Features
Go With The Flo
Maxtec, Salt Lake City UT is pleased to announce our new MaxFLO2. The MaxFLO2 provides an affordable method for mixing and monitoring air and oxygen in both high flow (0-50 liters per minute) and low flow (0-10 liters per minute) applications. Each unit comes equipped with dual flow meters and a mixed gas analysis port for intermittent or continuous monitoring of FiO2. When used in conjunction with our MaxO2+A handheld oxygen analyzer, users can mix and measure accurate oxygen concentrations with added confidence. Gas ratios are also visibly identified on the face of the unit to allow for fast, accurate flow settings. Every unit also includes a built-in pole mount and is backed by a Maxtec 24 month warranty. Contact (800) 748.5355, www.maxtecinc.com.
Collaboration
Covidien and GE Healthcare announced a five-year, global collaboration to incorporate Covidien measurement technologies into GE Healthcare patient monitors. The Nellcor Respiratory Function portfolio, which includes Nellcor pulse oximetry with OxiMax Technology, and the BIS Brain Monitoring system, are now available on many GE Healthcare patient monitors. This includes the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. The Covidien collaboration reflects GE Healthcare’s commitment to maintain an open monitoring architecture, bringing together streams of patient data and making it usable for clinicians at the point of care. The collaboration leverages the Covidien portfolio of patient monitoring technologies, including: Nellcor pulse oximetry with OxiMax Technology, a cardiac-based pulse oximetry platform, which accurately monitors patients at all acuity levels and in challenging conditions. The Nellcor pulse oximetry solution from Covidien offers SpO2, Pulse Rate and Respiration Rate in a single sensor design. INVOS Cerebral/Somatic Oximetry monitors site-specific oxygen levels to optimize end-organ perfusion and help protect against devastating major organ morbidity and neurological injury. BIS Brain Monitoring measures the effects of anesthetics and sedatives on the brain. Contact covidien.com or gehealthcare.com.
Artful
Having received clearance under Section 510(k) from the US Food and Drug Administration, Spacelabs Healthcare is adding the qube patient monitor to its Art of Monitoring portfolio. Inspired by the revolutionary style of the company’s XPREZZON patient monitor, qube breaks with tradition to offer a fresh, new perspective in compact monitoring. Small and lightweight – with a battery life that goes the distance – qube offers portability, accessibility and heightened connectivity – perfect for emergency, general/step-down, and post-anesthesia care units. qube is mountable anywhere – wall, bedrail, anesthesia system – and can be detached via a quick-release feature, for immediate mobility. Caregivers can access current, critical patient information, from bedside throughout transport, to provide the ultimate level of patient care. Contact spacelabshealthcare.com.
Bilirubin Sebinar
Radiometer University presents a webinar: Shedding Light on Bilirubin: Definition, dangers, detection and decisions , Tuesday, April 25, 2012, 1:00 - 2:00 PM EST. This valuable free webinar, which is being repeated due to overwhelming response, will explore the chemistry and metabolism of bilirubin and clarify the importance of its rapid and accurate detection. The webinar will review bilirubin chemistry and metabolism, illustrate the utility of total bilirubin measurement, identify methods of measurement, explain the characteristics of serum, transcutaneous and whole blood bilirubin measurement, identify situations which dictate measurement of fractionated and total bilirubin, and propose a path to improving the differentiation of pediatric biliary disease. It is intended for lab professionals, POC coordinators, RTs, and pediatric clinicians, including PICU and NICU nurses. The presenter is Dennis Dietzen, PhD, DABCC, FACB, Associate Professor of Pediatrics and Pathology at Washington University, where he directs the Core Laboratory and Metabolic Genetics Laboratory at St Louis Children’s Hospital. The webinar offers one PACE credit, and is approved for 1 CRCE Contact Hour by AARC, and 1 Florida CE credit. To register, visit www.radiometeramerica.com/webinars or call (434) 202-8365.
Ventilation Webinar
Advances in Neonatal Conventional Ventilation is the title of the upcoming webinar sponsored by Maquet. Presented by Pradeep Mally, MD, with the Pediatric Department, Neonatology Division, NYU Langone Medical Center, the webinar will briefly explore the history of conventional ventilation for the neonatal population and will feature emerging technologies. Participants will be challenged to examine both current practices and new innovations including NAVA (Neurally Adjusted Ventilatory Assist). The webinar will be held May 10 at 1 PM ET. Register at http://respiratory-care-sleep-medicine.advanceweb.com/webinar/webinar.aspx?rid=429.
