Background: To demonstrate the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System, particularly in the pediatric patient population, a retrospective observational study was conducted in 2021 and 2022. Methods: Following study design, IRB approval, and investigator selection, data were collected for all patients needing intraosseous access—adult and pediatric. The primary endpoint was the success rate for achieving intraosseous access; the secondary endpoint was the rate of adverse events. Following initial data collection, additional data were collected and a sub-set analysis was conducted to demonstrate the same in pediatric patients only, which is the focus of this report. Results: Data for 106 pediatric cases were collected. The success rate for achieving intraosseous access and infusion was 96.2%. There were three adverse events in two patients (1.9%); none serious or previously unreported. The mean duration of device use was 60 h (SD = 46). For 46 patients, the device was used for up to 48 h, and for another 45 patients, the device was used for a longer duration. Conclusions: This report is the first characterization of the safety and performance of the Arrow EZ-IO Intraosseous Vascular Access System when used in the pediatric population for longer dwell times (>24 h), with no serious complications reported. Performance and safety objectives were met. The results of this real-world evidence study are in alignment with findings from the clinical literature concluding that, for pediatric patients, the Arrow EZ-IO Intraosseous Vascular Access System is safe and effective for providing vascular access in urgent, emergent, and medically necessary situations, in which intravenous access is difficult or impossible to obtain. In addition, this study supports the use of intraosseous access for dwell times greater than 24 h.

OBJECTIVE:To collect real-world data to demonstrate the safety and performance of Arrowg+ard Blue® /Arrowg+ard Blue Plus® (AGB/AGB+) central venous catheters (CVCs). METHODS:This observational, retrospective study involved patients who required AGB/AGB+ CVCs at designated general hospitals in USA (22), UK (19) and Germany (2). Data were extracted from electronic medical records. There were no specific inclusion/exclusion criteria. Primary endpoint was successful treatment without an adverse event (AE). Secondary endpoint was rate of AEs. RESULTS:In total, 384 cases were included from 43 centres and most patients (74%) were >35 years of age. A success rate of 99%, and an overall AE rate of 0.8% were observed. Moreover, the overall infection rate was lower than typically reported for standard catheters. In addition, power injection of contrast media was successful in all 51 cases. CONCLUSIONS:This study indicates the AGB/AGB+ CVCs perform as intended with a high success rate and few AEs. Further large-scale, controlled studies are required to confirm our findings.

BACKGROUND:Historically, intraosseous (IO) vascular access devices cleared to market by the US FDA have been restricted to 24-h use. An observational study was conducted to determine the safety of IO access for a period up to 48 h in adult volunteers. METHODS:A 2-arm randomized, stratified, parallel assignment, prospective interventional study was conducted at ICON Early Phase Services in San Antonio, Texas, United States. Study subjects were adult volunteers who were healthy or with a history of mild to moderate renal disease and/or controlled diabetes. Subjects were randomized to receive IO access (Arrow EZ-IO Vascular Access System, Teleflex Medical Incorporated, Morrisville, NC, USA) in the proximal humerus or the proximal tibia and maintain the indwelling catheter for 48 h. Subjects were monitored for the entire dwell time. A culture specimen was drawn from the indwelling catheter tip before removal and insertion site x-rays were taken. RESULTS:121 subjects were randomized: 79 healthy, 39 with diabetes, and three with diabetes and renal insufficiency. The mean catheter dwell time was 48.0 ± 0.2 h. Overall first attempt success rate was 98.4%. Infusion pain was the most commonly reported adverse event. There were no serious complications or unanticipated adverse events. CONCLUSIONS:This is the first known study examining the safety of IO access over a 48-h dwell time. The study corroborates the literature findings, demonstrates device safety, and provides evidence supporting the extended indication for a dwell time to 48 h in adult patients. IO placement and infusion best practices/guidelines were confirmed or established.

