1997 Jun - Jet injectors may transmit blood-borne infections

A CLINICAL, EPIDEMIOLOGIC AND LABORATORY STUDY ON AVOIDING THE RISK OF TRANSMITTING VIRAL-HEPATITIS DURING VACCINATIONS WITH THE DERMOJET PROTECTED BY AN ANTICONTAMINANT DISPOSABLE DEVICE

Jet injectors may transmit blood-borne infections, such as hepatitis B virus (HBV) and human immunodeficiency virus (HIV). To evaluate the safety of an anticontaminant disposable device which protects the jet injector apparatus, 22714 healthy subjects were intradermally, inoculated (38162 inoculations) with a variety of vaccines. All the subjects were systematically followed-up clinically and epidemiologically for 6-18 months after inoculation; blood samples from 1619 subjects, before and 60-75 days after inoculation, were examined by enzyme-linked immunosorbent assay (ELISA) for HBV, hepatitis C virus (HCV) and HIV. Before vaccination 212 (13.09%) subjects were positive, 204 positive for HBV markers and eight for the HCV marker. None of the subjects were positive for the anti-HIV marker. During the clinico-epidemiological surveillance and the laboratory investigations mentioned above no clinical viral hepatitis B or C case and no seroconversion to positivity for HBV or HCV markers among the susceptible persons in the group were reported Considering That in similar situations there is a theoretical risk of transmission as high as 1 per 388 to 1 per 3367 injections and that in our case 38162 inoculations were performed in 22714 subjects with the same Dermojet protected by the same type of anticontaminant disposable device, no contamination risk being reported the conclusion can be reached that jet injectors can be safely used in the medical practice if they are protected by the sterile anticontaminant disposable device. (C) 1997 Elsevier Science Ltd.

Author:  DIMACHE G, CANTACUZINO INST, BACTERIAL VACCINES LAB, SPLAIUL INDEPENDENTEI 103,POB 1-525, BUCHAREST 70100, ROMANIA Source:  VACCINE 1997 JUN;15(9):1010-1013

1990 Sep - An outbreak of hepatitis B associated with jet injections in a weight reduction clinic.

From January 1984 through November 1985, 31 clinical cases of hepatitis B occurred among attendees of a weight reduction clinic (clinic 1). Before the onset of illness, each case-patient had received a series of injections of human chorionic gonadotropin administered by jet injectors at clinic 1. Clinical history, risk factor assessment, serologic evaluation, and review of clinic injection records were obtained on 287 (84%) of 341 persons who had attended clinic 1 in the first 6 months of 1985. Of this cohort, 21% (60/287) had evidence of acute infection with hepatitis B virus (either documented clinical cases or antibody to hepatitis B core antigen, IgM positive). Of persons who had been given human chorionic gonadotropin at the clinic during the period studied, 24% (57/239) of those receiving human chorionic
gonadotropin only by jet injector experienced acute hepatitis B virus infection. None of the 22 persons who had received injections only by syringe experienced hepatitis B virus infection. Stopping the use of the jet injectors on July 2, 1985, at clinic 1, was associated with the termination of this outbreak.

This investigation demonstrated that jet injectors can become contaminatedwith hepatitis B virus and then may be vehicles for its transmission.

Author:
Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan
JM,

Address:
Division of Field Services, Centers for Disease Control, Atlanta, GA 30333.

Abbreviated Journal Title: Arch Intern Med
Date Of Publication: 1990 Sep
Journal Volume: 150
Page Numbers: 1923 through 1927
Country of Publication: UNITED STATES
Language of Article: Eng
Issue/Part/Supplement: 9
ISSN: 0003-9926

THE ASSISTANT SECRETARY OF DEFENSE
 WASHINGTON, D.C. 20301-1200
 HEALTH AFFAIRS

Honorable Man B. Mollohan
United States House of Representatives
Washington, DC 20515-4801

Dear Congressman Mollohan:

JUL 9, 1998

Thank you for your letter dated June 1, 1998, regarding Mr. (Deleted) concerns about the use within the Department of Defense (DoD) of jet injectors for immunization.

