Frequently Asked Questions

General Questions

What is FAST1?

FAST1 is a sternal intraosseous (IO) infusion device designed specifically for use by military personnel. Pyng launched the first ever FDA-cleared IO system designed specifically for use in the sternum during adult and adolescent emergency intervention.FAST1 delivers lifesaving fluids and medication to the heart and vascular system in less than one minute. FAST1 is specifically designed for safe and effective use of IO in emergency conditions when traditional intravenous access fails. Features such as speedy vascular access, a protected infusion site, and a depth control mechanism make FAST1 ideal for emergency use, and allows IO infusion to be used in adults and adolescents 12 years of age and older.

How quickly can FAST1 be placed?

FAST1 can be placed and vascular access (essentially equivalent to a central venous line) achieved in 10 seconds with medications reaching the heart within 30 seconds. First attempts for central venous lines have a 60% success rate, with a mean insertion time of 9.9 minutes.

How rapidly does FAST1 deliver fluids?

Not all IO is clinically equal. Sternal IO delivers medications to the heart 2-3 times faster and in higher therapeutic concentrations than tibial IO in cardiac arrest patients. With the actual insertion of FAST1 complete within 10 seconds, medications reach the patient’s heart within 30 seconds.

How quickly can fluids be infused using FAST1

Fluids and medications have been infused into the sternum at: Gravity drip 30-80 ml/min. Pressure cuff 125 ml/min. Syringe 250 ml/min.

Can CPR be performed on a patient with FAST1 in place?

Yes. FAST1 allows for continuous chest compressions. A quick comparison of the chest compression site and FAST1 Target Patch clearly shows no interference between the two. In fact, users find it easier to manage treatment from a single location near the patient’s head.

Is FAST1 sterile?

Yes. FAST1 is a sterile, single-use device, which minimizes infections and protects against cross contamination.

Does FAST1 require a Remover Tool?

No. FAST1 does not require a remover tool. Simply grasp the Infusion Tube firmly at the site of insertion and pull in one continuous motion until removed (do not start/stop).

When to Use FAST1

When is FAST1 the best treatment option?

FAST1 is your quick, safe, reliable alternate to IV for the infusion of fluids and medications. More than one million attempts to place IV lines fail each year. Even successful IV placement can take up to 10 minutes. ILCOR, AHA, ATLS, ACLS and TC3 guidelines now recommend IO as an alternative treatment when IV cannot be obtained.

What medications can be administered through FAST1?

Any medications or fluids that can be administered using IV can be infused using FAST1. Healthcare providers should refer to local protocols for listings of approved substances.

On what age/size patients can FAST1 be used?

FAST1 has received clearance for use in patients 12 years of age and older from the US FDA, Health Canada, and the EU. This expanded use eliminates the need to stock and carry different products for these patients.

Can FAST1 be used in surgical procedures?

FAST1 can be used to obtain vascular access whenever infusion of medications and fluids is required in emergency settings.

When is it appropriate to use FAST1 instead of a Central Venous Line?

Any trained medical personnel can place FAST1, making it a safe, simple, accessible, short-term alternative to a Central Venous Line.

Intraosseous Infusion – General

What is intraosseous infusion (IO)?

Intraosseous infusion is the medical procedure of getting fluids, such as emergency medications, into a patient’s blood circulation by delivering them into the marrow space inside a bone. The standard resuscitation guidelines – ILCOR, AHA, ATLS, ACLS and TC3 — recommend IO as an alternative treatment for the infusion of medications and fluids when placement of an IV is difficult or impossible.

Why is the sternum the preferred IO infusion site?

The manubrium, the top bone of the sternum, makes an ideal IO site for several reasons. The landmark is very easy to locate, readily accessible, extremity trauma does not preclude its use. Most importantly, sternal IO delivers medications to the heart 2-3 times faster and in higher therapeutic concentrations than tibial IO.

What is the difference between IV and IO?

IV infusion is performed by entering a vein in soft tissue such as the forearm, leg, or neck. IO infusion is performed by delivering fluids to the marrow space inside a bone, usually the sternum or tibia. Blood drains from the bone marrow space directly back into the peripheral circulation via the venous system.

How common is intraosseous infusion?

IO has been used since 1922 and sternal IO kits were used by the US Military in WW II. IO infusion has been commonly used in children since the 1950s because their veins are often tiny and hard to locate, making IO quicker in emergency situations. The adoption of adult emergency IO infusion first required the development of suitable equipment. FAST1 was proven to effectively fill this gap in emergency medicine. The device provides a fast, safe, and effective alternative to vascular access in adults and adolescents 12 years of age or older. In fact, IO is now the recommended alternative to IV treatment for the infusion of medications and fluids according to both the ILCOR and AHA Guidelines.