Clinical literature suggests blood drawn from intraosseous (IO) catheters show blood count and some chemistry values closely mirror venous samples. Other IO values approximate venous values; some will not correlate. Certain point-of-care (POC) analyzers have yielded acceptable results. However, most reported data was based on IO specimens obtained prior to any infusions or flush. This pilot study had 2 objectives: determine how long infusion must be stopped before drawing an IO specimen for analysis; and to determine if there is a difference between IO specimen results when the first 2 mL of IO blood were wasted and not wasted. IACUC approval was obtained. A CVC and multiple IO catheters were placed in the proximal humeri (PH), tibial and femoral bones of two swine. An i-STAT Handheld analyzer and Chem 8+ cartridges (Abbott Laboratories) were used to obtain lab results for the following analytes: sodium (Na), urea nitrogen (BUN)/urea, potassium (K), creatinine (Crea), chloride (Cl), hematocrit (Hct), calculated hemoglobin (Hgb), ionized calcium (iCa), TCO2, glucose (Glu), Anion Gap (AnGap). Specimens were injected into green top laboratory tubes (lithium heparin) then withdrawn for analysis. Time of specimen collection, analysis and results were noted. For the IO waste study, an initial 2 mL sample was aspirated by syringe; then a subsequent 2 mL sample was collected. Ten matched pairs were collected. In the post infusion wait time study, the initial IO 2 mL draw and the CVC catheter priming volume were discarded before specimen collection. After baseline, IO sites and the CVC were infused with 0.9% sodium chloride at 125 mL/hr. Infusion time was 5 minutes with start and stop times synchronized at all sites. The initial post infusion wait period was 5 minutes. Time intervals were reduced and results compared to baseline were noted to be similar with as little as 1 minute wait time post-infusion. A target wait of 2 minutes was chosen to stay similar to wait time recommendations in IV lab studies. Thirty-two (32) pairs of IO and CVC results were obtained. IO and CVC specimens collected 2 minutes after stopping the infusion were clinically similar for all analytes. The difference between IO and CVC results for iCa, Glu, Hct and Hgb was statistically significant, but not considered clinically significant. The greatest difference between specimens was found with Glu 53.28 ± 3.49 (IO) vs 56.91 ± 3.29 (CVC). For the comparison of the initial IO sample vs. post 2 mL waste, results for most parameters were near identical. Two initial aspirates could not be analyzed for K, Glu, and AnGap. One result for K was 8% higher in the initial vs. subsequent sample (6.6 vs 5.3 mmol/L). When IO vascular access is necessary and POC samples requested, the initial specimen drawn from the IO catheter for Chem 8+ lab analytes may be considered for sampling. If Chem 8+ values are needed, and IO infusion is occurring, a wait time of two minutes post-stopping the infusion may be adequate for analysis; and IO specimen values are comparable to CVC values.

Purpose To report clinical performance and longitudinal assessment of hemodialysis adequacy with the Arrow-Clark VectorFlow catheter, a symmetrical-tip device with a distal lumen configuration designed to reduce platelet shear stress and catheter thrombosis. Methods and materials We prospectively enrolled patients who required de novo placement of a chronic tunneled catheter for hemodialysis or exchange of a dysfunctional catheter as part of an Institutional Review Board (IRB)-approved protocol. Catheter patency, Kt/V, mean blood-flow (Qb), and pump pressures were obtained at baseline and at monthly intervals to 90 days. Results Forty-six subjects were enrolled into the study. During the 90-day observation period, maximum blood-flow rate averaged 355-398 mL/minute; mean Qb averaged 333-392 mL/minute. Mean Kt/V values were consistently ≥1.5. Dwell-time was 15-114 days, for a total of 2997 catheter days (mean 71.4 days). Excluding patients who died during the study and those receiving surgical access, overall intervention-free catheter patency rate was 94.9%, 92.2% and 88.8% at days 30, 60, 90, respectively. There were no acute complications. During the follow-up period, three patients developed complications (6.5%). Two catheter infections occurred (0.7/1000 catheter days) and one catheter malfunctioned; a rate of 1.0/ 1000 catheter days for all complications. Conclusions The VectorFlow catheter produced safe, effective hemodialysis with Kt/V ≥1.5. A single catheter occlusion occurred and a low rate of infection was seen. Results support the hypothesis that the VectorFlow design reduces thrombogenic risk during clinical performance.