Approved
Discovery Laboratories, Inc announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. For more visit www.surfaxin.com
Surfactant Benefits
Cornerstone Therapeutics announced a new analysis published in the eFirst Pages section of the Pediatrics website reporting significant benefits in mortality rate and the need for redosing when treating neonatal respiratory distress syndrome (RDS) with Cornerstone’s CUROSURF (poractant alfa) Intratracheal Suspension.1 The objective of the independently performed meta-analysis was to compare the efficacy of CUROSURF versus Survanta (beractant) and Infasurf (calfactant) with respect to clinical outcomes among preterm infants with RDS. The analysis was led by Neetu Singh, MD, at Dartmouth Hitchcock Medical Center. Researchers included the data following a systematic literature search. As a result, five published randomized controlled trials (RCTs) comparing CUROSURF and Survanta were included in the analysis, enrolling a total of 529 infants. There were no trials that met the designated criteria comparing Infasurf to CUROSURF. In this review, it is important to note the initial surfactant dose administered to infants in each included RCT. (The FDA approved initial dose for CUROSURF is 200 mg/kg versus 100 mg/kg for Survanta. Two of the five RCTs included a subgroup of infants that received a low initial dose of CUROSURF (100 mg/kg). This dose is not approved in the United States therefore the results of that subgroup are not reported here.) Following the analysis, authors concluded that the 200 mg/kg initial dose of CUROSURF may result in superior short-term clinical outcomes, compared with Survanta, when used for the treatment of preterm infants with established RDS. There were no significant differences in respect to complications of prematurity between CUROSURF and Survanta. Key findings of the subgroup comparing the 200 mg/kg initial dose of CUROSURF to the 100 mg/kg of Survanta included: A significant reduction in mortality rates was found in infants treated with the 200 mg/kg initial dose of CUROSURF compared with those treated with the 100 mg/kg initial dose of Survanta. Those treated with CUROSURF experienced a relative risk reduction of 70% (RR: 0.29 [95 percent CI: 0.12-0.66], p=.004). The need for redosing was significantly lower with the 200 mg/kg initial dose of CUROSURF, with a relative risk reduction of 36 percent compared with the 100 mg/kg initial dose of Survanta (RR: 0.64 [95 percent CI: 0.53-0.83]; p=0.0008). As with any meta-analysis, there are a few important limitations to note. This systematic review yielded a small number of relevant articles on surfactants that were considered sufficiently rigorous to be included (7 of the 92). In addition, each study included a relatively small patient population. Due to this, the largest study (Ramanathan R, et al 2004) contributed approximately 55% of all patients included in the analysis, as well as most of the weight and average of the summary treatment effect. Lastly, the included studies analyzed clinical outcomes only until hospital discharge and did not examine long-term outcomes such as neurodevelopmental outcomes. The authors also noted that the results of this systematic review and meta-analysis are consistent with previously published reviews on this subject. Most recently, a retrospective study compared all-cause, in-hospital mortality in more than 14,000 preterm infants with RDS.2 This retrospective study found that the group receiving a 200 mg/kg initial dose of CUROSURF was associated with a significantly reduced likelihood of death compared to Infasurf and a trend toward reduced mortality when compared with Survanta. (The 100 mg/kg initial dose is not approved for use in the U.S. Per the product labeling, the approved initial dose for CUROSURF is 200mg/kg.) [References: 1. Singh, N, et al. Pediatrics. 128(6): December 1, 2011; e1588 -e1595; 2 Ramanathan R, et al. Journal of Perinatology. Advance online publication: September 1, 2011. Cornerstone licensed CUROSURF US rights from Chiesi Farmaceutici S.p.A. (Parma, Italy) as part of a broader transaction it completed with Chiesi in May 2009. CUROSURF is a registered trademark of Chiesi Farmaceutici, S.p.A. Survanta is a registered trademark of Abbott Laboratories, Inc. Infasurf is a registered trademark of ONY, Inc.
