Unsterile Mass Jet Injections: CDC Researchers Divulge Hazards of Ped-O-Jet Injectors During 1960s & 1970s Mass Vaccination Campaigns

During the 1960s and 1970s, the Communicable Disease Center (CDC) sent young men to traverse the globe in a noble effort to control outbreaks and eradicate viruses. Two of the most notable mass vaccination campaigns were the Smallpox Eradication Program and the Measles Control Program. Recently, the CDC has made accessible the interviews of these admirable men reflecting upon their travels. These interviews reveal the true first-hand accounts of how mass vaccination campaigns were conducted abroad and includes information previously not included within scientific studies. Their honesty has been greatly appreciated.

 

“We didn’t really use much sterile technique.”

Researchers recall the lack of sterilization within their interviews.

“The jet injector nozzle actually did press up against the skin,” said Dr. William Foege in a 2006 interview at CDC Headquarters in Atlanta, Georgia. “At that time, people were quite sure that there was no chance of cross-contamination, that the vaccine came out at high pressure, but we’ve subsequently changed our mind about this, and that’s why we don’t use jet injectors at this point” (Harden, 2006a).

Dr. Foege, the former Director of CDC from 1977-83, served in the Smallpox Eradication Program in Nigeria in his early years as a missionary and then as a CDC staffer. During his career he administered tens-of-thousands of jet injections and he now acknowledges that the previous understanding of jet injector safety was incorrect and jet injectors due, in fact, pose a risk of cross-contamination.

Another CDC researcher, Dr. Deane Hutchins, served in CDC’s Smallpox Eradication Program in Nigeria and Sierra Leone. Dr. Hutchins also described lack of sterilization.

I realized that you could train uneducated people to do a health program. For example, these vaccinators that we had had very little education. Sterile technique was still unheard of, and we didn’t really use much sterile technique. We did not clean off arms before people were vaccinated. We told the vaccinators that if they dropped the nozzle of the jet injector on the ground, clean it off with some alcohol or something. They would just brush it off and put it back on. We did studies to see if there were any adverse effects, and there was no significant increase in infections from this lack of sterile technique (Harrar, 2006).

Yet the tests to ascertain any adverse effects from the use of the Ped-O-Jets were not capable of testing for Hepatitis B, Hepatitis C or HIV at the time. In fact, these viruses were still unknown to mankind.

Dr. Stanley Foster, who served in CDC’s Smallpox Eradication Program in Nigeria and Bangladesh, stated in a personal interview with this author, “At that time the question was the effectiveness of the Ped-o-Jet not the risk of infection” (Foster, 2017).

CDC photographs have also captured the lack of sterilization during these vaccination campaigns. The following photograph captures a young child receiving a smallpox vaccination in Nigeria in 1969. Notice the mass vaccination is being conducted within a field and the vaccinator is bare foot. When the jet gun is stowed in the carrying case it rests next to the foot pedal. Therefore, any dirt on the pedal would fall and contaminate the jet gun. Also notice the second vaccinator, who is wearing a hat, is smoking a cigarette while he awaits to give a vaccination.

1969 Smallpox Vaccination in Nigeria - Lack of Sterilization

(Unknown, 1969)

This photograph, captured during a mass vaccination in Nigeria, documented bleeding at the injection site. Notice the young girl in the center of the photo, standing to the right of the vaccinator dressed in a white lab coat. The girl is holding her right bicep after receiving a Ped-O-Jet injection. Now notice the infant being held on the far right side of the image. Upon his bicep is a piece of cotton or cloth tinged with a droplet of blood.

Nigerian parents brought their children for smallpox vaccination

 

Locals Trained to Be Vaccinators

Local healthcare workers were trained in the use of the Ped-O-Jet, as shown in this 1968 photo of Nigerian healthcare workers after a training class. Dr. Hutchins had noted at certain times “uneducated” locals were trained to administer vaccinations (Harrar, 2006).

1968 Ped-O-Jet Training Class in Nigeria

(Unknown, 1968)

 

Speedy Injections

Dr. Foege described the haste at which the immunizations were given.

You set up a rhythm: grab the arm, step on the hydraulic lever, shoot, and the person would continue on. You could do a thousand people an hour, and I remember at one point doing a prison in eastern Nigeria, where they had the inmates lined up, and they were actually pushing them through by hitting them with sticks. I did 600 people in twenty minutes, because it was such a regimented line that you could just grab people and do them so fast. At one point, I recall doing over 11,000 smallpox immunizations in one day. So, yes, you could do this very quickly (Harden, 2006a).

Bob Baldwin, who served as CDC’s Regional Operations Officer in French-speaking West Africa, remembers the chaotic crowds.

I do remember being out there and immunizing kids with a ped-o-jet in each hand, smallpox in this gun and measles vaccine in this gun, and I’m pushing down on the foot pedal for this gun, to charge it and give the kid an immunization, and the other one with the other hand. And they’re crowding around, and crowding to the point where you couldn’t work. The Africans were so afraid that you were going to run out of vaccine, that their children weren’t going to get immunized, that they would just…And so I had to, a number of times I had to stop and just say to the headman or to the chief, you’ve got to get the people lined up, in a line. I can’t work here. I mean, if I can’t work, I can’t immunize them (Diallo, 2006).

Unbeknownst to Mr. Baldwin holding a jet injector in each hand was an improper technique. The vaccinator must hold the jet gun in one hand and use his or her opposite hand to support the vaccinee’s arm as well as to pull the flesh tight to receive a proper vaccination.

 

Frequent Maintenance Repairs

Despite the effectiveness and efficiency of the Ped-O-Jets, the guns required frequent maintenance and repairs.

Dennis Olsen, who served as an Operations Officer for CDC’s Smallpox Eradication Program in Liberia, recalled the vast amount of training that went into learning how to repair the Ped-O-Jet injectors.

I spent a lot of time in training programs because we were using Ped-O-Jet equipment, and so we spent a lot of classroom time in operations maintenance of it. And, of course, we had to wait for supplies to come in (Drew, 2006a).

David Bourne, who assisted in CDC’s mass vaccination campaign in Ethiopia while serving as a Peace Corps volunteer said the jet guns “often broke down especially in the desert” (Decker, 2008).

Another researcher described the poor-quality with which the Ped-O-Jet was made. “Unfortunately, the Ped-O-Jets were not made for the military. They were made for CDC by a firm in New York, and I don’t think they were up to the same quality level,” said Jay Friedman, who served as CDC’s Operations Officer in the West African nations of Mali, Gabon, and Nigeria (Drew, 2006b).

However, Mr. Friedman is misinformed. The Scientific Equipment Manufacturing Corporation (SEMCO) manufactured both the electric model known as the Multidose, and the non-electric foot pedal known as the Ped-O-Jet. When SEMCO sold-off the devices to Vernitron Medical Products, both devices were still manufactured under one company. Moreover, the U.S. military not only invented but also used both the electric and foot-operated models. Therefore his assumption that the jet injectors were not being made to the same quality is inaccurate. His personal testimony about the functioning of the Ped-O-Jet injectors and the quality of their parts, however, carries valuable weight and insight.

Mr. Friedman continued to say,

The guns would break-not so much break, as their internal valves and springs would wear out or get stuck. The nozzles would clog, for which we had special wires to ream them out. And especially the pedal, the pedal pump. I think they were made of aluminum with Teflon O-rings acting as piston rings. And this aluminum, being a soft metal, would wear out very quickly. Being an ex-mechanic, I had to fix them all the time, although I trained Malians to work on them, which is not very difficult. And we spent a lot of time fixing these Ped-O-Jets. In fact, in Mali, we had 1 guy, a vaccinator, assigned full-time to work on Ped-O-Jets that were being used out in the field. So we had to transport them back to the capital to have this guy work on them. The simple repairs could be done in the field. But any time the pedal pump broke, you had to send it in. You had to re-machine the whole piston when that happened… (Drew, 2006b).

The following CDC photograph shows Operations Officer, Lloyd Wade, repairing a Ped-O-Jet in 1967 while smoking a cigarette.

1967 Ped-O-Jet Repair While Smoking Cigarette

(Robbins, 1967)

 

“Lack of good communication…”

Bob Baldwin also recalled how the Ped-O-Jets would breakdown and the urgency of acquiring the parts to fix the guns for the next campaign.

…the lack of good communications in those days. I mean, back and forth to where you needed, either to alert people that you were coming to a certain village on a certain day to immunize, or it was communicating to Lagos, to the site we needed certain ped-o-jet parts, because, you know, 10 of our guns are down, and we really need these for the next campaign, and the rainy season is coming, and we need them tout suite, you know, right away (Diallo, 2006).

Dr. Ralph Henderson, who served as CDC’s Deputy Director of the West African Smallpox Program and later served as an Assistant Director General for the World Health Organization’s Expanded Immunization Program, described the troubles of getting Ped-O-Jet parts and the lack of supplies.

One of my problems as advisor was firing off cables about getting spare parts for the jet injectors. They kept running out of some tiny points-I didn’t know what they were, but I think that on a regular engine they’d be called the points. They relate to the electrical system. Forget it. But that’s all I knew. And I knew that they were burning out, and they couldn’t get spare parts. So one of my jobs as a technical advisor, very technical, was to send cables back saying, “Send more of these things because they can’t run the injectors.” Nor did CDC send enough diluent, so we were often using Evian, one of the French bottled waters, as diluent for the measles vaccine (Harden, 2006b).