Copyright © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

Copyright © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

Copyright © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

Study ObjectivesThe intraosseous (IO) vascular access route is an effective option for vascular delivery of critically needed drugs and fluids. Flow rates are site and device size dependent with a wide range of reported infusion flow rates through the proximal humerus and tibia using a 15 g needle set. First described by Tocantins in 1940, the sternum was among the first bones used for IO access. This site option is important when other sites are contraindicated, as with injuries sustained due to explosives when the manubrium may be the most accessible uninjured site; yet there is a paucity of published data describing infusion flow rates and other performance characteristics through this bone. In 2012, an FDA-cleared manually inserted multi-site (sternum, humerus and tibia) IO device was introduced (Arrow EZ-IO T.A.L.O.N, Teleflex Inc., Reading, PA) primarily for military and tactical medicine use. A prospective, single site study of the T.A.L.O.N. device was conducted to examine performance characteristics, including flow rates; using healthy volunteers as study subjects.MethodsIRB approval was obtained and subjects were recruited. Prior to insertion into subjects, device training was conducted with mannequins and cadavers. The device consists of a 38.5 mm, 15 g needle set used with a sternal locator to establish IO access in the sternum, and without locator for extremity access. Twenty four sternal IO insertions were performed by 8 certified military trained medics. To simulate a field scenario and assess needle retention during movement, insertions were made on a litter positioned on the floor. Subjects were then lifted and transferred to an examination table. For infusion pain 2% preservative and epinephrine-free lidocaine was given; then contrast was injected for visualization by fluoroscopy to verify placement and rule out extravasation. Normal saline (NS) was infused using a pressure bag with flow rates calculated after 3 minutes of infusion with gravity and infusion pressures of 100 mm Hg, 200 mm Hg, and 300 mm Hg. The NS bag was weighed before and after each infusion to determine volume infused. Subjects were monitored for signs of extravasation during infusion. A second contrast bolus was given after the last infusion pressure tested to determine if extravasation occurred during the pressure infusion.ResultsSubject mean age was 33.4 ± 8.8 years; 79% were male. Subject mean body mass index (BMI) was 26.3 (range: 17.1-31.7). Four subjects (17%) had a BMI greater than 30, but had palpable landmarks and did not have excessive tissue overlying the insertion site. Successful needle placement was initially confirmed by aspiration in 100% of cases. After the subjects were moved, one case of minor extravasation (noted after the 100 mm Hg infusion) and one case of needle dislodgment were observed under fluoroscopy, yielding a first attempt placement success rate with functionality of 92%. In no cases was there penetration of the posterior cortex of the manubrium. The mean infusion rates were gravity: 1130 ±. 692 mL/hr (n=23), 100 mm Hg: 3374 ± 1370 mL/hr (n=23), 200 mm Hg: 4619 ± 1785 mL/hr (n=21) and 300 mm Hg: 5327 ± 1724 mL/hr (n=22).There were no serious complications.ConclusionResults suggest that the T.A.L.O.N. may be used by military and tactical medicine personnel to safely and successfully establish IO vascular access in the sternum with excellent infusion flow rates. Study ObjectivesThe intraosseous (IO) vascular access route is an effective option for vascular delivery of critically needed drugs and fluids. Flow rates are site and device size dependent with a wide range of reported infusion flow rates through the proximal humerus and tibia using a 15 g needle set. First described by Tocantins in 1940, the sternum was among the first bones used for IO access. This site option is important when other sites are contraindicated, as with injuries sustained due to explosives when the manubrium may be the most accessible uninjured site; yet there is a paucity of published data describing infusion flow rates and other performance characteristics through this bone. In 2012, an FDA-cleared manually inserted multi-site (sternum, humerus and tibia) IO device was introduced (Arrow EZ-IO T.A.L.O.N, Teleflex Inc., Reading, PA) primarily for military and tactical medicine use. A prospective, single site study of the T.A.L.O.N. device was conducted to examine performance characteristics, including flow rates; using healthy volunteers as study subjects. The intraosseous (IO) vascular access route is an effective option for vascular delivery of critically needed drugs and fluids. Flow rates are site and device size dependent with a wide range of reported infusion flow rates through the proximal humerus and tibia using a 15 g needle set. First described by Tocantins in 1940, the sternum was among the first bones used for IO access. This site option is important when other sites are contraindicated, as with injuries sustained due to explosives when the manubrium may be the most accessible uninjured site; yet there is a paucity of published data describing infusion flow rates and other performance characteristics through this bone. In 2012, an FDA-cleared manually inserted multi-site (sternum, humerus and tibia) IO device was introduced (Arrow EZ-IO T.A.L.O.N, Teleflex Inc., Reading, PA) primarily for military and tactical medicine use. A prospective, single site study of the T.A.L.O.N. device was conducted to examine performance characteristics, including flow rates; using healthy volunteers as study subjects. MethodsIRB approval was obtained and subjects were recruited. Prior to insertion into