Nigeria Forced to Use Ped-O-Jet Injectors in 1996 Despite Fears of Spreading Hepatitis and AIDS

May 1, 2017

In 1996, during one of the most severe meningococcal meningitis outbreaks in the history of Nigeria, health officials were forced to use Ped-O-Jet injectors due to a shortage of syringes and needles.

The official report of the mass vaccination campaign by Mohammed and colleagues (2000) stated,

“There was a dearth of supplies, particularly of syringes and needles, which made it necessary to use ‘Ped-O-Jet’ injectors (Vernitron, Carlstatdt, NY, USA) for vaccinating most of the people. These are manually operated jet injectors which deliver 0.5 mL of the vaccine into the deltoid muscle of the arm. The nozzle is placed about 1 cm from the skin surface (no contact is allowed), but inaccurate application often results in physical contact and bleeding, raising concerns about transmission of infectious agents such as hepatitis viruses and HIV.”

The jet injectors vaccinated “most” of the 13.4 million Nigerians immunized in the campaign.

Furthermore, the report openly admitted the risk of spreading infectious diseases via the Ped-O-Jet injector to prevent the further spread of meningitis.

“An important problem of mass vaccination in Africa is the inadequate supply of syringes and needles, necessitating the use of ‘Ped-O-Jet’ injectors for vaccination, as happened during this epidemic. We may never know how many infectious agents (including hepatitis B and C viruses and HIV) were transmitted as a result of using these injectors, but clearly their use must be stopped as soon as practicable.”

The fear generated during this mass vaccination campaign caused the World Health Organization to change its official stance advising “against the use of jet injectors under any circumstances” (Fields, 1996). The risk of spreading Hepatitis B, Hepatitis C and HIV with the Ped-O-Jet was realized beyond just being biologically plausible. The risk is, in fact, real.

Moreover, the report by Mohammed and colleagues demonstrates a demographic other than veterans of the United States military arguing the risks and hazards of Ped-O-Jets.

2000 Mohammed- A severe epidemic of meningococcal meningitis in Nigeria, 1996

Due to proprietary reasons this study can be accessed here.

References:

  • (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.
  • (Mohammed et al., 2000) Mohammed I, Abdussalam N, Alkali AS, Garbati MA, Ajayi-Obe EK, Audu KA, Usman A, Abdullahi S. A Severe Epidemic of Meningococcal Meningitis in Nigeria, 1996. Royal Society of Tropical Medicine and Hygiene, 2000 (94): 265-270.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Nigerians Recall Mass Jet Injector Vaccinations As Children

April 20, 2017

Nigeria 1969

During the 1960s and 1970s, mass vaccination campaigns sought to eradicate diseases such as polio, measles, and smallpox from the face of the earth. Vaccination teams from the US Public Health Service, the World Health Organization, and the non-profit Christian organization, Brother’s Brother Foundation, trekked the globe to educate foreign governments and medical personnel, isolate infectious pathogens, and to immunize all.

These medical expeditions have been well documented within government reports and photographs. Autobiographies by several health officials have also recorded the journeys. Yet never have these events been told by those who received the vaccinations. For the first time ever, those who received mass jet injector vaccinations in Nigeria as children tell what they remember.
What do you remember most of about the mass jet injector vaccinations?

“I remember getting my inoculation in 1968/69 in elementary school in Ibadan!! Gosh, I still remember it so vividly because it was so painful, and it left that unique mark,” reminisced a gentleman.

“Yes, I’m looking at the scar on my left arm,” said another gentleman.

“We called it ‘numba’ in primary school,” said a lady.

Another lady said, “Numba…like a bite mark on your arm!”

“The injections were quite painful then,” another gentleman recalled. “I still remember the horror on our faces when the health workers arrived at our school in 1975 and our headmaster delivered us unto their hands. I have never seen so many crying children in such close proximity—we were all united in terror.”

Another gentleman said, “Still on my left arm. Everyone collected ‘numba.’”

“Frightful,” declared yet another man. “The health workers hold that thing like it’s a pistol. The searing pain and the sure abscess that follows, who can forget!… some of the pupils running away and refusing to be vaccinated, chiefly as a result of the pains. We were vaccinated—this was in the late 1970s—against such diseases like polio, measles, and yellow fever.”

Nigerian child is receiving a smallpox vaccination

Was the whole village and community vaccinated all at once? I asked.

“The vaccination was done at the village level and it usually took 1 to 2 days to complete before they moved onto the next village within the community. The event took place at the village primary school, hence the pupils were first vaccinated before adults,” said the first gentleman.

Were there any fears with use of the jet injector?

“To the best of my knowledge, there was none, aside from the pains associated with the vaccination and the attendant abscess the most often (would say up to 80% developed into abscess).”

Another gentleman wittily reflected, “ A man was receiving what he will never understand.”

