► Ventilators, Intensive Care, Neonatal/Pediatric This Product Comparison covers the following device term and product code as listed in ECRI Institute’s Universal Medical Device Nomenclature System™ (UMDNS™): Ventilators, Intensive Care, Neonatal/Pediatric [14-361] Ventilators, Intensive Care, Neonatal/Pediatric, High-Frequency [18-793]

Manufacturers Acoma Medical Industry Co Ltd Bio-Med Devices Inc CareFusion Respiratory Covidien Nellcor/Puritan Bennett Draeger Medical Inc eVent Medical Inc F Stephan GmbH Medizintechnik Ginevri srl Hamilton Medical Inc Heinen & Loewenstein GmbH & Co KG Heyer Medical AG Impact Instrumentation Inc Intermed Equipamento Medico Hospitalar Ltda MAQUET Medical Systems USA Newport Medical Instruments Inc Sechrist Industries Inc Siare Engineering International Group Srl SLE Ltd

Scope of this Product Comparison This Product Comparison covers intensive care ventilators designed for neonatal and/or pediatric ventilatory support. Although some of the models listed in the chart may have high-frequency-ventilation capabilities, units that provide only high-frequency ventilation are not covered in this report. For related information, see the following Product Comparisons: Anesthesia Units Oxygen Monitors Ventilators, Intensive Care Ventilators, Portable/Home Care

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Ventilators, Intensive Care, Neonatal/Pediatric Ventilators, Transport These devices are also called: mechanical ventilators, neonatal ventilators, pediatric ventilators, positive-pressure ventilators, time-cycled ventilators.

Purpose ​Neonatal/pediatric intensive care ventilators provide temporary or permanent ventilatory support for preterm and critically ill infants or small children who suffer from respiratory failure or have reduced lung compliance, excessive airway resistance, apnea, or other conditions such as congenital heart disorders. These mechanical ventilators promote alveolar ventilation (i.e., oxygen [O2] diffusion and carbon dioxide [CO2] elimination) by generating positive pressure to inflate the lungs and open additional alveoli for improved gas exchange.

Principles of Operation Mechanical ventilators can have several different cycling mechanisms (the method used to end the inspiratory phase), such as volume, pressure, or time. In the past, most neonatal ventilator models were strictly time-cycled machines, but many of the models now available provide multiple cycling options. Time-cycled ventilators terminate inspiration at the end of a preset time interval (e.g., 1 second); these types are also pressure limited—if a set pressure is reached, it is maintained until the end of the set inspiratory time. A ventilator that does not limit pressure can create high pressures, resulting in an excessive volume of gas being delivered, which can overdistend the lungs and cause serious complications. Pressure-cycled ventilators terminate inspiration when a pre-set pressure limit is reached. Volume-cycled ventilators terminate inspiration when a pre-set tidal volume is reached. Although volume-cycled ventilators are used extensively on older children and adults, they were rarely used on neonatal patients until new models with more advanced features began to appear on the market. A typical neonatal ventilator system consists of a breathing circuit, a humidification system, gas-delivery systems, monitors and their associated alarms, and gas sources for oxygen and compressed air. The breathing circuit is composed of low-compliance, flexible, small-bore tubing (approximately 1 cm [3/8 in] in diameter) and the associated connectors; controls are used to determine the operating mode and setting variables. During each positive-pressure breath, the lungs expand in proportion to the volume of gas delivered until a preset pressure, volume, or time limit is reached. A valve then opens to relieve pressure in the lungs, allowing the patient to passively exhale. Neonatal ventilators require an integral or add-on air-oxygen proportioner (also called an oxygen blender) to deliver a fraction of inspired oxygen (FiO2) between 21% and 100%. Because changes in the FiO2 delivered through the ventilator usually alter the patient’s PaO2 value, FiO2 adjustments are commonly used to treat hypoxemia (low oxygen levels in the blood) and prevent hyperoxemia (high oxygen levels in the blood). High PaO2 values can be especially dangerous for premature infants. To assure accuracy, delivered FiO2 levels should be continuously monitored with an integral or add-on oxygen analyzer. The air-oxygen gas mixture should also be heated and humidified to approximate normal body temperature and humidity before being delivered to the patient. An add-on heater-humidifier device designed specifically for neonatal ventilator applications should be used for this purpose.