What are the dosages required for IO infusion?

IO dosages using the FAST1 are the same as those used in IV infusion, as both procedures route directly into the patient’s bloodstream.

Using FAST1

How much training is required to use FAST1?

FAST1 is designed to take the guess-work out of establishing an IO line. Training time is minimal while skill retention is maximized. Most healthcare providers are able to learn how to use FAST1 within minutes, usually after practicing on a mannequin only two or three times. Even years after initial training and with no subsequent practice or refresher courses, users have reported they were able to insert FAST1 quickly and accurately.

How much pressure is needed to use FAST1?

Typical force for FAST1 is approximately 44.7 lbs. (in SimStern block), compared to 90 lbs. for CPR.

How does FAST1 depth control work?

The depth control mechanism of FAST1 is designed to ensure release of the bone portal of the Infusion Tube at a pre-set depth. It utilizes the surface of the manubrium as a reference point. The mechanism ensures that the bone portal does not penetrate any further than the pre-set depth from the surface of the manubrium. The proven consistent thickness of the manubrium in adults and adolescents 12 years of age or older allows the Infusion Tube to be safely placed within the marrow space, regardless of variations in tissue thickness.

Do the Stabilizer Needles enter the sternum?

No. The Stabilizer Needles ensure the device deploys accurately, are responsible for depth control, and help in achieving perpendicularity. They enter only the tissue above the bone.

Can CPR be performed while FAST1 is in place?

Yes. FAST1 has been specifically designed to be compatible with all other emergency procedures.

Can other treatments be performed with FAST1 in place?

Yes. FAST1 has been specifically designed to be compatible with all other emergency procedures including CPR, tracheotomy, cricothyroidotomy and C-spine collar.

How long can FAST1 remain in place?

FAST1 is designed to be left in place for a maximum of 24 hours.

How soon can another FAST1 device be used on the same patient?

A new FAST1 device may be placed immediately after the original device has been removed. A small amount of leakage may occur through the hole created by the first infusion.

FAST1 and Safety

Has FAST1 been clinically tested?

FAST1 has been subject to extensive lab and field testing. The safety and effectiveness of the device has been verified during field trials conducted by ambulance services, air ambulance services, military medics, and hospital emergency departments throughout the United States and Canada.

Is FAST1 FDA cleared?

Yes, FAST1 is cleared for use as a medical device in the USA. Pyng Medical also has clearance to market FAST1 in Canada and Europe, and various other countries worldwide including Australia and South Africa.

Is FAST1 safe when transporting patients?

FAST1can be inserted while transporting the patient in moving vehicles such as ambulances and helicopters. With the Target Patch ensuring precise placement every time, the patented automatic depth control, the low-profile, and secure tubing, patients can be transported safely and without delay.

How does FAST1 protect operators?

FAST1 features dual sharps protection. The Stabilizer Needles, Stylet, and Infusion Tube are covered by a large Sharps Protection Cap before use. After use, the retracted Stabilizer Needles are pushed into the red, foam-filled Sharps Foam Plug. For additional protection, the Sharps Protection Cap can also be fitted securely over the Sharps Foam Plug after use.

Is there a risk of infection?

The risk of infection is less than the risk of infection using IV under similar conditions.

Is a sternal intraosseous infusion procedure painful?

It is recommended that if FAST1 is inserted in a conscious patient that a topical anesthetic be applied.

How long does it take for the bone to heal?

No long-term damage to bone or marrow has been identified as a result of IO infusion. The bone will heal within a few weeks.

Is there a risk of air embolism?

The risks of air embolism are less than those associated with IV infusion. There are no documented cases of air embolism in literature pertaining to IO infusion.

Bibliography

  1. 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.
  2. LaRocco, BG, Wang HE, Intraosseous Infusion, Prehospital Emergency Care, APR/JUN 2003;7,2: 280-285.
  3. Dubick, MA, Holcomb JB, A Review of Intraosseous Vascular Access: Current Status and Military Application, Military Medicine 2000, 165:7; 552-559.
  4. Macnab, Andrew, Christenson, Jim, Findlay, Judy, Horwood, Bruce, Johnson, David, Jones, Lanny, Phillips, Kelly, Pollack, Charles, Robinson, David J., Rumball, Chris, Stair, Tom, Tiff any, Brian and Whelan, Max : A new system for sternal intraosseous infusion in adults. Prehospital Emergency Care, 4:2, 173-177.