Many photographs captured looks of concern and apprehension and rightfully so. What were they to think as unknown foreigners arrived in their village with an unheard of device that resembled a pistol to prevent them from an unheard of disease? Success of the vaccination campaign was only the result of local officials who ensured the injections were safe.

Nigerian children were photographed as they received vaccination

Are these devices still used in your childhood village today? If not, when was the last time you remember jet injectors being used?

“The last time I remembered it being used was around 1981 and I can’t remember it still being used afterwards. Reason would be that the community’s clinic was ‘upgraded’ to a cottage hospital and most of the immunizations for kids took place there.”

Although vaccinated as young children, the experiences were so unique and fearful that they were forever imprinted within their memories. In fact, almost all who have been inoculated with these devices have not forgotten the experience.

* Names were withheld for privacy.

© Shaun Brown and Jet Infectors, 2017.

Babies and Breadwinners: 1961 Mass Polio Vaccination Campaign

April 4, 2017

Paralytic poliomyelitis, most commonly referred to as polio, once immobilized a nation in fear as the disease paralyzed children with no known cause. In the early 1950s, there were roughly 20,000 cases of polio diagnosed per year. In 1952, at the height of the epidemic, the disease took more than 3,000 lives (Sokol, 1997). Thankfully within the same year, Jonas Salk created an effective vaccine. In 1955, after almost three years of testing, the Salk polio vaccine was announced to the world. Salk’s vaccine was a medical relief to the nerves of many.

Babies and Breadwinners

Babies and Breadwinners was a government film documenting the mass Polio Vaccination Campaign of 1961. “This title referred, of course, to those two poorly immunized groups, the children five years and under and the young adults,” wrote Dr. Maynard Mires in the Delaware Medical Journal (Mires, 1961).

The film, produced by the Communicable Disease Center (more presently known as the Center for Disease Control and Prevention), was to be informative and encouraging in the implementation of mass vaccination campaigns across the nation.

Set in the city of Columbus, Georgia, the film documented the first of three phases of a vaccination campaign. Thirty-eight locations were set-up across the city over eight days. Vaccinations were free. People walked up, were vaccinated with the Hypospray Multidose Jet Injector, and then continued on their merry way. “A simple injection means polio protection.”

Babies and Breadwinners- 1961

The film also documented the lack of sterilization between jet gun inoculations. In the photo above, taken from the event in downtown Columbus, the vaccinator held the Hypospray Jet Injector in one hand and appropriately held the patient’s arm with his other hand. The jet injector was attached to a motor enclosed in a carrying-case on the table. Also placed upon the table, near the center, is a vaccine vial and a red protective cap to cover the jet injector nozzle when not in use. Upon the far right side of the table is a microphone belonging to the cameraman in the black suit. There appears to be a material object on the bench below the table, although this object remains unclear. As the video demonstrates, a nurse standing to the right side wipes the patient’s arm with cotton dipped in acetone. The jet injector, however, was used consecutively person after person. The nozzle was never wiped in between vaccinations.

1961 Babies and Breadwinners- turning of the lever

Video footage also captured vaccinators reaching toward the nozzle following injections. A snapshot of the video, above, demonstrates this action. A 1966 self-instructional lesson by the CDC, titled “Jet Injector Operation, Model K3,” pictured below, informs vaccinators how to use the Hypospray Multidose Jet Injector and explains this behavior. Before administering an injection the vaccinator must turn the cocking lever from the “Fill” position to the “Injection” position. Then immediately following the injection, the cocking lever must be turned-back to the “Fill” position to allow the vaccine vial to fill the drug reservoir with the next dosage.

1966 CDC- Hypospray Multidose Jet Injector Instructions

The video footage also captured a disregard for protocol. The CDC’s operating instructions stated, “Squeeze trigger for full THREE SECONDS (count: ‘One thousand one, one thousand two, one thousand three’).” Yet the film repeatedly documented vaccinators holding the jet injector for only one second, as shown in the clip below. Also note the nozzle was never wiped or cleansed in between injections.

In two instances the video captured the wiping of the injection site immediately following the jet injection. The incidents were unique as the video demonstrates the majority of the vaccinees did not have their arm wiped. In the following clip, a nurse cleansed a girl’s arm with cotton dipped in acetone whereupon a vaccinator administered an injection. Afterwards the nurse immediately wiped the girl’s arm, in a downward motion, with the same cotton. (You may need to watch twice to capture the motion). The girl then clutched her arm as her mother carried her away. The nurse discarded the dirty cotton which accidentally landed on the table. Then the next child stepped forward to receive a vaccination. The jet injector nozzle was never wiped or cleansed.

In another clip, a boy, appearing in the foreground, had just received a vaccination. Holding a piece of cotton within his left hand he wiped the injection site on the deltoid area of his right arm.

So why was the post-injection wiping important?

