Stratis 0.5mL Needle-free Injection System – marketing clearance for the following Indications for Use:
The PharmaJet Stratis® Needle-free Injection System is intended to deliver various medications and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine to the body. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It may be used for adults and children. It can also be used by patients authorized by their physicians to self-inject, or to have other individuals administer injections of prescribed medication.
Vaccines
Currently, there are 24 vaccine preventable diseases in the world, with children receiving slightly more than half, and adults the balance of all vaccinations. In some cases, booster shots for various vaccines are needed throughout a person’s life-time. In other cases, vaccines are offered for special purposes:
- Childhood vaccines
- Travelers’ vaccines
- Seasonal vaccines
- Adult vaccines
Therapeutics
Many therapeutics are injected IM or SC in 0.5 mL volumes. Ask your doctor. A few are approved in 0.5 mL volumes and are often administered at home:
- Migraines
- Infertility and other treatment hormones
Helping “Belenophobics” (people who fear needles)
Ten to twenty percent of the population is apprehensive of needles, and studies show a preference for alternatives to needle and syringe injections. Many people experience no pain while others feel mild pressure or a pinch-like sensation. In all situations however, the strong fear of being poked by a needle is eliminated by the use of needle-free.
I am petrified of receiving needles, my philosophy as a nurse is “better to give than receive” and usually pass on the yearly flu shot because of my fear. After receiving the injection with the Pharmajet (needleless system) I would definitely receive vaccines in the future and would feel more comfortable in administering to “others” that I am not “hurting” them in the process of wellness and prevention. - Nurse, R.N. BSW. MS.
Eliminating needle stick injury
In the U.S. alone, there are over 800,000 needle-stick injuries and a $2 billion burden for needle disposal costs and testing/treatment of needle-stick injuries. With needle free, healthcare workers are spared the occupational risk of being infected by blood borne pathogens through needle stick injuries. 74% of nurses say they would not consider working for an employer that does not provide safety syringes. Nearly two-thirds (64%) report being accidentally stuck by a needle while working, and an incredible 74% report being stuck by a contaminated needle!1
Eliminating Needle Re-use
Internationally, an estimated 40-70% of needles are re-used and are a source for infection, patient injuries and an estimated 1.3 million deaths. The World Health Organization estimates that 50% of needle-syringe injections are unsafe2, and that over 23 million people contract hepatitis, HIV, and other diseases each year because of this practice3. There are examples in every country of needle re-use, including in well funded healthcare environments. Auto-disabled syringes are reducing this risk. Once used, the PharmaJet syringe is also auto-disabled and cannot be re-used.
Reduced sharps disposal
Disposal of sharp medical waste requires costly sharps disposal services. PharmaJet’s needle-free syringe can be disposed of in the same way as a used bandage, thus making it simple and inexpensive.
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Notice: Please refer to Instructions For Use to ensure safe injections and to review risks.
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1. American Nurses Association; “2008 Study of Nurses’ Views on Workplace Safety and Needlestick Injuries”; Summer 2008.
2. Bill and Melinda Gates Children’s Vaccine Program; “Unsafe Injections, Fatal Infections”; Occasional Paper #2; page 3; May 2000.
3. World Health Organization; Dept. of Essential Health Technologies; “Safety of Injections – Global Facts & Figures.”
4. World Health Organization; “(GIVS) Global Immunization Vision and Strategy 2006-2015″; October 2005; page 44.