 

Conclusion

These interviews give us several insights. For instance, we gain: 1) knowledge of what the CDC thought of jet injectors during the 1960s; 2) knowledge of how jet injectors were administered, and 3) knowledge about the performance of Ped-O-Jet injectors.

During the 1960s the CDC assumed the high velocity of the jet stream would not allow any cross-contamination. A common idea of the time that since there was no needle there was no risk. Although no safety test was conducted to confirm this assumption. As Dr. Foster stated, “At that time the question was the effectiveness of the Ped-o-Jet not the risk of infection.” However, as Jet Infectors has previously reported, the CDC first evaluated the safety of jet injectors in 1977 and found cross-contamination was possible.

The CDC researchers interviewed now admit there was no sterile technique when using the Ped-O-Jet. Bill Foege, the former Director of the CDC, acknowledged the Ped-O-Jet allowed for cross-contamination. Other interviews revealed vaccinators failed to sterilize the nozzle after accidentally dropping the Ped-O-Jet on the ground. Photographs captured vaccinators smoked cigarettes when performing inoculations and maintenance on the jet gun.

In numerous interviews are evidence that vaccinators used the Ped-O-Jet improperly. In one instance, a vaccinator held a jet gun in each hand, which means he failed to support the arm of the vaccinee and thus the injection was administered incorrectly. Several interviews reported vaccinators administered thousands of injections within a short time. Administering 600 jet injections in twenty minutes would mean an injection was given every two seconds (one second for the vaccination and another second for the next person in line to step-up). This demonstrates the vaccinator failed to hold the jet gun against patients’ arms for a full three seconds as per the manufacturer’s recommendation. In one instance, vaccinators used Evian water in the absence of diluent, yet the effectiveness of such an on-the-fly concoction was never previously tested.

The interviews also document numerous maintenance issues. Mr. Friedman noted the shoddy quality with which the Ped-O-Jets were made. The nozzle often became clogged and required being “reamed” out with a wire brush, thus potentially damaging the nozzle orifice. Moreover, the wearing of O-rings and the destruction of the aluminum foot-pedal demonstrate these Ped-O-Jet injectors were used beyond their intended life span.

Whether used within mass vaccination campaigns or within the United States military, Ped-O-Jets were assumed safe, administered by vaccinators with limited training, conducted in haste, at times improperly used, and faced frequent maintenance issues.

 

Note:
In no way is this article to assign blame to any of the CDC researchers interviewed, to the CDC in general or to the local volunteers who partook within the vaccination campaigns. At the time, knowledge of blood-borne pathogens was primitive. This article is purely to document how the Ped-O-Jet injectors were used and to gain a better understanding of what the CDC knew and thought of jet injectors throughout the 1960s and 1970s.

 

References:

© Shaun Brown and Jet Infectors, 2016 – 2017
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PATH’s Fluorescein Testing on Ped-O-Jet Injectors

The Program for Appropriate Technology in Health (PATH), funded by the Bill and Melinda Gates Foundation, has been a major contributor in the development of safer jet injection technology. Although during the development of safer, next generation jet injectors, PATH needed to assess how bad were the Ped-O-Jet injectors.

Around 2003-2004 PATH conducted a “simple” test to assess the safety of the HSI-500, a prototype jet injector manufactured by Felton International, Inc. The “simple” test was an in vitro fluorescein contamination test, which made any contamination visible due to the use of a fluorescein dye. The highly concentrated fluorescein dye was used as a surrogate for high titer Hepatitis B infection (FDA, 2005).

PATH - Example of a Positive Fluorescein Sample

(Zehrung, 2003)

“The fluorescein assay really exceeds the PCR [polymerase chain reaction] methods in terms of a detection limit,” explains Darin Zehrung, the Associate Technical Officer at PATH. “So it’s very sensitive, it’s very specific in terms of an assay. And we believe a good surrogate aside from human testing to demonstrate cross-contamination safety” (FDA, 2005).

For this experiment PATH used the Ped-O-Jet injector as a comparative model. The HSI-500 and the Ped-O-Jet injector were both sterilized and administered an injection into a test fixture containing a fluorescein dye. Each of the jet injectors then fired the subsequent shot into vials and the ejectates were evaluated. The threshold for contamination was defined as detection of more than 10 picoliters within the 0.5 cc sample. Results for the Ped-O-Jet found 75 out of 100 (75%) samples contained more than 10 picoliters of fluorescein. Results for the HSI-500 found no contamination (Zehrung, 2004). These results indicated the Ped-O-Jet cross-contaminated a sufficient volume of fluorescein from the infected host to the next dose.

PATH had conducted performance and safety evaluations on the Ped-O-Jet, as noted within these pictures. Note in the photograph on the right, a drop of fluid remains on the nozzle tip post-injection.

PATH's Performance Testing of Ped-O-Jet

(Zehrung, 2003)

 

In March of 2004, PATH attended a CDC/WHO conference on jet injector safety which focused on establishing safety requirements for disposable-cartridge jet injectors. The meeting delved into evaluating several unknown factors. “The questions are how infectious is blood? How do we measure it? How do you model the risk? What level of risk is acceptable?” (FDA, 2005). Members of the conference were in agreement that quantities smaller than 10 picoliters could be infectious.

Based upon this conclusion, PATH altered the threshold of contamination from 10 picoliters to 0.04 picoliters. PATH conducted their fluorescein test a second time using the new 0.04 picoliter threshold level. Results demonstrated cross-contamination with the Ped-O-Jet but no cross-contamination with the HSI-500 jet injector.

Mr. Zehrung explained the results of the experiment in detail at a 2005 FDA conference on jet injector safety. For reasons unknown Mr. Zehrung refers to the Ped-O-Jet as a “first generation MUNJI device.” Although in other sources, he disclosed this was in fact the Ped-O-Jet injector (Zehrung, 2003; Zehrung, 2004).

Mr. Zehrung: So you may not be able to see these pictures. This is a first generation MUNJI device. I think that those are familiar with these technologies know what that device would be called. And you can see after injection into the test fixture, there is contamination at the injection site. There’s a combination of splash back as well as contact contamination during the injection process. You see that it’s contaminated with the fluorescein dye.
The same is true for the protector cap injector. This is the protector cap on the nozzle face itself.  It’s hard to see in this photo, but this protector cap post injection into the test fixture is also contaminated. But the down stream sample collected after injection into the text fixture is demonstrated to be free of cross- contamination.
Next slide.
So this is a slide showing the comparison of first generation MUNJI testing with this method versus a protector cap injector. These are the number of samples. So for a 100 samples with the first generation MUNJI device, all were contaminated, a 100 percent with an average contamination rate of 268 picoliters. In comparison with the protector cap injector for 300 samples, all samples were free of cross-contamination (FDA, 2005).

This is worth repeating. Mr. Zehrung presented images from the test which demonstrated the Ped-O-Jet as well as the injection site were both contaminated with fluorescein dye. This type of contamination is known as splash-back. The protector cap for the PCNFI was also contaminated with fluorescein. These results demonstrate that no matter the model or generation of jet injector gross-contamination upon the injection site and the nozzle are natural phenomenon of jet injection.

Results of the Ped-O-Jet found contamination in 100 out of 100 (100%) of the samples. The average volume of fluorescein contamination within the ejectates was 268 picoliters. This shows gross cross-contamination by the Ped-O-Jet. Mr. Zehrung stated of these results, “we believe that this [i.e., the fluorescein testing] is a very useful and powerful method to demonstrate contamination risk with the earlier devices” (FDA, 2005).

PATH’s fluorescein testing of the Ped-O-Jet further illuminates the degree of contamination these devices posed.

References:

  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Zehrung, 2003) Zehrung D. PATH’s Experience from Jet Injector R&D and Field Assessment in Developing Countries. Presentation for Innovative Administration Systems for Vaccines. Rockville, Maryland. 18 December 2003.
  • (Zehrung, 2004) Zehrung D. Jet Inject for Mass Immunization: Design Update and Safety Testing Strategy. Presentation for Global Vaccine Research Forum. 10 June 2004.

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

 

Experts Claim Cases of Jet Injector Transmission Would Not be Documented

Numerous professionals have stated it would be difficult to impossible to document transmission via jet injectors. Hepatitis C most often progresses asymptomatically and would not be detectable without ongoing active surveillance. However, Hepatitis C was not identified until 1989 and a test to identify the virus was not created until 1992, therefore it would have been impossible to document any incidents of transmission before 1992.

  • Dr. Bruce Weniger, formerly the Lead Researcher on Vaccine Technology within the CDC and known as Mr. Jet Injection, is one of, if not the, leading expert on jet injectors. In Dr. Weniger’s professional opinion, he states,

MUNJIs are inherently unsafe. Their re-use without intervening sterilization of fluid pathways which may be exposed to patient blood or tissue fluid violates established principles that apply to other critical medical devices. One cannot rely of the absence of documented cases of disease transmission beyond the California outbreak. It is unlikely that routine post-marketing surveillance would link sporadic cases to prior MUNJI use (Weniger, 2005).