subjects, device training was conducted with mannequins and cadavers. The device consists of a 38.5 mm, 15 g needle set used with a sternal locator to establish IO access in the sternum, and without locator for extremity access. Twenty four sternal IO insertions were performed by 8 certified military trained medics. To simulate a field scenario and assess needle retention during movement, insertions were made on a litter positioned on the floor. Subjects were then lifted and transferred to an examination table. For infusion pain 2% preservative and epinephrine-free lidocaine was given; then contrast was injected for visualization by fluoroscopy to verify placement and rule out extravasation. Normal saline (NS) was infused using a pressure bag with flow rates calculated after 3 minutes of infusion with gravity and infusion pressures of 100 mm Hg, 200 mm Hg, and 300 mm Hg. The NS bag was weighed before and after each infusion to determine volume infused. Subjects were monitored for signs of extravasation during infusion. A second contrast bolus was given after the last infusion pressure tested to determine if extravasation occurred during the pressure infusion. IRB approval was obtained and subjects were recruited. Prior to insertion into subjects, device training was conducted with mannequins and cadavers. The device consists of a 38.5 mm, 15 g needle set used with a sternal locator to establish IO access in the sternum, and without locator for extremity access. Twenty four sternal IO insertions were performed by 8 certified military trained medics. To simulate a field scenario and assess needle retention during movement, insertions were made on a litter positioned on the floor. Subjects were then lifted and transferred to an examination table. For infusion pain 2% preservative and epinephrine-free lidocaine was given; then contrast was injected for visualization by fluoroscopy to verify placement and rule out extravasation. Normal saline (NS) was infused using a pressure bag with flow rates calculated after 3 minutes of infusion with gravity and infusion pressures of 100 mm Hg, 200 mm Hg, and 300 mm Hg. The NS bag was weighed before and after each infusion to determine volume infused. Subjects were monitored for signs of extravasation during infusion. A second contrast bolus was given after the last infusion pressure tested to determine if extravasation occurred during the pressure infusion. ResultsSubject mean age was 33.4 ± 8.8 years; 79% were male. Subject mean body mass index (BMI) was 26.3 (range: 17.1-31.7). Four subjects (17%) had a BMI greater than 30, but had palpable landmarks and did not have excessive tissue overlying the insertion site. Successful needle placement was initially confirmed by aspiration in 100% of cases. After the subjects were moved, one case of minor extravasation (noted after the 100 mm Hg infusion) and one case of needle dislodgment were observed under fluoroscopy, yielding a first attempt placement success rate with functionality of 92%. In no cases was there penetration of the posterior cortex of the manubrium. The mean infusion rates were gravity: 1130 ±. 692 mL/hr (n=23), 100 mm Hg: 3374 ± 1370 mL/hr (n=23), 200 mm Hg: 4619 ± 1785 mL/hr (n=21) and 300 mm Hg: 5327 ± 1724 mL/hr (n=22).There were no serious complications. Subject mean age was 33.4 ± 8.8 years; 79% were male. Subject mean body mass index (BMI) was 26.3 (range: 17.1-31.7). Four subjects (17%) had a BMI greater than 30, but had palpable landmarks and did not have excessive tissue overlying the insertion site. Successful needle placement was initially confirmed by aspiration in 100% of cases. After the subjects were moved, one case of minor extravasation (noted after the 100 mm Hg infusion) and one case of needle dislodgment were observed under fluoroscopy, yielding a first attempt placement success rate with functionality of 92%. In no cases was there penetration of the posterior cortex of the manubrium. The mean infusion rates were gravity: 1130 ±. 692 mL/hr (n=23), 100 mm Hg: 3374 ± 1370 mL/hr (n=23), 200 mm Hg: 4619 ± 1785 mL/hr (n=21) and 300 mm Hg: 5327 ± 1724 mL/hr (n=22).There were no serious complications. ConclusionResults suggest that the T.A.L.O.N. may be used by military and tactical medicine personnel to safely and successfully establish IO vascular access in the sternum with excellent infusion flow rates. Results suggest that the T.A.L.O.N. may be used by military and tactical medicine personnel to safely and successfully establish IO vascular access in the sternum with excellent infusion flow rates.

Study ObjectivesVascular access is critical in managing unstable patients in the emergency department (ED). For difficult vascular access patients, intraosseous (IO) vascular access is an option. Often, they may need computed tomography (CT) scans with contrast for diagnostics; administered by a power injector. IO access to deliver contrast for CT examination has been reported as safe and successful. However, evidence is limited; and consists of a few case reports, preclinical studies and one clinical study with the focus on diagnostic image adequacy. A preclinical study was conducted to examine the immediate effects of power injection of contrast media on the medullary cavity and marrow in mature swine.MethodsInstitutional Animal Care Use Committee approval was obtained. IO access was established bilaterally in the proximal humeri (PH) of anesthetized swine (N=8). One unit of blood was transfused in each site, prior to power injection, as part of another study. One proximal humerus then received power injection of 150 mL of contrast media at a rate of 5 mL/second and the contralateral limb served as the control, yielding a sample size of 7 matched pairs (one infusion malfunctioned). Fluoroscopy was used to evaluate for extravasation. Both PHIO sites were flushed with 10 mL