Innovative Products
Respiralogics, based in San Marcos, CA and owned and operated by the management team of David Thompson and Beth Keifer, collectively brings more than 60 years of clinical, educational and technical expertise in the critical care field. The longtime partners’ goal is to free clinicians to focus on patient care. The company’s suite of products focuses on the respiratory care field. Respiralogics’ product line includes: Babi.Plus Bubble nCPAP System for delivery of non-invasive respiratory support for premature and small infants; Sil.Flex Stoma Pad and Sil.Flex TC Pad, ergonomically designed cushions intended to redistribute pressure at stoma sites, improving patient comfort and minimizing skin breakdown; Danny Ties, unique tracheostomy tube holders with a softer and more comfortable fit around the neck for patients of all ages; and Venti.Plus Test Lungs and Babi.Plus nTest Lung, great tools to simulate the respiratory system that demonstrate mechanical ventilator applications and perform ventilator circuit testing prior to clinical use. (Babi.Plus, Sil.Flex and Venti.Plus are trademarks of A Plus Medical. Danny Ties is a trademark of Leckie Medical Products, Inc.) Visit www.respiralogics.com.
Simplified Delivery
Discovery Laboratories, Inc released new data showing that use of AFECTAIR resulted in as much as a 70% reduction in the amount of nitric oxide required to deliver the desired dose of the therapeutic gas when compared with current standard of care (SoC) (p < 0.001). AFECTAIR, the company’s newest product candidate, has been developed by Discovery Labs to simplify the delivery of inhaled therapies for critical care patients requiring ventilatory support. The new AFECTAIR data were presented at the 2011 Hot Topics in Neonatology Congress, an internationally recognized medical meeting dedicated to advancing the practice of neonatology. Results from the study suggest that AFECTAIR may be an effective alternative to the SoC among ventilatory circuit devices used for the delivery of inhaled nitric oxide. The investigators also commented that the results of this study support further investigation of AFECTAIR in the delivery of other costly medical gases using various methods of ventilation. AFECTAIR is a series of proprietary ventilator circuit/patient interface connectors and related componentry. AFECTAIR simplifies the delivery of any inhaled therapies to critical care patients requiring ventilatory support. According to national health statistics and market assessment data, it is estimated that more than 1.3 million patients annually, in the United States and European Union, receive aerosolized medications while requiring ventilator support. Discovery Labs is implementing a regulatory plan that potentially will allow for the introduction of AFECTAIR in the United States and the European Union in 2012. This in-vitro study was supported by Discovery Labs and designed to compare the performance of AFECTAIR, a proprietary ventilator circuit patient interface connector, with a current SoC ventilator system in the delivery of nitric oxide under simulated neonatal ventilator conditions. The simulated breathing pattern was maintained within narrow ranges and the delivery of oxygen was not different between the study conditions. The investigators observed a 50 to 70% decrease in nitric oxide utilization requirements to achieve desired inhaled nitric oxide dose with AFECTAIR, compared with SoC (p < 0.001). Study investigators concluded that AFECTAIR significantly decreased the nitric oxide utilization requirements to achieve the desired inhaled nitric oxide concentration and that results of the study support further investigation of AFECTAIR in the delivery of other medical gases and with other ventilation methods. Contact www.discoverylabs.com.
Results from HeRO RCT
In a long-running randomized study of over 3,000 preterm infants, those whose care included the Heart Rate Observation System, or HeRO monitor, experienced greater than 20% reduced mortality, effectively saving one infant’s life for every 48 who were monitored. The results of this multicenter study of the HeRO monitor, co-sponsored by the National Institutes of Health and Medical Predictive Science Corporation (MPSC), appear in The Journal of Pediatrics. HeRO is a pioneering monitoring system for premature infants that detects early signs of distress, commonly caused by infection and other potentially life-threatening illnesses. HeRO generates an hourly numeric score that quantifies the prevalence of abnormal patterns in each patient's heart rate and provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are better founded. The study, “Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial,” was conducted from April 2004 to September 2010 at leading neonatal intensive care units at the University of Virginia, Wake Forest University, University of Alabama at Birmingham, Vanderbilt University, University of Miami/Jackson Memorial Hospital, Greenville SC Hospital System, Winnie Palmer Children’s Hospital and Pennsylvania State University. There were 152 deaths (10.2%) in the group that received standard NICU care and 122 deaths (8.1%) in the group that received standard NICU care plus HeRO monitoring, an absolute risk reduction of 2.1%. There were no significant differences in demographics between the two groups, nor any of the other outcomes measured by the study. The patented monitoring technology was developed at the University of Virginia and licensed to Medical Predictive Science Corporation in Charlottesville, VA. The monitor, which is made by MPSC, has been cleared by the FDA to monitor neonatal distress and is being used by hospitals across the country. Contact www.mpsc.biz.