  • In 1977 the Hepatitis Laboratories Division of the Center for Disease Control secretly conducted safety testing upon the Ped-O-Jet injector. The researchers called for “specifically designed prospective seroepidemiologic studies” to assess the risk of hepatitis transmission via jet injectors (CDC, 1977). Yet no one heeded the call.
  • In 1994 researchers within the CDC retested the safety of the Ped-O-Jet Injector. They noted, “The detection of rare, silent transmission would have been difficult, however, and likely to have been missed without active surveillance” (Grabowsky et al., 1994). Therefore, just because there were no documented cases does not mean transmission of blood-borne pathogens did not occur.
  • In 1996 the CDC and WHO held a conference on jet injector safety, in which participants had noted, “For an asymptomatic infection like hepatitis B, serosurveys would be required to detect transmission of the virus; in the absence of such data, it is impossible to state with any assurance that transmission has not occurred” (Fields, 1996). Hepatitis C most often progresses asymptomatically as well and therefore would not be detectable without ongoing active surveillance.
  • The Armed Forces Epidemiological Board, which is an expert advisory board of civilian physicians and scientists that assists the Department of Defense with medically related issues, stated within a January 9th of 1998 memorandum that no active prospective surveillance studies have been performed to uphold the safety record of jet injectors (AFEB, 1998).

References:

  • (AFEB, 1998) Armed Forces Epidemiological Board. Recommendation on Jet Injectors. AFEB (15-1a) 98-6. January 9, 1998.
  • (CDC, 1977) CDC. DHEW Memorandum: Informal Quarterly Report of October-December 1977. From: Special Investigations Section (Petersen NJ, Bond WW, Carson LA) to: Deputy Director (Favero MS), Hepatitis Laboratories Division, Phoenix, AZ (unpublished).
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (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.
  • (Weniger, 2005) Weniger B. Safety of Multi-use-nozzle Jet Injectors (MUNJIs) for Bloodborne Pathogen Cross-contamination [draft]. Conference Notes. 7 August 2005.

 

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Dr. Sabin Warned of Hepatitis Risk From Jet Injectors in 1976

Dr. Albert Sabin, the creator of the oral polio vaccine, warned jet injectors could spread hepatitis in 1976. Several newspapers had reported upon Dr. Sabin’s comments.

During a meeting amongst health professionals planning a mass vaccination campaign for swine flu, Dr. Sabin interrupted a speaker to voice his concerns.

The York Daily Record reported in 1976, “Sabin…stood up during a speech by state epidemiologist Dr. Richard Parker to challenge the state and national strategy against swine flu.”

The article further stated, “Sabin also warned jet-injector guns could possibly spread disease during a mass immunization campaign” (York Daily Record, 1976).

In response to Dr. Sabin’s comments, the CDC purported that jet injectors are safe to use. The Salt Lake Tribune printed the following:

Defends Jet Gun Safety
Jet injector guns, which can inoculate up to 800 persons an hour, were being used in the immunization clinics. The CDC said that contrary to a charge by Dr. Albert Sabin, the discoverer of oral polio vaccine, the jet guns are safe to use and do not transmit any disease such as hepatitis (Salt Lake Tribune, 1976).

Yet the CDC did not conduct any safety testing upon the jet injector until 1977, in which the Hepatitis Laboratories Division did find the transmission of hepatitis via jet injectors was possible. See article – CDC’s Unpublished Jet Injector Studies – Part I

Dr. Sabin, like several others during his time, was correct to question the safety of jet injectors.

  • In 1962, the Eli Lilly Company warned, “If the nozzle becomes contaminated with blood or serum, it should be replaced or resterilized before further use to prevent the transmission of serum hepatitis virus or other infectious agents from one person to another.” See article – 1962 – Eli Lilly Warns of Hepatitis Transmission Via Jet Injection
  • In 1967, Dr. Sol Rosenthal studied the transference of blood between consecutive vaccinees when using a jet injector. Dr. Rosenthal stated, “It was reasoned that if the detection of the transference of erythrocytes (hemoglobin) or serum could be assayed, one might infer that the parenteral hepatitis agent would likewise be transferred” (Rosenthal, 1967).
  • In 1970, M.G. Kremer raised concern over the cross-contamination of serum hepatitis from jet injectors in the British Medical Journal. Kremer wrote, “The injector is not sterilized between injections, and in many cases it produces a small amount of bleeding at the injection site. The injector could thus become contaminated with blood, thus transmitting, for instance, hepatitis virus to subsequent patients” (Kremer, 1970).
  • During a 1971 National Institute of Health conference on tuberculosis vaccinations, the consensus from members was jet injectors do produce blood during the administering of vaccination and the possibility of transferring hepatitis cannot be excluded (DHEW, 1972). See article – 1971 NIH Conference Recognizes Bloody Jet Injectors Pose Risk For Hepatitis

 

References:

  • (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.
  • (Kremer, 1970) Kremer MG. Jet vaccination [letter]. Brit Med J 1970; 4:303.
  • (Rosenthal, 1967) Rosenthal SR. Transference of blood by various inoculation devices. Am Rev Respir Dis. October 1967; 96(4):815-819.
  • (Salt Lake Tribune, 1976) Salt Lake Tribune. Swine Flu Drive Moves With Few Side Effects. Salt Lake City, Utah. 3 October 1976. pg. 2.
  • (York Daily Record, 1976) York Daily Record. Dr. Sabin Opposes Mass Swine Flu Shots. York, Pennsylvania. 23 September 1976. pg. 2.

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FDA Reviews Jet Injector Safety

Following the 1996 CDC/WHO conference, the FDA initiated a hearing to review the safety of multi-use nozzle jet injectors (MUNJIs). The timeline below shows FDA’s two hearings on jet injector safety, which eventually led to the development of a guidance document.

 

1999 FDA Hearing – Guidance Development For Jet Injectors
In August of 1999, the FDA held its first ever hearing on jet injector safety. The purpose of the panel discussion was to develop a guidance document and identify regulatory standards to help improve the jet injection industry. Amongst the attendees were members of the FDA, Dr. Bruce Weniger of the CDC, PATH, and several jet injector manufacturers.

Dr. Charles Edmiston, associate professor of surgery at Medical College of Wisconsin, served as Chairman of the panel discussion. Dr. Edmiston stated, “we need to keep abreast of how this technology may actually be responsible for transmitting infections in the future, like hepatitis C.” (FDA, 1999).

The panel heard presentations on jet injector use over the last fifty-years, and forty-years of research demonstrating the risk of transmitting infectious pathogens.

Only one attendee upheld the safety of MUNJIs. Robert Harrington, former CEO and President over the Ped-O-Jet, shouted from the audience, “It was used by the Army for 35 years and it [the jet injector nozzle] 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.” Jet Infectors has since presented evidence demonstrating Mr. Harrington’s comments were outright lies. (See article – Improper Military Jet Injector Vaccinations)

At the conclusion of the conference, the panel gave two recommendations: 1) To continue post market surveillance on the use of MUNJI devices. Post market surveillance monitors the safety of a device, such as a jet injector, after it has been released for public use. 2) To explore creating a standardized method for testing the safety of jet injectors (FDA, 2005a).

Despite the in depth discussions no regulatory changes or guidance document resulted from this conference.

 

2005 (Aug 9) FDA Hearing – MUNJI Safety
The FDA held a second hearing on the safety of MUNJI devices. The meeting was a long overdue extension of the first conference.

Present were members of various departments within the FDA, also Dr. Martin Friede from the WHO, representatives from PATH and other industry consultants and organizations. [Dr. Weniger of the CDC was scheduled to attend but had to cancel.]

The primary focus of the meeting was to “discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors” (Federal Register, 2005), which was one of the recommendations given at the 1999 hearing.

The hearing had been the most comprehensive discussion yet on the risks of MUNJI devices. Dr. Friede of the WHO gave an explicit presentation on the inherent design faults of MUNJIs, presented numerous studies that evaluated cross-contamination and addressed how those studies upheld to later advances in science (FDA, 2005a).

The panelists also addressed pertinent questions such as the adequate volume of blood for transmitting viruses and whether an acceptable level of risk exists when using MUNJIs (FDA, 2005b). Many of the questions had already been discussed within a WHO/CDC meeting held in 2004 but were reiterated for the FDA panel members.

No conclusions were reached by the end of the hearing. The FDA advisory committee did not release a draft guidance on jet injectors until 2009.

 

2009 FDA Draft Report – Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
In 2009, the FDA published a draft guidance on needle-free devices for public review and comment. The publication was the first ever guidance document for needle-free devices. Previously multi-use nozzle jet injectors circumvented regulatory standards. Devices developed prior to the 1976 regulation of medical devices were “grandfathered” onto the market. Jet injectors developed after the enactment of the 1976 law cleared regulation on the basis that they were substantially equivalent to multi-use nozzle jet injectors already on the market (Weniger & Papania, 2013). These loopholes allowed MUNJIs to bypass safety testing in the past.