If the jet gun was held firmly against the vaccinee’s skin, and immediately following the injection there was a need to wipe the injection site of the vaccinee, then whatever was on the vaccinee’s arm was also on the nozzle of the jet injector. Despite the fact that we do not know what was being wiped, whether the substance was blood, splash-back of vaccine after after penetrating the outer layer of skin or a combination thereof, this footage demonstrates at that time the jet injector was contaminated and no longer sterile.

In our series, Faulty Design Created Inherent Risk, Mitragotri (2006) demonstrates through microcinematography the nozzle becomes contaminated through a phenomenon known as splash-back.

The complete video can be accessed here.
References:

  • (Mitragotri, 2006) Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nature Reviews Drug Discovery 5:543–548, 2006.
  • (Mires, 1961) MH Mires. Babies and Breadwinners. Delaware Medical Journal. September 1961. pp. 270-272.
  • (Sokol, 1997) Sokol B. Fear of Polio in the 1950s. [Online Article] Available at: http://www.plosin.com/beatbegins/projects/sokol.html.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

1971 NIH Conference Recognizes Bloody Jet Injectors Pose Risk For Hepatitis

February 9, 2017

NIH’s discussion on the risk of transmitting hepatitis via jet injectors in 1971 was completely forgotten and almost forever lost within the pages of an archaic book. Jet Infectors discovery casts new light on this old issue. What was once lost and forgotten is now rediscovered.

Jet Infectors strives to publish accurate, intriguing, and worthy content. Countless hours are poured into research, networking, writing and editing. As always Jet Infectors encourages the sharing of its posted content as long as credit is given to Jet Infectors. Plagiarism will not be tolerated.

Tuesday, October 26, 1971
Bethesda, Maryland

U.S. Surgeon General, Dr. Jesse Steinfield, convenes a conference to discuss the status and efficacy of tuberculosis vaccinations. Prominent health officials, physicians, and professors arrive at the John E. Fogarty International Center for Advanced Study in the Health Sciences, within the National Institute of Health complex, for the three-day conference.

Amongst the thirty-eight attendees are such prominent officials as the—

  • Surgeon General of the U.S. Public Health Service for the Department of Health, Education and Welfare, Dr. Jesse Steinfield
  • Director of the Armed Forces Epidemiological Board Commission on Immunization and co-inventor of the Ped-O-Jet, Dr. Abram Benenson
  • Assistant Director of Research Service for the Veterans Administration [Department of Veterans Affairs], Dr. James Matthews
  • Assistant Executive Vice President of the American Medical Association, Dr. William Barclay
  • Director of the National Institute of Allergy and Infectious Diseases, National Institute of Health, Dr. Dorland Davis
  • Special Assistant to the Office of the Director of the National Institute of Allergy and Infectious Diseases, Dr. Earl Chamberlayne
  • Director of State and Community Services Division for the Center for Disease Control, Dr. J. Donald Millar

Dr. Sol Roy Rosenthal, the Director of the Institution for Tuberculosis Research at the University of Illinois takes the podium to present his findings upon the mass BCG vaccinations of British schoolchildren. Several minutes into his presentation, he appropriately raises concern about the presence of blood during these mass vaccinations with jet injectors.

“During the high pressure injection, traces of blood may cover the inside of the bell adjacent to the skin and the possibility of transfer of infectious hepatitis must be considered,” said Dr. Rosenthal.

_________________________________

Rosenthal saw what so many other health officials failed to see during the 1960s. The mass skin-testing and vaccination programs, along the introduction and implementation of multi-dose jet injectors, and the increased incidence of viral hepatitis all during this era prompted Rosenthal to assess the safety of vaccination devices. He questioned if jet injectors were jet infectors.

Not only did Rosenthal witness and participate in the mass BCG vaccinations of schoolchildren but he also evaluated a multi-dose jet injector, the Hypospray Model K-3, for blood contamination during the immunizations. His findings are reported in his 1967 article, Transference of Blood By Various Inoculation Devices.

Rosenthal’s observation of bloody jet injectors and the risk this posed compelled him to present his findings within this NIH conference in 1971.

_________________________________

With a room of captivated health officials and peers, Rosenthal expounded upon his findings.

Sampling the inside of the bell and testing for hemoglobin by the benzidine method, it was found that with one apparatus 22 of 248 samples gave positive benzidine tests (8.9 percent) and with another similar apparatus and a different operator 46 of the 139 samples gave positive tests (34 percent)…Visible bleeding from the site of inoculation was noted in 50 percent of the tests and may have been responsible for the variations in the size of the wheals (DHEW, 1972).

_________________________________

A benzidine test detects for the presence of blood. The test is conducted by swabbing a sample and then placing the swab into a test tube. A benzidine solution is mixed and then poured into the test tube. When benzidine oxidizes with hemoglobin a chemical reaction causes the sample to turn a blue-green color; thus indicating the sample is positive for blood.

Based upon Rosenthal’s findings, 8.9 % and 34% of the samples from the jet injector nozzle were contaminated with blood. In all, 68 out of 387 (17.6%) of the samples were positive for blood contamination.