Petitioned
FDA petitioned to retract pediatric extension for Ikaria’s INOmax nitric oxide product: The US Department of Health and Human Services has been sent a Citizen Petition requesting that the Food and Drug Administration rescind the Pediatric Exclusivity extension approved for Ikaria in 2010 that extends their patent protection for their nitric oxide gas for six months beyond the US patent expiration date. The Pediatric Exclusivity Statute was designed to give extended protection to pharmaceutical companies that perform new pediatric studies at the request of the FDA. FDA documents disclosed that Ikaria first approached the FDA in April of 2008 requesting that the FDA write them a letter requesting additional studies for INOmax nitric oxide gas to study the effects on premature infants to prevent BPD.1 Ikaria submitted three studies, two of which were statistically negative trials, to fulfill the requirements of the Statute. The third study demonstrated a statistical benefit, however the FDA found that because of issues raised by their analysis (data quality, different post hoc statistical analyses, and lack of p value adjustments for interim analyses), the statistical determination was difficult to discern.2 However, the Pediatric Exclusivity Guidance Document specifically states that, “FDA does not believe it would be consistent with the intent of the statute to accept data collected prior to the Written Request if such data are already known to provide no useful information.”3 The petitioner cited the irregularity of the Ikaria request in that all three studies were completed by March of 2008, two of which were completed in 2005. Therefore, at the time of the Ikaria letter to the FDA and the subsequent FDA letter to Ikaria, the data from the negative trials had been collected (two of the trials were published in 2006)4,5 and therefore as negative trials, should never have been submitted or accepted by the FDA in applying for coverage by this statute. The petitioner argued that this extension granted to Ikaria prevents generic suppliers of pharmaceutical nitric oxide gas from entering the market. The petitioner expects that the FDA will review their granting of the Pediatric Exclusivity and hopefully open the market to generic competition six months earlier, potentially saving the US healthcare system tens of millions of dollars in that period. [Footnotes: 1. Curtis J. Rosebraugh, Department of Health and Human Services, Food and Drug Administration, Written Request, IND 106088, NDA 020845, Application Type: GI-1, Ino Therapeutics Inc., 04/30/2010. 2. Medical Officer Review, Division of Pulmonary, Allergy and Rheumatology Drug Products (HFD-570), Application #: 20-845, Proprietary Name: INOmax, Review Date: November 19, 2010. 3. Guidance for Industry, Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Revised, September 1999. 4. Kinsella JP, et al. Early Inhaled Nitric Oxide Therapy in Premature Newborns with Respiratory Failure. N Engl J Med 2006;355:354-64. 5. Ballard RA, et al. Inhaled Nitric Oxide in Preterm Infants Undergoing Mechanical Ventilation. N Engl J Med 2006;355:343-53.
 Partnering
Hamilton Medical and Rega are joining together, with Hamilton’s recently-launched HAMILTON T1 mobile ventilator to be used on Rega’s fleet of air ambulances. Rega is the first air rescue service in the world to equip their fleet of air ambulances with this advanced mobile intensive care ventilator HAMILTON-T1 as launching partner. The HAMILTON-T1 ventilator features a compact, powerful design that increases the availability of appropriate modes of therapy for ventilated intensive care patients outside the hospital. It covers the full range of clinical requirements: invasive ventilation, automated ventilation with Adaptive Support Ventilation (ASV) – invented by Hamilton Medical, and non-invasive ventilation (NIV). This portable transportation platform is appropriate for all patients, from pediatric to adult. Hamilton manufactures al its products at its green manufacturing facility in Switzerland. Contact www.hamilton-medical.com.
Team Training
GE Healthcare, Inc announced an agreement that grants GE Healthcare’s Maternal Infant Care division (MIC) exclusive rights for distribution and marketing of the KC BioMedix NTrainer pulsatile neurostimulation system. The NTrainer System incorporates a pulsating pacifier and reinforces nonnutritive suck (NNS) in infants and then measures the progress of their ability to suck. This device, currently in use at leading US hospitals, is backed by clinical studies and world-class research. Clinically, the NTrainer enables neonatal caregivers the ability to better manage incompetent feeding in neonates by providing a standardized assessment tool to measure NNS performance. NNS is an essential neurological building block in an infant’s coordination of sucking, swallowing and breathing, a capability required for independent oral feeding and the development of a healthy baby. (NTrainer System is a trademark of KC BioMedix. Contact gehealthcare.com or kcbiomedix.com.
