OBJECTIVE: To investigate the risk of adverse events in the clinical use of infant incubators of three kinds of national medical devices in Zhejiang Province. METHODS: Semi-quantitative matrix analysis was used to analyze the risk of adverse events related to incubator products in Zhejiang province from August 2018 to August 2019. RESULTS: Through the risk analysis of 213 cases of adverse events of infant incubator product, the risk point and degree of the product in practical clinical application were evaluated. CONCLUSIONS Through the evaluation results of the production enterprises, medical institutions put forward relevant recommendations to reduce the risk of product use to prevent the recurrence of serious adverse events in the use of the product and spread.
Humans ; Incubators, Infant ; Infant

OBJECTIVE: To study the safety and efficacy of magnetic resonance imaging (MRI)-compatible incubator in cranial MRI examination for neonates. METHODS: A total of 120 neonates who were hospitalized in three hospitals and needed to undergo MRI examination were randomly divided into a control group and an experimental group, with 60 neonates in each group. The neonates in the experimental group were transferred with MRI-compatible incubator and underwent cranial MRI examination inside the MRI-compatible incubator, and those in the control group were transferred using a conventional neonatal transfer incubator and then underwent MRI examination outside the incubator. The two groups were compared in terms of the primary efficacy index (total examination time), secondary efficacy indices (times of examination, MRI completion rate on the first day of use), and safety indices (incidence rate of adverse events and vital signs). RESULTS: There were no significant differences in total examination time, times of examination, and MRI completion rate on the first day of use between the two groups ( CONCLUSIONS The use of MRI-compatible incubator does not significantly shorten the examination time of cranial MRI, but it does provide a relatively stable environment for examination with acceptable safety. There is a need for further studies with a larger population.
Humans ; Incubators, Infant ; Infant, Newborn ; Magnetic Resonance Imaging/instrumentation* ; Prospective Studies ; Skull/diagnostic imaging*

The standard terms of infant incubators with high clinical risk and high incidence of adverse events has been tested through the introduction of YY/T 0841-2011 standard, an on-site inspection scheme for using infant incubators has been proposed, the problems existing in the inspection are analyzed and reasonable suggestions are put forward, this paper provides a certain technical reference for the whole life cycle management of the infant incubator.
Humans ; Incubators, Infant ; Infant ; Physical Examination

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.
Incubators ; Incubators, Infant ; standards ; Infant, Premature ; Quality Control ; Software

Neonatology in pediatrics became a part of medical school curricula in Korea in 1954-1959. Specific treatments and procedures in the neonatal field were adopted around this period, for example, antibiotics, oxygen therapy, and the exchange transfusion procedure were established in 1950-1960. Usage of an infant incubator was implemented along with the establishment in 1960. The trend of separation between a premature infant care unit and newborn nursery room enabled the specialized treatment of high-risk infants in the 1970s. Assisted ventilation with continuous positive airway pressure and phototherapy was initiated in 1978. The recent concept of a neonatal intensive care unit was established in 1980, and it made so-called neonatal intensive care such as mechanical ventilation and intensive monitoring available. The Korean Society of Neonatology was founded in 1993. The usage of pulmonary surfactant in the 1990s, accelerated the improvement of respiratory distress syndrome survival, and it resulted in the nationwide opening of neonatal intensive care unit in hospitals. The high frequency ventilator and inhaled nitric oxide were introduced in the 2000s. The Korean Neonatal Network was commenced as a nationwide systemic database for very low birth weight infant registry in 2010. Accordingly, the history of Korean neonatology can be summarized as 50 years in total, and 35 years in a narrow sense. During this era, neonatal care in Korea has improved remarkably and has achieved a great survival rate for high-risk neonates, preterm infants, and micro-premies. In this review, we intend to provide an overview of the history, efforts, and outcomes of Korean neonatology activity that have led to these achievements.
Anti-Bacterial Agents ; Continuous Positive Airway Pressure ; Curriculum ; Humans ; Incubators, Infant ; Infant ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Intensive Care, Neonatal ; Korea* ; Neonatology* ; Nitric Oxide ; Nurseries ; Oxygen ; Pediatrics ; Phototherapy ; Pulmonary Surfactants ; Respiration, Artificial ; Schools, Medical ; Survival Rate ; Ventilation ; Ventilators, Mechanical

According to current assembly situation of infant incubator in company A, basic industrial engineering means such as time study was used to analyze the actual products assembly production and an assembly line was designed. The assembly line was modeled and simulated with software Flexsim. The problem of the assembly line was found by comparing simulation result and actual data, then through optimization to obtain high efficiency assembly line.
Equipment Design ; Humans ; Incubators, Infant ; Infant ; Software

