Care and Maintenance of the EZ-IO in the Critical Care Setting Thank you for taking the time to participate in Vidacare’s training program on the EZ-IO vascular access system. This training program is designed to provide the practitioner with the key skills and knowledge to be competent in caring for a patient with an EZ-IO in place.   This program is designed to be used in concert with hands-on practice with the EZ-IO device, various needle sets, and an array of simulation insertion aids such as synthetic bones of varying density. If at any time you have a question that needs clarification and is within the province of Vidacare staff to answer, please feel free to contact the Clinical Manager in your area to get a clear, concise and thorough answer. You can find the contact information for your Clinical Manager at www.vidacare.com or by calling 1-866- 479-8500.

Training Objectives Discuss how EZ-IO is utilized in the hospital setting Identify the 3 EZ-IO needle set sizes Review A&P of the intraosseous space Discuss on-going care, and troubleshooting of the IO Address pain management for IO related infusion pain Demonstrate how to remove the EZ-IO   T 463 Rev A

Why IO? EZ-IO is a safe, proven alternative: Alternative to central line access when long-term central lines are not absolutely required A bridge to immediate vascular access until a necessary central line can be placed with maximal sterile precautions in an optimal environment Leidel B, Kirchhoff C, Bogner V 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). T 463 Rev A

EZ-IO Benefits: Entry of fluids/medications/blood products into the central circulation is equivalent to central lines in speed of delivery Extremely low complication rate The Infusion Nurses Society considers IO insertion to require less skill set than peripheral IV access Fast, safe, easy to use Hoskins S, Kramer G, Stephens C, Zachariah B. Efficacy of epinephrine delivery via the intraosseous humeral head route during CPR. Circulation. 2006;114:II_1204. Davidoff J, Fowler R, Gordon D, et al. Clinical evaluation of a novel intraosseous device for adults: prospective, 250-patient, multi-center trial. JEMS. 2005;30:S20-23. Infusion Nurses Society. Position Paper: The Role of the Registered Nurse in the Insertion of Intraosseous (IO) Access Devices Available at: www.ins1.org. Accessed April, 2009. T 463 Rev A

Length and color are the only differences between Needle Sets EZ-IO Needle Sets Needle Selection is based primarily on tissue depth overlying the insertion site.   Three Needle Sets 5 mm mark or “black line” 15 gauge The EZ-IO system has three Needle Sets to choose from.   The pink needle which is 15 mm in length The blue needle which is 25 mm in length The yellow needle which is 45 mm in length All three Needle Sets are 15 gauge. The EZ-IO needle is a uniquely designed needle tip that cuts into the bone allowing for a relatively painless insertion. This technology creates a hole in the cortex that is the same size as the needle thus minimizing the risk of extravasation and dislodgement. Since the EZ-IO is inserted gently with minimal pressure, the risk of micro-fractures is also greatly reduced if not eliminated. 15 mm/15g 25 mm/15g 45 mm/15g Length and color are the only differences between Needle Sets T 463 Rev A

Anatomy of Intraosseous Access Intraosseous needles are placed in the proximal and distal ends (epiphysis) of long bones such as the tibia and humerus due to the thinner compact bone and abundance of cancellous (spongy) bone found at these sites. Within the micro-vasculature inside the medullary space, lies a hyper-coagulable fibrin mesh as well as red and yellow marrow. Since this is the space where all blood cells derive from, we can follow the pathway from the medullary space to the venous system. Within the epiphysis or medullary space lies a vast system of canals that blood and fluid can travel through to reach the central circulation.   The myth often perpetuated is that it takes a long time for fluids, medications, or blood infused into the intraosseous space to reach the central circulation. To the contrary, any fluid instilled into the intraosseous space gains access to the central circulation within just a few seconds. A study out of UTMB in Galveston by Kramer, et al. measured peak serum concentrations of epinephrine and found that epinephrine infused via the intraosseous humeral site has the identical peak serum concentration as if it were instilled via a subclavian central line.1     Kramer GC, Hoskins SL, Espana J, et al. Intraosseous drug delivery during cardiopulmonary resuscitation: relative dose delivery via the sternal and tibial routes. Acad Emerg Med 2005;12(5):s67. This real-time flow rate studies demonstrate how quickly IV contrast infused into the medullary space is disseminated into the central circulation. The video on the left shows dye infused through the proximal tibia. It is rapidly absorbed into the popliteal and femoral vasculature. The video on the right shows how rapidly dye reaches the right atrium when instilled via the proximal humerus, again demonstrating direct correlation between subclavian and proximal humerus for infusion of fluids.    Contrast infused in a caprine model for illustration. Results in humans may vary.  Hoskins SL, Zachariah BS, Copper N, Kramer GC. Comparison of intraosseous proximal humerus and sternal routes for drug delivery during CPR. Circulation 2007;116:II_933. Medications instilled into the intraosseous space reach the central circulation within a few seconds T 463 Rev A

