Hummi Micro Draw Blood Transfer Device. An Important Addition to Your IVH Bundle

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Hummi Micro Draw Blood Transfer Device An Important Addition to Your IVH Bundle

Hummi Micro Draw & Micro T Connector For Infec6on Control and IVH Risk Reduc6on The Next Genera6on System for Closed Micro Blood Sampling for the Neonate Also Providing an Important Addi6on to Your IVH Bundle This combina,on of microbial barrier protec,on u,lizing a closed port Micro T and the ability to gain access directly to the catheter hub with a closed Micro Sampling Device providing lower clearance and flush volumes and reduced pressures for sampling, provides both Infec,on Control and IVH risk reduc,on characteris,cs all in the same system. No other system for blood sampling in the Neonate can provide both of these very important clinical advantages. 2

The Next Genera6on System for Closed Micro Blood Sampling for the Neonate con,nued v Waste/holding is reduced by 70% vs. current methods (0.5mL vs. 1.5mL) v Flush volumes are reduced by 80% vs current methods (0.3mL vs. 1.5mL) v Saline values remain more stable vs. current methods v Only 1.3mL total blood / fluid movement required for blood sampling vs. 4-6mL for current methods v The Hummi remains closed to atmosphere during access and blood sampling directly from catheter hub v Waste/holding and sample blood is collected without nega6ve pressure v Flushing the umbilical catheter is completed with only 0.30mL, and mul,ple closed flushes (10 with 3mL syringe) are possible without flush syringe change out (inf- ivh) 3

Complications of Prematurity Four major complications of prematurity contribute to 90% of all the costs related to the treatment of the premature infant. 4

Major Complications of Prematurity 1. RDS - Respiratory Distress Syndrome 2. BPD - Broncho Pulmonary Dysplasia 3. NEC - Necrotizing Enterocolitis 4. IVH / PVL Intraventricular Hemorrhage and Periventricular Leukomalacia 5

What is IVH & PVL? Intraventricualr Hemorrhage (IVH) of the newborn is bleeding into the fluid filled areas (ventricles) inside the brain. The condi,on occurs most oven in babies that are born prematurely. Periventricular Leukomalacia (PVL) is a type of brain injury. PVL actually represent small holes in the brain due to the death of small areas of brain,ssue around the normal fluid filled cavi,es (ventricles) of the brain. OVen these 2 condi,ons are referred to as PVH/IVH, or PV/IVH as they are oven present together, and have prematurity as a key factor for development. 6

IVH Why? Primarily a^ributed to: Increased Vascular Fragility Disturbances to Cerebral Blood Flow (CBF) Possibly, but Not OVen Disorder of Platelet Count, Coagula,on Dr. John Golden, D.O. Neonatologist, Pediatrix Medical Group of WA, Tacoma General Hospital, Sept. 2014 7

What is a Bundle? v A bundle is a selected set of interven,ons or processes of care dis,lled from evidence- based prac,ce guidelines that when implemented as a group provide a more robust picture of the quality of care provided. v The implementa,on of the bundle is aimed at tracking change in prac,ce and repor,ng how oven these evidence- based interven,ons are used. Levy et al Cri,cal Care Med 2004 8

As Part of an IVH Bundle the Hummi Micro Draw has Unique Clinical Implications for Reducing Risk Factors for IVH / PVL Hummi Micro- Draw Blood Transfer Device has clinical implica6ons for reducing the known risk factors for IVH / PVL development from the use of: 1. Umbilical Arterial Catheters (UAC) and 2. Umbilical Venous Catheters (UVC) 9

Key Neonatal Risk Factors and Clinical Characteristics for Development of IVH / PVL 1. Prematurity 2. Low Gesta,onal Age 3. Low Birth Weight 4. Use of Umbilical Artery Catheter (UAC) or Umbilical Venous Catheter (UVC) 10

Other Risk Factors 5. Use of Inotropic Agents for hypotension 6. Metabolic Acidosis 7. Development of RDS Respiratory Distress Syndrome 9. Development of Sepsis 10. Surgical Procedure 11. Transfusion of Red Blood Cells 8. Mechanical Ventilation 11