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Ventilators, Intensive Care, Neonatal/Pediatric Two types of positive-pressure ventilators are used for neonatal applications: conventional and high frequency. Conventional ventilation uses breathing rates and tidal volumes close to those of normal breathing. High-frequency ventilation is a specialized form of respiratory support that uses very small tidal volumes and extremely high breathing rates. Most neonatal ventilators provide conventional ventilation.

Controls Controls are used to select the breathing mode and ventilation parameters (e.g., tidal volume, breathing rate, FiO2). For the ventilator to produce a prescribed breathing pattern, various parameters can be independently set, such as length of the inspiratory or expiratory phase, rate of mechanical breaths, waveform shape, tidal volume, flow rate, peak pressure, and positive end-expiratory pressure. The I:E ratio is a measured indication of the partitioning of a breath into inspiration and expiration. In most cases, the expiratory time is set longer than the inspiratory time (e.g., I:E ratio 1:2 or 1:3) to allow full exhalation before the next breath; however, an inverse ratio may also be used when required for specific types of patients (e.g., an I:E ratio of 1:0.5 has been shown to improve PaO2 levels and decrease mortality in some neonates). Because inverse I:E ratio settings are not commonly used, some ventilators signal when an inverse I:E ratio has been reached. Ventilator controls for positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) work by restricting flow from the exhalation valve to maintain a set (user-defined) amount of positive pressure in the breathing circuit, even at the end of the expiratory phase. This increased baseline pressure helps keep small airways and alveoli in the lung inflated in order to increase lung volumes and improve oxygenation (i.e., the diffusion of oxygen across the alveolar capillary membrane). PEEP or CPAP may be used to raise the patient’s PaO2 (partial pressure of oxygen in arterial blood) level without requiring an increase in the FiO2 (high FiO2 levels for extended periods of time can be toxic to lung tissue). PEEP is utilized for patients on the ventilator who have poor oxygenation (low PaO2) but also require full ventilatory support to maintain adequate PaCO2 (partial pressure of carbon dioxide in arterial blood) levels. CPAP is utilized for patients who have poor oxygenation but can breathe spontaneously and do not require full ventilatory support. Because high levels of PEEP or CPAP can decrease venous return causing a drop in blood pressure and cardiac output, both must be used cautiously on patients who are hemodynamically unstable.

Operating modes Neonatal/pediatric ventilators have several operating modes; a mode of operation defines the algorithm that will be used to initiate (trigger) and end (cycle) a machine breath. Different modes can provide either full or partial ventilatory support, depending on the individual patient’s condition and clinical requirements. For more information on the different ventilation modes, see the table included. The control mode provides full support to patients who cannot breathe for themselves; it is infrequently used. In this mode, the ventilator provides mandatory breaths at preset time intervals and does not allow the patient to breathe spontaneously. This mode may require the patient to be unconscious or sedated to stop spontaneous attempts to breathe asynchronously with the ventilator. Assist/control (A/C) mode also provides full support by delivering mandatory breaths at preset time intervals and assisted breaths whenever the ventilator senses the patient’s inspiratory effort. This mode is designed for patients who have difficulty breathing but can still initiate inspiration. A breath is triggered whenever a patient’s breathing effort is detected, by either a drop in pressure in the breathing circuit (pressure triggering) or as a difference in flow between the circuit’s inspiratory and expiratory limbs (flow triggering).