IO Care and Use Use the EZ-Stabilizer to secure the IO Monitor the site and posterior compartments for signs of fluid extravasation and/or tissue edema If these signs are present, discontinue infusion and remove IO Any medication that can be safely given through a peripheral vein can be safely given through the IO IO and IV doses are identical Any medication that can be safely given through a peripheral vein can safely be infused into the medullary space. Use caution with hypertonic saline solutions of longer than 30 minute duration. Von Hoff DD, Kuhn JG, Burris HA, Miller LJ. Does intraosseous equal intravenous? A pharmacokinetic study. American Journal of Emergency Medicine 2008; 26:31-8. Dubick MA, Kramer GC. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=9140581 Hypertonic saline dextran (HSD) and intraosseous vascular access for the treatment of haemorrhagic hypotension in the far-forward combat arena. Ann Acad Med Singapore 1997; 26:64-9.   T 463 Rev A

IO Care and Use Flush with 3-5ml of saline before and after medication administration The IO space is hypercoagulable and may need to have a continuous flow of fluids and/or may need be flushed several times throughout treatment to avoid clotting Continually reassess and manage infusion related pain T 463 Rev A

Laboratory Analysis Attach syringe directly to the secured and stabilized hub Draw 2ml for waste Aspirate IO blood for standardized labs May use heparinized syringe Label tubes as IO blood Blood draws for laboratory testing are frequently acquired from the medullary space. Since the cavity within the intraosseous space is lined with a viscous fibrin material, it is important to aspirate and discard 2ml before obtaining a sample for lab analysis. Correlation between medullary samples and venous samples may be done to ensure correct interpretation (label the tubes as IO blood).   Miller L, Philbeck T, Montez D, Spadaccini C. A new study of intraosseous blood for CBC and chemistry profile. Annals of Emergency Medicine 2009; 54(3):S59. T 463 Rev A

IO Lab Analysis Study Compared lab results between IO and IV in human volunteers The following lab values produced a statistically significant correlation between IO and venous blood: Glucose, BUN, Creatinine, Chloride, Calcium, Hematocrit, Hemoglobin WBC was higher Blood gases – IO values were between arterial and venous Miller L, Philbeck T, Montez D, Spadaccini C. A new study of intraosseous blood for CBC and chemistry profile. Annals of Emergency Medicine 2009; 54(3):S59. T 463 Rev A 10

The Right Amount of Pressure The pressure in the medullary space is approximately 1/3 of the patients arterial pressure Pressurizing fluids for infusion is required to obtain maximum flow rates For aggressive fluid resuscitation a rapid infuser may increase flow rates The pressure in the medullary space is approximately 1/3 of the patient’s mean arterial pressure. This is important to remember because the pressure outside the bone in the IV bag must be higher than the pressure inside the bone to achieve flow. Therefore, fluids or medications must be delivered under pressure to obtain maximum flow rates. Rapid fluid infusers can be used for aggressive fluid resuscitation.      T 463 Rev A

Troubleshooting If fluids will not infuse: Disconnect IV tubing from EZ-Connect extension set and flush EZ-Connect with 10ml of saline To obtain maximum flow rates, infuse with pressure (pressure bag, rapid infuser or pump) Assure the clamp on the EZ-Connect is open T 463 Rev A

Troubleshooting If fluids will not infuse: If EZ-Connect appears to be occluded, replace extension set If infusing with a rapid infuser or pump, troubleshoot the infusion equipment If unable to restore flow through the IO, or if signs of extravasation or edema develop, remove the IO and replace at an alternative site if IO vascular access is still necessary T 463 Rev A