of normal saline post-contrast injection. After the swine were euthanized both front limbs were separated from the body, at a level superior to the PHIO insertion site with the IO needle left in situ. Cross sections of the proximal humeri were cut with a diamond saw to identify the needle tip insertion site and attempts were made to include the needle tract. The pathologist was unaware of which limb had received power injection and was asked to identify any cellular or structural damage to the area immediately adjacent to the injection site in a necropsy examination of both limbs. After rapid decalcification (RDO), cassettes with tissues were processed thru graded alcohols and xylene, infused with paraffin, stained, and observed under light microscopy for lesions. Sections were observed and graded for physical differences including hematopoetic bone marrow wash out, intact stroma/fat, hemorrhage, presence of trabecula, and cortical thickness.ResultsThe mean maximum infusion pressure was 80.1 psi (range 61-95). Marrow wash-out varied by one degree or less for each pig when limbs were compared. The amount of trabecular fracture caused by the placement of the IO needle could not be histologically separated from possible loss of trabecula due to high pressure power-infusion of contrast or administration of blood. Of all samples evaluated, 6 had some degree of hemorrhage in one level, which was graded the same in 4 of the pigs, +1 in the limb without the injection for pig B and +2 for one level in an injected limb for pig F. Humeri from 2 swine showed small extraosseal extravasations. Limitations of this study include use of a swine model; and the clinical significance of the small extraosseal extravasations is unknown.ConclusionIn swine receiving power-injected contrast there was essentially no histological difference between the limbs examined post-infusion. This supports the safety of IO power infusion of CT contrast. When considered with previous studies demonstrating CT image adequacy after IO contrast administration, these findings may further support the utility of power-injected contrast delivered via the IO route. Study ObjectivesVascular access is critical in managing unstable patients in the emergency department (ED). For difficult vascular access patients, intraosseous (IO) vascular access is an option. Often, they may need computed tomography (CT) scans with contrast for diagnostics; administered by a power injector. IO access to deliver contrast for CT examination has been reported as safe and successful. However, evidence is limited; and consists of a few case reports, preclinical studies and one clinical study with the focus on diagnostic image adequacy. A preclinical study was conducted to examine the immediate effects of power injection of contrast media on the medullary cavity and marrow in mature swine. Vascular access is critical in managing unstable patients in the emergency department (ED). For difficult vascular access patients, intraosseous (IO) vascular access is an option. Often, they may need computed tomography (CT) scans with contrast for diagnostics; administered by a power injector. IO access to deliver contrast for CT examination has been reported as safe and successful. However, evidence is limited; and consists of a few case reports, preclinical studies and one clinical study with the focus on diagnostic image adequacy. A preclinical study was conducted to examine the immediate effects of power injection of contrast media on the medullary cavity and marrow in mature swine. MethodsInstitutional Animal Care Use Committee approval was obtained. IO access was established bilaterally in the proximal humeri (PH) of anesthetized swine (N=8). One unit of blood was transfused in each site, prior to power injection, as part of another study. One proximal humerus then received power injection of 150 mL of contrast media at a rate of 5 mL/second and the contralateral limb served as the control, yielding a sample size of 7 matched pairs (one infusion malfunctioned). Fluoroscopy was used to evaluate for extravasation. Both PHIO sites were flushed with 10 mL of normal saline post-contrast injection. After the swine were euthanized both front limbs were separated from the body, at a level superior to the PHIO insertion site with the IO needle left in situ. Cross sections of the proximal humeri were cut with a diamond saw to identify the needle tip insertion site and attempts were made to include the needle tract. The pathologist was unaware of which limb had received power injection and was asked to identify any cellular or structural damage to the area immediately adjacent to the injection site in a necropsy examination of both limbs. After rapid decalcification (RDO), cassettes with tissues were processed thru graded alcohols and xylene, infused with paraffin, stained, and observed under light microscopy for lesions. Sections were observed and graded for physical differences including hematopoetic bone marrow wash out, intact stroma/fat, hemorrhage, presence of trabecula, and cortical thickness. Institutional Animal Care Use Committee approval was obtained. IO access was established bilaterally in the proximal humeri (PH) of anesthetized swine (N=8). One unit of blood was transfused in each site, prior to power injection, as part of another study. One proximal humerus then received power injection of 150 mL of contrast media at a rate of 5 mL/second and the contralateral limb served as the control, yielding a sample size of 7 matched pairs (one infusion malfunctioned). Fluoroscopy was used to evaluate for extravasation. Both PHIO sites were flushed with 10 mL of normal saline post-contrast injection. After the swine were euthanized both front limbs were separated from the body, at a level superior to the PHIO insertion site with the IO needle left in situ. Cross