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Ventilators, Intensive Care, Neonatal/Pediatric Another mode called synchronized intermittent mandatory ventilation (SIMV), delivers controlled breaths at a set frequency and also allows the patient to breathe spontaneously through the ventilator with no mechanical assistance. The mandatory breaths in this mode are synchronized with the patient’s spontaneous breathing effort if that effort occurs sufficiently close to the time the mandatory breath would have been produced. This reduces the possibility of lung overinflation, which can result from stacking a mandatory breath on top of a spontaneous breath. In both A/C and SIMV modes, the mandatory rate is usually set high enough to ensure adequate ventilation in the event that the patient fails to breathe or their spontaneous breaths are too small or too weak to trigger the ventilator. Another, less common mode of ventilation is airway-pressure-release ventilation (APRV). APRV is sometimes used to treat acute lung injury in patients who require mechanical support. In this mode, the clinician sets a high-pressure level and a low-pressure level as well as a time (number of seconds) to remain at each level (the time at low pressure is typically shorter than the time at high pressure). The ventilator then switches between the two pressure levels at

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Ventilators, Intensive Care, Neonatal/Pediatric the set time intervals while allowing the patient to breathe spontaneously at either level. Carbon dioxide exits the lungs passively whenever the airway pressure drops to the lower level. When this brief release period ends, the airway pressure rapidly returns to the higher level. APRV mode can often provide ventilatory support without raising the airway pressure above typical CPAP levels; consequently, barotrauma and adverse hemodynamic effects may occur less frequently than with other (conventional) modes of mechanical ventilation. Pressure support (PS) is an adjunct mode that reduces the work of spontaneous breathing on the ventilator by delivering a preset level of positive pressure to the patient’s airway during each spontaneous inspiratory effort. This short “pressure boost,” reduces the work of the patient’s respiratory muscles and minimizes the effort needed to draw air into the lungs. It also compensates for the additional work of breathing imposed by the ventilator tubing, machine valves, and artificial airway. Pressure support can be utilized in either the SIMV or CPAP modes. Most modern neonatal ventilators can deliver both volume- and pressure-controlled breaths that can be used to provide either full or partial ventilatory support. With volume-controlled breaths, a control system is used to ensure that the set tidal volume is delivered during each inspiratory cycle. If the pressure generated during any breath exceeds a user-set high-pressure limit or pressure-relief valve setting, the breath is cut off and the set volume may not be fully delivered. Although volume-controlled ventilation was typically only used for adult and pediatric patients, advancements in ventilator technology have made this form of ventilation more acceptable for neonatal patients. Pressurecontrolled breaths regulate flow delivery to attain a clinician-set peak inspiratory pressure level during each breath. Because pressure-controlled breaths are affected by changes in airway resistance and lung compliance, the volume of air delivered during each breath may vary. Combination modes, which are now available on many ventilator models (although different ventilator vendors use different terminology), deliver pressure-controlled breaths that correspond to a “target” tidal volume. In combination mode, the ventilator begins at a low inspiratory pressure level which is incrementally

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Ventilators, Intensive Care, Neonatal/Pediatric increased from breath to breath until the target tidal volume is achieved. The ventilator then uses that inspiratory pressure for each breath unless changes in the patient’s airway parameters (i.e., airway resistance, lung compliance) necessitate adjustments. As a result, combination modes may provide more effective ventilation for patients whose lung characteristics change frequently. Some neonatal ventilators can provide high-frequency ventilation (HFV). High-frequency ventilation delivers very small tidal volumes at a near-constant mean airway pressure (MAP) at frequencies higher than those produced during the fastest possible breathing (i.e., above 100 breaths per minute). There are two general types of HFV, highfrequency jet ventilation (HFJV) which delivers high-frequency pulses of gas with passive exhalation, and highfrequency oscillatory ventilation (HFOV) which delivers high-frequency breaths with active (i.e., negative pressure) exhalation. Proponents of high-frequency ventilation have found that it can reduce circulatory depression and barotrauma (pressure-induced lung damage) and can improve gas exchange in some infants. Some ventilator models provide only high-frequency ventilation; a few can provide a combination of conventional and high-frequency ventilation. Several manufacturers offer unique modes that deliver support to the patient based on the amount of effort (as opposed to pressure support where the level of support is static). One vendor offers proportional assist ventilation (PAV), in which the level of support is proportional to the patient’s demand based on applying a specialized software algorithm to traditional flow and pressure measurements. In PAV, the clinician is guided to change support settings to keep the patient’s work of breathing within a comfort zone calculated by the ventilator. Another vendor offers neurally adjusted ventilatory assist (NAVA), in which the patient’s effort is determined by measuring the electrical activity in the diaphragm. With NAVA, the clinician selects a level of support, which serves as a multiplier to the received electrical signal to determine the amount of flow to deliver to the patient. A specialized nasogastric (NG) tube must be inserted into the patient to use the NAVA option.

