Contents:

• Bibliography, manufacturers, patents
• R&D funding sources
• FDA Center for Devices & Radiological Health (CDRH)
• International Organization for Standardization (ISO)
• Policies (WHO, CDC, and DoD)
• Conferences
• Press coverage
• Assoc. of Needle-free Injection Manufacturers (ANFIM)
• Devices
• Injection safety
• History
• News service

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• Small Business Innovation Research (SBIR) funding program
  • SBIR Phase I Contract Solicitation PHS 2007-1 (FY2007 cycle) from the Immunization Safety Office/CDC (see nominal page 62; actual page 67 of 109). Application deadline: 6 November 2006. 
  • SBIR general information and application instructions (look for "contracts", not "grants") 
• Grand Challenges in Global Health initiative: Grand Challenge #3: Develop Needle-free Delivery Systems for Vaccines (Bill & Melinda Gates Foundation and Foundation of the National Institutes of Health) (Closed. Letters of Intent deadline: 9 January 2004).
• 65 - Antigen Sparing Pandemic Influenza Vaccine. Solicitation no. ORDC-VB-05-08. Contract solicitation and subsequent amendments to develop medical devices and/or domestically-manufactured antigen-sparing influenza vaccines for FDA licensure and human usage, solicited by the National Vaccine Program Office and Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services.
• National Institute of Allergy and Infectious Diseases SMALL BUSINESS BIODEFENSE PROGRAM (no. PAS-02-149) (6 August 2002)

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• General Hospital and Personal Use Devices Panel - meeting on safety of multi-use-nozzle jet injectors, 9 August 2005 (including links to agenda, summary, roster, and transcript).

• General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee - meeting on needle-free devices and jet injectors, 2 Augiust 1999: 
   
  • Meeting Announcement: .txt ASCII version (5Kb)
    .pdf version (20Kb) 
     
  • Transcript (needle-free topic starts page 141): 
    .rtf rich text format version (306Kb)
    pp. 1-100 (4.2Mb) .pdf version
    pp. 101-200 (4.1Mb) .pdf version
    pp. 201-251 (2.0Mb) .pdf version
     
  • Summary minutes
       
• CDRH Assistance for Small Manufacturers

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• N4 - List of members (Jul 1999) (.pdf 11Kb) (.doc 39Kb, see N15)
• N13 - List of members (Oct 1999) (.pdf 14Kb) (.doc 125Kb, see N15) 
• N15 - List of members (Jan 2000) (.doc 22kB, supersedes N4, N13)
• 2001-June-20: Document ISO/AWI 21649 ("Needle-free injectors for medical use -- Requirements and test methods") by Working group 4 (TC 84/WG 4) passed Preliminary (00) and Proposal stages (10), and approved as a new project (stage 10.99) 
• 2001-June: Draft standards moved to Preparatory stage / Registration substage 20.00 under ISO Technical Committee 84 (TC 84) "Medical devices for injections"
• 2003-February: "Progress Towards Developing Standards for Needle-free Injectors for Medical Use": Powerpoint® presentation explaining process and status of draft standard, by working group Convenor, Robert R. Nesbitt, at 8th International Conference on Needle-free and Auto Injectors, London, 24-25 February 2003.
• 2003-March: Draft International Standard, Stage 4, in process of 5-month circulation to all member organizations/countries of ISO for comments. Contact Convenor or Secretary for copy and instructions for submitting comments through your national standards organization.
• Meetings:
  • Toronto, 3 June 1999
  • Minneapolis, 19-21 October 1999
  • London, 1-2 March 2000
  • Conference calls (Atlanta node), 17 April, 4 May 2000
  • Stockholm, 16-17 May 2000
  • Washington, DC, 14-15 September 2000
  • Lisbon, 22-23 January 2001
  • Portland, Oregon, 11-12 July 2001
  • Copenhagen, Denmark, 3-4 December 2001 
  • Franklin Lakes, NJ, USA, 8-9 April 2002 
  • Reykjavik, Iceland, 19-20 August 2002
  • Orlando, Florida, USA, 27 January 2003
  • Scottsdale, Arizona, USA, 2-3 February 2004
  • Indianapolis, Indiana, USA, 22-23 June 2005
• 2006-Jan-Mar: Draft International Standard ISO 21649 submitted to member bodies for final approval.
• 2006-June-1: Final publication as international standard "ISO 21649 Needle-free injectors for medical use -- Requirements and test methods"

