[System Integration of Infant Incubators' Quality Control Testing Based on MCU].

This study is aimed to design the testing system of multiple parameters of the incubators, and to make their quality control plans. Also it is required to establish a model of data collection and processing based on MCU, and to program the host computer software in order to analyze data. The result shows that the testing system is accurate and stable; also it is convenient to collect the data. This testing system is a good complement of the quality control of incubators. It has a high practical value in improving medical safety and reducing the occurrence of adverse events.

A Handy Preterm Infant Incubator for Providing Intensive Care: Simulation, 3D Printed Prototype, and Evaluation.

Preterm infants encounter an abrupt delivery before their complete maturity during the third trimester of pregnancy. Polls anticipate an increase in the rates of preterm infants for 2025, especially in middle- and low-income countries. Despite the abundance of intensive care methods for preterm infants, such as, but not limited to, commercial, transport, embrace warmer, radiant warmer, and Kangaroo Mother Care methods, they are either expensive, lack the most essential requirements or specifications, or lack the maternal-preterm bond. This drove us to carry this original research and innovative idea of developing a new 3D printed prototype of a Handy preterm infant incubator. We aim to provide the most indispensable intensive care with the lowest cost, to bestow low-income countries with the Handy incubator's care, preserve the maternal -preterm's bond, and diminish the rate of mortality. Biomedical features, electronics, and biocompatible materials were utilized. The design was simulated, the prototype was 3D printed, and the outcomes were tested and evaluated. Simulation results showed the best fit for the Handy incubator's components. Experimental results showed the 3D-printed prototype and the time elapsed to obtain it. Evaluation results revealed that the overall performance of Kangaroo Mother Care and the embrace warmer was 75 ± 1.4% and 66.7 ± 1.5%, respectively, while the overall performance of our Handy incubator was 91.7 ± 1.6%, thereby our cost-effective Handy incubator surpassed existing intensive care methods. The future step is associating the Handy incubator with more specifications and advancements.

Neonatal ethanol exposure from ethanol-based hand sanitisers in isolettes.

OBJECTIVE: The aims of this study is to measure the ethanol vapours in the isolette after use of hands cleaned with ethanol-based hand sanitiser (EBHS). METHODS: Two squirts (1.5 mL) of hand sanitiser were rubbed on hands for 10 or 20 s before inserting the hands in the isolette for 5 min. Ethanol vapours were measured in the isolette with photoionisation detector and alcohol breathalyser for 30 min. RESULTS: Peak ethanol concentration in the isolette was considerably higher with a 10 s hand rub (381±192 ppm) compared with a 20 s hand rub (99±50 ppm), and dissipated to ≤5 ppm within 30 min. Under routine care, EBHS use by care providers exposes neonates in isolettes to 3.7-7.3 or 1.4-2.8 mg/kg ethanol per day with 10 or 20 s hand rubs, respectively. The expected blood level from average single exposure is 0.036 mg/dL with 10 s hand rub and may increase further with multiple exposures in a short period. CONCLUSION: Preterm neonates in the isolette are at risk of inadvertent exposure to ethanol. The expected blood alcohol level from this exposure is small and below 1 mg/dL level recommended by European Medicines Agency to limit the ethanol exposure in children. The unintended ethanol exposure can be avoided by rubbing hands for at least 20 s after applying EBHS.

Failing to meet relative humidity targets for incubated neonates causes higher heat loss and metabolic costs in the first week of life.

AIM: Frequent nursing procedures can modify a newborn infant's thermal environment when their incubator is opened. This study evaluated the impact of relative humidity (RH) on preterm infants in closed incubators and calculated their heat loss and additional metabolic cost. METHODS: We studied 45 preterm infants born before 32 + 0 weeks, nursed at the neonatal intensive care unit at Amiens University Hospital, France from January 2009 to November 2011. Their body, skin and air temperatures and the incubator's RH were continuously recorded from day 1 to 8 of life, and the differences between the measured and target RH were calculated. Body heat loss (BHL) was also calculated. RESULTS: On day one, the measured RH (68.7 ± 1.0%) was significantly lower than the target RH (75%, p < 0.05), but this difference, together with BHL (p < 0.001) and evaporative heat loss (p < 0.001), fell significantly over time (p < 0.05). The additional metabolic cost correlated with the difference between measured and target RH (p < 0.001). CONCLUSION: RH from day 1 to 8 was below the recommended target value for preterm infants and resulted in high evaporative and greater total BHL and additional metabolic cost. The findings pose numerous challenges, including nursing care and incubator design.