Monitors and alarms Neonatal/pediatric intensive care ventilators are equipped with a variety of monitors and alarms to detect equipmentrelated problems and changes in patient status, to ensure that the user adjusts settings to achieve effective ventilation, and to reduce the risk of ventilator-induced injury (e.g., barotrauma). Variables that are typically monitored and displayed on the ventilator include: A continuous indication of airway, peak, mean, and baseline pressures Mechanical and spontaneous respiratory rates I:E ratio Oxygen concentration (FiO2) Exhaled volumes of mechanical and spontaneous breaths (tidal volumes) and accumulated volume over one minute (exhaled minute volume) Graphics monitors typically include graphs of pressure, volume, and flow versus time. To track the patient’s progress, the monitor calculates patient pulmonary mechanics (e.g., lung compliance, airway resistance) from monitored variables. Pressure-volume loops, which are graphs of pressure versus volume over a single breath, and flow-volume loops, which are graphs of flow versus volume over a single breath, can help to identify breathing abnormalities and obstructive or restrictive changes in the lung. Graphics monitors are usually integrated into the ventilator unit, but some manufacturers sell them as an add-on option. In addition, graphics monitors allow the clinician to optimize ventilator settings values and assist with diagnostics. Because the consequences of incorrect or inadequate mechanical ventilation can be severe, ventilators are equipped with audible and visual alarms to notify clinicians of changes in the patient’s condition or of device problems. Most ventilators have alarms for apnea, high and low respiratory rate, high and low pressure, loss of power, loss of supply gases, system malfunctions, incorrect O2 concentration, and exhaled volume. Some ventilators also have baselinepressure alarms; the low-baseline-pressure alarm alerts clinicians to PEEP or CPAP pressure losses, which can affect the patient’s O2 saturation; the high­baseline­pressure alarm alerts clinicians to inadvertent increases in PEEP or CPAP levels, which can prevent complete exhalation or compromise the patient’s hemodynamic status. An alarm

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Ventilators, Intensive Care, Neonatal/Pediatric should also be activated if disconnections occur in the breathing circuit or if flow resistance is encountered. A loss of power or the gas supply, or other conditions affecting a ventilator’s ability to operate, should trigger an alarm and allow the patient to spontaneously breathe air or the specified gas mixture. All critical alarms should be easy to identify and impossible to disarm indefinitely. Additionally, to prevent injury to the patient until clinicians can respond to alarms, ventilators incorporate a number of safety features such as the ability to release pressure in the breathing circuit if/when the high-pressure alarm setting is exceeded. Another feature is the presence of backup ventilation, in which the ventilator will initiate breaths at a predetermined volume and rate if/when it senses that the patient’s breathing efforts have ceased, or the ventilator has malfunctioned.

