The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre-and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
Mt Everest has been gaining popularity from casual hiking athletes, climbers, and ultra-endurance marathon runners. However, living and sleeping at altitude increases the risk of injury and illness. This is because travel to high altitudes adversely affects human physiology and performance, with unfavourable changes in body composition, exercise capacity, and mental function. This is a case report of a climber who reached the summit of Mt Everest from the north side. During his 40-day expedition, we collected sleep quality data and night-time heart rate variability. During the night inside the tent, the air temperature ranged from −12.9 to 1.8 °C (−5.8 ± 4.9 °C) and the relative humidity ranged from 26.1 to 78.9% (50.7 ± 16.9%). Awake time was 17.1 ± 6.0% of every sleep-time hour and increased with altitude (r = 0.42). Sleep time (r = −0.51) and subjective quality (r = 0.89) deteriorated with altitude. Resting heart rate increased (r = 0.70) and oxygen saturation decreased (r = −0.94) with altitude. The mean NN, RMSSD, total power, LF/HF, and SD1 and SD2 were computed using the NN time series. Altitude reduced the mean ΝΝ (r = −0.73), RMSSD (r = −0.31), total power (r = −0.60), LF/HF ratio (r = −0.40), SD1 (r = −0.31), and SD2 (r = −0.70). In conclusion, this case report shows that sleeping at high altitudes above 5500 m results in progressively reduced HRV, increased awakenings, as well as deteriorated sleep duration and subjective sleep quality. These findings provide further insight into the effects of high altitude on cardiac autonomic function and sleep quality and may have implications for individuals who frequently spend time at high altitudes, such as climbers.
Studies on clinical adverse events in hospitals have identified the Operating Room (OR) as the most probable place for medical error. Therefore, it is highly important to improve efficiency and safety within the OR. We decided to review the current available evidence in the literature on the topic of OR efficiency and safety; we identified the limitations and pitfalls within the OR, searched for the roots for their existence and described future directions and recommendations. In addition, we explored the economic cost implications as they pertain to the OR use under those limitations, all of which synthetically, bring forward the necessity that things need to change within the OR otherwise a healthcare unit's finances will continue to take significant losses. Finally, we briefly describe a future solution for the OR.
Human Factors Engineering (HFE) principles were initially implemented in safety-related procedures in aviation and other high-risk industries to minimize human error-related risks. The introduction of HFE in healthcare aims not to eliminate the 'human factor,' but rather to enable 'engineering' to redesign clinical settings to become resilient to unanticipated events related to operational and/or safety shortcomings. Given the complexity of the Operating Room (OR) and the sociotechnico-cognitive activities that occur during a surgical operation, HFE needs to consider a wide spectrum of Surgical Flow Disruptions (SFD), such as miscommunications, fatigue, workload, physical layout of the site etc. The increase of fully automated/computer-assisted surgical systems into everyday surgical practice highlights the need for specialized technical skills and a subsequent change in mind-set and intraoperative decision-making. The complexity of the modern OR calls out for incorporation of a culture safety also illustrated by the close interaction of Usability Engineering (UE) and Risk Management (RM) throughout the lifecycle of a medical system and by Regulations currently in force. This article discusses the practical parameters of HFE incorporation into surgical practice and aims to highlight how this holistic redefinition of OR settings promotes patient and medical staff safety through mitigation of error-prone processes.
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