Drug Delivery
Ikaria, Inc, announced that the Center for Devices and Radiological Health (CDRH) branch of the FDA has granted 510(k) clearance for compatibility of its INOMAX drug-delivery systems with six additional respiratory care devices. The INOMAX DS and the INOMAX DSIR are now compatible with more than 50 makes of ventilators, anesthesia systems and other respiratory care devices. The INOMAX DS and INOMAX DSIR are proprietary drug-delivery systems that deliver INOMAX (nitric oxide) for inhalation, the only drug approved by the FDA to treat hypoxic respiratory failure (HRF) associated with pulmonary hypertension in term and near-term infants greater than 34 weeks gestational age. INOMAX selectively relaxes pulmonary blood vessels, improves oxygenation and treats HRF in this fragile newborn population. The FDA’s clearance of compatibility with these respiratory care devices makes Ikaria’s INOMAX drug delivery systems fully compatible with most invasive mechanical ventilation methods and non-invasive respiratory strategies used in NICUs, including CPAP and nasal cannulae. The INOMAX drug-delivery systems are now compatible with the following additional respiratory care devices: Newport e360; Impact Instrumentation EMV+ Ventilator; Teleflex Comfort Flo Humidification System and Nasal Cannula; Dräger Babylog VN500; Dräger Evita Infinity V500, and; Vapotherm Precision Flow. The INOMAX DS and INOMAX DSIR drug-delivery systems are part of a comprehensive offering known as the INOMAX therapy package. In addition to use of Ikaria’s proprietary, FDA-cleared drug-delivery systems, the INOMAX therapy package includes INOMAX (nitric oxide) for inhalation, distribution, emergency delivery, technical and clinical assistance, quality maintenance, on-site hospital training, 24/7/365 customer service, and all related disposable items. Contact inomax.com or ikaria.com.
Safe and Continuous
Aerogen of Galway, Ireland, has launched a new syringe and tube-set that enables medical personnel to safely continuously nebulize a patient by completely eliminating the danger of tubing misconnections. Luer connector systems, common to many healthcare catheters, tubes, administration sets, extension sets, and syringes, have been at the heart of many catheter/tubing misconnections. The ease of connection between these luer lock connectors have led to misconnections that have inadvertently linked unrelated systems, and at times, have resulted in serious adverse events. Until now, this risk was inherent in continuous nebulization set-ups. Aerogen’s new continuous nebulization tube set incorporates non-standard connectors that cannot be misconnected onto any other device being used with the patient. The new tube set is compliant with the European Harmonised Standard EN 13455-1 and with the FDA guidelines on prevention of tubing misconnections. Contact www.aerogen.com, or Tri-anim, Aerogen’s US distributor.
Reintubation & Surfactant
Discovery Laboratories, Inc announced that the Journal of Neonatal-Perinatal Medicine recently published a manuscript reviewing an important data analysis from the Surfaxin (lucinactant) Phase 3 clinical trial program. The manuscript is entitled “Reintubation and risk of morbidity and mortality in preterm infants after surfactant replacement therapy” (Guardia et al, Volume 4, Number 2, 2011). This is the first peer-reviewed manuscript describing neonatal patient compromise following reintubation.The analysis demonstrates that, for preterm infants at risk for respiratory distress syndrome (RDS) who received prophylactic surfactant therapy and were extubated, subsequent reintubation is a highly predictive risk factor for mortality and major complications of prematurity. The analysis also indicates that infants treated with Surfaxin had a significantly lower incidence of subsequent reintubation and improved survival without reintubation, compared with infants who received animal-derived surfactants Survanta (beractant) and Curosurf (poractant alfa), the current standard of care. Infants who are extubated following surfactant therapy often relapse and require reintubation. Although increased mortality and morbidity in adults requiring reintubation is well described in medical literature, the consequences of reintubation in preterm infants have not been previously reported. Data from Discovery Labs’ Phase 3 RDS clinical trials were assessed in a post-hoc analysis to evaluate the consequences of reintubation as well as the potential effect of surfactant choice on reintubation rates and subsequent clinical outcomes in preterm infants. The recently published manuscript highlights the following observations: Infants who were successfully extubated and did not require reintubation experienced low mortality rates across all treatment groups, while infants who were subsequently reintubated had a statistically significant higher mortality rate, 0.5% vs. 18%, respectively (p < 0.05). Infants who required reintubation had significantly higher rates of six major complications of prematurity, including BPD, necrotizing enterocolitis, sepsis, and intraventricular hemorrhage. Infants treated with Surfaxin demonstrated a significantly lower reintubation rate compared with those infants treated with animal-derived surfactants, Curosurf (33% vs. 47% respectively; p < 0.05) and Survanta (35% vs 43% respectively; p < 0.05). Infants treated with Surfaxin demonstrated a significantly higher combined outcome of survival without reintubation compared with those infants treated with animal-derived surfactants, Curosurf (67% vs 53% respectively; p < 0.05) and Survanta (65% vs 57% respectively; p < 0.05). Surfaxin is an investigational drug product that has not been approved by the FDA or any other world health regulatory authority. Top-line data of this post-hoc analysis was previously presented at the 2008 AARC. International Respiratory Congress. Contact www.discoverylabs.com.
