamination between injections with multiple-use nozzle needle-free injectors: a safety trial.

Multiple-use nozzle jet injectors (MUNJIs), a type of needle-free injector, use a high-pressure stream to penetrate skin and deliver medicament. Concerns for their potential to transmit blood borne pathogens led to development of a hybrid MUNJI for use in mass immunizations. The HSI-500, referred to here as a protector cap needle-free injector (PCNFI), utilizes a disposable cap as a shield between the reusable injector nozzle and the skin to reduce the risk of contamination. This study aimed to determine the presence of hepatitis B virus (HBV) contamination in post-injection ("next person") samples immediately following injection in HBV-carrier adults. Tolerability and pain were also assessed. The study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate). The injections were very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding (7.8%). 55.2% of participants experienced no pain while 42.3% experienced mild pain following injection.

Vaccine Weekly
August 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 injector

This article was prepared by Vaccine Weekly editors from staff and other reports.

Follow up
http://cphl.phls.org.uk/divisions/nsi/lhi/highlights.htm (if this link no longer works, click here
transmission 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 inspection
Jet 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.
	(1997-12-05) DoD Medical Materiel Quality Control Program (MMQCP) issues withdrawal of automatic jet hypodermic injection units (MMQC-97-1169).
	(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).
	(1998-11-25) Navy Bureau of Medicine and Surgery authorizes military use of new disposable-cartridge jet injector (Preventive Medicine Directorate).
	Current DoD policies and information available at the Military Immunization Information Source http://www.cdc.gov/nip/dev/jetinject.htm

U.S. Department of Defense (DoD)

FDA Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities. Snap shot as of 9/18/08 http://www.fda.gov/bbs/topics/ENFORCE/ENF00058.html 


Product: Vernitron Majestic Table Top Sterilizers, Models 8080,
V8000, or R816 a table top steam autoclave with an
8" x 8" x 16" chamber. Recall #Z-738/740-0.

Code:
All of the above model numbers manufactured prior to 1985. (note: these autoclaves were used to sterilize the Ped-o-Jet Jetguns used by the military. Sterilization could not be guaranteed.)

Manufacturer:
Vernitron Better Built Corporation (OOB), Carlstadt, New Jersey.

Recalled by:
Vernitron Medical Products, also known as Ped-O-Jet International, Dayton, New Jersey, by letter
February 26, 1990. Firm-initiated field correction ongoing.

Distribution:
Nationwide, Canada, Korea.

Quantity:
Firm estimates fewer than 100 uncorrected units remain on market.

Reason:
The locking hub may detach from the unit at high pressure as a projectile and may also cause a compromise of sterility of the contents of the sterilizer.

CDC- MMWR Recommendations and Reports

The following CDC staff members prepared this report:* John C. Watson, MD, MPH Charles W. LeBaron, MD Sonja S. Hutchins, MD, MPH Stephen C. Hadler, MD Walter W. Williams, MD, MPH National Immunization Program, CDC

Jet Injectors

Jet injectors that use the same nozzle tip to vaccinate more than one person (multiple-use nozzle jet injectors) have been used worldwide since 1952 to administer vaccines when many persons must be vaccinated with the same vaccine within a short time period. These jet injectors have been generally considered safe and effective for delivering vaccine if used properly by trained personnel; the safety and efficacy of vaccine administered by these jet injectors are considered comparable to vaccine administered by needle and syringe.

The multiple-use nozzle jet injector most widely used in the United States (Ped-o-Jet) has never been implicated in transmission of bloodborne diseases. However, the report of an outbreak of hepatitis B virus (HBV) transmission following use of one type of multiple-use nozzle jet injector in a weight loss clinic and laboratory studies in which blood contamination of jet injectors has been simulated have caused concern that the use of multiple-use nozzle jet injectors may pose a potential hazard of bloodborne-disease transmission to vaccine recipients (10). 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. The potential risk of bloodborne-disease transmission would be greater when vaccinating persons at increased risk for bloodborne diseases such as HBV or human immunodeficiency virus (HIV) infection because of behavioral or other risk factors (11,12).

Multiple-use nozzle jet injectors can be used in certain situations in which large numbers of persons must be rapidly vaccinated with the same vaccine, the use of needles and syringes is not practical, and state and/or local health authorities judge that the public health benefit from the use of the jet injector outweighs the small potential risk of bloodborne-disease transmission. This potential risk can be minimized by training health-care workers before the vaccine campaign on the proper use of jet injectors and by changing the injector tip or removing the jet injector from use if there is evidence of contamination with blood or other body fluid. In addition, mathematical and animal models suggest that the potential risk for bloodborne-disease transmission can be substantially reduced by swabbing the stationary injector tip with alcohol or acetone after each injection. It is advisable to consult sources experienced in the use of jet injectors (e.g., state or local health departments) before beginning a vaccination program in which these injectors will be used. Manufacturer's directions for use and maintenance of the jet injector devices should be followed closely.

Newer models of jet injectors that employ single-use disposable nozzle tips should not pose a potential risk of bloodborne disease transmission if used appropriately.

(((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.txt


SUBJ/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 AND
RECOMMENDATIONS NOTICE. REF B IS NAVMEDLOGCOM DRUG RECALL
NUMBER 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 HM1
SPICER, 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 UUUUU
RUCKMEA T CG II MEF
RUWICBD T CG FIRST FSSG
RUWICBE T CG I MEF

R 251800Z NOV 98 ZYB PSN 895734I36
FM BUMED WASHINGTON DC//24//
TO AIG SEVEN SEVEN EIGHT THREE
AIG SIX NINE FOUR SEVEN
INFO AIG ONE THREE SEVEN SEVEN SIX
BT
UNCLAS //N06230//
MSGID/GENADMIN/BUMED//

Revised: November 30, 2008 .All information is posted without profit
or payment for research and is for educational purposes only,
in accordance with Title 17 U.S.C. section 107.