Incidence of IVH / PVL in Premature Infants with Umbilical Catheter Use Lee et.al 2010: Case Group IVH / PVL Control Group IVH / PVL Umbilical Arterial Catheter (UAC) 23.7% 7.6% Umbilical Venous Catheter (UVC) 27.9% 5.1% 12

Blood Withdrawal and Infusion via Umbilical Catheters The withdrawal and infusion of blood via the umbilical catheter can cause a significant rapid change of cerebral blood flow of preterm infants. Bray, et.al Biol. Neonate 2003; 84: 187-193 13

Benefit For the IVH Bundle Hummi Micro Draw Ø Maintaining stable cerebral blood flow is paramount to avoiding damage to premature brain cells due to excessive volumes and pressures created during a blood sampling procedure with umbilical catheters Ø The Hummi reduces blood and fluid volume movement by 70% during blood sampling from umbilical catheters and eliminates nega6ve pressures during blood collec6on, thus reducing the risk of altering cerebral blood flow. 14

The Risk for IVH Development Reduction in intra-ventricular hemorrhage by elimination of fluctuating cerebral blood flow velocity in preterm infants Perlman, et.al Have demonstrated that the alteration from auto-regulation to a pressure passive circulatory pattern appears to be an important step in the development of PV / IVH. New England Journal of Medicine 1988; 309 204-9 15

The Risk for IVH Development Premature infants brains have some ability to regulate pressure and blood flow some of the,me but not all of the,me. Since the baby s brain cells are underdeveloped, excessive movement of blood and fluid in an out of the heart and brain during a blood draw can damage the underdeveloped cells and change them from auto- regula6on to a passive state, where no regula6on of pressures takes place. This is a high risk situa,on for the development of IVH, which is damage to the cells, leading to bleeding in the brain. If severe enough, mental retarda,on and cerebral palsy can develop. 16

The Risk for IVH Development Umbilical Artery Catheter Blood Sampling Volume and Velocity: Impact on Cerebral Blood Volume and Oxygenation in Very Low Birth Weight Infants Roll et al. Changes in cerebral hemodynamics and Oxygenation are thought to be major causes of Intracranial Hemorrhage and Periventricular Leukomalacia in premature infants. Roll, et.al Acta Paediatrical 2006; 95: 68-73 17

Benefit for IVH Bundle Hummi Micro Draw Ø Decreased oxygen supply (ischemia) and decreased blood flow to the brain are both causa6ve factors for IVH and PVL development according to Roll et al. Ø When using the Hummi for blood draws, the volume of blood and fluid movement is significantly reduced from current methods, thereby reducing the risk of decreasing blood flow and oxygena6on to the brain. The Hummi only moves 1.3mL in total fluid when doing a blood draw vs. 4-6mL with current methods. Known de- oxygena,on has been reported at 1.8mL of total fluid movement during a blood draw. 18

The Risk for IVH Development Umbilical Artery Catheter Blood Sampling Volume and Velocity: Impact on Cerebral Blood Volume and Oxygenation in Very Low Birth Weight Infants Roll et al. This study demonstrates that blood sampling from an Umbilical Arterial Catheter (UAC) induces an inevitable decrease in Cerebral Blood Volume and Cerebral Oxygenation in preterm infants. In contrast to our expectations, reducing sampling velocity failed to prevent the reduction of oxygen supply to the preterm infant s brain associated with the blood withdrawal from a UAC. Sampling volume appears to be central in determining the magnitude of this decrease. Roll, et.al Acta Paediatrica, 2006; 95: 68-73 19

Benefit for IVH Bundle Hummi Micro Draw Total sampling volume of blood and flush is now known to be a prime cause of reduced cerebral blood volume and reduced oxygenation during umbilical catheter sampling. The Hummi Micro Draw reduces the total sampling volumes by 70%, and flush volumes by 80%, thus reducing the risk for reduced cerebral blood volume and reduced oxygena6on which is known to be a causa6ve factor for IVH development. 20