Alarm-enhancement systems Ventilator alarms are crucial for safeguarding the health and lives of patients. Therefore, it is vital that they be readily detected in even the busiest, noisiest hospital departments. Alarm-enhancement systems, which communicate ventilator alarms to locations where they are more likely to be detected by caregivers, can be helpful. There are four basic categories of ventilator alarm enhancements: Interfacing ventilators with physiologic monitors Incorporating commercially available systems for centralized monitoring of ventilator alarms Interfacing ventilators with nurse-call systems Utilizing remote annunciators for ventilator alarms The various alarm-enhancement options range widely in complexity, cost, and the types of care settings for which they are likely to be suitable. For more information on alarm-enhancement systems and ventilator/physiologic monitoring system interfaces, see the Health Devices citation in the bibliography.

Communication interfaces Most ventilators have a standard or optional interface through which the ventilator can be connected to a bedside monitor or information system. Ventilator settings, monitored variables, and information on alarms can be transmitted through this interface. On some units, the interface can connect two ventilators, synchronizing them so that they can independently ventilate both lungs (e.g., for a patient with unilateral lung disease).

Reported Problems Serious cardiopulmonary and neurologic complications can occur when an infant is being ventilated; therefore, a ventilated infant should not be left unattended. High PaO2 levels in the blood can lead to retrolental fibroplasia and blindness. High FiO2 levels in the gas delivered by the ventilator can lead to O2 toxicity and exudative and necrotizing changes associated with bronchopulmonary dysplasia (BPD), which continues to be a leading cause of morbidity and mortality in prematurely born infants. O2 levels must be constantly monitored. Development of ventilator-associated pneumonia can also occur, particularly in infants with prolonged intubation. Bacterial contamination introduced while the breathing circuit or humidifier is being changed, as well as during tracheal suctioning, may make ventilated infants more susceptible to pneumonia. The infant lung is fragile and easily damaged by high pressures, which can be a result of decreases in lung compliance, the patient not breathing in synchrony with the ventilator, obstruction of the exhalation portion of the circuit, or failure of the exhalation valve to open. Limiting the PIP and MAP can help prevent barotrauma, pulmonary interstitial emphysema, BPD, and reduced cardiac output. Many units have an adjustable high-pressure-relief valve, an immediate high-pressure alarm, and a means of automatically venting the patient circuit to reduce pressure. The failure to trigger a mechanical breath by an infant who is breathing spontaneously increases the work of

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Ventilators, Intensive Care, Neonatal/Pediatric breathing and may prolong the duration of mechanical ventilation and increase the incidence of complications. An important consideration in patient-triggered ventilation is the period of time that elapses from achievement of the trigger threshold to a measurable rise in proximal airway pressure. This period is called system response time or trigger delay. Long trigger delays increase the work of breathing and the risk of asynchrony. Of particular concern are ventilator cycles that are triggered by pressure or flow changes in the breathing circuit and not by the patient’s actual inspiratory effort. Gas leaks around endotracheal tubes, in the ventilator circuit, or oscillations caused by the movement of excessive condensation in the tubing can cause pressure or flow changes that initiate false ventilator cycling (autocycling). Clinicians must be astute in detecting autocycling during patient-triggered ventilation in order to avoid excessive ventilation. Some ventilators monitor information about endotracheal tube leaks and automatically enable adjustments in trigger sensitivity to compensate. Acute respiratory distress syndrome, in which diffuse lung injury suddenly develops in critically ill patients, can also occur. Patients with acute respiratory distress syndrome are particularly prone to lung overdistention, especially when conventional tidal volumes are used because the number of alveoli available for gas exchange is markedly reduced as a result of fluid accumulation, consolidation, and atelectasis. There is also evidence that underinflation or inadequate end-expiratory pressures can result in damage to injured or surfactant-depleted lungs, compromising the patency of the alveoli and leading to hypoxemia and hypercapnia (high PaCO2 levels in the blood). An infant’s high­resistance airways may cause a large difference between the proximal airway pressure measured in the breathing circuit and the actual alveolar pressure in the lungs. In such instances, the patient may be underventilated. The small diameter of the endotracheal tube can also increase resistance requiring higher driving pressures for effective ventilation. The use of heated humidifier systems in neonates and infants intubated for mechanical ventilation has been associated with serious problems. Malfunction of these systems can result in severe tracheal or pulmonary damage, including burns. Common problems include excessive condensation (rain-out) in the ventilator circuit, overhydration, and nosocomial infections. Overhydration can lead to alveolar collapse, small-airway obstruction, atelectasis, and surfactant inhibition. To reduce problems with rain-out, most neonatal breathing circuits have water traps to capture condensation and/or internal heated wires to maintain gas temperatures and prevent cooling which causes moisture to form. Breathing circuit tubing can be accidentally disconnected if not attached securely. Ventilators should alarm audibly and visually whenever a partial or complete disconnection or a leak occurs in a breathing circuit. Ventilators should also have audible and visual alarms to signal loss of power, loss of gas supply, excessive pressure in the breathing circuit, and other potentially hazardous conditions.