PURPOSE: The purpose of this study was to identify whether hearing a recording of mother's voice affected physiological reactions, behavioral state related to sleep and weight of very low birth weight (VLBW) infants. METHODS: This was a nonequivalent control group pre-post test quasi-experimental design. The participants were 11 VLBW infants in the experimental group and 11 in the control group. In the experimental group, a recording of mother's voice was played to her infant by voice recorder four times each day for five minutes over 10 consecutive days in the incubator. RESULTS: For physiological response (heart rate, respiration rate, oxygen saturation), there were statistically significant differences between the experimental and control groups. Behavioral state during sleep was more very quiet and quiet in the experimental group. In the daily weight change, there was no significant difference between the experimental and control groups. CONCLUSION: The findings suggest that, for VLBW infants, the intervention of hearing a recording of mother's voice had some significance as a nursing intervention having a positive impact. Such interventions can help pediatric nurses to stabilize the physiological response and maintenance more very quiet sleep state and improve VLBW infants' growth.
Body Weight ; Evaluation Studies as Topic ; Hearing* ; Humans ; Incubators ; Infant* ; Infant, Very Low Birth Weight* ; Mother-Child Relations ; Mothers ; Nursing ; Oxygen ; Respiratory Rate ; Voice*

Neonatal intensive care was introduced much later in Korea than in Europe and the United States, where it was introduced during the last decade of the 19th century. During the 1950s-60s, general supportive neonatal care could be provided in nurseries, and during the 1960s-70s, incubator care could be given to preterm infants in premature rooms. In the 1980s, neonatal intensive care could be provided to premature and sick full-term infants in neonatal intensive care units (NICUs) of some major medical centers; the quality of neonatal intensive care improved and the number of NICUs rapidly expanded during the 1990s and 2000s. It can be assumed that the rapid development of neonatal intensive care in Korea may have been induced by the improvement in the Korean socio-economical environment, public demand, numerous study visits and lectures in Korea by distinguished foreign neonatologists, return of native Korean neonatologists trained at famous foreign institutions, and establishment of Korean medical societies (e.g., the Korean Society of Perinatology and the Korean Society of Neonatology). As a result, neonatal and infant mortality rates have dramatically decreased in Korea, especially the mortality rates of low birth weight, very low birth weight, and extremely low birth weight infants. However, despite present and future difficulties in Korea, it is essential to develop and promote the more advanced and institutionalized neonatal intensive care with the set-up of regionalization and transportation system at the perinatal centers in cooperation with primary and secondary hospitals, the government, city, and communities.
Europe ; Humans ; Incubators ; Infant ; Infant Mortality ; Infant, Low Birth Weight ; Infant, Newborn ; Infant, Premature ; Infant, Very Low Birth Weight ; Intensive Care Units, Neonatal ; Intensive Care, Neonatal ; Korea ; Lectures ; Local Government ; Nurseries ; Perinatology ; Societies, Medical ; Transportation ; United States

BACKGROUND: Extended-spectrum beta-lactamase-producing (ESBL) Klebsiella pneumoniae is an important cause of nosocomial infections in neonatal intensive care units (NICUs). This study aimed to reduce ESBL-producing K. pneumoniae in the NICU by using infection control measures. METHODS: We performed prospective surveillance cultures, monitoring, and education for infection control in the NICU between May and August 2011. Specimens were collected from all infants and the environment including stethoscopes, thermometers, ventilators, incubators, etc. The anterior nares and hands of healthcare workers were also screened. We inspected infection control practices and provided feedback. The level of infection control awareness was measured using a questionnaire. RESULTS: The level of awareness and performance of hand washing increased significantly after intervention (both P<0.001). The environmental management of healthcare providers also improved significantly (P=0.001). The yield of ESBL-producing K. pneumoniae from clinical specimens decreased gradually throughout the study period (30.4% in May to 12.6% in August). Central catheter-related K. pneumoniae bacteremia decreased from 1.3/1000 to 0/1000 catheter-days. CONCLUSION: Infection control measures including education, monitoring, and surveillance can lower the incidence of ESBL-producing K. pneumoniae in the NICU.
Bacteremia ; beta-Lactamases ; Cross Infection ; Delivery of Health Care ; Hand ; Hand Disinfection ; Health Personnel ; Humans ; Incidence ; Incubators ; Infant ; Infant, Newborn ; Infection Control ; Intensive Care Units ; Intensive Care Units, Neonatal ; Intensive Care, Neonatal ; Klebsiella ; Klebsiella pneumoniae ; Pneumonia ; Prospective Studies ; Stethoscopes ; Thermometers ; Ventilators, Mechanical

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.
Humans ; Incubators, Infant ; standards ; Infant, Newborn ; Materials Management, Hospital ; organization & administration ; Safety Management ; Temperature