Frequently Asked Questions
Below are answers to some of the most commonly asked questions about the benefits and use of the FAST1® Intraosseous Infusion System. Please contact us if you have questions not answered here.
FAST1® Intraosseous Infusion System
1. What is FAST1®?
2. How quickly can FAST1® be placed?
3. How rapidly does FAST1® deliver fluids?
4. How quickly can fluids be infused using FAST1®?
5. Can CPR be performed on a patient with a FAST1® in place?
6. Is FAST1® sterile?
7. Does FAST1® require a Remover Tool?
When to Use FAST1®
8. When is FAST1® the best treatment option?
9. What medications can be administered through FAST1®?
10. On what age/size patients can FAST1® be used?
11. Can FAST1® be used in surgical procedures?
12. When is it appropriate to use FAST1® instead of a Central Line?
Intraosseous Infusion
13. What is intraosseous infusion (IO)?
14. Why is the sternum the preferred IO infusion site?
15. What is the difference between IV and IO?
16. How common is intraosseous infusion?
17. What are the dosages required for IO infusion?
Using FAST1®
18. How much training is required to use FAST1®?
19. How much pressure is needed to use FAST1®?
20. How does FAST1® depth control work?
21. Do the Stabilizer Points enter the sternum?
22. Can CPR be performed while FAST1® is in place?
23. Can other treatments be performed with FAST1® in place?
24. How long can FAST1® remain in place?
25. How soon can another FAST1® be used on the same patient?
FAST1® and Safety
26. Has FAST1® been clinically tested?
27. Is FAST1® FDA cleared?
28. Is FAST1® safe when transporting patients?
29. How does FAST1® protect operators?
30. Is there a risk of infection?
31. Is a sternal intraosseous infusion procedure painful?
32. How long does it take for the bone to heal?
33. Is there a risk of air embolism?
FAST1® Intraosseous Infusion System
1. What is FAST1®
FAST1® is a sternal intraosseous infusion device that delivers lifesaving drugs and fluids to the heart in less than one minute. The FAST1® Intraosseous Infusion System 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 FAST1® ideal for emergency use, and allows IO infusion to be used in adults and adolescents as young as 12 years of age.
2. How quickly can FAST1® be placed?
FAST1® can be placed and vascular access, essentially equivalent to a central line, can be achieved in 10 seconds with drugs reaching the heart within 30 seconds.
3. How rapidly does FAST1® deliver fluids?
Chest is Best™. Not all IO is clinically equal. Sternal IO delivers drugs 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, drugs reach the patient’s heart within 30 seconds.
4. How quickly can fluids be infused using FAST1®?
Flow rates for FAST1® are:
Gravity drip 30-80 ml/min.
Pressure cuff 125 ml/min.
Syringe 250 ml/min.
5. Can CPR be performed on a patient with a FAST1® in place?
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.
6. Is FAST1® sterile?
Yes. FAST1® is a sterile, single-use device, which minimizes infections and protects against cross contamination.
7. Does FAST1® require a Remover Tool?
Blue is New! The new FAST1®, available since March 2008, does not require a Remover Tool. When you see the blue tip on the Infusion Tube, simply grasp the Tube firmly at the site of insertion and pull to remove.
Note: With older FAST1® devices — those with Infusion Tubes that do not have a blue tip — the Remover Tool must still be used.
When to Use FAST1®
8. When is FAST1® the best treatment option?
FAST1® is your quick, safe, reliable alternate to IV for the infusion of fluids and drugs. Over a million attempts to place IV lines fail each year. Even successful IV placement can take up to 10 minutes. Both ILCOR and AHA guidelines now recommend IO as an alternative treatment when IV cannot be obtained.
9. What medications can be administered through FAST1®?
Any medications or fluids that can be administered using IV can be infused with the FAST1®. Health care providers should refer to local protocols for listings of approved substances.
10. 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.
11. Can FAST1® be used in surgical procedures?
The FAST1® can be used to obtain vascular access whenever infusion of drugs and fluids is required in emergency settings.
