All-In-One Sternal Intraosseous Infusion Device – Compact Rigid Tube Packaging

Fast vascular access & high flow rates supported by clinical evidence

When seconds count, you need an Intraosseous Infusion route and device that will enable you to get critical fluids and medications into the bloodstream as quickly and reliably as possible.

The answer is the Sternal IO route and the FASTTactical Sternal IO Device:
Recent clinical evidence indicates the Sternal route for Intraosseous Infusion improves patient outcomes, and FASTTactical gives you an easily identifiable and repeatable landmark, and the fast deployment and high flow rates you need to save lives.

Compact Rigid Tube Packaging – All-In-One Device

  • New small profile rigid tube packaging means FASTTactical fits easily into your medical bag, while the hard tube packaging protects the device from damage and keeps it sterile.
  • FASTTactical is an all-in-one device, which means you don’t have to choose needles, worry about batteries, or mess around with different parts. This Sternal IO device is ready to go when you are.

Pyng Medical is now part of Teleflex. For ordering or other information, contact Teleflex customer service: 1.866.246.6990 or cs@teleflex.com


Why Intraosseous Infusion and FASTTactical?

A Safe, Effective and Fast Alternative to Traditional Intravenous Access

  • Any fluid or medication that can be delivered intravenously (by IV), can be delivered via IO at approximately the same or faster rate.
  • As an accepted standard of care and treatment modality, IO infusion is endorsed by the American Heart Association, Advanced Trauma Life Support, and Advanced Cardiac Life Support courses, as well as the European Resuscitation Council. IO is also taught as part of military medicine training and Tactical Combat Casualty Care guidelines.
  • FASTTactical can be placed and vascular access achieved in 10 seconds (essentially equivalent to a central venous line) with medications reaching the heart within 30 seconds.
  • The Sternum is the easiest and most reliable IO site to locate and place. The Humeral site is difficult to locate and it’s hard to keep devices in place during transport. The Tibia site gives poor flow rates as compared to Humeral and Sternal IO sites.
  • Clinical data indicates the Sternal route for IO (as compared to humeral or tibial) improves patient outcomes. See go.pyng.com/sternal-io for details.
  • FASTTactical is the most reliable and easy to use IO device featuring an all-in-one design, with no drilling, batteries, multiple parts, or needles to choose.
  • Pyng Medical is the pioneer in Sternal IO technology. FASTTactical is based on the trusted & proven design of Pyng’s FAST1 Sternal IO System, which has been used by the US Military for more than 13 years.

“When time and venous access are imperative, FAST can pull any provider out of a jam – any level of provider can place it effectively.” Lt. Lanney C. Jones, Chief Flight Paramedic, MS Medflight IE, Richmond, VA


 

Pioneering Sternal IO Technology Since 1997

Pyng Medical is the pioneer in sternal intraosseous infusion technology. In 1997, Pyng received clearance for FAST1, the first FDA-cleared IO system designed specifically for use in the sternum during adult emergency intervention. In 2008, FAST1 was cleared for use in adolescents 12 years of age and over. FAST1 has been trusted and used by military and combat personnel for more than 12 years. In fact, more military and combat personnel use FAST1 sternal IO than any other sternal or tibial IO device.

In 2013, Pyng launched FASTResponder, which includes all the trusted and proven features of FAST1, but modified to specifically meet the needs of civilian emergency medical services and hospital critical care personnel. FASTCombat was launched soon after, a device similar in all ways to FASTResponder, but in combat colors. In 2016, Pyng introduced FASTTactical for both civilian and military use.

FASTTactical is built on the design of FASTResponder & FASTCombat, but includes unique rigid tube packaging making it ideal to fit in medical bags, while protecting the device and keeping it sterile.  


Who is FASTTactical Sternal IO for?

FASTTactical is designed for use by both the military and in civilian pre-hospital and hospital settings whenever fast vascular access is required or when traditional intravenous access fails. The success rates for IO infusion are as high as or higher than for traditional IV infusion. Additionally, 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.

