Frequently Asked Questions
Q: What is Vidacare®?
A: Vidacare Corporation is a privately held, San Antonio-based medical device company focused on the development of new and innovative products in the emergent care industry. The Company owns the exclusive rights to innovative intraosseous technology developed at the University of Texas Health Science Center-San Antonio and is the manufacturer of the EZ-IO® product system, including the EZ-IO® needles for adult patients (weighing greater than or equal to 40 kg) and pediatric patients (weighing between 3 kg and 39 kg), the leading products for immediate vascular access when conventional IV access is challenging or impossible.
Intraosseous (IO)
Q: Is difficult vascular access an issue? Why is access with a traditional IV difficult?
A: IVs cannot be started in over 6 million emergency patients annually, resulting in thousands of deaths every year. In situations in which the patients' veins collapse due to shock, low blood pressure, cardiac arrest, etc., IVs are extremely difficult to start often resulting in no vascular access or significant delays in obtaining vascular access. This issue results in difficult situations for paramedics, nurses and emergency physicians attempting to gain vascular access in life threatening situations. A significant number of central venous catheters (central lines) are placed each year, with a high complications rate, in patients for whom IV's cannot be started.
Q: How often is IO access needed in pre-hospital and ER settings?
A: Annually in the United States, there are over 19 million patients for whom it is necessary to gain vascular access to administer life saving drugs and fluids. IV access is difficult or impossible in the Emergency Room in over 2,690,000 patients annually and, in pre-hospital, another 3.8 million patients totaling over six million patients for which IO access should be considered as a means of rapid vascular access.
Q: What has been used before IO infusion products?
A: Current solutions to IV failure consist of alternate treatments such as administration of fluids through the endotracheal tube (ET), SQ, IM, rectal, oral, nasal, inhalation, sub-lingual, and transdermal routes. None of these paths have shown to be effective in emergency situations. In particular, the ET has been shown to be ineffective in delivering drugs according to the most recent ACLS guidelines. In the ED, central lines are placed in patients for whom IV access is difficult or impossible. However, this solution is expensive and plagued with an infection rate of nine percent, which on the average adds over $2000 in cost per line due to complications.
Q: What situations call for IO?
A: IO is recommended for use in situations in which IV access is difficult or impossible due to low blood pressure or difficulty finding a vein, such as cardiac arrest, status epilepticus, shock trauma, arrhythmia, dehydration, burns, diabetic, end stage renal disease, anaphylaxis, congestive heart failure, renal dialysis and sickle cell crisis. In other words, any patient who needs rapid vascular access but does not require a central venous catheter for monitoring purposes.
Q: Is IO better or just equal to IV for fluid, drug delivery?
A: The only human IO pharmacokinetic trial reported that IO flow levels are equal to that of IV as supported in the ACLS guidelines issues in December 2005. Drugs injected into the IO space of the tibia, sternum and humeral head all reach the central venous circulation within one second which is faster than drugs given through IV in a low flow perfusion state.
EZ-IO Product System
Q: What are the benefits of Vidacare's product vs. the competition?
A: The intraosseous products currently available are The EZ-IO® product system by Vidacare, Pyng Medical's F.A.S.T. 1 and Waismed's Bone Injection Gun (B.I.G.). The EZ-IO® product system consists of a small battery-powered device that penetrates through the bone in seconds with specifically designed and patented hollow drill needles for IO insertions in patients of all weights and sizes. This device is fast, stable, allows for control over insertion and provides a stable port for drug administration.
Q: What are the risks with this product - infection, leakage, bone not healing?
A: The documented overall complication rate associated with intraosseous insertion and infusion is less than 1 percent. Potential complications include extravasation (leakage), dislodgement of the needle, compartment syndrome, bone fracture, pain related to infusion of medications/fluids and infection. To date, there have been no reported complications from use the EZ-IO® product system. Overall IO experience in thousands of children and 4,000 adults show the infection rate to be less than 0.6 percent and those are usually not serious and can be treated as outpatients.
Q: How difficult is it to use?
A: The EZ-IO® product system establishes intraosseous access simply and without complications. The device uses a hollow drill to enter the bone using the small battery powered driver and enables immediate access for drugs and fluids. The system is reliable, easy to use and effective. Paramedics and emergency physicians can be trained to successfully use this device in a minimal amount of time and the training is well retained.
Q: How long does the insertion take?
A: Studies have shown the insertion using the EZ-IO® product system usually takes less than 10 seconds, while IV insertion takes an average of eight minutes.
Q: Can it be used by paramedics?
A: The EZ-IO® product system should only be used by the order of a licensed physician. In most states, EMT-P (paramedics), EMT-I and EMT-Basics work under the license of a physician (medical director). Therefore, paramedics who have been trained in the use of EZ-IO® can use the device in the field. Certain areas of the US have authorized the use of EZ-IO® systems by field responders.
Q: Where is your product being used: hospitals, EMS?
A: The EZ-IO® AD (40+ kg) is currently in use in hospitals and EMS services throughout the United States, as well as in Europe and Australia. In addition, the EZ-IO® AD (40+ kg) has been used by the U.S. military in the Middle East. The EZ-IO® PD (3-39 kg) was recently given 510(k) clearance by the FDA and is available throughout the United States.
Q: Pain/trauma vs. IV?
A: EZ-IO® AD (40+ kg) insertion has been well documented in conscious patients. Studies have shown that EZ-IO® insertion is well tolerated by conscious patients and is no more painful than a large bore peripheral IV stick. Patients have reported some pain after EZ-IO® insertion associated with the initial administration of fluid or medication. This is due to the extensive network of pressure sensitive nerves located within the medullary cavity. An initial bolus of Lidocaine has proven effective in alleviating this discomfort.
Q: What fluids and medications can I infuse IO?
A: Any fluid or medication that can be intravenously infused may be infused through the EZ-IO® product system. Drugs and fluids that are incompatible with each other can be infused through the EZ-IO® product system in a manner consistent with standard IV practice - flush the EZ-IO® system between drugs with saline.