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• World Health Organization (WHO) needle-free injection policy
  • WHO-recommended policy: Safety of injections in immunization programmes (document WHO/EPI/LHIS/96.05 Rev.1; .pdf 61Kb) 
    
• Centers for Disease Control and Prevention (CDC) needle-free injection policy
  • 2002 - General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians.  MMWR, 8 February 2002; Vol. 51 (No. RR-2);1-36 (see pp. 12-13) official .pdf version 
    unofficial .htm version
    
  • 1994 - General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), MMWR, 28 January 1994; Vol. 43 (RR01);1-38 (see pp. 7-8) official .pdf version (443Kb) 
    unofficial .htm version (246Kb)
    
• U.S. Department of Defense (DoD) needle-free injection policy chronology 
  • (1997-11-20) Ped-O-Jet® manufacturer (Keystone Industries, Cherry Hill, NJ) notifies Defense Supply Center Philadelphia (DSCP) (Defense Logistics Agency) of intent to withdraw as device supplier over liability concern for bloodborne disease transmission from multiple-use-nozzle design. 
     
  • (1997-12-05) DoD Medical Materiel Quality Control Program (MMQCP) issues withdrawal of automatic jet hypodermic injection units (MMQC-97-1169). 
     
  • (1997-12-07) DSCP issues Medical Products Quality Control System (MPQCS) device alert (DSCP 970147) as "cautionary measure", while noting the absence of bloodborne disease transmission case reports over 35 years of military use (followup MMQC-98-1019 dated 1998-Jan-30).
     
  • (1998-01-09) Armed Forces Epidemiological Board (AFEB) concurs with withdrawal of Ped-O-Jet® for "routine immunization", but availability for "public health emergency".  AFEB recommends use of "newer technology" devices with disposable parts for skin contact. 
     
  • (1998-04-20) Navy Bureau of Medicine and Surgery updates via BUMED notice 6230 its Immunization Requirements And Recommendations document (3.6Mb .pdf) prohibiting jet injector use until otherwise directed. 
     
  • (1998-04-28) AFEB recommends DoD formulate new needle-free injector specifications and support device research and development. 
      
  • (1998-07-09) Letter from Dr. Sue Bailey, Assistant Secretary of Defense, Health Affairs, to United States Representative Alan B. Mollohan (D-WV), explaining DoD policy on jet injectors in response to the concerns of a constituent of the Congressman.  
    
  • (1998-1999) Manufacturer discontinuation of large multi-dose vials for yellow fever, meningococcal, and tetanus-diphtheria vaccines because of military withdrawal of Ped-O-Jets® capable of using them (MMQC-99-1248 dated 1998-Nov-03 and MMQC-99-1251 dated 1999-Aug-12). 
     
  • (1998-11-25) Navy Bureau of Medicine and Surgery authorizes military use of new disposable-cartridge jet injector (Preventive Medicine Directorate). 
    
  • Current DoD policies and information available at the Military Immunization Information Source

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• 11th Annual International Conference on Needle-free and Auto Injectors, London, UK, 27-28 February 2006 (Management Forum, UK) 
  
• 10th Annual International Conference on Needle-free and Auto Injectors, London, UK, 28 February - 1 March 2005 (brochure) (Management Forum, UK) 
    
• 7th Annual Conference on Vaccine Research, Arlington, VA, USA, 24-26 May 2004 (program and abstracts) (National Foundation for Infectious Diseases)  
  • Symposium 1 - Needle-free Vaccination (25 May):
    • Trends, challenges, and opportunities for jet injection technology
    • Transcutaneous immunization: a clinical vaccinology perspective
    • Overview of mucosal immunization
    • Pulmonary inhalation of aerosols or dried powders: the measles model
• 9th Annual International Conference on Needle-free and Auto Injectors, London, UK, 23-24 February 2004 (brochure) (Management Forum, UK) 
    
