• FASTResponder Sternal IO Intraosseous Infusion Device

hot-prod_logo-1Introducing: FASTResponder Sternal IO 

No Drilling. No Batteries. A New Approach to IO is Here. 

 


When seconds count, you need the easiest, most reliable all-in-one sternal IO that simply works - period.

FASTResponder is the newest sternal intraosseous device from Pyng Medical. Developed for first responders and first receivers, FASTResponder is specifically designed to be as easy to learn, simple to use, and fail-safe as possible – even for first time users and new medical professionals.

View a Video Demo of FASTResponder:

 


 

7 Reasons to Choose FASTResponder Sternal IO:

  1. Compact & lightweight design fits nicely into your emergency bag or on your crash cart.

  2. Batteries not included – or needed. Which means FASTResponder is always ready to go when you are.

  3. Quick and easy site location. The sternum is much easier to locate and access than the long bones.

  4. Reliable & consistent access with automatic depth control built in.No choosing the right pin or worrying about too much pressure.

  5. All-in-one design makes it simple to learn and hard to make mistakes, even for first time users.

  6. Low profile tubing means your IV is more secure and hard to dislodge during transport.

  7. Less pain for your patient both on insertion and infusion. Lidocaine is not required in many cases.

 



Why Sternal IO for Vascular Access?

Traditionally, intravenous (IV) access has been used for rapid fluid and medication administration during resuscitation. IV access times and the ability to start an IV vary greatly among users and the situational environment. Starting an IV on a patient with hypovolemic shock or cardiac arrest presents a real challenge. Alternatives to IV access such as central venous catheterization or a venous cut-down are very time consuming and challenging in the best of situations. Most pre-hospital medical personnel are not equipped or trained to perform these procedures.

Intraosseous (IO) Infusion systems enable the user to rapidly, safely and effectively administer emergency fluids and medications into the vascular system through the bone marrow of the manubrium.

Think of the bone marrow as the “non-collapsible vein”. The primary indication for use for IO Infusion is the need for rapid or emergent vascular access when conventional/intravenous access has failed. Many organizations define this as two failed IV attempts. IO Infusion is an accepted standard of care and treatment modality. It is endorsed by the American Heart Association, Advanced Trauma Life Support, Advanced Cardiac Life Support courses as well as the European Resuscitation Council. IO Infusion is also taught as part of military medicine training and Tactical Combat Casualty Care guidelines. Success rates for IO infusion are as high as or higher than IV.

Any fluids or medications that can be administered via IV can also be administered via IO Infusion. Flow rates and volume that can be delivered by IO Infusion are comparable to IV and the time for fluids or medications to reach the vasculature, concentrations in the blood, and effects on target organs are similar between IO Infusion and IV.

Pyng Medical’s FASTResponder™ IO Infusion device is safe to use in patients 12 years of age and older. Procedures to administer IO infusion, with either product, are relatively simple and can be taught quickly to all medical providers in military, pre-hospital, or hospital environments.

FASTResponder can be used safely and effectively during CPR, so that CPR guidelines can be followed, and also can be used when a cervical spine collar is in place. Learn more about IO and CPR.

 


Indications for Use

The main indication for use is the need for rapid or emergent vascular access when conventional / intravenous access has failed. Most organizations define this as two failed IV attempts. (1)

The rate of IV failure varies significantly based on the skill level of the provider, the location in the prehospital or hospital environment, associated injuries and the blood pressure of the patient. Studies have shown a 60% to 95% IV infusion success rate. Another study focused just on emergency IV access demonstrated a 10% failure rate. The average time it takes to initiate an IV infusion also varies significantly from 1.5 minutes to 13 minutes. (2,4,6,7,11)

Central venous catheterization (CVC) is a commonly taught, physician level skill that is often used if IV access can not be obtained. This is a challenging procedure under the best of conditions. IO infusion can be used in emergent situation as a “bridge” to a CVC; allowing rapid vascular access until a CVC can be performed under better conditions. First attempt for a CVC is 60% with a mean time of 9.9 minutes in one study. CVC’s also have higher rates of infection noted at 5.3 per 1,000 catheter days as compared to IO infusion. (6)

A venous cut-down is another alternate procedure if IV access cannot be obtained. This is taught in ATLS and some military medical training. The mean infusion time for the cut-down group was 6.6 +/- 4.3 minutes. (10,13)

Intraosseous Capabilities

The sternal IO infusion device can be inserted and used during CPR and does not interfere with other resuscitation requirements. This device can also be used with a cervical spine collar in place for immobilization. (2) The device can be inserted through deep skin burns. (3)

The success rates for IO infusion are as high as or higher than for traditional IV infusion.

