September 12, 2017
In 1993, the Center for Disease Control and Prevention (CDC) retested the safety of the most widely-used jet injector—the Ped-O-Jet. The investigation was the agency’s second evaluation into Ped-O-Jet, and third overall evaluation of jet injector devices.
The ongoing investigation into jet guns was prompted by three circumstances: 1) An increased awareness of HIV and viral hepatitis, which had caused a growing fear of virus transmission within the medical community at the time; 2) Two previous CDC investigations (i.e., 1977 and 1986) failed to demonstrate jet injectors were risk free; and 3) Investigations of the Ped-O-Jet in Brazil in 1991 detected blood within the subsequent shots which were not associated with visible bleeding.
“As part of an ongoing epidemiologic investigation of HBV [Hepatitis B] transmission involving use of a jet injector,” wrote lead CDC researcher Dr. Mark Grabowsky in an unpublished study, “we conducted comparative laboratory studies to examine the potential risk of the transmission of bloodborne viruses should the injector become contaminated” (Grabowsky et al., 1994). The findings, although never published, were not kept a secret and an abstract was made known to the public in the Spring of 1994.
Amongst Grabowsky’s team were: Epidemiologists, Dr. Stephen Hadler and Dr. Robert Chen, from CDC’s National Immunization Program; microbiologist, Walter Bond from CDC’s Hospital Infections Program; and epidemiologist Dr. Glaucus de Souza Brito from the Brazilian Ministry of Health.
Many of researchers had previous experience in assessing the safety of jet injectors. Dr. Hadler was a part of CDC’s evaluation of the Med-E-Jet in 1986. Dr. de Souza Brito had extensively used and tested the Ped-O-Jet in Brazil. Most interestingly though, Mr. Bond had been involved within all three of CDC’s safety testing of jet injectors.
In this third evaluation CDC sought “to estimate the risk of bloodborne disease transmission from a jet injector” and to determine if swabbing the Ped-O-Jet injector nozzle had an effect on reducing the risk of transmission (Grabowsky et al., 1994).
It is important to note a major shift in the rhetoric by CDC. As noted above, the CDC stated its purpose was to assess the “risk of bloodborne disease transmission from a jet injector” (Grabowsky et al., 1994). However, four-years prior, CDC researchers Canter and colleagues (1990), recommended “training in the use of jet injectors, and care in cleaning and disinfection procedures to ensure the continued safe use of these instruments” (Canter et al., 1990). Within a time period of four-years, the CDC went from “the continued safe use” of jet injectors to estimating the “risk of bloodborne disease transmission from a jet injector.”
Overview of Study
Unequivocally, CDC knew jet injectors could act as vehicles in the transfer of pathogens. CDC also knew these devices posed a risk especially amongst highly infectious viruses. “It was estimated that viruses that circulate in high titers in blood, such as HBV (10x-8/ml) and LDH virus (10x-7/ml), could be transferred during a procedure if the jet injector were contaminated during use,” stated Grabowsky in reviewing CDC’s 1986 investigation of the Med-E-Jet (Grabowsky et al., 1994).
The time had come to assess how much of a risk the Ped-O-Jet posed. Grabowsky and colleagues used two methods to assess this risk: an Animal Model and a Mathematical Model.
What did Grabowsky’s investigation reveal? CDC’s Animal and Mathematical Models
- (Canter et al., 1990) Canter J, Mackey K, Good LS, Roberto RR, Chin J, Bond WW, Alter MJ, Horan JM. An outbreak of hepatitis B associated with jet injections in a weight reduction clinic. Arch Intern Med. 1990 Sep; 150(9):1923-7.
- (Grabowsky et al., 1994) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes. Unpublished manuscript draft, dated January 3, 1994.