12. When is it appropriate to use FAST1® instead of a Central Line?
Any trained medical personnel can place FAST1®, making it a safe, simple, accessible, short-term alternative to a Central Line.
Intraosseous Infusion
13. What is intraosseous infusion (IO)?
Intraosseous infusion is the medical procedure of getting fluids, such as emergency drug solutions, into a patient’s blood circulation by delivering them into the marrow space inside a bone. The standard resuscitation guidelines — ILCOR and AHA — recommend IO as an alternative treatment for the infusion of drugs and fluids when placement of an IV is difficult or impossible.
14. Why is the sternum the preferred IO infusions site?
Chest is Best™. 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, and it is thinner and easier to penetrate than other bones. Most importantly, sternal IO delivers drugs to the heart 2-3 times faster and in higher therapeutic concentrations than tibial IO.
15. 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.
16. How common is intraosseous infusion?
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 has now received regulatory clearance for use in adolescents as young as 12 years of age. In fact, IO is now the recommended alternative to IV treatment for the infusion of drugs and fluids according to both the ILCOR and AHA guidelines.
17. What are the dosages required for IO infusion?
IO dosages using FAST1® are the same as those used in IV infusion, as both procedures route directly into the patient’s bloodstream.
Using FAST1®
18. How much training is required to use FAST1®?
The FAST1® Intraosseous Infusion System is designed to take the guess-work out of establishing an IO line. Training time is minimal while skill retention is maximized. Most health care providers acquire mastery of FAST1® within minutes, usually after practicing on a manikin 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.
19. How much pressure is needed to use FAST1®?
Typical force for FAST1® is 35 lbs., compared to 90 lbs. for CPR.
20. How does FAST1® depth control work?
The FAST1®’s depth control mechanism 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 as young as 12 years of age allows the Infusion Tube to be safely placed within the marrow space, regardless of variations in tissue thickness.
21. Do the Stabilizer Points enter the sternum?
No, the Stabilizer Points ensure the device deploys accurately, are responsible for depth control, and help in achieving perpendicularity. They enter only the tissue above the bone.
22. Can CPR be performed while FAST1® is in place?
Yes. FAST1® has been specifically designed to be compatible with all other emergency procedures.
23. 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 and C-spine collar.
24. How long can FAST1® remain in place?
FAST1® is designed to be left in place for a maximum of 24 hours.
25. How soon can another FAST1® 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
26. Has FAST1® been clinically tested?
Yes, 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.
References on FAST1® and intraosseous infusion
27. Is FAST1® FDA cleared?
Yes, FAST1® is cleared for use as a medical device in the USA. The FDA 510(K) number to market FAST1® in the United States is K080865. Pyng Medical also has clearance to market FAST1® in Canada and Europe, and various other countries worldwide including Australia and South Africa.
Accreditation
28. Is FAST1® safe when transporting patients?
FAST1® can 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.
29. How does FAST1® protect operators?
FAST1® features dual sharps protection. The Stabilizer Points, Stylet, and Infusion Tube are covered by a large sharps protection cap before use. After use, the retracted Stabilizer Points are pushed into the orange, foam-filled sharps plug. For additional protection, the pre-use sharps cap can also be fitted securely over the sharps plug after use.
30. Is there a risk of infection?
The risk of infection is similar to the risk of infection using IV under similar conditions. In FAST1® uses to date, there have been no reports of infection.
31. Is a sternal intraosseous infusion procedure painful?
It is recommended that if FAST1® is inserted in a conscious patient that a topical anesthetic is applied. Patients have verified that no pain is experienced after anesthesia. One patient described the sensation as less uncomfortable than giving blood. Doctors have advised that, if the system were applied without anesthetic, the pain would be similar to striking a shin against a table. Pain is not an issue in unconscious or obtunded patients.
32. 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.
33. 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, and it has not occurred in field trials of FAST1®. Pyng Medical recognized the potential and specifically engineered the device to minimize the risk of this complication.
