FASTResponder Sternal Intraosseous Device

Frequently Asked Questions

General Questions

What is FASTResponder?

FASTResponder is a sternal intraosseous (IO) infusion device designed specifically for use by civilian pre-hospital and hospital personnel. FASTResponder is a sternal intraosseous device that delivers lifesaving fluids and medication to the heart and vascular system in less than one minute. FASTResponder is specifically designed for safe and effective use of IO in emergency conditions. Features such as speedy vascular access, a protected infusion site, and a depth control mechanism make FASTResponder ideal for emergency use, and allows IO infusion to be used in adults and adolescents 12 years of age and older.

How quickly can FASTResponder be placed?

FASTResponder 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 FASTResponder 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 FASTResponder complete within 10 seconds, medications reach the patient’s heart within 30 seconds.

How quickly can fluids be infused using FASTResponder

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 FASTResponder in place?

Yes. FASTResponder allows for continuous chest compressions. A quick comparison of the chest compression site and FASTResponder Target Foot 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 FASTResponder sterile?

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

Does FASTResponder require a Remover Tool?

No. FASTResponder 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 FASTResponder

When is FASTResponder the best treatment option?

FASTResponder 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 FASTResponder?

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

On what age/size patients can FASTResponder be used?

FASTResponder 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 FASTResponder be used in surgical procedures?

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

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

Any trained medical personnel can place FASTResponder, 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. FASTResponder 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 FASTResponder are the same as those used in IV infusion, as both procedures route directly into the patient’s bloodstream.

Using FASTResponder

How much training is required to use FASTResponder?

FASTResponder 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 FASTResponder within minutes, usually after practicing on a mannequin only two or three times.

How much pressure is needed to use FASTResponder?

Typical force for FASTResponder is 32 lbs. (in SimStern block), compared to 90 lbs. for CPR.

How does FASTResponder depth control work?

The depth control mechanism of FASTResponder 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 with the Target Foot help in achieving perpendicularity. They enter only the tissue above the bone.

Can CPR be performed while FASTResponder is in place?

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

Can other treatments be performed with FASTResponder in place?

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

How long can FASTResponder remain in place?

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

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

A new FASTResponder 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.

FASTResponder and Safety

Has FASTResponder been clinically tested?

FASTResponder has been subject to extensive testing. The safety and effectiveness of the device has been verified during testing conducted for regulatory approval.

Is FASTResponder FDA cleared?

Yes, FASTResponder is cleared for use as a medical device in the USA, Europe, Canada and many other countries worldwide. The FDA 510(K) number to market FASTResponder in the United States is K130487.

Is FASTResponder safe when transporting patients?

FASTResponder can be inserted while transporting the patient in moving vehicles such as ambulances and helicopters. With the Target Foot 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 FASTResponder protect operators?

FASTResponder features dual protection. The Stabilizer Needles, Stylet, and Infusion Tube are covered by the needle cover and the Target Foot. After use, the stabilizer needles and stylet are retracted into the device and covered by the Needle Cover.

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 FASTResponder 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.