Sensory exposure of neonates in single-room environments (SENSE): an observational study of light.

OBJECTIVES: To measure the internal and external light exposure of incubators and open cots in an Australian single-room configured neonatal unit and compare findings to current recommendations. METHODS: Light meters were placed in the internal and external environment of incubators and open cots within occupied single rooms in a tertiary-level neonatal unit between 15 September and 28 October 2015. Data were recorded in one-second increments over a minimum of 48 hours per room. RESULTS: Internal median light in incubators and open cots predominantly fell below 50 lux, with low amplitude diurnal cycling. Incubator covers substantially reduced external light exposure, contributing to very low light conditions (<10 lux). Periodically, light inside incubators peaked six times greater than the maximum recommendation of 600 lux. Overall, internal incubator and open cot lighting in the neonatal unit met American Academy of Pediatrics and American College of Obstetricians and Gynecologists recommendations for 65.1% of the time during the day and 25.6% overnight. Australasian Health Infrastructure Alliance recommendations were met for 6.7% of the time during the day and 2.4% overnight. CONCLUSIONS: Overall, light levels fell predominantly below 50 lux with peak periods of extreme light exposure. Low amplitude cyclic light was evident, but it remains unknown if this is sufficient to produce an effect on circadian entrainment, especially in preterm neonates. Current guidelines do not stipulate optimal cyclic light levels in neonatal units to promote circadian rhythms in the newborn population. Further research to determine well-defined lighting parameters for neonates of different gestations is paramount.

Differences in Temperature Changes in Premature Infants During Invasive Procedures in Incubators and Radiant Warmers.

Premature infants tend to lose heat quickly. This loss can be aggravated when they have received an invasive procedure involving a venous puncture. This research uses crossover design by conducting 2 intervention tests to compare 2 different treatments on the same sample. This research involved 2 groups with 18 premature infants in each. The process of data analysis used a statistical independent t test. Interventions conducted in an open incubator showed a p value of .001 which statistically related to heat loss in premature infants. In contrast, the radiant warmer p value of .001 statistically referred to a different range of heat gain before and after the venous puncture was given. The radiant warmer saved the premature infant from hypothermia during the invasive procedure. However, it is inadvisable for routine care of newborn infants since it can increase insensible water loss.

Testing of mechanical ventilators and infant incubators in healthcare institutions.

The medical device industry has grown rapidly and incessantly over the past century. The sophistication and complexity of the designed instrumentation is nowadays rising and, with it, has also increased the need to develop some better, more effective and efficient maintenance processes, as part of the safety and performance requirements. This paper presents the results of performance tests conducted on 50 mechanical ventilators and 50 infant incubators used in various public healthcare institutions. Testing was conducted in accordance to safety and performance requirements stated in relevant international standards, directives and legal metrology policies. Testing of output parameters for mechanical ventilators was performed in 4 measuring points while testing of output parameters for infant incubators was performed in 7 measuring points for each infant incubator. As performance criteria, relative error of output parameters for mechanical ventilators and absolute error of output parameters for infant incubators was calculated. The ranges of permissible error, for both groups of devices, are regulated by the Rules on Metrological and Technical Requirements published in the Official Gazette of Bosnia and Herzegovina No. 75/14, which are defined based on international recommendations, standards and guidelines. All ventilators and incubators were tested by etalons calibrated in an ISO 17025 accredited laboratory, which provides compliance to international standards for all measured parameters.The results show that 30% of the tested medical devices are not operating properly and should be serviced, recalibrated and/or removed from daily application.