sections of the proximal humeri were cut with a diamond saw to identify the needle tip insertion site and attempts were made to include the needle tract. The pathologist was unaware of which limb had received power injection and was asked to identify any cellular or structural damage to the area immediately adjacent to the injection site in a necropsy examination of both limbs. After rapid decalcification (RDO), cassettes with tissues were processed thru graded alcohols and xylene, infused with paraffin, stained, and observed under light microscopy for lesions. Sections were observed and graded for physical differences including hematopoetic bone marrow wash out, intact stroma/fat, hemorrhage, presence of trabecula, and cortical thickness. ResultsThe mean maximum infusion pressure was 80.1 psi (range 61-95). Marrow wash-out varied by one degree or less for each pig when limbs were compared. The amount of trabecular fracture caused by the placement of the IO needle could not be histologically separated from possible loss of trabecula due to high pressure power-infusion of contrast or administration of blood. Of all samples evaluated, 6 had some degree of hemorrhage in one level, which was graded the same in 4 of the pigs, +1 in the limb without the injection for pig B and +2 for one level in an injected limb for pig F. Humeri from 2 swine showed small extraosseal extravasations. Limitations of this study include use of a swine model; and the clinical significance of the small extraosseal extravasations is unknown. The mean maximum infusion pressure was 80.1 psi (range 61-95). Marrow wash-out varied by one degree or less for each pig when limbs were compared. The amount of trabecular fracture caused by the placement of the IO needle could not be histologically separated from possible loss of trabecula due to high pressure power-infusion of contrast or administration of blood. Of all samples evaluated, 6 had some degree of hemorrhage in one level, which was graded the same in 4 of the pigs, +1 in the limb without the injection for pig B and +2 for one level in an injected limb for pig F. Humeri from 2 swine showed small extraosseal extravasations. Limitations of this study include use of a swine model; and the clinical significance of the small extraosseal extravasations is unknown. ConclusionIn swine receiving power-injected contrast there was essentially no histological difference between the limbs examined post-infusion. This supports the safety of IO power infusion of CT contrast. When considered with previous studies demonstrating CT image adequacy after IO contrast administration, these findings may further support the utility of power-injected contrast delivered via the IO route. In swine receiving power-injected contrast there was essentially no histological difference between the limbs examined post-infusion. This supports the safety of IO power infusion of CT contrast. When considered with previous studies demonstrating CT image adequacy after IO contrast administration, these findings may further support the utility of power-injected contrast delivered via the IO route.

Despite relatively few documented complications associated with intraosseous (IO) vascular access, the US Food and Drug Administration (FDA) restricts catheter dwell time to 24 hours for IO devices. This may contribute to placement of central venous catheters for difficult vascular access patients in whom an IO placement would otherwise suffice, contributing to an increased risk for complications and costs. Many clinicians have requested that the IO catheter dwell time be extended to at least 48 hours.

Intraosseous (IO) vascular access is useful for fluid and medication delivery and blood sampling when intravenous access is difficult or impossible to obtain. Serum lactate is a potentially useful biomarker when managing patients with severe sepsis or trauma. IO blood values have been shown to correlate with IV blood values for a number of laboratory tests; however, there has been no clinical data indicating the suitability of IO blood for determining serum lactate levels. The objective of this study was to compare IO and venous blood to determine if there is a correlation between samples from the two sources for serum lactate levels. The study protocol was approved by IntegReview IRB and healthy volunteer subjects were consented. From each arm of 15 study subjects, peripheral venous specimens (1.0mL) were collected by phlebotomy, followed by intraosseous specimens drawn from a proximal humerus IO needle (EZ-IO, Vidacare Corp, Shavano Park, TX). A 1.0mL IO blood sample was drawn after discarding the first 1.5 - 2.0 mL of blood drawn from the IO catheter. Each IO and venous sample was analyzed for lactate levels, using the I-Stat point-of-care analyzer. Means and Pearson's correlation were computed to assess the relationship between IO blood lactate levels and venous blood lactate levels. Of 30 specimens from each source, 23 matched pairs of samples were obtained. For 7 sample sets, matched pairs were not obtained due to IO blood clotting prior to injection into the I-Stat sample cartridges. The mean IO blood lactate level was 1.00 ± 0.54 mmol/L; and the mean venous blood lactate level was 1.08 ± 0.50 mmol/L. There was a positive correlation between IO blood lactate and venous blood lactate (R2 = 0.623, n = 23, p <0.001; Figure). Lactate levels obtained from IO blood appear comparable to lactate levels from venous blood, and those values are reflected in positive correlation. While results are promising, the subjects in this study were healthy and results may not accurately reflect the results seen in patients who are septic or have other illnesses and injuries where lactic acidosis is a factor. Further investigation is needed to determine if the relationship between IO and IV values exists in shock patients.