FDA’s draft document served as an instruction manual for those submitting a pre-market application for needle-free devices. The document discussed design features, construction materials, performance testing, sterility issues and product labeling. Applicants finally knew what information the FDA wanted in order to be granted pre-market approval of a prototype.

The draft document acknowledged the risk of cross-contamination with jet injectors and advised against development of such reusable devices. The FDA stated,

Disease transmission may result from cross-contamination in reusable needle-free injectors, e.g., Multi-Use-Nozzle Jet Injectors (MUNJIs). There is a potential for disease transmission when blood contamination of the fluid path or injectable product occurs during a previous injection. Contamination can occur on the skin-contacting surface of the injector or inside the injector from splash-back. It is also possible that the replaceable cap may become contaminated…FDA generally recommends against developing injectors that require between-use cleaning of any component in or around the fluid path (FDA, 2009).

 

2013 FDA Report – Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
In June of 2013 the FDA published its final version of the guidance document for needle-free devices. FDA received several comments on the 2009 draft guidance, which led to several changes.

One such change was the heightened language in the section cautioning against the use of multi-use nozzle jet injectors due to the risk of cross-contamination. The final version stated,

The vast majority of injectors are approved or cleared for single patient use. In general, multi-patient use injectors (e.g., reusable needle-free Multi-Use-Nozzle Jet Injectors) raise significant concerns for the risk of blood born pathogen and skin contaminant transmission from patient to patient. For example, there is a potential for disease transmission when blood contamination of the fluid path or the injectable product occurs during a previous injection. Contamination can occur on the skin-contacting surface of the injector or inside the injector from splash-back. It is also possible that the replaceable cap may become contaminated. In addition, in-between use cleaning of any component in or around the fluid path may result in contamination (emphasis added) (FDA, 2013).

Here the FDA clearly advises against the use of multi-use nozzle jet injectors due to significant concerns of cross-contamination of blood-borne pathogens between patients.

 

Conclusion
FDA’s 1999 and 2005 hearings eventually led to the development of a guidance document for premarket submissions of needle-free devices. Ultimately the FDA discouraged the use of MUNJIs due to “significant concerns” of blood-borne disease transmission. By 2013 disposable-cartridge jet injectors were standardized for administering immunizations.

Following the 1999 hearing, the FDA was to continue post market surveillance of MUNJIs devices. Personally, I question how involved was this post-market surveillance. It is my presumption that the FDA only assessed complaints filed under their reporting system known as MedWatch. The FDA should have been in communication with the Department of Defense and Department of Veterans Affairs to inquire if soldiers and veterans, who were the largest population subjected to jet injectors, had experienced any adverse effects or if any large outbreaks, such as Hepatitis C, had emerged.

Lastly and most interestingly, despite the vast amount of information presented on the inherent risks of MUNJIs within these two hearings, the FDA never sought a ban on MUNJI devices. In 2013, I sought clarification on this issue. The FDA stated,

According to FDA’s updated communication on the use of jet injectors to deliver vaccines, data to support their safety and effectiveness have not been submitted to the FDA for evaluation. However, the FDA has not “banned” them. [Full copy of letter here.]

One would wonder, if a medical device has been discouraged due to significant concerns why not impose a ban?

 

References:

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

Inherent Faults of the Ped-O-Jet

In reviewing research on the safety-testing of the Ped-O-Jet, the faults of this widely-used device have emerged. These are issues extending beyond the complaints of the Ped-O-Jet being too heavy for delivering hundreds to thousands of inoculations, issues with the nozzle orifice clogging too easily and the gun’s necessary need for routine maintenance. Without question such performance issues would affect the safety of the device. However, we are focusing on the inherent faults that prevent the Ped-O-Jet from ever being called safe.

Jet Infectors - Ped-O-Jet Diagram

(Ismach, 1978)

 

I. Wiping the external surface of the Ped-O-Jet’s nozzle did not prevent cross-contamination. Whether the nozzle was wiped or not wiped transmission of relevant volumes of blood capable of transmitting blood-borne pathogens were observed (Grabowsky et al., 1994; Hoffman et al., unpublished). This was due to a phenomenon called retrograde flow.

 

II. Retrograde Flow. During the end of jet injection process, the pressure of the jet stream impinging the skin would be less than the pressure of the fluid deposited within the newly constructed hole in the vaccinee’s arm. Since the jet stream was too weak to further deepen the hole, the deposited fluid moved backwards and flowed out of the hole and back into the jet injector. This would be an undesirable, yet expected phenomenon in almost every jet injection due to the continuous depletion of pressure.

  • Joy Baxter and Samir Mitragotri both described the mechanical workings of jet injection in their 2006 paper. Baxter, a researcher for Unilever Research and Development, and Mitragotri, a chemical engineer at Harvard University, wrote, “Backflow of the jet is observed during hole formation if the volumetric rate of hole formation in the skin is smaller than the volumetric flow rate of the jet liquid into the skin” (Baxter & Mitragotri, 2006).
  • In 1997 the World Health Organization (WHO) hypothesized of retrograde flow as preliminary data from safety tests were reported. The WHO stated,

contamination of the fluid path occurs along the jet-stream at the end of the shot when pressures in the liquid column at the site of the injection begin to exceed the pressures at the injector head…Similar conclusions can be reached from the results of parallel tests in-vitro on the PED-O-JET (now AM-O-JET) at the Programme for Appropriate Technology in Health (PATH – USA). These tests confirmed a correlation between the extent of contamination and the level of back-pressure in simulated skin models (WHO, 1997).

  • Peter Hoffman studied cross-contamination via jet injectors at the request of the WHO and found retrograde flow within his laboratory investigations of the Ped-O-Jet. Hoffman stated,

some of the liquid injected form[ed] a pocket below the injection site. This will be under maximum pressure towards the end of the injection process, before sufficient dispersion into surrounding tissues has occurred to release pressure. This will coincide with a lessening of pressure from the injector. When the pressure from the injector is exceeded by the back-pressure from the tissue pocket, backflow through the pathway in the skin created by the injector could occur. This liquid will contain blood from the destruction of small blood vessels during the injection process and can have different pathways after it has emerged from the skin according to the type of injector. Injectors that have direct skin contact will form a continuous fluid pathway between the skin and injector. As the outward pressure from the injector dies away at the end of an injection, back-pressure from the fluid in the tissue pocket will cause blackflow out of the skin to inside the injector’s fluid pathway (Hoffman et al., 2001).

  • In quoting Rebecca Voelker who paraphrased it so simply, “Hoffman said jet injection builds pressure in the skin that is greater than the pressure in the injector, causing a small backflow of blood onto the device” (Voelker, 1999).
  • In 1977, researchers Philip Neufeld and Leon Katz from the Bureau of Medical Devices at Canada’s Department of National Health and Welfare studied the Ped-O-Jet. The researchers noted “a low-pressure ‘tail’ at the end of the injection” (Neufeld & Katz, 1977). Here is evidence that low-pressure at the end of the injection existed in the Ped-O-Jet in the 1970s during the height of this device. The low-pressure at the end of the injection indicates the likelihood of retrograde flow, in which the vaccine, commingled with blood, went back into the Ped-O-Jet.

 

 

III. The Ped-O-Jet’s check-valve did not prevent fluid and blood on the nozzle tip from being sucked back into the internal fluid pathway and drug reservoir.

Close-up of the Ped-O-Jet Nozzle

 

Ped-O-Jet Ball Check Outlet Valve #44(Ismach, 1962)

  • Inventor of the Ped-O-Jet, Aaron Ismach, stated within his 1962 patent that his invention is “free from danger of sucking fluid back from a patient either during or after the firing cycle is completed so that the danger of cross-infection is almost completely avoided” (Ismach, 1962). His assertion reveals MUNJIs faced issues with check-valves. Subsequent researcher has revealed the Ped-O-Jet was no exception to this inherent design fault.
  • In 1977, CDC’s Hepatitis Laboratories Division conducted safety testing on the Ped-O-Jet. The researchers observed a drop of fluid remained on the injector nozzle after firing and would disappear back into the nozzle orifice within 3 to 5 seconds. The researchers concluded, “These manipulations causing disappearance of the fluid drop are common during clinical use of the jet injector” (CDC, 1977).
  • In 1994, the CDC retested the safety of the Ped-O-Jet. After artificially contaminating the underbelly of a shaved rabbit with Hepatitis B surface antigen (HBsAg), a sterile Ped-O-Jet was placed upon the site and administered an injection. The subsequent injection was fired into a vial and tested for HBsAg. The results found the ejected fluid of the next shot fired was positive for HBsAg in 19 out of 50 (38%) of the samples (Grabowsky et al., 1994). Cross-contamination of HBsAg from the skin surface to the ejectate of the subsequent shot was due to either fluid suck-back or retrograde flow.
  • The CDC collaborated with American Jet Injector Corporation and the University of Florida to test the safety of the Am-O-Jet, a MUNJI device. The Am-O-Jet was an identical design of the Ped-O-Jet. Within this study the researchers admit the check-valve had been redesigned; thus further implicating the inherent design faults of previous Ped-O-Jet models. It is noteworthy to add, the researchers found rates of contamination were significant with the Am-O-Jet (Sweat et al., 2000).