Effects of Handling and Environment on Preterm Newborns Sleeping in Incubators.

OBJECTIVE: To describe the total sleep time, stages of sleep, and wakefulness of preterm newborns and correlate them to levels of sound pressure, light, temperature, relative air humidity, and handling inside incubators. DESIGN: Observational, correlational study. SETTING: A neonatal intermediate care unit. PARTICIPANTS: Twelve preterm newborns, who were 32.2 ± 4.2 weeks gestational age and weighed 1,606 ± 317 g. METHODS: Sleep records were assessed by polysomnograph. Environmental variables were measured with a noise dosimeter, light meter, and thermohygrometer. To record time and frequency of handling, a video camera was used. All recordings were made for an uninterrupted 24-hour period. RESULTS: Mean total sleep time in 24 hours was 899 ± 71.8 minutes (daytime = 446 ± 45.3 and nighttime = 448 ± 60.2). Mean wakefulness was 552 ± 94.0 minutes. The predominant stage was quiet sleep. A significant correlation was identified only between the levels of light and wakefulness (r = 0.65 and p = .041). CONCLUSION: The environmental conditions and care provided to hospitalized preterm newborns did not influence sleep except for high light levels, which increased wakefulness. Nurses in clinical practice should implement strategies to promote and protect sleep by decreasing newborns' exposure to excessive light.

[Infection Prevention in Premature Infants and Newborns in Thuringia: Implementation of Recommendation of the Commission for Hospital Hygiene and Infection Prevention (KRINKO)]. / Infektionsprävention bei Früh- und Neugeborenen in Thüringen: Umsetzung der Empfehlung der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO).

Systematic recording of practical implementation of current recommendations of KRINKO for the prevention of nosocomial infections in premature and newborn infants in children's hospitals in Thuringia. All neonatal treatment centers in Thuringia (n=18) were included in this survey. Answer were received from 83% (15/18). Degree of compliance was 100% in level-1 (3/3) and level-2 centers (5/5), and 70% in level-3 centers (7/10). The aim of the questionnaire was to evaluate infection prevention measures as well as structural/organizational parameters in neonatal centers in Thuringia. Preventive measures as well as weekly screening for colonization was fully performed in patients with a birth weight <1 500 g (n=205) at all centers. Additionally, prolonged screening and colonization surveillance measures were performed in 60% of all units until discharge from the hospital. Results related to structural/organizational parameters and especially structural conditions in neonatal centers in Thuringia pointed up challenges (2 m minimum distance between incubators in 27% (n=4/15), isolation in single room in 53% (n=8/15)). Insufficient number of staff also hamper the complete implementation of KRINKO recommendations (intensive care unit: patient/staff ratio (MW±SD) 2.5±1.1; newborn area 4.3±0.9). Analysis shows actual rate of implementation of KRINKO recommendations as well as structural/organizational parameters in neonatal treatment centers in Thuringia. It provides important points for discussion regarding necessary staff numbers and structural conditions. Analysis could also be used for future surveys in other regions in Germany.

Decreasing sound and vibration during ground transport of infants with very low birth weight.

OBJECTIVE: To measure the effectiveness of modifications to reduce sound and vibration during interhospital ground transport of a simulated infant with very low birth weight (VLBW) and a gestational age of 30 weeks, a period of high susceptibility to germinal matrix and intraventricular hemorrhage. STUDY DESIGN: Researchers measured vibration and sound levels during infant transport, and compared levels after modifications to the transport incubator mattresses, addition of vibration isolators under incubator wheels, addition of mass to the incubator mattress and addition of incubator acoustic cover. RESULT: Modifications did not decrease sound levels inside the transport incubator during transport. The combination of a gel mattress over an air chambered mattress was effective in decreasing vibration levels for the 1368 g simulated infant. CONCLUSION: Transport mattress effectiveness in decreasing vibration is influenced by infant weight. Modifications that decrease vibration for infants weighing 2000 g are not effective for infants with VLBW. Sound levels are not affected by incubator covers, suggesting that sound is transmitted into the incubator as a low-frequency vibration through the incubator's contact with the ambulance. Medical transportation can apply industrial methods of vibration and sound control to protect infants with VLBW from excessive physical strain of transport during vulnerable periods of development.