Two From Smiths
The babyPAC emergency and transport ventilator from Smiths Medical is MRI compatible and allows for precise oxygen concentrations. Its variable gas mixing system extends cylinder life and allows precise selection of oxygen concentration. Calibrated inspiratory pressure control provides continuous adjustment of the end inspiratory pressure. Separate controls provide careful management of inspiratory/expiratory time and pressure to suit patient breathing requirements. It ,as four operating modes: CMV+PEEP; CMV+ Active PEEP, IMV+CPAP and CPAP. Adjustable pneumatic pressure relief with alarm provides a wide range of options. Dual function PEEP/CPAP control allows continuous adjustment of pressure... The Pneupac VR1 emergency ventilator offers a single control for setting the frequency and tidal volume, including a clock-stop setting at the recommended adult position. This portable ventilator enables rapid setup in demanding circumstances. Auto /manual controls, a patient demand system, MR compatibility, and other features provide the means to manage respiratory emergencies. Its oxygen powered unit eliminates the need for electricity. Linked manual controls allow it to be used in a variety of chest compression and ventilation options in cardiac life support. MR compatibility provides maximum flexibility for transport within the hospital. Contact www.smiths-medical.com/pneupac.
New Platforms
Covidien announced that three new platforms for its Puritan Bennett 840 ventilator ― the Puritan Bennett 840 Neonatal ventilator, the Puritan Bennett 840 Universal ventilator and the Puritan Bennett 840 Pediatric-Adult ventilator ― are now available in the United States. The Puritan Bennett 840 Neonatal ventilator helps clinicians safely deliver, manage and monitor a ventilation regimen tailored for even the smallest and most critically ill neonatal patients. It offers the ability to set a tidal volume as small as 2 mL for neonates weighing as little as 300 grams without having to change to another ventilator. The Puritan Bennett 840 Universal ventilator for every patient type, from neonatal to adult, includes a neonatal CPAP mode that enables clinicians to flexibly deploy noninvasive ventilation in neonates. It supports patient-ventilator synchrony, which has been shown to facilitate spontaneous breathing. The ventilator includes features that effectively match the patient’s respiratory demand and adapt to changes in patient condition. The Puritan Bennett 840 Pediatric-Adult ventilator for pediatric to adult patients helps clinicians provide improved levels of ventilatory support by offering multiple therapies of ventilation, including invasive and noninvasive methods, as well as more advanced modes of ventilation.* [* Xirouchaki N, Kondili E, Vaporidi K, et al. Proportional assist ventilation with load-adjustable gain factors in critically ill patients: comparison with pressure support. Intensive Care Med. 2008; 34(11):2026-2034; Alotaibi G, Kacmarek R, Scanlan C. Comparison of dual mode ventilation among selected adult critical care ventilators using a programmable lung simulator. Respir Care. 2004. (Abstract).] Contact www.covidien.com.