For EMS

When it comes to establishing critical vascular access in the field, seconds count. That’s why emergency medical services and first responders count on FASTTactical Sternal IO. With no batteries required, FASTTactical is the most reliable IO option available in the field. And with a low profile design, tubing remains in place when transporting patients in difficult conditions, including loading patients into ambulances or aircraft.

For the Military

Pyng Medical’s FAST1 device has been trusted by the military for years. Now, the military can access the next generation device featuring an all-in-one design and hard rigid tube packaging to take up as little space as possible – while protecting the IO device from damage in extreme conditions.
Small and portable with no batteries required, FASTTactical is a smart addition to every crash cart and critical care unit. When intravenous access fails, emergency nurses and doctors can quickly gain vascular access using a reliable sternal IO that relies on operator force only and features automatic depth control. No drilling or spring loading.
 

Why Sternal IO?

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..

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.

Think of the bone marrow as the “non-collapsible vein”.

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 FASTTactical™ Sternal IO device is safe to use in patients 12 years of age and older. Procedures to administer IO infusion are relatively simple and can be taught quickly to all medical providers in military, pre-hospital, or hospital environments. FASTTactical 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.

7 Reasons to Choose FASTTactical Sternal IO

  1. Compact rigid tube protective packaging that easily fits in medical bags.
  2. Clinical evidence supports the Sternal IO Route
  3. Faster fluid delivery via the Sternum
  4. Sternal IO is less painful than Tibial or Humeral IO
  5. The sternum is an easy and consistent site to locate
  6. Sternal IO can be used with standard EMS procedures, like CPR
  7. The Sternal IO route and the FAST devices have saved lives for more than 13 years

FASTTactical Sternal IO Device Benefits:

  • Rigid Hard Tube Packaging: The small profile packaging means FASTTactical fits easily into your medical bag, while the rigid packaging protects the device from damage and keeps it sterile.
  • All-In-One Device: With No Batteries Required: FASTTactical is an all-in-one device, which means you don’t have to choose needles, worry about batteries, or mess around with different parts. This Sternal IO device is ready to go when you are.
  • Easy Sternal Site Location: Unlike the long bones, the flat bone in the sternum/manubrium is easy to locate and access, even for first time users.
  • No Drilling. No Pins. Simply Reliable and Easy to Use: FASTTactical all-in-one IO is engineered for automatic depth control. This means you don’t need to guess which needle to use or worry about how much pressure to apply with your drill.
  • Easy to Learn Even for New Medical Professionals: FASTTactical was designed as an all-in-one IO in order to be as easy to learn and fail-safe as possible. After insertion, you simply remove the device and your built-in IV connector is ready for you to connect your IV tube and rapidly deliver fluids and medication into the vascular system.
  • Less Pain on Insertion and Fluid Delivery: Your patients will not only experience much less pain on insertion to the sternal site vs. the long bones, but will feel less pain with fluid delivery from the sternal site. In many cases, lidocaine is not required.
  • Low Profile Tubing: FASTTactical features low profile tubing, which lies nearly flat against the patient. This eliminates many of the bumping hazards that could dislodge the IV, especially during transport.
  • Clear Plastic Protector Dome for Added Security: Protect your IV even further with a plastic dome which fits securely over the insertion site.

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 pre-hospital 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 cannot be obtained. This is a challenging procedure under the best of conditions. IO infusion can be used in an 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:

FASTTactical 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, dopamine, 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 to 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)

Sternal IO and CPR:

 FASTTactical is compatible with all current recommendations and procedures for conducting CPR chest compressions. Sternal-IO-and-CPR FASTTactical is placed in the manubrium of the sternum. The manubrium is located at the cephalad (top) portion of the sternum. The hand placement for CPR chest compressions is located just cephalad of the xiphoid process (bottom portion) of the sternum. Sternal-IOThe position and placement of FAST devices and the hands for chest compressions are separated by the entire body of the sternum. Deployment of FASTTactical Sternal IO can be accomplished while chest compressions are temporarily halted, which takes only a few seconds. Chest compressions (if done correctly) will not affect the placement of the FAST infusion tube. With proper deployment of FASTTactical, chest compressions can continue while fluids are administered.

Bibliography

  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.