Purchase Considerations Included in the accompanying comparison chart are ECRI Institute’s recommendations for minimum performance requirements for neonatal/pediatric intensive care ventilators. The requirements are separated into two categories— basic units and mid/high units. The differences for these two categories are based on performance criteria for controls, operating modes, monitored parameters, and alarm functionality. At minimum, the ventilator should be capable of time-cycled, pressure-limited operation and should offer A/C and SIMV ventilation modes. It should also offer pressure support for spontaneous breaths and provide PEEP and CPAP support. The ventilator should monitor airway pressure, respiratory rate, I:E ratio, and minute volume; controls should be available for FiO2, PEEP/CPAP, flow rate, tidal volume, inspiratory time, sensitivity, and pressure limit. Visual and auditory alarms should be available for high and low PIP, low CPAP/PEEP, high/low minute volume, high/low respiratory rate, gas supply loss, and power failure. All alarms should be distinct and easily identified. Also, if alarm volume is adjustable, it should not be possible for the volume to be turned down so low that the alarm is inaudible. Although an audible-alarm silencing feature is recommended, the alarm must reactivate automatically if

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Ventilators, Intensive Care, Neonatal/Pediatric the condition is not corrected. Whenever an alarm is silenced, a visual display should remain on to clearly indicate which alarm is disabled. The delivered O2 or O2/air mixture should be continuously monitored with an O2 analyzer that includes an alarm for concentrations above or below the set level (e.g., ±5%). The O2 analyzer (either included with the ventilator or purchased separately) should be placed on the inspiratory side of the breathing circuit during monitoring. Controls (i.e., switches, knobs) should be clearly identifiable, and their functions should be self-evident. The design should prevent misinterpretation of displays and control settings. Controls should be protected against accidental setting changes (e.g., due to someone brushing against the panel) and sealed to prevent fluid penetration. Patient and operator safety and system performance should not be adversely affected by fluid spills.

Other considerations Reusable and disposable breathing circuits are typically offered separately by ventilator manufacturers and many other suppliers. Breathing circuits should be thoroughly tested using the ventilators with which they are to be used to ensure compatibility.

Environmental considerations As a result of increasing concerns over the environment and the conservation of resources, many manufacturers have adopted green shipping and production methods, as well as features that improve the energy efficiency of their products or make them more recyclable. In addition, healthcare facilities and device manufacturers have begun to adopt green initiatives that promote building designs and work practices that reduce waste and encourage the use of recycled materials. Although safety features are the most important consideration, models that use rechargeable batteries, enable paperless electronic data storage, or are shipped with less packaging material, are ideal. Facilities should look for manufacturers who offer buy-back or trade-in programs. If a supplier does not offer such an arrangement, the hospital must absorb the costs of disposing of the system according to local environmental protection laws when it is replaced.