Neopuff Piece
Fisher & Paykel Healthcare launched its enhanced Neopuff Infant T-Piece Resuscitator and the new Ergonomic T-Piece Resuscitation Circuit. The enhanced Neopuff Infant T-Piece Resuscitator provides further functionality and usability while continuing to raise the standard of care for infant resuscitation. The experience, training, concentration and fatigue level of the operator do not affect the pressures delivered. The Neopuff can accept and deliver oxygen concentrations from 21% to 100% coming from a flow meter or a blender. The T-Piece Circuit can connect to infant resuscitation masks or endotracheal tubes. The fast-acting medical-grade manometer ensures accuracy and constant reassurance of mask seal and delivered PIP and PEEP. Consistent PEEP can be delivered to assist with breathing during transport or ventilator circuit change. The new Ergonomic T-Piece Resuscitation Circuit is the first of its kind and the third circuit in Fisher & Paykel Healthcare's range of resuscitation circuits. It includes a new PEEP valve orientation for comfortable and controlled hand positioning, especially when attached to an endotracheal tube. The circuit has an improved PEEP valve adjustment to avoid unintentional changes in PEEP and a longer circuit length for better access to your infants. Lastly, this new circuit contains a duckbill port for suctioning and surfactant delivery. The new Ergonomic T-Piece Circuit is available separately or kitted with one of five sizes of neonatal resuscitation mask, ranging from the world's smallest micro-preemie mask through to pediatric-sized masks. All resuscitation masks are specifically designed to fit comfortably to the infant's face and provide a complete seal for optimal resuscitation. Fisher & Paykel Healthcare is also pleased to release the first humidified resuscitation system for those hospitals that need to resuscitate for an extended period of time. The Neopuff Infant T-Piece Resuscitator and Classic T-Piece Humidified Circuit deliver humidified gas to help protect the pulmonary epithelium and reduce heat and moisture loss especially during prolonged resuscitation. Contact Fisher & Paykel Healthcare at www.fphcare.com.
FDA Clearance
Instrumentation Laboratory (IL) announced that it has received clearance from the FDA to market the first-ever, rapid point-of-care, lab-quality blood test for measuring total bilirubin (tBili) in newborns. The new tBili assay is performed on IL’s GEM Premier 4000 critical care analyzer. It allows clinicians to receive lab-quality test results in 90 seconds from whole blood in the Neonatal Intensive Care Unit (NICU), rather than waiting up to an hour for results from the lab, using traditional chemistry methods. tBili assays performed on the GEM Premier 4000 are not affected by moderate turbidity or hemolysis, ensuring accuracy. Additionally, from a single whole blood sample, a full range of analytes can be measured, including Blood Gas, Electrolytes, Glucose, Lactate and full CO-Oximetry, for an efficient and comprehensive assessment of patient status. IL announced the FDA clearance of the tBili assay at the Annual Meeting of the American Association for Clinical Chemistry in Anaheim, CA. At the meeting, IL also introduced GEMweb Plus Custom Connectivity, software for automated information management. GEMweb Plus is the only software to provide system-wide, bi-directional capabilities from any networked PC of GEM Premier 4000 analyzer. GEMweb Plus provides complete control of all networked analyzers, regardless of location, to enhance quality assurance and regulatory compliance. GEM Premier 4000 critical care analyzer provides blood gas, electrolyte and metabolite analysis with integrated CO-Oximetry testing. It features IL’s patented Intelligent Quality Management (iQM), a real-time, automated, quality assurance system that continuously detects, corrects and documents, to assure quality results and compliance, 24/7, regardless of operator or testing location. iQM, coupled with its cartridge-based technology and ease of use, allows the GEM Premier 4000 analyzer to provide consistent, accurate, lab-quality results throughout the hospital. Products mentioned above are trademarks of Instrumentation Laboratory Company and/or one of its subsidiaries or parent companies. Contact www.ilus.com.
Siemens RAPIDLab® 1200
Siemens RAPIDLab® 1200 series of blood gas analyzers offers neonatal bilirubin (nBili) point of care testing with 60 second turnaround time,detects elevated levels of bilirubin. If undetected, this condition can lead to a variety of health issues in newborn infants, from jaundice to neurological disorders, and in severe cases, brain damage.
Siemens neonatal bilirubin (nBili) test requires 100uL sample of whole blood, measuring 2-30 mgdl and does not require any sample preparation, while providing fast and accurate results and does not increase monthly operating costs. Siemens RAPIDLab systems, nBili testing is conducted as part of a neonatal test panel that includes blood gas, pH, electrolytes, metabolites, total hemoglobin and CO-oximetry, with no additional reagents needed for nBili testing. For additional information, visit www.usa.siemens.com/bloodgas. |