McNabb states “The success rate of vascular access for sternal IO users with training but no previous clinical experience with the IO system was 74%; for those with at least one previous IO device use, 95%…” Median access time for all users was 60 seconds while mean access time was 77 seconds (4)

Another study notes first time IO access and infusion success from 80% – 100%, “typically” in 1 minute or less and the majority of IO insertions completed within 2 minutes in all studies. (8)

The flow rate or infusion rate of an IO infusion are comparable to the traditional IV infusion. (8) Flow rates will vary based on a number of factors. The two most important variables are the blood pressure of the patient and the type of infusion system used. Up to 80 ml/minute was achieved using the tradition gravity feed drip system, and greater than 150ml/minute using a syringe bolus technique. (4,11,15)

Any fluids or medications that can be administered by the IV route can be administered IO. (9) Commonly used medications and fluids used in resuscitation that have been used with IO infusion include but are not limited to lidocaine, epinephrine, doapamine, vasopressin, blood, plasma hypertonic saline, 0.9% normal saline, Lactated Ringer’s, morphine, valium, succinylcholine, heparin, antitoxins and methylpredisolone. (8)

The pharmacokinetics of IO infusion are similar to IV regarding time to enter the vasculature, concentrations in the blood and effects on target organs. (10)(9)

With regard to clinically effective doses to target organs IO infusion is equivalent or quicker than IV. Note, that in cases of severe shock changes in peripheral venous flow rates make venous access very difficult and may potentially delay the time for medications to reach the target organs by IV. (5) The paper by Halvorsen states “….a number of studies have indicated essentially identical plasma concentrations or onset of physiologic effects of drugs and fluids when IO infusions were compared to both central or peripheral intravenous infusions…”(7)

The sternal IO procedure is relatively simple and can be utilized by multiple levels and types of medical providers in the pre-hospital and hospital environments. It has been used by EMT- Basics to EMT Paramedics, military medics, nurses, physician’s assistants and physicians. In the pre-hospital environment it provides a safe and quick alternative to the traditional IV. (7,8) A 93.1% “overall correct use” rate was documented after only a 1 hour lecture followed by 1 hour hand-on practice in a study using EMT-Basic students as the sample group. (12)


Technical Bibliography/References

  1. LaRocco, BG, Wang HE, Intraosseous Infusion, Prehospital Emergency Care, APR/JUN 2003;7,2: 280-285.
  2. Frascone, R, et. Al. Obtaining Vascular Access: Is There a Place for the Sternal IO?, Air Medical Journal 2001, 20;6: 20-22.
  3. Frascone, R, et. al., Successful Placement of an Adult Sternal Intraosseous Line Though Burned Skin, Journal of Burn Care & Rehabilitation, SEP/OCT 2003, 306-308.
  4. Macnab, A, et. al., A New System For Sternal Intraosseous Infusion In Adults, Prehospital Emergency Care, APR/JUN 2000; 4;2: 173-177.
  5. Von Hoff, DD, et. al., Does Intraosseous Equal Intravenous? A Pharmacokinetic Study, American Journal of Emergency Medicine 2008; 26:31-38.
  6. Leidel, BA, et. al., Is The Intraosseous Access Route Fast and Efficacious Compared to Conventional Central venous Catheterization In Adult Patients Under Resuscitation In the Emergency Department? A Prospective Observational Pilot Study, Patient safety In Surgery 2009; 3:24: 1-8.
  7. Halvorsen, LH, et. al., Evaluation of an Intraosseous Infusion Device for the Resuscitation of Hypovolemic Shock, Journal of Trauma 1990, 30:6; 652-659.
  8. Dubick, MA, Holcomb JB, A Review of Intraosseous Vascular Access: Current Status and Military Application, Military Medicine 2000, 165:7; 552-559.
  9. DeBoer, S, et. al., Intraosseous Infusion: Not Just For Kids Anymore, Emergency Medical Services 2005, MAR; 34(3):54; 55-63.
  10. Cotton, BA, et. al., Guidelines for Prehospital Fluid Resuscitation in the Injured Patient, Journal of Trauma 2009, 67:2; 389-401.
  11. Koschel, MJ, Sternal Intraosseous Infusions, American Journal of Nursing 2005, 105:1; 66-68.
  12. Miller, DB, et. al., Feasibility of Sternal Intraosseous Access By Emergency Medical Technician Students, PreHospital Emergency Care 2005, 9:2; 73-78.
  13. Emergency War Surgey, 3rd Revision 2004, multiple authors and editors; Borden Institute, pp. 8.1-8.4.
  14. Combat Medic Field Reference, 2005, multiple authors and editors; Jones and Bartlett Publishers, pp. 13-23, 209-214.
  15. Johnson, DL, Cadaver testing to Validate Design Criteria of an Adult Intraosseous Infusion System, Military Medicine 2005, MAR;170:3; 251-257.

 

 

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Download the FASTResponder Brochure

 

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