Before continuing several clarifying points need to be made. The “bell,” aforementioned by Rosenthal, refers to the spherical shape of the nozzle. This is explained in greater detail within his article, in which he wrote, “The principle involved in this instrument is to depress the skin by a central post [referring to the nozzle]; the depth of the depression is governed by the free margin of a bell that surrounds the post” (Rosenthal, 1967).

Second, Rosenthal’s statement that “blood may cover the inside of the bell” does not refer to the internal components of the nozzle. The procedural methods of the study never mentioned any disassembling of devices for testing. His statement is, however, referring to the central point of the nozzle. This skin-contacting portion of the nozzle was swabbed and tested for blood.

Lastly, the mention of the word “infectious hepatitis” can be of great confusion. Infectious hepatitis is an outdated medical term referring to what is now identified as the Hepatitis A virus, which is primarily acquired from ingestion of contaminated food and water. Rosenthal’s use of the word at the 1971 conference is incorrect by todays standards. However, within his 1967 article, he appropriately used the terms viral hepatitis and parenteral hepatitis. Viral hepatitis is an inclusive term which acknowledges all forms of hepatitis (A, B, C, D, E). Parenteral hepatitis refers to hepatitis that is acquired through means other than the mouth such as through blood and bodily fluids and is primarily associated with Hepatitis B, C, and D.

It is important to note these terms were used before the identification of Hepatitis A in 1973. Hepatitis B, identified in 1967, was still a new discovery. It is likely the word infectious hepatitis was incorrectly used as a synonym for parenteral hepatitis. The fact that Rosenthal’s study tested jet injectors for blood contamination affirms this point.

_________________________________

Following Rosenthal’s presentation a discussion ensued amongst the attendees and a consensus was reached. The written account of the consensus stated,

The jet method of vaccination would save time as compared to the intradermal method. The possibility of transfer of infectious hepatitis, however, is not excluded. When compared to using disposable units of the multiple-puncture method, the time for vaccination is about the same for both. By the latter method, transference of infectious hepatitis is entirely ruled out; no expensive apparatus is needed, and it can be applied for mass vaccination as well as for individual vaccinations (DHEW, 1972).

Lets put this into perspective. Amongst the attendees of the conference were top health officials, elite scientists, and top-notch doctors and all concurred on the following points:

  • Blood contamination upon jet injectors during mass vaccinations occurs.
  • The risk of transmitting hepatitis via mass jet injections is not excluded. In other words the risk exists.
  • When compared to other vaccination methods, the jet injector is too risky and too expensive, and thus should not be used when more viable options are available.
  • The Multiple-puncture method for BCG vaccination is a safer, more versatile, and more economical approach.

In 1972, the Department of Health, Education and Welfare (DHEW) published an overview of the conference, in a publication titled, Status of Immunizations in Tuberculosis in 1971. The book included synopses to all presentations and outlined the ensuing discussions. Overtime numerous copies of the publication survived but were rarely ever referenced.

status-of-immunization-in-tuberculosis-in-1971
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.
  • (Rosenthal, 1967) Rosenthal SR. Transference of blood by various inoculation devices. Am Rev Respir Dis. October 1967; 96(4):815-819.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Seeing is believing: A Close-up of the Bifurcated Needle

January 2, 2017

Jet injectors were once used to administer smallpox vaccinations. Although with the invention of the bifurcated needle, administration of smallpox vaccine became simpler, faster, and more practical than with jet injectors.

Fenner and colleagues (1988) wrote,

A few disadvantages of jet injectors emerged during the campaigns in which they were used. In contrast to the simplicity of bifurcated needles, the jet injector required meticulous care and maintenance and considerable repair skills, which could not always be provided despite all the efforts to prepare a detailed, profusely illustrated manual.

As shown in the diagram below, bifurcated needles consisted of a forked-end. In between the forks, or prongs, held a droplet of smallpox vaccine. The vaccinator would perform the multi-puncture technique by pricking the skin with the ends of the prong. The technique consisted of pricking the skin 15 times within a small circular area.

bifurcated-needle

(WHO, 1968)

During the smallpox eradication campaign of the 1960s and 1970s bifurcated needles were reused. Sterilization of the needles were performed by placing 100 needles into a specialized plastic container which would then be submerged into boiling water. Holes in the bottom of the container would let-out the water (Fenner et al., 1988).

Both the jet injector and bifurcated needle have been implicated in spreading the hepatitis C virus amongst those who received smallpox vaccinations in Pakistan. “These results suggest that the widespread prevalence of hepatitis C infection in Pakistan may be an unintended consequence of the country’s smallpox vaccination program” (Aslam, 2005).

Weniger, Jones and Chen (2008) concluded, “Some iatrogenic infections with HBV likely occurred in countries where unsafe MUNJIs [Multiple-use Nozzle Jet Injectors] and unsterile BNs [Bifurcated Needles] were used.”
Statistical analyses and professional opinions by leading experts carry a lot of evidentiary weight. Although photographic evidence creates a new perspective to understanding.