Troubleshooting If fluids will not infuse: Consider heparin lock between uses Consider heparin or urokinase to open blocked IO Follow your institutional policy for clotted vascular access devices T 463 Rev A

Intraosseous Usage and Pain It is a common misconception that the insertion of the IO is the primary cause of pain. Anecdotally, piercing of the skin and actual insertion into the medullary space is reported as 2-3 on a 10 point pain scale. Many patients and volunteers rate the pain of insertion similar to, or less than that of insertion of an 18g peripheral IV. For patients able to perceive pain, there can be significant discomfort associated with the initial flush as well as infusion. Although the bone is a non-collapsible cavity it is also non-expandable. Therefore, rapid expansion and pressure changes occur within the bone as a result of fluid delivery.    Paxton JH, Knuth TE, Klausner HA. Humeral head intraosseous insertion: The preferred emergency venous access. The Journal of Trauma® 2009:67(3): 606-11. Fowler RL, Pierce A, Nazeer S et al. 1,128 case series: Powered intraosseous insertion provides safe and effective vascular access for emergency patients. Manuscript in preparation for submission to Annals of Emergency Medicine. Insertion pain is specific, and of short duration Infusion pain is general, diffuse and protracted T 463 Rev A

*Physician must determine appropriate dosage range Pain Management Consider 2% lidocaine without preservatives or epinephrine (cardiac lidocaine) IO for patients responsive to pain prior to flush. Follow institutional protocols/policies. Medications intended to remain in the medullary space, such as a local anesthetic, must be administered very slowly until the desired anesthetic effect is achieved.   Note:  Physician must authorize appropriate dosage range and titration (see Pain Management Bibliography M-220 for information).  The amount of lidocaine required to achieve pain relief in awake and responsive patients may vary based on individual differences and distracting injuries or conditions. Clinical correlation and judgment are required. Vidacare publication M-220 is an annotated bibliography of clinical research studies that address management of IO infusion pain and can be used as a resource for clinicians to determine appropriate dosage range and method of administration.    *Physician must determine appropriate dosage range T 463 Rev A

Maintain axial alignment – DO NOT rock the syringe EZ-IO Removal Maintain axial alignment – DO NOT rock the syringe Rotate syringe clockwise while pulling straight back To remove the EZ IO begin by clamping the EZ-Connect tubing. The tubing is removed with counter- clockwise rotations of the Luer lock. Any size syringe with a standard Luer lock tip can then be attached to the EZ IO needle hub and will act as a handle for removing the IO needle. Stabilize the patient’s extremity. The syringe that is attached to the IO hub is then rotated in a clockwise direction. This action releases the tight seal in the cortex. Continue rotating clockwise and pull straight out. It may take several rotations to remove the IO needle. Avoid rocking the needle. Bleeding at the IO site is anticipated to be minimal unless certain medications or medical conditions lead to increased bleeding. Local pressure at the site may be warranted in these circumstances. The site is cleaned with an approved skin antiseptic and in most cases only a simple adhesive strip or minimal dressing is required.   Back the EZ-IO catheter out of patient while stabilizing the extremity. T 463 Rev A

Aftercare Following EZ-IO removal, apply gentle pressure and dress site appropriately Inform the patient that soreness is normal for up to forty-eight hours following removal There are no weight bearing or ambulation restrictions following removal of the IO The patient should be able to assume normal activities as soon as their primary medical condition allows Notify physician if signs and symptoms of infection develop at or around the insertion site T 463 Rev A

Clinical Support Wrist band 24 hour Emergency Line 1-800-680-4911 www.vidacare.com Clinical Feedback form Vidacare provides 24/7 live clinical support to our clinical partners utilizing our 800 hotline (800-680-4911) which is featured on our patient wristbands, in addition to our website (www.vidacare.com). Vidacare places tremendous value on direct clinical feedback, so we invite you to visit our website to gain the newest, cutting edge product information as well as provide us with your direct feedback on our products performance. T 463 Rev A

Please review “Directions For Use” before using the EZ-IO QUESTIONS? Please review “Directions For Use” before using the EZ-IO T 463 Rev A