 

IV. Every time the Ped-O-Jet became contaminated it remained contaminated for the following two consecutive shots. This means once the Ped-O-Jet became contaminated with blood, the next two people in line would be exposed to that blood. Once the Ped-O-Jet became contaminated with a blood-borne pathogen, the next two people in line would be exposed to that blood-borne pathogen.

Transmission

  • CDC’s 1977 investigation of the Ped-O-Jet found, after the nozzle was contaminated, the ejected fluid of the next shot fired was positive for HBsAg in 4 out of 5 (80%) of the samples. The second shot fired after the nozzle was contaminated was positive in 3 out of 5 (60%) of the samples. The third, fourth and fifth shots fired were all negative. These results indicated that once the Ped-O-Jet became contaminated it remained contaminated for the next two consecutive shots (CDC, 1977).
  • CDC’s 1994 investigation of the Ped-O-Jet administered a sterile injection to the underbelly of a HBsAg-contaminated rabbit and then administered a subsequent shot into five vials. The test was repeated 10 times. So each test consisted of five samples and ten tests were conducted creating a total of 50 samples. The researchers only reported that 19 of the 50 samples were HBsAg-positive indicating that more than just the first shots were contaminated. We can presume that all ten of the first shots were positive and therefore nine of the seconds shots tested were positive (Grabowsky et al., 1994).
  • In WHO’s 1998 field trial in Brazil, researchers administered a Ped-O-Jet injection to patients infected with Hepatitis B and Hepatitis C. After administering an injection, the subsequent three injections were fired into three separate vials. Results found that 13 out of 117 (11.1%) of the subsequent first shots contained more than 10 picoliters of blood. Results of the second “shot” found 4 out of 117 (3.4%) of the samples were positive and the third “shot” found no contamination (Hoffman et al., unpublished).

 

V. In studies upon humans, cross-contamination of blood occurred via the Ped-O-Jet despite the lack of visible bleeding at the injection site or any visible blood contamination upon the Ped-O-Jet’s nozzle.

  • The Brazilian Ministry of Health conducted a study to assure the safety of the Ped-O-Jet during routine military vaccinations in 1991. The researchers found, “there was little to no correlation between visible bleeding and detection of occult blood in the successive vaccine doses. Only one person had both” (de Souza Brito et al., 1994; de Souza Brito, 1996). There was no visible bleeding at the injection site in 27 out of 28 (96.4%) of the ejectates which contained blood, indicating blood transferred within microscopic levels not visible to the human eye.
  • In 1998 the WHO chose to replicate the Brazilian study. In this field trial, human volunteers infected with Hepatitis B and Hepatitis C received an injection with a Ped-O-Jet injector. There was no visible bleeding at the injection site in 14 of the 29 (48.2%) of the ejectates which contained blood. Of which 11 samples of no visible bleeding were the first shot after becoming contaminated and 3 samples were the second shot after becoming contaminated (Hoffman et al., unpublished).

This same phenomenon has been observed within other jet injector models. Even though these other studies did not use the Ped-O-Jet, they establish the occurrence of cross-contamination despite the lack of visible bleeding is an established and systemic phenomenon associated with jet injection.

  • In a Dutch study, researchers assessed the degree of cross-contamination after using a Med-E-Jet injector on mice chronically infected with lactic dehydrogenase (LDH) virus (a highly infectious pathogen). Results found 16 out of 49 (33%) mice became infected with the LDH virus after receiving injections from a Med-E-Jet injector. Most shockingly, researchers observed “post-injection bleeding was relatively uncommon,” occurring in only two out of 49 (4%) of the mice. Assuming the two bleeders were amongst the mice who became infected with LDH, indicates at least 14 out of 16 (88%) of the mice became infected despite the lack of visible bleeding (Brink et al., 1985).
  • A field trial for a protector cap needle-free injector, known as the HSI-500 and as the JIMI, upon humans infected with Hepatitis B found the Hepatitis B virus was cross-contaminated regardless of the single-use protector cap being placed over the nozzle. The study also found, there was no visible bleeding at the injection site in 7 out of the 17 (41.1%) injections that tested positive for Hepatitis B. This indicates that cross-contamination of Hepatitis B virus successfully occurred within microscopic levels of blood not visible to the human eye. This study also demonstrated that Hepatitis B was able to permeate the single-use protector cap and enter the jet injectors internal fluid pathway (Kelly et al., 2008).

 

These inherent faults, as described above, are evidence the Ped-O-Jet allowed cross-contamination of blood and blood-borne pathogens between subsequent vaccinees. The Ped-O-Jet was not superior to any revival device but suffered the same undesirable effects that impacted all jet injectors.

 

References:

  • (Baxter & Mitragotri, 2006) Baxter J, Mitragotri S. Needle-free liquid jet injections: mechanisms and applications. Expert Rev Med Devices Sep 2006;3(5):565-74.
  • (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.
  • (CDC, 1977) CDC. DHEW Memorandum: Informal Quarterly Report of October-December 1977. From: Special Investigations Section (Petersen NJ, Bond WW, Carson LA) to: Deputy Director (Favero MS), Hepatitis Laboratories Division, Phoenix, AZ (unpublished).
  • (de Souza Brito, 1996) de Souza Brito G. Multi dose jet injectors and safety aspects in Brazil. CDC & WHO Meeting on Jet Injectors. Atlanta, October 2-3, 1996. (communication paper).
  • (de Souza Brito et al., 1994) de Souza Brito G, Chen RT, Stefano IC, Campos AM, Oselka G. The risk of transmission of HIV and other blood-born diseases via jet injectors during immunization mass campaigns in Brazil. 10th International Conference on AIDS, Yokohama, 7-12 August 1994;10(1):301 (abstract no. PC0132, http://www.aegis.com/conferences/10wac/pc0132.html).
  • (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.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunisation. Vaccine. 16 July 2001;19(28-29):4020-4027.
  • (Kelly et al., 2008) Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.
  • (Neufeld & Katz, 1977) Neufeld PD & Katz L. Comparative evaluation of three jet injectors for mass immunization. Canadian journal of public health, 1977, 68: 513-516.
  • (Sweat et al., 2000) Sweat JM, Abdy M, Weniger BG, Harrington R, Coyle B, Abuknesha RA, Gibbs EP. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids. Ann NY Acad Sci 2000;916(31):681-682.
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA May 26, 1999;281(20):1879-1881.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection, Geneva, 18-19 March 1997. Geneva: World Health Organization, Global Programme on Vaccines and Immunizations, document, 1997;1-37.

 

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

1966 CDC Oblivious to Risk of Bleeding During Smallpox & Measles Ped-O-Jet Vaccinations

In 1966 the Center for Communicable Diseases planned a mass smallpox and measles vaccination campaign in Western and Central Africa. The 259-page “Manual of Operations” thoroughly planned and strategized for a mass vaccination in a foreign land, chartering unknown territory. The manual reveals what CDC knew and thought about jet injectors during the 1960s.

Documented within the pages are several references to bleeding following jet injections:

  • pg. 31 “An individual will be required who can wipe off excess smallpox vaccine from the vaccination site, who might also dispense cotton when local bleeding occurs.”
  • pg. 36 “There might also be a further gap of 15-20 yards between the injection area and the area where cotton, vaccination certificates, etc. are dispersed.” The mention of cotton is indicative of bleeding following the jet injection.

However, the most incriminating portion of the manual, on page 38, shows CDC was oblivious to the risk of bleeding during the mass vaccination campaigns.

Post-vaccination Swabbing
Following intradermal injection there is frequently a residue of vaccine remaining on the skin surface which may run down the arm and after intradermal and particularly subcutaneous injection, there may be some temporary bleeding at the site of inoculation. Bleeding is of little consequence except that it is occasionally alarming to the vaccinee, but a residua of smallpox vaccine on the skin surface is undesirable because of the possibility of autoinoculation or spread of virus to others and to the environment in general.

For these reasons, cotton or other absorbent material should be part of the routine supplies of an operating field team. A local volunteer can be assigned the task of swabbing the vaccination sites and dispensing cotton to vaccinees as indicated (emphasis added).

1966 CDC - Weset and Central African Smallpox Eradication:Measles Control Program - Manual of Operations pg. 38

“Bleeding is of little consequence,” stated the CDC. Clearly, the administration was ignorant to the risk of transmitting blood-borne viruses. The CDC’s disregard for bleeding during jet injections would also indicate the presence of blood was either underreported or not reported within their studies on jet injection in the 1960s.

In preparation for mass vaccination campaigns in distant and remote areas, the manual described how to cold sterilize jet injectors. On pages 257 to 258, the vaccinator is instructed to “scrub disassembled parts with a scrub brush in a pan of soapy (bar soap) water.” Then after rinsing in clean water to reassemble the jet injector and “fill chamber with tincture of iodine solution (gun in cocked position) and leave for 5 minutes.” Followed by flushing the gun with 10 shots of sterile water.

CDC stated this sterilization method has been proven effective.

This process for sterilization was tested by contaminating four injectors with dirt containing 20,000 aerobic and anaerobic organisms per gram (dirt treated so that spores were present). With this degree of contamination, no growth was obtained from any of the guns.