Seeing is believing! These close-up images of the bifurcated needle magnify the reality that this instrument could have easily became infected with blood-borne pathogens.

Here is the Bifurcated Needle.
The tip of a bifurcated needle used to vaccinate individuals wit

Here is the Bifurcated Needle with smallpox vaccine between the prongs.
Close up of the tip of a bifurcated needle used to vaccinate ind

Here the image is magnified 41 times.

Roughened surface at the tip of a bifurcated smallpox vaccinatio
When magnified 187 times, striations in the metal emerge. Crevices appear within the prong area.
Oughened surface at the tip of one of the prongs of a bifurcated

When magnified 747 times, the bifurcated needle appears to be a completely foreign object. The metal appears porous. Ridges and valleys emerge within the prong area.
Roughened surface at the tip of one of the prongs of a bifurcate
Now is it so hard to imagine blood or viruses getting within these porous regions or getting attached upon the sharp microscopic ridges of the metal?

Today, bifurcated needles are still used in administering smallpox vaccine. Although now they are intended to be single-use, disposable needles. One needle, one patient.

Hmm…if only the jet injector nozzle was also photographed with a magnifying camera.

ped-o-jet-close-up

Acknowledgements:
Photos are courtesy of http://www.pixnio.com and are published under public domain.

References:

  • (Aslam et al., 2005) Aslam M, Aslam J, Mitchell BD, Munir KM. “Association Between Smallpox Vaccination and Hepatitis C Antibody Positive Serology in Pakistan Volunteers.” Journal of Clinical Gastroenterology. 2005 Mar;39(3):243-6.
  • (Fenner et al., 1988) Fenner F, Henderson DA, Arita I, Je〉ek Z, Ladnyi ID. Smallpox and its Eradication, Geneva: World Health Organization, 1988 (ISBN 92 4 156110 6).Available at: http://www.who.int/smallpox/9241561106.pdf.
  • (Weniger, Jones, & Chen, 2008) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods. 2008.
  • (WHO, 1968) World Health Organization. Instructions for smallpox vaccination with bifurcated needle. World Health Organization, Geneva. 1968. Available at: http://apps.who.int/iris/bitstream/10665/67962/1/SE_68.2.pdf.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

 

Concern Over Use of Protector Cap Needle-Free Injectors

December 26, 2016

Jet Infectors embarked to answer one question-
Are Jet Infectors still being used today?

So far no such devices are being used to administer vaccinations. However, a preliminary investigation found discrepancies within needle-free literature which, in good faith, must be clarified.

Jet Infectors found protector cap needle-free injectors (PCNFI) are currently being used as medical instruments in a beauty clinic in Pretoria, South Africa.

The PCNFI device used in Pretoria is known as Med-Jet MBX. The device consists of a single-use disposable plastic cap which acts as a barrier in protecting the reusable nozzle, internal fluid pathway, and drug reservoir from foreign particles.

However, PCNFI devices do not eliminate the risk of disease transmission between consecutive patients. Therefore, it is imperative that the reusable nozzle, internal fluid pathway, and drug reservoir are autoclaved after use on each patient. These pieces are to be treated no different than any other surgical device in need of autoclaving.

Med-Jet MBX has been marketed worldwide for applications in dermatology, cosmetics and mesotherapy. Although the device is still awaiting FDA approval within the United States.

Med-Jet MBX is manufactured and distributed by Medical International Technologies (MIT Canada) of Saint-Laurent, Canada. Med-Jet MBX, nor MIT Canada, have ever been implicated in any outbreak. An Internet search found no complaints against Med-Jet or MIT Canada whatsoever.

Jet Infectors reached-out to Karim Menassa, President and CEO of MIT Canada who was pleasant and forthcoming about his products.

“Our user manual clearly states that the reusable portion of the fluid path must be sterilized before injecting any patients,” said Mr. Menassa. “For example, Dr. Benohanian has purchased several reusable fluid paths and sterilizes after every patient.”

Although here lies some confusion and thus the sole reason for publishing this article. A paper published by Antranik Benohanian M.D. and Danielle Brassard M.D., both of Saint-Laurent, Canada and fond advocates of the Med-Jet MBX, does not state the device must be autoclaved after being used on each patient.

“Multiple injections could still be performed on a same patient, but not on a subsequent patient unless the anticontaminant disposable device is changed to avoid cross contamination,” wrote Benohanian and Brassard (2010).

Herein the authors attribute the anticontaminant disposable device as being the protector cap and is distinguished separately from the jet injector. Nowhere was it stated the reusable components of the jet injector were to be autoclaved in between patients.

The authors reiterated, “When the tip of the nozzle comes in direct contact of the skin, the risk of cross-contamination may occur. This requires the replacement of the disposable nozzle with a sterile one before using the injector on a subsequent patient.”