• Innovative Administration Systems for Vaccines, Rockville, MD, USA, 18-19 December 2003 (Office of the Assistant Secretary for Public Health Emergency Preparedness, U.S.Department of Health and Human Services) 
    
• 8th Annual Conference on Needle-free and Auto Injectors, London, UK, 24-25 February 2003 (Management Forum, UK) 
    
• Needle-free Injection Systems, Philadelphia, PA, USA, 3-4 December 2002 (Barnett International) 
   
• 7th Annual Conference on Needle-free and Auto Injectors, London, UK, 25-26 February 2002 (Management Forum, UK) 
    
• 6th Annual Conference on Needle-free and Auto Injectors: An Update on Technology and Application, London, UK, 26-27 February 2001 (Management Forum, UK) 
   
• 5th Annual Conference on Needle-free and Auto Injectors: An Update on Technology and Application, London, UK, 28-29 February 2000 (Management Forum, UK) 
   
• Conference on Needle-free Injection Technology, Bethesda, MD, USA, 31 March - 1 April 1999 
    
• 1st Annual Conference on Vaccine Research, Washington, DC, USA, 30 May - 1 June 1998 
  • Symposium 8 - Vaccine Delivery Technologies: Beyond Needle and Syringe. Presentation abstract S29: "Needle-Free Parenteral Jet Injection: Past, Present, and Future" 

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• MAKING MEDICINE EASIER TO SWALLOW, by Lorilyn Rackl, Daily Herald (Chicago), 18 November 2002
   
• THIS WON'T HURT A BIT: Shots Pain Free, by Dina Blair, WGN-TV news video, Chicago, IL, 3-4 April 2002 (written summary)
   
• Reviving and Old Technology for Large-scale Vaccination, by Christopher Snowbeck, Pittsburgh Post-Gazette, 20 November 2001
   
• Eradication Efforts Need Needle-free Delivery, JAMA, 26 May 1999 (original format .pdf version, pp. 3-5, 173Kb) 
   
• Needle-free Injections Face Obstacles, Skin & Allergy News 30(8):13, 1999
   
• Jet Injector Blues: A Market in Transition, Rick Mendosa's Diabetes Directory, 10 May 1999 
    
• Ouchless Medicine, American Medical News, 7 December 1998
     
• Look Mom, No Pain, ABC News, 28 September 1998
    
• Shot in the Dark, Metro, 6-13 August 1998
   
• Alternative Vaccination Strategies Aimed at Decreasing Number of Injections, Infectious Diseases in Children, June 1998 
   
• The Jet Injector Paradox, Diabetes Wellness Letter, February 1998 
    
• Taking the 'Ouch" out of Vaccinations, The Scientist, 19 January 1998. 
   
• No More Pinpricks for the Diabetics, The Indian Express, 22 December 1997
   
• Lafene offers needle-free shots to help prevent winter illnesses, Kansas State Collegian, 6 November 1997
   
• Needle-free Injections Possible, Mail & Guardian, 27 May 1997 
   
• Betaseron Administered in a Needle-Free System for Multiple Sclerosis, Doctor's Guide, 1 July 1996

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• The Association of Needle-free Injection Manufacturers (ANFIM) is an industry trade association created in 1997 to promote understanding and advancement of needle-free injection technology, provide news and communication, and represent the industry to regulatory and technical standards organizations and the public
   
• 2006 membership application and dues schedule. 
    
• Further information, contact:  Chair - Linda D'Antonio or Treasurer - Chris Farrell 

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• AdvantaJet™, GentleJet™ (Activa Brand Products) 
    
• Am-O-Jet™ (American Jet Injector, Inc.)
    
• Antares MJ 6 (see Medi-Jector Choice™), MJ 7 (see Medi-Jector Vision™, also sold as ZomaJet™ and SciTojet™), MJ 8, MJ 10 (Antares Pharma) 
    
• Avant Guardian 101 (Avant Medical Corporation)
     
• HSI-500™ (Felton International / PATH)  
    
• Crossject™ (Crossject SA)
   
• Biojector2000® (Bioject, Inc.)
   