[The practice and proposals for standardized management of neonatal insulation technology].

In clinical practice, incubators can contribute to better diagnosis and treatment of diseases. Currently, insulation medical equipment used for the newborn are mainly warm-boxes. With the use popularity of warm-boxes in the country, medical accidents caused by improper use are on the increase. According to neonatal insulation technology and standardized management of practice, this article puts forward technical requirements of infant incubators with constant temperature and humidity, operation regulations and management specifications to better regulate the use of such devices. Meanwhile, it also suggests national related departments to formulate "incubator technology management norms" and "warm-box technology and practice", intending to standardize industry behaviors and ensure medical safety.

Assessment of radiant temperature in a closed incubator.

In closed incubators, radiative heat loss (R) which is assessed from the mean radiant temperature (Tr) accounts for 40-60% of the neonate's total heat loss. In the absence of a benchmark method to calculate Tr--often considered to be the same as the air incubator temperature-errors could have a considerable impact on the thermal management of neonates. We compared Tr using two conventional methods (measurement with a black-globe thermometer and a radiative "view factor" approach) and two methods based on nude thermal manikins (a simple, schematic design from Wheldon and a multisegment, anthropometric device developed in our laboratory). By taking the Tr estimations for each method, we calculated metabolic heat production values by partitional calorimetry and then compared them with the values calculated from V(O2) and V(CO2) measured in 13 preterm neonates. Comparisons between the calculated and measured metabolic heat production values showed that the two conventional methods and Wheldon's manikin underestimated R, whereas when using the anthropomorphic thermal manikin, the simulated versus clinical difference was not statistically significant. In conclusion, there is a need for a safety standard for measuring TR in a closed incubator. This standard should also make available estimating equations for all avenues of the neonate's heat exchange considering the metabolic heat production and the modifying influence of the thermal insulation provided by the diaper and by the mattress. Although thermal manikins appear to be particularly appropriate for measuring Tr, the current lack of standardized procedures limits their widespread use.

Healthful environments for hospitalized infants.

PURPOSE: Medical and technological advances dominate the design of infant incubators because of their essential role in the survival of critically ill neonates. Yet other important design considerations, such as caregiver interaction, discomfort at bedside, and harmful materials, often are overlooked. The purpose of this paper is to consider the effects of existing incubator designs and to suggest criteria for the next generation of infant incubators. BACKGROUND: Incubators of the mid-1940s established an industry standard that exists to this day: portholes in an infant chamber positioned over a mechanical system, resting on top of storage cabinets or drawers. This design is unresponsive to many of the infants' needs and significantly influences parent/infant interaction. The physical effects and social barriers that the incubator presents to the health and well-being of infants are compounded by the use of unhealthful substances and materials such as formaldehyde. Collectively, these conditions call for an incubator that not only ameliorates physical and social obstacles, but also uses benign materials. CONCLUSIONS: Simple alterations to existing incubator design, such as introducing color and pattern, providing arm rests, and freeing space beneath the infant chamber to accommodate seated caregivers, would encourage more prolonged periods of contact with the infant occupants, thereby improving their behavioral organization and recovery. Replacing harmful materials with alternatives such as formaldehyde-free substrates in the cabinetry also will improve the developmental outcomes of the infant occupants. These types of recommended changes embrace the intent of the incubator to provide a controlled, secure environment while acknowledging that incubators are not merely medical equipment, but the living spaces of their infant occupants.

The sound of operation and the acoustic attenuation of the Ohmeda Medical Giraffe OmniBed™.