Safety testing by Kelly and colleagues (2008) found a PCNFI device, manufactured by PATH and Pulse Needle Free Systems, USA, failed to prevent contamination past the protector cap barrier. In 8.2 percent of the samples, Hepatitis B was found to have gone through the protector cap and into the internal components of the jet injector. Most startling, researchers observed no visible bleeding at the injection site in 7 out of the 17 injections that tested positive for cross-contamination of the Hepatitis B virus.

At this time it remains unclear how the beauty clinic in Pretoria is using the jet injector. When asked about sterilization procedures, the beauty clinic failed to respond and ceased all further communication.

Med-Jet MBX and other PCNFI devices can be used safely as medical instruments. Although it is important for users to know replacing the disposable cap does not sterilize the jet injector. The device must be autoclaved before being used on each patient.

PCNFI devices are not to be used in administering vaccinations.

If you know of a Jet Infector currently being used please fill-out the form on the following link.

References:

  • (Benohanian and Brassard, 2010) Benohanian A, Brassard D, “Needle-Free Jet Injection Revisited”, Review Report, 2010.
  • (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.

Copyright Notice

© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

What Is A Jet Injector?

October 23, 2016

A jet injector, also commonly referred to as an air gun, air jet injector, pneumatic injector, or jet gun injector, is a needle-free instrument that uses a high-pressure stream of liquid medicament to penetrate the skin and achieve a percutaneous administration of medicine or vaccine. The concept most resembles a powerful squirt gun penetrating through skin.

Initially jet injectors were developed as an easier method for delivering insulin to diabetic children who had a fear of needles. Soon thereafter developers designed a type of jet injector which reused the same nozzle tip to vaccinate multiple people. These jet injectors, known as high workload jet injectors, were designed for use in mass immunizations, in which a large population needed to be vaccinated at a rapid rate. The concept reduced the overuse and disposal of single-use syringes and needles, and prevented the accidental needle stick injuries to the immunizing staff.

Definitions
Jet injectors are defined in law under Title 21 of the Code of Federal Regulation. These devices are listed under sections for General Hospital and Personal Use Devices and Dental Instruments.
Nonelectrically powered jet injectors are defined in section 880.5430 as a “nonelectrically powered device used by a health care provider to give a hypodermic injection by means of a narrow, high velocity jet of fluid which can penetrate the surface of the skin and deliver the fluid to the body.”
Other types of jet injectors have been defined by their design features. Gas-powered jet injectors are defined in section 872.4465 as a “syringe device intended to administer a local anesthetic. The syringe is powered by a cartridge containing pressurized carbon dioxide which provides the pressure to force the anesthetic out of the syringe.”
Spring-powered jet injectors are defined in section 872.4475 as a “syringe device intended to administer a local anesthetic. The syringe is powered by a spring mechanism which provides the pressure to force the anesthetic out of the syringe.”

Classifications
These devices can be divided into various classes or categories based upon different factors. Factors such as:

  • Intended Market—Is the intended population human or animal? Medical professionals have used jet injectors for administering vaccines, therapeutic drugs, anesthetics, antibiotics, anticoagulants, antivirals, corticosteroids, cytotoxics, immunomodulators, insulin, hormones, and vitamins (Weniger & Papania, 2008). Veterinarians have used jet injectors to deliver vaccinations to various animals, but mainly livestock.
  • Intended Usage—Devices can be used by health professionals for vaccinating multiple patients or can be used solely for self-administration whereupon one patient uses one device (Weniger & Papania, 2008). The largest market for self-administering jet injectors is for administering insulin.
  • Frequency of vaccinations—High Workload versus Low Workload Jet injectors. High workload jet injectors are devices which can inject more than 150 people per hour. These devices are designed for use in mass immunization campaigns, in which a large number of people need to be vaccinated at a rapid rate. Low workload jet injectors are devices which can inject on average 30 people per hour. These devices are intended for use in physicians’ offices (Bykowski, 1999).
  • Design of the Drug Compartment—The drug compartment has been redesigned over the years to overcome the inherent risk of cross-contamination via the nozzle and internal fluid pathways. These design changes can be best classified by using the term “generation.” Below are descriptions of first generation, second generation and third generation jet injectors whereupon each succeeding generation has been an improvement to the faults of the previous generation.