• Cool.Click® (Serono) (made by Bioject, Inc., see VitaJet)
   
• DermoJet® & Vacci-Jet (Société AKRA DERMOJET) (distributor Robbins Instruments) (photo) 
   
• Helios™ "gene gun" (Bio-Rad Laboratories, Inc.) 
     
• Iject™ (Bioject, Inc., see Biojector 2000®)
     
• Hyjettor™ (Tokyo Sokuhan Co., Ltd. [now Nidec Tosok Corporation], Japan)
   
• IM-O-JET™ (Institut Mérieux, Lyon, France [later acquired Pasteur Vaccins to become Pasteur-Mérieux Sérums et Vaccins and then Pasteur Mérieux Connaught; later becoming Aventis Pasteur which after merger became sanofi-pasteur]; see Mini-Imojet™, below)  
    
• Injex™ (Equidyne Systems, Inc.)  (a supplier)  
    
• IntraJect® (Aradigm Corporation [device acquired from Weston Medical, Ltd.])
    
• J-Tip® (National Medical Products, Inc.)
   
• LectraJet™ (patent family members 1, 2, 3, & 4) (D'Antonio Consultants International [DCI], Inc.) 
   
• MadaJet™ (MADA Medical Products, Inc.)
   
• Med-E-Jet® (Evans Enterprises)
   
• Medi-Jector® Choice™ and Vision™ (see Antares Pharma, formerly Medi-Ject Corp.)
   
• Med-Jet®, Agro-Jet® (Medical International Technologies [MIT], Inc.)
    
• MEDiVAX™ (Program for Appropriate Technology in Health-PATH) 
      
• Mesoflash® [Isajet™] (Prolitec SA, formerly Béarn Mécanique Aviation S.A.) (U.S. patent family members 5049125 and D277506)
   
• mhi-500™ (InsulinJet™) (The Medical House, PLC)
   
• Mini-Imojet™ (Galy1992 *, Spiegel1994a *, Fisch1996, Parent du Châtelet1997, Schlumberger1999) [Institut Mérieux, Lyon, France [later acquired Pasteur Vaccins to become Pasteur-Mérieux Sérums et Vaccins and then Pasteur Mérieux Connaught; later becoming Aventis Pasteur which after merger became sanofi-pasteur]; see IM-O-JET™, above) 
    
• Mini-Ject™ (Biovalve Technologies, Inc.)
    
• Ped-O-Jet® (Keystone Industries, Inc.) 
   
• Penjet™ , Penjet™/Micro (PenJet Corporation)
   
• PharmaJet™ (PharmaJet, Inc.)
   
• PMED™ (powder mediated epidermal delivery device) (PowderMed Ltd.)
   
• Pro-Jeey 2000 (Heng Yang Weida Science Technology)
   
• SeroJet™ (Serono, Inc.)
   
• SICIM JET2000 and DG77 injectors (SICIM Medical Jet S.p.A.)
   
• SNAP JET® (Cambridge Biostability Ltd.)
   
• SQ-PEN™, SQ-X™ (Medical House Products, Ltd.)
   
• Syrijet™ (Mizzy, Inc., a division of Keystone Industries)
   
• US patent 5911703 (Avant Drug Delivery Systems, Inc.)
   
• VACCIJET™ Electrique & VACCIJET™ Manuel  (ENDOS Pharma; formerly ENDOSCOPTIC), Laons, France (US patent D420,739)
   
• Vitajet® (Bioject, Inc.) 