Abstract Introduction For decades, the standard methods of performing bone marrow and bone biopsy procedures in patients with varying bone densities have remained unchanged; despite the fact that the manual method of performing these biopsies has significant limitations; including patient discomfort, needle-related adverse events, and operator physical ability. As a consequence, interventional radiologists are often asked to perform these procedures for patients with difficult-to-reach biopsy targets. In 2010, a new battery/rotary powered biopsy device was introduced, initially for bone marrow sampling; then for examination of focal lesions of bones; procedures often performed by interventional radiologists using image guidance. In a retrospective study sponsored by Vidacare Corporation, an examination of one radiology and one pathology groups' initial experience using the device at a single center was conducted to determine the performance characteristics of the new biopsy device. Methods Medical records at Holy Family Hospital from March 2010 to July 2012 were examined, and data for patients who had undergone biopsy procedures using the powered device (OnControl, Vidacare Corp, Shavano Park, TX) were compiled. Data included patient demographics, biopsy type, imaging type, analgesia/anesthesia type, anatomical location, number of passes, room time, procedure time, and complications. Pathology data included specimen dimensions, grading for crush and thermal artifact, presence of hemorrhage, overall quality, and ability to provide a definitive or descriptive diagnosis. Results 64 patients had biopsy procedures using the powered device by 11 clinicians. Mean patient age was 63.5±15.6; 61% were female. Eleven patients received bone marrow aspiration and biopsy (BMAB) to diagnose/rule out hematological disorders. For the bone marrow biopsy procedures, pathology examination revealed the mean specimen length was 14.8±6.8mm; mean specimen volume was 87.9±64.2mm3 (vs. mean length of 11.0±5.5mm and mean volume of 20.4±9.0mm3 reported for patients receiving manual biopies in a separate study*) Of those specimens, 54.5% were intact, 91.9% were graded excellent or good (compared to 80% rated excellent or good for patients receiving manual biopsies in a separate study*), and the pathologist was able to provide either definitive or descriptive diagnosis for 100% of the cases. For the remaining cases, patients received bone biopsy procedures for focal lesions. Procedures were performed on vertebrae and the ilium in 39% and 38% of the cases, respectively. Other bones included the sacrum, femur, pubis, humerus, rib, and tibia. For all procedures, the mean number of passes was 1.3±0.7, and mean procedure time was 17.8±9.8 minutes. There were no complications. Conclusions For random marrow sampling and focal lesions, the powered system yielded outstanding specimens, particularly with respect to volume. Use of the powered device resulted in increased yield rates and higher quality specimens compared to manual devices; as well as easier and faster performance of biopsies, a broader spectrum of potential users (due to the decreased physical requirements for the biopsy), and reduced radiation exposure to patients and operators. The powered devices were especially useful when sampling hard bones and difficult-to-reach bone lesions. Shorter procedure time and diminished physician effort using the new system vastly improved operator ergonomics. The system also transformed previously inaccessible focal lesions into viable biopsy targets. *Berenson JR, Yellin O, Blumenstein B, Bojanower D, Croopnick J, Aboulafia D, et al. Using a powered bone marrow biopsy system results in shorter procedures, causes less residual pain to adult patients, and yields larger specimens. Diagnostic Pathology 2011;6:23 Disclosures: Symington: Vidacare Corporation: Consultancy, Honoraria, Research Funding. Off Label Use: Not really off-label but could be interpreted as off-label. The study device has a specific indication to be used to biopsy bone marrow, bones of the iliac crest and vertebra and a general indication for bone lesions. Some specific bones other than iliac crest and vertebra were treated, studied and mentioned in this abstract, which could be interpreted as off-label use. Martinez:Vidacare Corporation: Research Funding. Cohen:Vidacare Corporation: Research Funding. Miller:Vidacare Corporation: Co-inventor of study device, Co-inventor of study device Patents & Royalties, Employment. Philbeck:Vidacare Corporation: Employment.

Purpose Central venous catheters (CVCs) are often placed to resuscitate unstable emergency department (ED) patients. In an observational study, we assessed intraosseous (IO) vascular access in the hospital, and compared results to published experiences with CVC placement. Methods Patients who would typically receive a CVC were considered for the study. Vascular access was gained using a powered IO device. Data collection included placement success, placement time, ease-of-use, satisfaction with flow rates, complications and subsequent CVC placement. Results A total of 105 cases were studied from six centers. Mean age was 48.0±28.0 years and 53% were men; 85% of the patients were medical cases, and 53% were in cardiac/respiratory arrest. Of those, 48% returned to spontaneous circulation. A total of 94% of placements were successful on the first attempt. Mean time to IO access was 103.6±96.2 seconds. There was one serious complication – a lower extremity compartment syndrome. IO access costs $100/patient. Conclusions The data revealed faster and more successful IO catheter placement than reported for CVCs, few complications and high user satisfaction. For simple placements, cost savings for IO access vs. CVCs was $195/procedure. If 20% of the 3.5 million CVCs placed annually were replaced with IO catheters, cost savings could approach $650 million/year. We conclude that IO access in place of CVCs delivers high value in terms of being a safe, fast and effective mode of vascular access for patients in the hospital setting, with potentially substantial cost savings. These data indicate that IO access is a cost effective and viable alternative to problematic CVC lines.