The Risk for IVH Development Risk Factors for Periventricular Intraventricular Hemorrhage in Premature Infants Use of umbilical catheters and infusion and transfusion of blood products are all related to circulatory volume changes directly. These findings suggest that hemodynamic changes of systemic and cerebral circulation are important for the development of PV IVH in preterm newborns. Lee, et.al Journal Korean Medical Science 2010; 25: 418-424 21

Benefit for IVH Bundle Hummi Micro Draw Ø Lee confirms what Roll discovered, but takes it one step further and defines the risk factors even further, implica,ng the use of Umbilical catheters as a prime causa,ve factor in the development of IVH / PVL. Ø The Hummi addresses the concerns that Lee has about Umbilical Catheter use for blood drawing by reducing the required volumes to do a blood sampling procedure by 70% and eliminates nega6ve pressures during sampling, thus reducing the risk for the development of IVH / PVL. 22

More Delicate Hemodynamic Balancing Has Come To Be More Essential As the survival rate of extremely preterm infants has remarkably increased recently, more delicate hemodynamic balancing has come to be more essential than any other perinatal factors that have been proposed in previous studies for the prevention of PV-IVH. Lee et. al 2010, The Korean Academy of Medical Science The goal of maintaining hemodynamic balance in the neonate is paramount in reducing the risks for the development of IVH (Intraventricular Hemorrhage) and PVL (Periventricular Leukomalacia), which are the primary causative factors in the development of Mental Retardation and Cerebral Palsy in the premature infant. Lee et. al 2010, The Korean Academy of Medical Science 23

Benefit for IVH Bundle Hummi Micro Draw Ø Lee summarizes by stating that upsetting the delicate balance of the blood flow to the premature infants brain is a major factor in the development of IVH / PVL. Keeping this balance of blood flow, pressure changes and oxygen imbalance during blood sampling procedures is one of the most important perinatal factors for the prevention of IVH / PVL in premature infants. Ø As we now know, the Hummi provides the opportunity to reduce these risk factors as demonstrated by Roll, Perlman, Bray and Lee. The Hummi represents the next generation system for reducing Infection Risk and at the same time reducing the significant risk for the development of IVH /PVL in the premature infant when drawing blood from Umbilical Catheters. 24

Volume of Fluid Movement as a Percentage of Total Blood Volume during Umbilical Catheter Blood Sampling 25

UAC Single Blood Sampling using Hummi Micro-Draw 26

Benefit for IVH Bundle Hummi Micro Draw Clinical Implications from Reduced Saline Flush v 80% Reduction in Saline Flush Volume per UAC Blood Draw v 0.30mL Flush vs. 1.5mL Flush v Reducing the Impact of Flush Volumes on Body Water and Sodium Values v Allows fluid and electrolyte changes in the low gestational age infant to occur more appropriately during the first week of life v Reduced risk for alteration of Cerebral Blood Flow during Umbilical Catheter Blood Sampling, a known risk factor for IVH development 27

Saline Flush Reduction 28

Saline Flush Reduction 29

Benefit for IVH Bundle Hummi Micro Draw Reducing the Risk Factors for IVH / PVL Associated with Umbilical Catheter Use The Hummi Micro-Draw represents a new closed method for doing umbilical catheter sampling that reduces the total movement of blood and fluid during the draw procedure by 70% for every blood draw vs current methods. This reduction in blood and fluid movement significantly reduces the risk for alteration in cerebral hemodynamics, including cerebral blood flow alterations and cerebral de-oxygenation which can lead to the development of IVH / PVL. 30

Hummi Closed Needleless Micro-Draw Blood Transfer Device and Micro T System The Hummi Micro-Draw and Micro T T-Connector System a simple, closed, yet effective solution to reducing the risk factors for the development of IVH / PVL and Infection in the premature infant when using umbilical catheters. Why not use the product for your IVH bundle that provides for reduced infection risk and the lowest possible blood / fluid movement in and out of the low birth weight baby, when it has been demonstrated that current methods definitely pose a higher risk in use for UAC blood sampling? 31

Hummi Needleless Micro-Draw Blood Transfer Device 32

Hummi Needleless Micro-Draw Blood Transfer Device Ques6ons? 33