The neonatal intensive care unit (NICU) is an environment that provides premature and fragile infants with health provisions needed to make a complete recovery. Premature infants are often born before their auditory systems have had an opportunity to fully mature. Research has shown that the ambient acoustic environment in the NICU exceeds the maximum noise level recommended by the American Academy of Pediatrics, even after measures have been taken to decrease noise levels. The purpose of this study is to evaluate noise levels inside an Ohmeda Medical Giraffe™ OmniBed™, the natural attenuation of the incubator, and the effects of modifications on attenuation and reverberation within the Giraffe TM OmniBed™. The normal operation of the Giraffe™ OmniBed™ is 41.7 dBA which indicates a lower noise of operation than previous studies. The Giraffe™ OmniBed™ naturally attenuates 12 dBA. Leaving an access latch or portal door open causes a statistically significant (P=.001) increase in sound within the bassinet. All modifications in the no-noise and the noise conditions showed a statistically significant (P=.001) drop in L(eq) when compared to baseline.

Observational study of treatment space in individual neonatal cot spaces.

PURPOSE: Technology developments in neonatal intensive care units have increased the spatial requirements for clinical activities. Because the effectiveness of healthcare delivery is determined in part by the design of the physical environment and the spatial organization of work, it is appropriate to apply an evidence-based approach to architectural design. This study aimed to provide empirical evidence of the spatial requirements for an individual cot or incubator space. SUBJECTS AND METHODS: Observational data from 2 simulation exercises were combined with an expert review to produce a final recommendation. A validated 5-step protocol was used to collect data. Step 1 defined the clinical specialty and space. In step 2, data were collected with 28 staff members and 15 neonates to produce a simulation scenario representing the frequent and safety-critical activities. In step 3, 21 staff members participated in functional space experiments to determine the average spatial requirements. Step 4 incorporated additional data (eg, storage and circulation) to produce a spatial recommendation. Finally, the recommendation was reviewed in step 5 by a national expert clinical panel to consider alternative layouts and technology. RESULTS AND CONCLUSIONS: The average space requirement for an individual neonatal intensive care unit cot (incubator) space was 13.5 m2 (or 145.3 ft2). The circulation and storage space requirements added in step 4 increased this to 18.46 m2 (or 198.7 ft2). The expert panel reviewed the recommendation and agreed that the average individual cot space (13.5 m2/[or 145.3 ft2]) would accommodate variance in working practices. Care needs to be taken when extrapolating this recommendation to multiple cot areas to maintain the minimum spatial requirement.

Hazard report. Infants may fall through insecure ports on incubators.

If the iris ports or access ports on infant incubators are not sufficiently secure, infants may work their way through the ports and fall. To reduce this risk, users should make sure that the ports are closed securely following each use. When possible, users should pass tubing through the incubator hood's grommets instead of through the larger and potentially less secure iris ports.

Variability in incubator humidity practices in the management of preterm infants.

AIM: To determine current practice and opinion in relation to incubator humidity use in the management of preterm infants in neonatal intensive care units (NICU's) within the Australian and New Zealand Neonatal Network (ANZNN). METHODS: A survey was conducted in 26 NICU's in the ANZNN. A senior clinical nurse in each perinatal centre participated in a telephone survey that focused on local humidification practices and on the clinicians' views and experiences of humidity use. RESULTS: All centres routinely used supplemental humidity in the management of preterm infants. The majority of centres (77%) had written protocols to guide practice. Eighty-eight per cent commenced humidity at a high level (relative humidity > or = 80%). There was wide practice variation in the gestational age parameters determining humidification use (all gestational ages up to 37 weeks), duration of use (3-77 days), timing of initiation (admission to 72 h after birth) and weaning practices. Perceived benefits of humidification included improved thermoregulation, skin integrity, and fluid and electrolyte balance and reduced transepidermal water loss. Perceived risks included sepsis and hyperthermia. CONCLUSIONS: Our study confirmed that incubator humidity is used routinely in the management of preterm infants in the ANZNN. Wide variation in humidification practices across NICUs reflects the paucity of research evidence. Perceived benefits and risks of humidity use were consistent with available literature. To optimise the care environment and provide an evidence base for practice further research is warranted.