Yet testing for organisms is not the same as testing for viruses. This manual gave no consideration to sterilizing against infectious viruses.

Seven months after the manual’s publication, a memorandum was issued stating the number of times for flushing the iodine solution was insufficient. Residual traces of iodine were found within the injector and were affecting the potency of the measles vaccine, as noted on page 259. This calls into question the CDC’s method for cold sterilization of jet injectors.

In 1977 the CDC finally investigated if serum hepatitis could be transmitted via jet injectors. Article – CDC’s Unpublished Jet Injector Studies – Part 1

 

A full copy of CDC’s 1966 manual, West and Central African Smallpox Eradication/Measles Control Program – Manual of Operations, is accessible here.

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

PCNFIs Fail to Prevent Contamination

Protector cap needle free injectors (PCNFI) were intended to be the safer mode of jet injection. The idea of placing a protective barrier between the patient’s skin and reusable nozzle allowed for the safety regulators sought and the expediency consumers wanted. As the timeline will show the concept of PCNFIs, although innovative, failed safety-testing and was abandoned as a means of administering immunizations.

Currently, several PCNFI devices are used as medical instruments. These devices are being used consecutively upon a single patient to administer anesthesia and medicine. As long as these devices are adequately sterilized through autoclaving before being used on a subsequent patient they pose no threat in the transmission of pathogens.

Am-O-Jet______________________________________________________________________________
1995
Robert Harrington, the former President and CEO of Vernitron Medical Products which previously owned Ped-O-Jet, creates the American Jet Injector company. He uses an identical design of the Ped-O-Jet to create the Am-O-Jet injector (FDA, 1999), which came in an electric model and a non-electric foot-pedal model.

1996 July
Am-O-Jet receives FDA 510(k) premarket approval on July 26th of 1996 (FDA, 1996).

1996 October
Harrington attends the CDC/WHO conference on jet injector safety and introduces his Am-O-Jet injector as a viable option for mass jet injection (Fields, 1996).

1997 May
Harrington attends the WHO/CDC conference on jet injector safety and announces plans to conduct safety-trials utilizing his Am-O-Jet injector. In the plan for one such trial, the Am-O-Jet would be used upon 1,000 Brazilian military recruits. After each injection the ejectate of the subsequent “shot” would be sent to United Kingdom’s Public Health Laboratory Service for testing (WHO, 1997). However, this field trial never used the Am-O-Jet or a protector cap. The study used Ped-O-Jet injectors owned by Brazil’s Ministry of Health. Moreover, the study used civilian volunteers infected with Hepatitis B and Hepatitis C and not military recruits.

1997 November
Keystone Industries conducts a product recall on the Ped-O-Jet over liability concerns that the device could transmit blood-borne pathogens. Article – Ped-O-Jet Withdrawal Letter to DoD Over Risk of Disease Transmission

1999
Harrington speaks at a FDA panel discussion on jet injector safety. “What is the future of Am-O-Jet’s high workload injectors? We believe in a traditional reusable nozzle, reusable work path. We’re continuing the production of that model,” said Harrington, who refuses to believe any safety risk exists with Ped-O-Jet / Am-O-Jet injectors (FDA, 1999). Moreover, Harrington outright lies, stating the device was used correctly within the U.S. military for 35-years and no evidence exists to the contrary. Article – Improper Military Jet Injections

2000
Am-O-Jet undergoes a Small Business Innovative Research Phase I project in conjunction with Dr. Bruce Weniger of the CDC, and Dr. James Sweat from the University of Florida. This safety-test replicated and expanded upon a previous safety study on jet injectors. Five different experiments were conducted in this series, including use of a plastic disposable nozzle. Within this study a saline solution was injected into a pig with the Am-O-Jet. The subsequent “shot” was fired into a vial and the ejectate was assessed for contamination using an ELISA (i.e., a highly sensitive test to detect albumin). Results of the study were not adequately reported although backsplash and contamination were observed (Sweat et al., 2000).

“We have detected contamination well above current levels that we would consider indeterminate or uninterpretable,” said Dr. Weniger (FDA, 1999). In other words, the researchers found rates of contamination were significant.

The results of Sweat and colleagues study were not fully published. Presumably Mr. Harrington did not wish to reveal results which would implicate his jet injector. Following this study, development of the Am-O-Jet was abandoned.

 

FELTON INTERNATIONAL___________________________________________________________
1998
Felton International, a jet injector developer and manufacturer, bought the rights to 17 Russian jet injectors from the Chemical Automatics Design Bureau of Voroenzh, Russia and MedEquipment. The BI-100 jet injectors utilize a protector cap between patients (Leon & Loskutov, 2005; Weniger, 2013).

2002 September
Felton Int. conducts three field evaluations for a prototype protector cap needle-free injector in Senegal. The device, which was shaped like a gun, was found to be bulky and hard to handle. In conjunction with PATH, the device’s grip was redeveloped into a “torch” grip design (Zehrung, 2003).

2003
Felton Int. receives an award from the U.S. Army for $119,570.00 to conduct a Phase I study on the development of a needle-free jet injection system. “The Phase I effort comprises detailed pharmacokinetic studies and preliminary and detailed device design. The fabrication of a size appropriate injector for test rodents will also be undertaken in Phase I.” (SBIR, 2003a).

Felton Int. receives a second award from the U.S. Army for $688,615.00 to conduct a Phase II study of their prototype jet injector.

The second phase of this project will consist of the following three tasks: 1) Develop and quantify a prototype needle-free injector. This task includes product, environmental and human safety testing. A protector cap will be used to prevent pathogen transfer between patients; 2) Conduct trials on non-human primates to determine the percent of enzyme delivered, the peak level of enzyme activity and the duration of the enzyme at that level; 3) Determine the efficacy of this enzyme as a bioscavenger by exposing injected rodents to OP or pesticides; and 4) Deliver a prototype injector to the Army for chemical warfare studies (SBIR, 2003b).

Felton goes on to state their overall goal:

The overall goal of this project is to provide the Army with a system to allow rapid injection of the enzyme into soldiers in the event of a chemical attack on the battlefield. In order to achieve this goal, the usability, safety and efficacy of the device will be proven. For the military, this device would allow rapid injection of troops prior to a potential chemical exposure. In this situation, troops should be injected 12 hours prior to possible exposure and re-injected weekly as long as the threat continues(SBIR, 2003b).

2003 November
Felton Int. presented a prototype protector-cap needle-free injector at the Joint Service Scientific Conference on Chemical & Biological Defense Research.

2004
PATH conducts an in vitro fluorescein test upon the HSI-500. Use of fluorescein dye made any contamination visible. Results of this test showed contamination upon the protector-cap but no contamination within the ejectate (FDA, 2005).

2004 August – October
Felton Int., in conjunction with PATH, conducted a pilot study at Huntington Medical Research Institute Liver Center in Los Angeles, California. The study assessed the safety of the prototype HSI-500, a protector-cap needle-free injector, upon 5-15 civilian volunteers who had a high titer of Hepatitis B. The aim of the study was to detect HBV within the ejectate following an injection into a HBV-carrier and to assess injection site bleeding (Zehrung, 2004). Results of the pilot study found no contamination, and led to the approval and development of a larger scale study in 2006 (Kelly et al., 2008).

2005 October
Felton Int. presented a prototype protector-cap needle-free injector to the Department of Defense Research. The presentation, titled Reintroducing High Workload Needle Free Jet Injectors to the US Military Medical Community, displayed the HSI-500 PCNFI device (Leon & Loskutov, 2005). The device was also known as the JIMI which was an acronym meaning Jet Injector for Mass Immunization.

2006 July – October
Felton Int. and PATH conducted a large-scale study upon the safety of the HSI-500. The study was conducted in Beijing, China among HBV-positive adults. Despite the cap’s design to prevent cross-contamination, “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%).” Data collected also found moderate bleeding (0.5%).

Most shockingly, the published data demonstrates but the researchers failed to discuss, that cross-contamination of HBV occurred without any visible bleeding at the injection site. In 7 out of the 17 injections that tested positive for cross-contamination researchers observed no visible bleeding at the injection site (see Table 1 within the study). This indicates that cross-contamination of blood-borne viruses successfully occurred within microscopic levels of blood not visible to the human eye (Kelly et al., 2008).

Following this study any development and testing upon the HSI-500 (JIMI) was abandoned. PCNFIs were deemed unsafe for administering immunizations upon consecutive patients.

Since Felton International (now Pulse Needle-Free Systems) received funding from the U.S. Army, I reached out to the company to further clarify if at anytime was the HSI-500 or any other of their devices utilized upon any military personnel. Ed Stevens, the company’s President stated, “No, that study never involved military personnel.  (It was not a human study.) Felton/Pulse devices were never used on U.S. military personnel, and now our products are only used on animals.”

 

Conclusion____________________________________________________________________________
Two publicized PCNFIs both failed to prevent contamination. The Am-O-Jet, a Ped-O-Jet that allowed a protector cap to cover the nozzle, failed to prevent cross-contamination in a laboratory trial on pigs (Sweat et al., 2000). Another PCNFI, the JIMI injector also known as the HSI-500, showed promising results in a pilot study at Huntington Medical Center, although later failed to prevent cross-contamination of hepatitis B in a field trial in China (Kelly et al., 2008). Further development of PCNFI devices for administering immunizations were abandoned and the industry focused on development of disposable-cartridge jet injectors for administering immunizations.