Cost containment Current ventilator designs offer an often-complicated variety of options, requiring a knowledgeable user. Staff shortages and frequent employee turnover in some hospitals often make adequate formal training on clinical equipment difficult. Therefore, ventilators with good human factors design offer a significant advantage. In addition, standardizing equipment helps minimize retraining and confusion among users of different models. Suppliers often give significant discounts when multiple units are purchased. A wide range of modes, variables monitored and controlled, and alarms are offered among different ventilator models. These features should be evaluated to determine which are needed for a particular patient population and clinical setting. Many adult ventilators now have software available for neonatal applications. Generally, the cost of the software is significantly lower than purchasing a new ventilator. Because these ventilators entail ongoing maintenance and operational costs, the initial acquisition cost does not accurately reflect the total cost of ownership. Therefore, a purchase decision should be based on issues such as lifecycle cost (LCC), local service support, discount rates and non-price-related benefits offered by the supplier, and standardization with existing equipment in the department or hospital (i.e., purchasing all ventilators from one supplier). An LCC analysis can be used to compare high-cost alternatives and/or to determine the positive or negative

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Ventilators, Intensive Care, Neonatal/Pediatric economic value of a single alternative. For example, hospitals can use LCC analysis techniques to examine the costeffectiveness of leasing or renting equipment versus purchasing the equipment outright. Because it examines the cash-flow impact of initial acquisition costs and operating costs over a period of time, LCC analysis is most useful for comparing alternatives with different cash flows and for revealing the total costs of equipment ownership. One LCC technique—present value (PV) analysis—is especially useful because it accounts for inflation and for the time value of money (i.e., money received today is worth more than money received at a later date). Conducting a PV/LCC analysis often demonstrates that the cost of ownership includes more than just the initial acquisition cost and that a small increase in initial acquisition cost may produce significant savings in long-term operating costs. For more information on PV/LCC calculations, readers should contact ECRI Institute’s SELECTplusTM Group. Hospitals can purchase service contracts or service on a time-and-materials basis from the supplier. Service may also be available from a third-party organization. The decision to purchase a service contract should be carefully considered. Purchasing a service contract ensures that preventive maintenance will be performed at regular intervals, thereby eliminating the possibility of unexpected maintenance costs. Also, many suppliers do not extend system performance and uptime guarantees beyond the length of the warranty unless the system is covered by a service contract. ECRI Institute recommends that, to maximize bargaining leverage, hospitals negotiate pricing for service contracts before the system is purchased. Additional service contract discounts may be negotiable for multiple-year agreements or for service contracts that are bundled with contracts on other similar equipment in the department or hospital.

Stage of Development ​Manufacturers have enhanced the monitoring of ventilator operation and patient condition by interfacing ventilators with other vital-signs monitors (e.g., end-tidal carbon dioxide) and adding graphic displays of flow, pressure, and volume waveforms, along with trended data. Also, flow sensors placed at the patient’s airway improve the accuracy of tidal volume measurements and allow quick detection of inspiratory efforts. The advances in microprocessor technology permit the continuing development of microprocessor-controlled ventilators, which can monitor more parameters and permit more precise ventilation.

Bibliography Carpenter T. Novel approaches in conventional mechanical ventilation for paediatric acute lung injury. Paediatr Respir Rev 2004 Sep;5(3):231-7. ECRI Institute: A life-saving reminder: improper use of ventilator alarms places patients at risk [problem reporting system]. 2009 Apr;38(4):124-5. Alarm-enhancement systems for ventilators [guidance article]. Health Devices 2004 Jan;33(1):5-23. Alarm-enhancement systems for ventilators: problems with physiologic monitoring interfaces. Health Devices 2004 Oct;33(10):354-5. Cable detachment on Hamilton Medical Galileo intensive care ventilator [hazard report]. Health Devices 2009 Feb;38(2):57. Disconnecting wall gas can interrupt ventilation on Dräger Evita 2 dura and Evita 4 ventilators [hazard report]. Health Devices 2004 Jan;33(1):26. Intensive care ventilators [evaluation update]. Health Devices 2006 Jun;35(6):230. Intensive care ventilators [evaluation]. Health Devices 2006 Apr;35(4):115-48.