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• International Sharps Injury Prevention Society
  
  
• 1998 Deadly Needles (feature series), San Francisco Chronicle 
  • 27-29/Oct 
  • 13-14-15-17/Apr, 8-14/May, 22/Jun, 24/Sep, 1/Oct 
  • 18/Dec
     
• California State Occupational Health and Safety Regulations
  • California Sharps Injury Control Program
  • Bloodborne Pathogens Regulatory Update  
  • Safety Needles and Needleless Systems Fact Sheet  
  • Sharps Injury Prevention Amendments 
  • California List of Needleless Systems and Needles with Engineered Sharps Injury Protection
     
• U.S. Department of Labor Occupational Safety and Health Administration (OSHA) 
  • Bloodborne Pathogens/Needlestick Prevention Safety and Health Topics page
  • Enforcement Procedures For the Occupational Exposure to Bloodborne Pathogens (OSHA Directive CPL 2-2.69 (2001-11-27)
     
• International Health Care Worker Safety Center, University of Virginia
  • Summary of legislative and regulatory actions in other U.S. states
     
• World Health Organization 
  • Immunization Safety  
  • Immunization Safety Priority Project  
  • Injection Safety Initiative
  • Safe Injections policies and documents
    • Publications list
  • Safety of Injections: WHO-UNICEF policy statement for mass immunization campaigns (1997 document WHO/EPI/LHIS/97.04 Rev.1) [also in French and Russian]. Replaced by Safety of infjections in immunization programs: WHO recommended policy (document WHO/EPI/LHIS/96.05 Rev.1, revision October 1998)   
  • Safety of injections: WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunization services (1999 document WHO/V&B/99.25)  
  • Vaccines and Biologicals (V&B) unit
  • Bulletin of the World Health Organization
    • Safe injection issue [1999;77(10):787-866]:
      • Y.J.F. Hutin & R.T. Chen: Injection Safety: A Global Challenge (.pdf 45Kb) 
      • L. Simonsen, et al: Unsafe injections in the developing world and transmission of bloodborne pathogens: a review (.pdf 285Kb) 
      • A. Kane, et al: Transmission of hepatitis B, hepatitis C and human immunodeficiency viruses through unsafe injections in the developing world: model-based regional estimates (.pdf 140Kb) 
      • M. Miller & E. Pisani: The cost of unsafe injections (.pdf 85Kb)
    • Immunization safety issue [2000;78(2):153-280] 
      
• FDA Center for Devices and Radiological Health (CDRH)
  • 1995 draft document: Supplementary Guidance on the Content of Premarket Notification [510(k)] Submissions for Medical Devices With Sharps Injury Prevention Features (.pdf 1.3Mb)

• Children's Vaccine Program (at the Program in Appropriate Technology in Health, with support from the Bill & Melinda Gates Foundation)
  • Safe injection page   

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•  Device for "Aquapuncture" manufactured by H. Galante et Compagnie, Paris. Studied clinically at the thermal baths of Pierrefonds, France, by Dr. L. Sales-Girons. Presented at the Imperial Academy of Medicine, 18 December 1866 by A. Béclard. Details from pages 43-44 of: Notice sur quelques nouveaux instruments et appareils de chirurgie fabriqués par H. Galante, 1866. (See bibliography for citations to Béclard and Galante.)
    
• Joannès Servajan, 19th Century thesis:l'Aquapuncture  (Index file card for 1872 thesis, Faculty of Medicine of Paris)
    
• Robert Andrew Hingson (1913-1996) - Father of the Jet Injector
  • Brother's Brother Foundation biography
  • 1967 polio campaign, Costa Rica (photo)
  • Robert Andrew Hingson, 83, A Pioneer in Public Health.  New York Times obituary, 1996-Oct-12, by Wolfgang Saxon, Late Edition - Final, Section 1, Page 52, Column 6
  • Robert Andrew Hingson, humanitarian.  The Atlanta Journal and The Atlanta Constitution obituary, 1996-Oct-13, by Kelleigh Scott, Page G10
  • Medical Giants exhibit on Robert Hingson, MD, at the American Society of Anesthesiologists office in Washington, DC. (Click images for medium size 77 Kb photographs. For large size 1.9 Mb photographs, click here: left image and right image.) (Exhibit prepared by George S. L. Bause, MD, MPH, Wood Library - Museum of Anesthesiology, Park Ridge, Illinois.)

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• Needle-free Injection Technology News Service
  • Disseminates news and related information via WebBoard® forum postings and e-mail broadcasts (must enroll separately for "mailing lists" option)
  • Maintains archives of prior broadcasts since inception in June 1999
  • To browse as a guest or to subscribe, click here:  http://vaxdev.forum.cdc.gov/ 

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