 

References:

  • (FDA, 1996) Food & Drug Administration. 510(k) Premarket Notification: American Jet Injector Corp. – K962017. Accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K926017.
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (Kelly et al., 2008) Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.
  • (Leon & Loskutov, 2005) Leon NJ & Loskutov AY. Reintroducing High Workload Needle Free Jet Injectors to the U.S. Military Medical Community. Presentation to Department of Defense Research. 1 October 2005.
  • (SBIR, 2003a) Small Business Innovation Research. Felton International: Developing Human-Compatible Needleless Delivery Systems for Administering Bioscavengers – Phase I. 2003. Accessible at: https://www.sbir.gov/sbirsearch/detail/165599.
  • (SBIR, 2003b) Small Business Innovation Research. Felton International: Developing Human-Compatible Needleless Delivery Systems for Administering Bioscavengers – Phase II. 2003. Accessible at: https://www.sbir.gov/sbirsearch/detail/165601.
  • (Sweat et al., 2000) Sweat JM, Abdy M, Weniger BG, Harrington R, Coyle B, Abuknesha RA, Gibbs EP. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids. Ann NY Acad Sci 2000;916(31):681-682.
  • (Weniger, 2013) Weniger BG. Jet Injection Bibliography. 11 July 2013.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]
  • (Zehrung, 2003) Zehrung D. PATH’s Experience from Jet Injector R&D and Field Assessment in Developing Countries. Presentation for Innovative Administration Systems for Vaccines. Rockville, Maryland. 18 December 2003.
  • (Zehrung, 2004) Zehrung D. Jet Inject for Mass Immunization: Design Update and Safety Testing Strategy. Presentation for Global Vaccine Research Forum. 10 June 2004.

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

Impact of CDC’s 1993-94 Unpublished Study – Part II

Following Grabowsky and colleagues evaluation of the Ped-O-Jet, officials within the CDC initiated meetings to discuss the risks of multi-use nozzle jet injectors (MUNJI).

1995 CDC / WHO Meeting – Review the Safety of Jet Injectors
In November of 1995, the CDC and World Health Organization (WHO) gathered for a meeting in London titled, Review the Safety of Jet Injectors. Those present were CDC and WHO experts on device safety, vaccine safety, and laboratory testing. Amongst the attendees were Dr. Robert Chen of the CDC, John Lloyd of the WHO, Dr. Peter Hoffman from the United Kingdom’s Public Health Laboratory Service, and a representative from PATH (Fields, 1996). Dr. Chen had previously been involved in CDC’s safety testing of the Med-E-Jet and Ped-O-Jet (Chen).

The goal of this meeting was to rewrite the safety standards for all jet injector devices. CDC and WHO both agreed, the “risk of cross infection must be zero” (PATH, 1996). The CDC explained this “zero tolerance” level means “no contamination should be detectable on any reusable surface of the deice that comes into direct or indirect contact with the patient’s skin” (Fields, 1996). Both agencies agreed for these devices to be attractive to consumers, they should remain “competitive with [the] current price of autodestruct syringes.” Moreover, both agencies recommended that jet injectors should be regulated and undergo testing to ensure safety performance (PATH, 1996).

WHO announced that Dr. Peter Hoffman of the UK’s Public Health Laboratory Service would be overseeing “the design and implementation of a new laboratory safety test to evaluate all injectors against this new standard” of zero tolerance (Fields, 1996).

 

1996 CDC & WHO Conference – Jet Injectors for Immunization, Current Practice and Safety, Improving Designs for the Future
In October of 1996, members of CDC’s National Immunization Program along with the WHO extended the discussion on jet injectors to include various health agencies, manufacturers, and consumers. The goal of this meeting was for all involved parties to discuss the safety of existing jet injectors and to develop more stringent specifications for the development of a new generation of jet injectors. Amongst the attendees of the meeting were CDC researchers Dr. Robert Chen and Walter Bond, as well as Dr. Glaucus de Souza Brito from the Brazilian Ministry of Health, former Ped-O-Jet CEO Robert Harrington and the current owners of Ped-O-Jet, Keystone Industries.

Walter Bond, who was a part of all three of CDC’s jet injector studies, served as an expert panelist on jet injector safety. “Existing jet injectors, such as Ped-O-Jet,” stated Bond, “are not particularly easy to contaminate, but once they are contaminated, they can indeed transmit disease” (Fields, 1996).

Also during the meeting, the committee identified the need for additional safety testing. “Examining ejectates from Ped-O-Jet vaccinations given to new military recruits in the U.S.…would represent best-use circumstances for the jet injector,” concluded the committee (Fields, 1996). However, in the following year Keystone Industries informed the Department of Defense (DoD) of its intent to withdraw and stop manufacturing the Ped-O-Jet over risk of cross-contamination. Consequently, in December of 1997 DoD stopped using all MUNJI devices, including the Ped-O-Jet. The study, which intended to examine the ejectates of Ped-O-Jet vaccinations from military recruits, was never conducted.

The 1996 joint CDC/WHO meeting also identified several countries had allowed jet injector devices to be grandfathered-in and thus bypass safety regulations.

During the Atlanta meeting in October 1996 it became clear that jet injectors in the United States, U.K., France and Italy had been ‘grandfathered in’ without national regulatory controls. The reason for this appeared to be the long history of use of jet injectors without recorded mishap.

The Food and Drug Administration of the United States informed the Atlanta meeting that they intend to review the status of jet injection devices with a view to develop such regulation in the near future (WHO, 1997).

 

The CDC/WHO conference led to further discussions about jet injector safety within CDC and WHO, initiated discussions within the FDA, and would later prompt the manufacturer of Ped-O-Jet to withdraw it’s product from the Department of Defense.

These subsequent discussions have been outlined within the following articles:

 

References:

  • (Chen) Chen, Robert. Curriculum Vitae. Accessed January of 2015.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (PATH, 1996) PATH. Low-workload Jet Injectors For Vaccine Delivery: 1987-1996. Program for Appropriate Technology in Health. 18 September 1996. pp. 1-5.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]

 

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)

 

CDC Evaluates the Risk of Multi-Use Nozzle Jet Injectors

Following the 1996 CDC/WHO conference, CDC continued to evaluate and engage in discussions on the risks of multi-use nozzle jet injectors (MUNJI). The timeline below shows the reports, conferences, and one collaborative study in which CDC investigated MUNJI devices. The timeline also shows a shift in CDC’s stance on jet injectors, from viewing MUNJI devices being permissible in dire situations to MUNJI’s being inherently unsafe and discouraging their use altogether.

 

1999 CDC Reports MUNJIs Pose Medium Risk in a JAMA article
In a 1999 Journal of the American Medical Association article by Rebecca Voelker is the revelation that the CDC viewed jet injectors with a reusable nozzle that was not swabbed between patients as a medium risk for cross-contamination (Voelker, 1999).
Therefore, even before the publishing of subsequent research on jet injector safety which demonstrated it did not matter if the nozzle was swabbed or unswabbed (i.e., Hoffman et al., 2001; Hoffman et al., unpublished; Sweat et al., 2000), the CDC viewed MUNJIs as a medium risk.

1999 Voelker - Eradication Efforts Need Needle-Free Delivery- CDC Diagram- Reusable nozzle is a medium risk

(Voelker, 1999)

 

2000 Am-O-Jet Fails Safety Test
The CDC collaborated with American Jet Injector Corporation and the University of Florida to test the safety of the Am-O-Jet, a MUNJI device. The Am-O-Jet had an identical design to the Ped-O-Jet. This study tested the potential for cross-contamination via the Am-O-Jet amongst calves and pigs. The design of the study replicated previous in vivo jet injector studies (Sweat et al., 2000). Dr. Bruce Weniger of the CDC and coauthor of the study stated, “We have detected contamination well above currently [sic] levels that we would consider indeterminate or uninterpretable” (FDA, 1999). In other words, the researchers found the rates of contamination were significant.

 

2002 (Feb. 8) CDC Report – General Recommendations on Immunization
CDC urged the use of MUNJI devices to be limited only in dire situations and when other, safer methods are not viable. The report stated,

Efforts are under way for the research and development of new high-workload JIs using disposable-cartridge technology that avoids reuse of any unsterilized components having contact with the medication fluid pathway or patient’s blood…the use of existing multiple-use-nozzle JIs should be limited . . . [and] considered when the theoretical risk for bloodborne disease transmission is outweighed by the benefits of rapid vaccination with limited manpower in responding to serious disease threats (e.g., pandemic influenza or bioterrorism event), and by any competing risks of iatrogenic or occupational infections resulting from conventional needles and syringes… (CDC, 2002).

CDC’s shift to dire use only was a minuscule step forward from the agency’s warning eight-years prior, which noted if jet injectors became contaminated there is a risk for disease transmission (CDC, 1994).