First Generation Jet Injectors consisted of reusable nozzles and internal fluid pathways. None of these devices had any disposable parts. Parts that became contaminated with blood had to be substituted until contaminated parts could be sterilized through autoclaving, a procedure that sterilized devices through steam and high-temperature within an enclosed container. These first generation devices were termed multi-use nozzle jet injectors or MUNJI. In more recent years, researchers termed MUNJIs as reusable-nozzle jet injector, which describe the same device. Reusable-nozzle jet injectors are defined as a “Needle-free jet injector for high-speed vaccination which feeds vaccine from multidose vials through reusable fluid chambers, pathways, and nozzles that are in contact with consecutive patients without intervening sterilization” (Ekwueme, Weniger, & Chen, 2002). These devices were found to act as vehicles allowing blood and disease to pass from one patient to the consecutive patient. The photographs below show various MUNJI devices.

jet-infectors-munji

(Weniger, 2004)

Second Generation Jet Injectors attempted to overcome this risk by implementing a single-use protector cap that covered the injector nozzle thus acting as a shield between the reusable nozzle and the patient’s skin. Following an injection the protector cap would be discarded and a new one put in its place. These second generation devices were termed protector cap needle-free injectors or PCNFI. The photographs below show PCNFI devices.

jet-infectors-pcnfi-1
(Weniger, 2004)

jet-infectors-pcnfi-2

(Kelly et al., 2008)

Kelly and colleagues (2008) found in their study that PCNFIs still allowed cross-contamination of the hepatitis B virus through contaminating the internal fluid pathway. Researchers learned to overcome the risk of cross-contamination that the internal fluid pathway and patient-contacting parts cannot be reused. Third Generation Jet Injectors completely overhauled the design of preexisting devices, by making the drug compartment, internal fluid pathway, and nozzle as a single-use disposable cartridge. Once this cartridge dispenses an injection it can no longer be reused and must be discarded. Depending upon the manufacturer the cartridge may also be referred to as an “ampoule,” “syringe,” “capsule,” or “disc” (International Standards Organization, 2006). These third generation devices were termed disposable-cartridge jet injectors or DCJI. So far, this design has overcome the risk of cross-contamination although further tests are needed. The photographs below show various DCJI devices.

jet-infectors-dcji

(Weniger, 2004)

Note: This article has been contributed to Wikipedia.

Resources:

  • (Bykowski, 1999) Bykowski M. Needle-Free Injection Devices Face Obstacles. Skin & Allergy News 30(8):13, 1999. Available at: http://www.us-medicalinc.com/needle-free.htm.
  • (Ekwueme, Weniger, & Chen, 2002) Ekwueme DU, Weniger BG, Chen RT. Model-based estimates of risks of disease transmission and economic costs of seven injection devices in sub-Saharan Africa. Bull World Health Organ 2002;80:859–70.
  • (International Standards Organization, 2006) International Standards Organization. Needle-free injectors for medical use — Requirements and test methods. 19 May 2006. ISO 21649:2006. Available at: https://web.archive.org/web/20070125081939/http://www.iso.org/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=35954&ICS1=11&ICS2=40&ICS3=20.
  • (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.
  • (Weniger, 2004) Weniger BG. New High-speed Jet Injectors for Mass Vaccination: Pros and Cons of Disposable-cartridge Jet Injectors (DCJIs) versus Multi-use-nozzle Jet Injectors (MUNJIs). WHO Initiative for Vaccine Research: Global Vaccine Research Forum. 8-10 June 2004, Montreux, Switzerland.
  • (Weniger & Papania, 2008) Weniger BG, Papania MJ. Alternative Vaccine Delivery Methods [Chapter 61]. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357-1392.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Unauthorized use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Archival Footage Captured Nozzles Were Not Wiped – Part 2

Jet Injectors = Jet Infectors

October 1, 2016

Yet again, here are more footage capturing mass jet injection vaccinations were never wiped in between consecutive patients.

“Point of No Return” is a 1975 film by the World Health Organization that follows a smallpox eradication team as they traverse the globe to eradicate smallpox.

point-of-no-return

Clip 1 of the video shows mass jet injection vaccinations being administered in Yugoslavia after a smallpox outbreak in the spring of 1972. The narrator states, “Within three weeks, out of a population of 21 million, they vaccinated 18 million people, including the newborn babies.” In part of the clip the vaccinators and assisting nurses are wearing latex gloves and in other clips are not. Like previous videos the clips show the administration of consecutive injections despite the lack of swabbing the tip of the jet injector.


Clip 2 of the video shows jet injections being administered rapidly with the vaccinator waving people over to his pernicious task. Protocol of holding the jet injector against patients’ arms for a count of three seconds has been neglected. Rather as soon as the nozzle of the injector is pressed against the skin the shot is administered and the jet injector removed.

The narrator, speaking on behalf of WHO, referred to the jet injector as “complicated although efficient machinery.”

Clip 3 of the video shows a WHO eradication campaign in Gambia. Jet injections are administered in each arm. “One arm for measles and one arm for smallpox.”

The body of evidence supports the testimonies of those who had the displeasure of experiencing such injections. Veterans columnist Roger Neumann once summed the process best by simply writing, “one shot, one line, no waiting.”
The complete video can be viewed here.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Archival Footage Captured Nozzles Were Not Wiped – Part 1

Jet Injectors = Jet Infectors

July 9, 2016

Archival footage of civilian mass vaccination campaigns captured jet injector nozzles were never wiped in between consecutive patients. “Since there is no needle the risk of hepatitis is eliminated,” numerous professionals from the 1950s and 1960s incorrectly thought.

