Impact of the 1985 Outbreak

For the past thirty-one years, the CDC led the public to believe that the 1986 report was the agency’s first investigation into jet injectors. The CDC assured that this outbreak was only due to the particular nozzle design of the Med-E-Jet and that all other jet injectors were safe. Omitted from any discussion or report was the fact that the agency had conducted safety testing of the Ped-O-Jet nine-years prior and found transmission was possible. Regardless of the 1985 outbreak, the CDC continued to use multi-use nozzle jet injectors.

Within the Department of Defense, the outbreak prompted the Armed Forces Epidemiological Board (AFEB) to discuss the risks of jet guns in a July 1st, 1986 meeting (Federal Register, 1986). The AFEB is an expert advisory board of civilian physicians and scientists that assists the Department of Defense with medically related issues. The AFEB even discussed the possibility of HIV being transmitted when jet injectors administer biological products, such as gamma globulin.

…the Board stated that the chance of transmitting HIV infection through gamma globulin given by jet injector was too remote to be significant. Those persons most responsible for formulating these decisions and recommendations had previously had extensive experience with the jet injector; Dr. Abram Benenson had worked with it since it was developed (Woodward, 1990).

However, here the AFEB’s conclusion was based upon outdated information. An extensive review of the literature on Dr. Abram Benenson and jet injectors reveals that the last time Dr. Benenson was involved in any safety testing of jet injectors was in 1959 during his employment with Walter Reed Army Institute of Research. Papers, either authored or co-authored by Benenson, and the commissions and committees in which he had served since 1959 only assessed the efficacy of the vaccines administered by jet injection and did not assess the safety of jet injector devices. Therefore, the AFEB’s basis for their decision was relied upon Dr. Benenson’s experience from 27-years prior.

Moreover, Jet Infectors review of the literature has found Dr. Benenson should have reached a conclusion contrary to his 1985 opinion. Personal statements previously made by Benenson are inconsistent with his 1985 opinion. These statements and instances include:

  • In a 1968 paper, Dr. Benenson disclosed “Difficulty was encountered with one of the jet injectors…” and reported, “all of the Pakistani employees of this laboratory developed an area of erythema at the site of jet injection…” (Benenson, Joseph & Oseasohn, 1968). The occurrence of erythema, superficial reddening of the skin as a result of injury causing dilatation of the blood capillaries, should have prompted an investigation into the risk of cross-infection, as well as questioned the sterility of this procedure.
  • In 1971, Dr. Benenson attended a NIH conference on the efficacy of tuberculosis vaccinations. During this conference, Dr. Sol Roy Rosenthal noted blood during the mass vaccination of school children and noted the potential for the transference of hepatitis. The committee for which Dr. Benenson was a part of concluded, in regards to jet injection, “The possibility of transfer of infectious hepatitis, however, is not excluded” (DHEW, 1972).
  • In 1978, Dr. Benenson attended a conference held by the AFEB on Leishmania skin testing. Benenson considered using jet injectors conduct the Leishmania test upon military personnel but said “I have looked at it as a practical procedure using the intradermal gadget on the jet injector which is not 100 percent” (AFEB, 1978).

Dr. Benenson had previously found jet injector devices to be “not 100 percent,” induced erythema at the site of injection, and had agreed with fellow conference members that due to the presence of blood during jet injections the risk of transferring hepatitis cannot be exlcuded.

Despite the in depth discussions the committee was reluctant to impose any changes in July of 1986 (Federal Register, 1986; Woodward, 1990). By 1987 the AFEB finally recommended the Med-E-Jet be banned within the Armed Forces and be removed from the Federal Stock System (Nikolewski & Wells, 1989). In March of 1988, the AFEB gave the recommendation “that the jet injector gun be used only with authorized military technical parts and that it be sterilized according to standard procedures” (Woodward, 1990).

Regardless of the AFEB’s recommendation that jet injector devices be autoclaved and used in accordance with “standard procedures” the Armed Forces continued to use jet injectors haphazardly. Military footage and a subsequent AFEB report in 1999 document the military’s disregard for abiding standard procedures and set protocols for sterilization.