We have no evidence that service members have acquired bloodborne infections (such as hepatitis B, hepatitis C, or human immunodeficiency virus) as a result of DoD's use of jet injectors. Concerns about the safety of jet injectors, however, have prompted us to discontinue the routine use of jet injectors within DoD. We are very interested in the development of new multi-dose, needle-free injectors that have no risk for transmission of bloodborne infections.

Hepatitis B, hepatitis C, and human immunodeficiency virus infections do occur among military members but at rates that are lower than those seen in civilian populations of the same age. Risk factors for acquiring these infections include: injecting illegal drugs (low in the military because of drug screening); unsafe sexual practices, including having multiple sexual partners; receiving blood transfusions in the years before donated blood was tested for these infections; and occupations, such as health care, involving exposure to blood and body fluids.

Jet injectors that use the same nozzle tip to vaccinate more than one person have been used worldwide since 1952 to administer vaccines when many persons must be vaccinated with the same vaccine within a short time period. The jet injector developed and most widely used by the military has never been implicated in transmission of bloodborne infections. However, there is concern that use of jet injectors may pose a potential risk for translating bloodborne infections to vaccine recipients. In 1985 there was an outbreak of hepatitis B caused by non- standard use of another type of jet injector in a civilian weight loss clinic. Laboratory studies in Brazil and the United Kingdom suggest that bloodborne transmission theoretically could occur with use of jet injectors. Recent U.S. Centers for Disease Control and
Prevention and World Health Organization reviews of these issues highlight that worldwide jet injectors have been generally considered safe and effective for delivering vaccines if used properly by trained personnel. Both  organizations, however, strongly encourage the development of new multi-dose, needle-free
injectors with no risk of transmission of bloodborne infections.

Although DoD has used jet injectors for many years, a DoD Medical Quality Assurance System Device Alert on December 9, 1997, recommended that use of all jet injectors be discontinued. This action was taken in response to a letter from Ped-O-Jet International, the manufacturer of the jet injector product most commonly used in DoD. The manufacturer notified us that they were discontinuing producing and servicing their product. Although their product never had a
reported case of cross-contamination and has had an exemplary record, they "strongly urged the Armed Forces to discontinue use of the product" until studies conclude that no risk is present for bloodborne disease transmission. The
Armed Forces Epidemiological Board (AFEB), a civilian scientific advisory board, reviewed DoD's action to discontinue use of jet injectors within the Department. The AFEB noted the highly probable safety record of the use of jet injectors in the military, but found that "there are no current data to counteract the current recommendation that jet injectors not be used within the DoD for routine immunization."

We hope that this information has been informative. Thank you for your continued interest in the health and welfare of the men and women in uniform who serve our Nation.

Sincerely,
Dr Sue Bailey

APPROPRIATIONS COMMITTEE
SSUBCOMMITTEE ON COMMERCE, JUSTICE, STATE & JUDICIARY
SUBCOMMITTEE ON VA, HUD & INDEPENDENT AGENCIES
BUDGET COMMITTEE
CONGRESSIONAL STEEL CAUCUS EXECUTIVE COMMITTEE

ALAN B. MOLLOHAN
1ST DISTRICT. WEST VIRGINIA

July 22, 1998
 

Dear Mr. (deleted):

An official with the Office of the Secretary of Defense has responded to my inquiry regarding your concern about the military continuing to use jet injection air guns to inoculate military personnel.  I am enclosing a copy of the report for your reference.

As you will note, officials concede that service members have acquired bloodbourne infections as a result of DoD's use of jet injectors.  It is believed that the rates of occurrence are much lower than those seen in civilian populations of the same age.  Although DoD has used injectors for many years, a DoD Medical Quality Assurance System Device Alert recommended that use of all jet injectors be discontinued.  I trust you will find the enclosed self-explanatory.

If I can be of service to you in any other way, please do not hesitate to let me know.

Most sincerely,
Alan B. Mollohan

ABM: cm
Enclosure