Study Objective: In 1922, Dr. CK Drinker of Harvard University described the circulation within bones and confirmed that fluids infused into the marrow were quickly absorbed into the central circulation. Initially for children, intraosseous vascular access was adopted as an effective alternative to peripheral intravenous, with first-attempt placement success rates generally reported at >90%. intraosseous access complications were addressed by Rosetti et al in a 1985 meta-analysis of 4,270 patients. They reported 37 complications, with infection including osteomyelitis being the most prevalent at 0.6%. Since Rosetti's report, several new intraosseous devices have emerged; and advanced techniques and guidelines have been developed. An updated safety profile for intraosseous access is discussed.Methods: Using PubMed and keywords "intraosseous access" and "intraosseous infusion," the clinical literature was examined for updated information regarding complications resulting from intraosseous access since 1985. For complications not reported in the literature, regulatory officials from intraosseous manufacturers were contacted for medical device reporting for device-related complications.Results: 192 articles describing intraosseous access since 1985 (post-Rosetti) were found through PubMed. In those, 6 individual cases of osteomyelitis were reported. Another serious complication associated with intraosseous access, compartment syndrome secondary to extravasation, was also reported 6 times. Of the 192 articles, 140 described the EZ-intraosseous access device (Vidacare Corporation, Shavano Park, TX) and 45 of those were clinical studies or case reports involving >4,100 patients. There were reports of 4 serious complications (rate <0.1%); all of them compartment syndrome secondary to extravasation. There were no cases of osteomyelitis. Less-serious complications included difficulty with removal of catheter, device malfunction, inadequate flow rate, dislodgement, and extravasation. Vidacare's medical device reporting records confirmed one case of osteomyelitis (not cited in the literature), out of approximately 1.5 million placements of its EZ-intraosseous device since 2004; which equates to an osteomyelitis rate <0.001% for that device.Conclusion: As reported in the literature, utility of intraosseous access devices is increasing with highly successful placement rates. Intraosseous access appears to be a safe procedure with a low complication rate, particularly when compared to that of central venous catheters. While never a prevalent problem for intraosseous access, published evidence suggests the rate of osteomyelitis occurrence has decreased substantially in recent decades. The low risk of both osteomyelitis and compartment syndrome may be reduced further with greater emphasis on prevention with proper insertion technique, frequent monitoring of the infusion site, and awareness of at-risk patients. Study Objective: In 1922, Dr. CK Drinker of Harvard University described the circulation within bones and confirmed that fluids infused into the marrow were quickly absorbed into the central circulation. Initially for children, intraosseous vascular access was adopted as an effective alternative to peripheral intravenous, with first-attempt placement success rates generally reported at >90%. intraosseous access complications were addressed by Rosetti et al in a 1985 meta-analysis of 4,270 patients. They reported 37 complications, with infection including osteomyelitis being the most prevalent at 0.6%. Since Rosetti's report, several new intraosseous devices have emerged; and advanced techniques and guidelines have been developed. An updated safety profile for intraosseous access is discussed. Methods: Using PubMed and keywords "intraosseous access" and "intraosseous infusion," the clinical literature was examined for updated information regarding complications resulting from intraosseous access since 1985. For complications not reported in the literature, regulatory officials from intraosseous manufacturers were contacted for medical device reporting for device-related complications. Results: 192 articles describing intraosseous access since 1985 (post-Rosetti) were found through PubMed. In those, 6 individual cases of osteomyelitis were reported. Another serious complication associated with intraosseous access, compartment syndrome secondary to extravasation, was also reported 6 times. Of the 192 articles, 140 described the EZ-intraosseous access device (Vidacare Corporation, Shavano Park, TX) and 45 of those were clinical studies or case reports involving >4,100 patients. There were reports of 4 serious complications (rate <0.1%); all of them compartment syndrome secondary to extravasation. There were no cases of osteomyelitis. Less-serious complications included difficulty with removal of catheter, device malfunction, inadequate flow rate, dislodgement, and extravasation. Vidacare's medical device reporting records confirmed one case of osteomyelitis (not cited in the literature), out of approximately 1.5 million placements of its EZ-intraosseous device since 2004; which equates to an osteomyelitis rate <0.001% for that device. Conclusion: As reported in the literature, utility of intraosseous access devices is increasing with highly successful placement rates. Intraosseous access appears to be a safe procedure with a low complication rate, particularly when compared to that of central venous catheters. While never a prevalent problem for intraosseous access, published evidence suggests the rate of osteomyelitis occurrence has decreased substantially in recent decades. The low risk of both osteomyelitis and compartment syndrome may be reduced further with greater emphasis on prevention with proper insertion technique, frequent monitoring of the infusion site, and awareness of at-risk patients.