Outside of the United States, the 1985 outbreak elicited a far different response. For many the outbreak served as proof that all multi-use nozzle jet injectors were unsafe and served as a catalyst for change.

In September of 1986, a Dutch committee on immunization opined that jet guns should no longer be used in the Netherlands (Bijkerk, 1986). The decision stemmed not only from the 1985 U.S. outbreak but also from a Dutch study by Brink and colleagues (1985) which demonstrated virus transmission from the use of jet guns.

By October of 1986, the World Health Organization (WHO) changed its policy on jet injector usage. WHO’s highly publicized statement said,

Until further studies clarify the risks of disease transmission associated with jet injectors, general caution in their use is recommended (WHO, 1986).

Their use should be restricted to special circumstances where the use of needles and syringes is not feasible because of the large numbers of persons to be immunized within a short period of time (WHO/UNICEF, 1987).

This change restricted the use of jet injectors to dire situations only.

By 1989, both UNICEF and WHO recommended establishing stricter safety guidelines for jet injectors. One recommendation addressed correcting an inherent problem with jet injectors. “[The] manufacturer must provide evidence that there shall be no reflux of external fluid into the fluid path way after repeated injections,” stated the report (UNICEF/WHO, 1989). Herein UNICEF and WHO identified the inherent problem of fluid suck-back and the risk of virus transmission this posed. It is important to note, fluid suck-back was observed in CDC’s 1977 investigation of the Ped-O-Jet and in CDC’s 1986 investigation of the Med-E-Jet.

As part of an ongoing investigation, the CDC reevaluated the safety of a multi-use nozzle jet injector in the early 1990s. This was the agency’s third investigation into the safety of the devices. Find out what they found – Part 3 – CDC Retests the Safety of Jet Injectors in 1993-94.

 

References:

  • (AFEB, 1978) Armed Forces Epidemiological Board. Proceedings of the Armed Forces Epidemiological Board Ad Hoc Subcommittee on Leishmaniasis. Washington, D.C. 11 April 1978.
  • (Benenson, Joseph & Oseasohn, 1968) Benenson, A.S., Joseph P.R., R.O. Oseasohn. Cholera Vaccine Field Trials in East Pakistan. 1. Reaction and antigenicity studies. Bull. Wld Hlth Org. 1968, 38, 347-357.
  • (Bijkerk, 1986) Bijkerk H. Het risico van ziekte-overdracht via een inentingspistool bestaat. [Risk of Disease Transmission Via Jet Gun Injection is Real]. Ned Tijdschr Geneeskd. 1986 Nov 8;130(45):2050. [article in Dutch]
  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (DHEW, 1972) Department of Health, Education and Welfare, Public Health Service, National Institutes of Health. Status of Immunization in Tuberculosis in 1971; DHEW Publication No. (NIH) 72-68, pp. 185-187. Washington, D.C., 1972.
  • (Federal Register, 1986) Armed Forces Epidemiological Board; Open Meeting. 51 Fed. Reg. 108 (June 5, 1986). Federal Register: The Daily Journal of the United States. 5 June 1986.
  • (Nikolewski & Wells, 1989) Nikolewski RR & Wells RA. “Appendix 3: A List of the Board’s Recommendations from 1955 through 1989.” The Armed Forces Epidemiological Board: It’s First Fifty Years. Available online: http://history.amedd.army.mil/booksdocs/itsfirst50yrs/appendices.html.
  • (UNICEF/WHO, 1989) UNICEF/WHO. Criteria for low-workload jet injectors: May 11, 1989, J. Bish UNICEF and RH Henderson, WHO/EPI.
  • (WHO, 1986) WHO/EPI. WHO/UNICEF Joint Guidelines. Selection of Injection Equipment for the Expanded Programme on Immunization. 1986. WHO/UNICEF/EPI.T5/ 86.27597.
  • (WHO/UNICEF, 1987) WHO/UNICEF. Expanded Program on Immunization-Joint WHO/UNICEF Statement on Immunization and AIDS. 1987. pp 18-19.
  • (Woodward, 1990) Woodward TE. The Armed Forces Epidemiological Board: Its first fifty years. Center of Excellence in Military Medical Research and Education. 1990.

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