Not wiping the nozzle increased the likelihood in the transmission of blood, blood-borne pathogens, and infectious material to subsequent vaccinees. Numerous studies have upheld this finding. This is worth repeating, the risk of cross-contamination is lowered, but not eliminated, by the wiping of the injector nozzle with an acetone cotton swab (CDC, 1986; FDA, 2005; Grabowsky et al., 1994; Hoffman et al., 2001).

Ultimately, it is a moot point on whether the nozzle was wiped or not. Inherent design faults allowed internal components, such as the nozzle orifice and drug reservoir, to become contaminated. Cleansing only the external components of the device did not remove internal contamination. Regardless, the jet injector acted as a vehicle in the transmission of pathogens between recipients.

However, if you are like me, seeing stock footage of the device not being wiped between patients still holds importance. The ignorance to such blatant hazards is shocking.


Miracle in Tonga
“Miracle in Tonga” is a 1965 CDC film documenting the testing of a Ped-O-Jet injector for the administration of smallpox vaccination. Here the CDC went to the island nation of Tonga to test the use of the jet injector amongst a healthy population that had no history of smallpox. (The complete video can be accessed at http://resource.nlm.nih.gov/7800975A). This film captures leading physicians within the CDC administering consecutive jet injections without ever wiping the nozzle.


Mission, measles- the story of a vaccine

“Mission Measles: The Story of a Vaccine” is a 1964 film by Merck Sharp & Dohme on the creation of a measles vaccine. US Public Health Service tested the vaccine upon over 730,000 Upper Volta Africans using a Ped-O-Jet injector. (The complete video can be accessed at http://collections.nlm.nih.gov/catalog/nlm:nlmuid-8901910A-vid). This film is another example of government physicians administering consecutive jet injections without ever wiping the nozzle.


Smallpox Vaccination Production

“Smallpox Vaccination Production” is a 1966 film by Connaught Medical Research Laboratories at the University of Toronto describing the production of smallpox vaccine. (The complete video can be accessed at http://www.museumofhealthcare.ca/explore/exhibits/vaccinations/smallpox.html). The film demonstrates the use of the Ped-O-Jet injector upon adults, whereupon the vaccinator failed to wipe the nozzle between subsequent vaccinees.

Archival Footage Captured Nozzles Were Not Wiped – Part 2

References:

  • (CDC, 1986) Centers of Disease Control. Epidemiologic Notes and Reports Hepatitis B Associated with Jet Gun Injection — California. MMWR 1986;35(23):373-376.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (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., 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.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

“Slight bleeding does occur in at least 10 per cent” of Jet Injections

Jet Injectors = Jet Infectors

June 22, 2016

In March of 1958, an article rapidly circulated within newspapers announcing the innovation of a needleless inoculating device. The article, written by columnist Dr. Herman Bundesen a distinguished member of the Chicago medical community, was supposed to foretell of an innovative medical break-through that would forever change the way vaccines were administered.

Dr. Herman Bundesen

Dr. Herman Bundesen

Unbeknownst to Dr. Bundesen, his article disclosed a major fact about mass jet injector vaccination campaigns. “Slight bleeding does occur in at least 10 per cent of those inoculated with the instrument.”

During the development and introduction of the multiple-use nozzle jet injector, made-up of all reusable parts, scientists knew that in AT LEAST 10 percent of the injections there would be SLIGHT BLEEDING. Moreover, here is evidence that scientists observed and recorded the number of bleeders following jet injections. Until now this bit of information has been suppressed.

Apply this information to later mass inoculation programs where hundreds of patients were lined-up single file. AT LEAST 10 percent bleed.

Apply this to our military personnel who where expeditiously herded through assembly-line inoculations. AT LEAST 10 percent bleed.

Despite the blatant admission to the presence of blood, the article goes on to state “no sterilization is necessary.” The hype of the device left many ignorant to the risk of blood contamination between recipients.

After further investigation, Dr. Bundesen was citing Dr. Abram Benenson’s 1959 article, Mass Immunization By Jet Injection.

1958 Connellsville PA
Here is the article in its entirety:

The Daily Courier
Connellsville, Pennsylvania
Tuesday, March 4, 1958
pg. 13

Four New Discoveries Mark Medical Advance
By Herman N. Bundesen, M.D.

THE advances that are made continually in medicine are really quite amazing, even to a doctor. That’s why I like to keep you informed, once each month, about what is new in the medical field.

Scientists have now developed a multiple dose jet injector which permits speedy administration of Salk polio vaccine in mass inoculation programs.

New Instrument
The new instrument, which has no needle, can inoculate patients as quickly as one every four to six seconds. The jet injection is relatively safe, although slight bleeding does occur in at least 10 per cent of those inoculated with the instrument.

It does away with the fear many patients have of a needle, and no sterilization is necessary.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.