 

2002 (Sept 16) CDC & WHO Meeting – Consultation on MUNJI Safety Evaluation
CDC and WHO hosted a meeting at CDC Headquarters in Atlanta to discuss the safety of MUNJI devices. Amongst the invited attendees were WHO, CDC, FDA, USAID, PATH, International Vaccine Institute, and members of academia. During this time, the CDC endorsed the use of MUNJI devices in dire situations until disposable-cartridge jet injectors became standardized (Weniger, 2005).

 

2004 (March 30) WHO & CDC Meeting – Consultation on MUNJI Safety Evaluation
WHO and CDC hosted a subsequent meeting on jet injector safety at WHO Headquarters in Geneva, Switzerland. The goal of this meeting was to establish criteria for a new generation of jet injector devices. The attendees attempted to answer several important questions relating to the matter of cross-contamination. Questions such as: “How infectious is blood? How do we measure it? How do you model the risk? What level of risk acceptable?” (FDA, 2005).

The attendees were in agreement that a fraction of a picoliter can transmit infection. This conclusion was far different from the previous, widely-accepted yet unofficial belief that Hepatitis B is transmissible in 10 picoliters of blood or greater (FDA, 2005).

The attendees deemed it was inappropriate to make health officials decide what was an “acceptable” level of risk from using MUNJIs (Weniger, 2005). The objective of the health industry is not to contemplate risk but to sustain life and improve health.

The attendees questioned the relevance of prior animal models and recommended all future jet injector safety trials use human HBsAg carriers and the most sensitive PCR assays for detecting contamination within ejectates (Weniger, Jones & Chen). The use of Hepatitis B surface antigen (HBsAg) was not purely to assess if Hepatitis B is transmissible via jet injection but to use HBsAg, a highly infectious pathogen, as a threshold in evaluating safety. The idea being if a highly infectious pathogen is transmissible than that model of jet injector is unsafe.

Most importantly, during this meeting the CDC finally decided to abandon its attempt in developing safer MUNJI devices and discouraged the use of all MUNJI devices under any circumstance (Weniger, 2005).

2004 (May 25-26) Seventh Annual Conference on Vaccine Research
Dr. Bruce Weniger, of CDC, summarized the downfall of MUNJI devices within his poster presentation at the Seventh Annual Conference on Vaccine Research. Dr. Weniger wrote, “The U.S. military withdrew them [MUNJIs] in 1997, and WHO and CDC now caution against their use” (Weniger, 2004).

 

2004 (June 8-10) WHO Conference – Fifth Global Vaccine Research Forum
At WHO’s Proceedings of the Fifth Global Vaccine Research Forum, Dr. Weniger again stated the risks and hazards of multi-use nozzle jet injectors. “Subsequent bench studies of it [Med-E-Jet] and the more common Ped-O-Jet indicated that their nozzles could become contaminated with hepatitis B virus and pose a risk for transmission between consecutive vaccines” (WHO, 2005).

 

2005 MUNJIs Are “Inherently Unsafe”
Dr. Bruce Weniger, of the CDC, believed MUNJIs were inherently unsafe.

MUNJIs are inherently unsafe. Their re-use without intervening sterilization of fluid pathways which may be exposed to patient blood or tissue fluid violates established principles that apply to other critical medical devices.

One cannot rely of the absence of documented cases of disease transmission beyond the California outbreak.

It is unlikely that routine post-marketing surveillance would link sporadic cases to prior MUNJI use (Weniger, 2005).

 

2006 (Dec. 1) CDC Report – General Recommendations on Immunization
CDC reported disposable-cartridge jet injectors overcame the risks of cross-contamination posed by MUNJIs. “In the 1990s, a new generation of JIs was introduced with disposable cartridges serving as dose chambers and nozzle. With the provision of a new sterile cartridge for each patient and correct use, these devices avoid the safety concerns for multiple-use-nozzle devices” (CDC, 2006a).

 

2006 CDC Report – Needle-free Intradermal Influenza Study
CDC stated MUNJIs are “inherently unsafe.”

Safety concerns arose over multi-use-nozzle jet injectors (MUNJIs)…which use the same nozzle to inject consecutive patients without intervening sterilization. A hepatitis B outbreak in the mid 1980s caused by one MUNJI as well as other published and unpublished studies of this and other devices, indicated blood and tissue fluid containing pathogenic agents could be transmitted among patients. This led to discontinuation and recommendations against their use in public health, and market removal in 1997 of the most common device, the Ped-O-Jet®.

Since the 1990s, a new generation of safer disposable-cartridge jet injectors (DCJIs) have appeared. DCJIs avoid the inherently unsafe design of MUNJIs, since the disposable cartridge has its own sterile orifice and nozzle and is discarded between patients (CDC, 2006b).

 

2011 (Jan. 28) CDC Report – General Recommendations on Immunization
CDC reiterates the risks and hazards of jet injectors.

Jet injectors that use the same nozzle for consecutive injections without intervening sterilization were used in mass vaccination campaigns from the 1950s through the 1990s; however, these were found to be unsafe because of the possibility of bloodborne pathogen transmission and should not be used (CDC, 2011).

 

1999 – 2006 CDC’s Needle-Free Injection Technology Webpage
From 1999 to 2006, the CDC had an entire webpage devoted to needle-free injection technology. Although the site, http://www.cdc.gov/nip/dev/jetinject.htm, has since been long taken down. The webpage once provided links to reports from international and government health agencies containing information about the risks and hazards of jet injectors and links to Department of Defense websites that detailed the withdrawal of the devices by one manufacturer and the discontinuation of their use by the military. Fortunately through web.archive.org this webpage along with a substantial number of its reports were archived. CDC’s jet injector webpage can be accessed here.

 

Conclusion
CDC discouraged the use of multi-use nozzle jet injectors only after a protracted investigation and numerous meetings. CDC first investigated the safety of jet injectors in 1977, and actively investigated MUNJI devices from 1993 to 2004. Their ultimate decision, to discourage MUNJI use under any circumstance, was long overdue considering their partners at the WHO discouraged the use of MUNJIs six-years earlier.

It is important to note that although up until 2004 the CDC endorsed the use of MUNJIs in dire emergencies the devices had not actually been used in a mass vaccination campaign within the U.S. since 1997 during a meningitis outbreak at Michigan State University (Paneth et al., 2000) and within the U.S. military since December 9th of 1997 (DoD, 1997). Whereas the WHO was quick to abandon MUNJI technology, the CDC wished to keep the devices as a contingency plan. It is my opinion that the agency’s reluctance to abandon the technology was ill-considered as it delayed the inevitable and prevented any seroepidemiological studies on prior MUNJI use.

Unequivocally, CDC’s jet injector studies demonstrated MUNJIs pose a risk in transferring blood-borne pathogens between patients. Since 2004, CDC has viewed MUNJIs as “inherently unsafe,” and has repeatedly discouraged their use.

Yet to date, CDC Headquarters in Atlanta has never listed multi-use nozzle jet injectors as a risk factor in transmitting blood-borne pathogens, even despite the high prevalence of Hepatitis C amongst those who had the greatest exposure to mass jet injector inoculations—Vietnam era veterans.

 

References:

  • (CDC, 1994) Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 43:(RR-1):7–8, 1994.
  • (CDC, 2002) Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). Morb Mortal Wkly Rep February 8, 2002;51 (No. RR-2): 1-35.
  • (CDC, 2006a) Center for Disease Control and Prevention. Recommendations of the advisory committee on immunization practices-(ACIP). Morb Mortal Wkly Rep. 55:(RR-15), 2006.
  • (CDC, 2006b) Centers for Disease Control and Prevention. Needle-free Intradermal Influenza Study. CDC-ISO-4785. 5 March 2006.
  • (CDC, 2011) Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices-ACIP. Morb Mort Wkly Rep. Vol. 60. No. 2. 28 Jan. 2011.
  • (DoD, 1997) Memorandum: Jet Hypodermic Injection Units. Philadelphia: Defense Logistics Agency. 9 December 1997.
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (Paneth et al., 2000) Paneth N, Kort EJ, Jurczak D, Havlichek DA Jr, Braunlich K, Moorer G, Vanderjagt D, Sienko D, Leiby P, Gibbons C. Predictors of vaccination rates during a mass meningococcal vaccination program on a college campus. J Am Coll Health. 2000 Jul;49(1):7-11.
  • (Sweat et al., 2000) Sweat JM, Abdy M, Weniger BG, Harrington R, Coyle B, Abuknesha RA, Gibbs EP. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids. Ann NY Acad Sci 2000;916(31):681-682.
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA May 26, 1999;281(20):1879-1881.
  • (Weniger, 2004) Weniger BG. Trends, challenges and opportunities for jet injection technology (presentation). National Foundation for Infectious Diseases. Seventh Annual Conference on Vaccine Research. 25-26 May 2004. Arlington Virginia.
  • (Weniger, 2005) Weniger B. Safety of Multi-use-nozzle Jet Injectors (MUNJIs) for Bloodborne Pathogen Cross-contamination (draft). Conference Notes. 7 August 2005.
  • (Weniger, Jones & Chen) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods.
  • (WHO, 2005) WHO. Proceedings of the Fifth Global Vaccine Research Forum. WHO/IVB/05.09. 2005.

 

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)