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Ventilators, Intensive Care, Neonatal/Pediatric Intensive care ventilators [evaluation]. Health Devices 2009 Mar;38(3):70-88. Intensive care ventilators [inspection and preventive maintenance procedure]. BiomedicalBenchmark. Procedure no. 458-20081015-01. Minimum requirements for ventilator testing [guidance article]. Health Devices 1998 Sep-Oct;27(9-10):363. Neonatal/pediatric intensive care ventilators [evaluation]. Health Devices 2002 Jul;31(7):237-55. Rainout from Fisher & Paykel’s 850 humidification system may affect performance of certain ventilators [hazard report]. Health Devices 2009 Feb;38(2):60-2. Some infant ventilators may shut down without backup power [hazard report]. Health Devices 2003 Jun;32(6):243-4. Upgraded software changes the oxygen sensor calibration procedure in Covidien’s Puritan Bennett 840 ventilator [user experience network]. Health Devices 2011 Sep;40(9):315. Ventilator “vent inop” alarms may not be communicated via ancillary notification systems [problem reporting system]. 2008 Dec;37(12):377-9. Garland, JS. Strategies to prevent ventilator-associated pneumonia in neonates. Clin Perinatol 2010;37:629-43. Pilbeam SP. Mechanical ventilation: physiological and clinical applications. St. Louis: Mosby-Year Book; 1992. Principi N, Esposito S. Ventilator-associated pneumonia (VAP) in pediatric intensive care units. Pediatr Infect Dis J 2007 Sep;26(9):841-3; discussion 843-4. Sinha SK, Donn SM. Newer forms of conventional ventilation for preterm newborns. Acta Paediatr 2008 Oct;97(10):1338-43. Turner KM, Basnight LL. Newborn ventilation. Pediatr Rev 2010 Aug;31(8):347-8. Last updated January 2012

Policy Statement The Healthcare Product Comparison System (HPCS) is published by ECRI Institute, a nonprofit organization. HPCS provides comprehensive information to help healthcare professionals select and purchase diagnostic and therapeutic capital equipment more effectively in support of improved patient care. The information in Product Comparisons comes from a number of sources: medical and biomedical engineering literature, correspondence and discussion with manufacturers and distributors, specifications from product literature, and ECRI Institute’s Problem Reporting System. While these data are reviewed by qualified health professionals, they have not been tested by ECRI Institute’s clinical and engineering personnel and are largely unconfirmed. The Healthcare Product Comparison System and ECRI Institute are not responsible for the quality or validity of information derived from outside sources or for any adverse consequences of acting on such information. The appearance or listing of any item, or the use of a photograph thereof, in the Healthcare Product Comparison System does not constitute the endorsement or approval of the product’s quality, performance, or value, or of claims made for it by the manufacturer. The information and photographs published in Product Comparisons appear at no charge to manufacturers. Many of the words or model descriptions appearing in the Healthcare Product Comparison System are proprietary names (e.g., trademarks), even though no reference to this fact may be made. The appearance of any name without designation as proprietary should not be regarded as a representation that is not the subject of proprietary rights.

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Ventilators, Intensive Care, Neonatal/Pediatric ECRI Institute respects and is impartial to all ethical medical device companies and practices. The Healthcare Product Comparison System accepts no advertising and has no obligations to any commercial interests. ECRI Institute and its employees accept no royalties, gifts, finder’s fees, or commissions from the medical device industry, nor do they own stock in medical device companies. Employees engage in no private consulting work for the medical device industry.

About ECRI ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for more than 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, healthcare processes, devices, procedures, and drug technology. ECRI Institute is one of only a handful of organizations designated as an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and is listed as a federal Patient Safety Organization by the U.S. Department of Health and Human Services. For more information, visit http://www.ecri.org.

Need to Know More? For further information about the contents of this Product Comparison, contact the HPCS Hotline at +1 (610) 825-6000, ext. 5265; +1 (610) 834-1275 (fax); or [email protected] (e-mail).

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