Frequently Asked Questions
Below are answers 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 addressed here.
The FAST1™ Intraosseous Infusion System
1. What is the FAST1™?
2. Has the FAST1™ been clinically tested?
3. Is the FAST1™ FDA registered?
Intraosseous Infusion
4. What is intraosseous infusion (IO)?
5. What is the difference between IV and IO?
6. How common is intraosseous infusion?
7. Why is the sternum the preferred IO infusion site?
The Benefits of FAST1™
8. How does the FAST1™ depth-control work?
9. How rapidly does the FAST1™ deliver fluids?
10. What medications can be administered through the FAST1™?
11. How quickly can fluids be infused using the FAST1™?
12. Can the FAST1™ be used in surgical procedures?
13. What are the dosages required for IO infusion?
14. Is the FAST1™ reusable?
Using the FAST1™
15. How much pressure is needed to use the FAST1™?
16. Can CPR be performed while the FAST1™ is in place?
17. Can a tracheotomy be performed with the FAST1™ in place?
18. Can a C-spine collar be used with the FAST1™ in place?
19. How long can the FAST1™ Intraosseous Infusion System remain in place?
20. How soon can another FAST1™ be used on the same patient?
FAST1™ Safety
21. How does the FAST1™ protect operators?
22. Is there a risk of infection with the device?
23. Is the procedure painful?
24. Will the FAST1™ procedure cause bruising?
25. How long does it take for the bone to heal?
26. Is air embolism a risk?
The FAST1™ Intraosseous Infusion System
1. What is the FAST1™?
The FAST1™ is a sternal intraosseous infusion device that delivers life-saving drugs and fluids to the heart in under a minute. The FAST1™ Intraosseous Infusion System is specifically designed for safe and effective use of IO under emergency conditions. Features such as speedy access, a protected infusion site, and a depth-control mechanism make the FAST1™ ideal for emergency use, and allow IO infusion to be used as a standard protocol in adults. The versatility of the FAST1™ also allows use as an alternative in non-emergency settings.
2. Has the FAST1™ been clinically tested?
Yes, the 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.
3. Is the FAST1™ FDA registered?
Yes, the FAST1™ is registered for use as a medical device in the USA. The FDA 510(K) number to market the FAST1™ in the United States is K970380. Pyng Medical also has clearance to market the FAST1™ in Canada and Europe, and various other countries worldwide including Australia and South Africa.
Intraosseous Infusion
4. 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.
5. 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.
6. 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. The 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.
7. 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. It is very easy to locate, readily accessible, it is protected from trauma to the extremities, and it is thinner and easier to penetrate than other bones. Most importantly, fluids infused into the sternum more rapidly reach the central circulatory system.
The Benefits of FAST1™
8. How does the FAST1™ depth-control work?
The FAST1™’s depth-control mechanism is designed to ensure release of the bone portal at a pre-set depth. It utilizes the surface of the manubrium as a reference point. The proven consistent thickness of the manubrium in adults allows the bone portal to be safely placed within the marrow space, regardless of variations in tissue thickness.
9. How rapidly does the FAST1™ deliver fluids?
The FAST1™ Intraosseous Infusion System quickly and reliably creates a port through which fluids can be infused into the sternum. Studies demonstrate that substances infused into the sternal marrow appear in the central circulatory system in under 30 seconds-faster than non-sternal sites.
10. What medications can be administered through the FAST1™?
Any medications or fluids that can be administered using IV infusion can be infused with the FAST1™. Health care providers should refer to local protocols for listings of approved substances.
11. How quickly can fluids be infused using the FAST1™?
It has been shown, in a study by George C Kramer, that delivery time of drugs to the heart in a patient in cardiac arrest was equivalent to that for a Central IV line, both of which were much faster than tibial IO infusion. A drug concentration of 50% had reached the heart within 21 seconds of starting infusion via the sternal IO, compared to 52 seconds via tibial IO. The study concluded that the sternal IO route “has some advantage in both time and efficiency” over the tibial IO route and that “sternal IO drug delivery may be fully equivalent to Central IV delivery.”
12. Can the FAST1™ be used in surgical procedures?
The FAST1™ can be used to obtain vascular access whenever infusion of drugs and fluids is required, including non-emergency hospital settings.
13. 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.
14. Is the FAST1™ reusable?
The FAST1™ was designed with patient safety in mind, as a sterile, single-use device. Attempts to re-sterilize or re-use the device in another patient are hazardous. For the safety of patients and users, Pyng Medical does not permit re-use or re-sterilization.
Using the FAST1™
15. How much pressure is needed to use the FAST1™?
Typical high peak force for the FAST1™ is 60 lbs., compared to 90 lbs. for CPR.
16. Can CPR be performed while the FAST1™ is in place?
Yes. The FAST1™ has been specifically designed to be compatible with all other emergency procedures.
17. Can a tracheotomy be performed with the FAST1™ in place?
Yes. The FAST1™ has been specifically designed to be compatible with all other emergency procedures.
18. Can a C-spine collar be used while the FAST1™ is in place?
Yes. The FAST1™ is compatible with cervical collars.
19. How long can the FAST1™ remain in place?
It is recommended that an individual FAST1™ should be left in place for a maximum of 24 hours.
20. 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™ Safety
21. How does the FAST1™ protect operators?
The FAST1™ features dual sharps protection. The bone probe needles, stylet, and Infusion Tube are covered by a large sharps protection cap before use. After use, the retracted bone probe needles and stylet are pushed into the foam-filled Sharps Plug. For additional protection, the pre-use cap can be fitted securely over the smaller post-use plug.
22. Is there a risk of infection with the device?
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.
23. Is the procedure painful?
It is recommended that if the FAST1™ is applied to 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.
24. Will the FAST1™ procedure cause bruising?
Minor bruising may occur as a result of the Introducer handle pushing against the patient’s skin.
25. 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.
26. Is air embolism a risk?
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 the FAST1™. Pyng Medical recognized the potential and specifically engineered the device to minimize the risk of this complication.
