A Simulation Systems Testing Program Using HFMEA Methodology Can Effectively Identify and Mitigate Latent Safety Threats for a New On-Site Helipad.

BACKGROUND: Fundamental changes in critical systems within hospitals present safety risks. Some threats can be identified prospectively, others are only uncovered when the system goes live. Simulation and Healthcare Failure Mode and Effect Analysis (HFMEA) can be used together to prospectively test a system without endangering patients. The research team combined iterative simulations and HFMEA methodologies to conduct simulation-based clinical systems testing (SbCST) to detect and mitigate latent safety threats (LSTs) prior to opening a hospital helipad. METHODS: This study was conducted in three phases. In Phase I, an interprofessional team created a process map and conducted a tabletop exercise, identifying LSTs that could theoretically occur during patient transfer from the new helipad. Using HFMEA methodology, steps predicted to be affected by the new helipad were probed. Identified LSTs were assigned a hazard score. Mitigation solutions were proposed. Results from Phase I were used to plan Phase II, which used low-fidelity simulation to test communication processes and travel paths. High-fidelity simulation was used in Phase III to test previously identified LSTs. RESULTS: Over three testing phases, 31 LSTs were identified: 15 in Phase I, 7 in Phase II, and 9 in Phase III. LSTs fell under the categories of care coordination, facilities, and equipment, and devices. Eighteen (58.1%) were designated "critical" (hazard score ≥ 8). CONCLUSION: A three-phase SbCST program using HFMEA methodology was an effective tool to identify LSTs. An iterative approach, using results of each phase to inform the structure of the next, facilitated testing of proposed mitigation strategies.

Muscle loading in exoskeletal orthotic use in an activity of daily living.

Strokes are the leading cause of major adult disability with up to 85% of U.S. survivors experiencing hemiparesis. Physical characteristics of upper-extremity exoskeletal orthotics, used in stroke rehabilitation, were evaluated in terms of performance of activities of daily living (ADL), perceived exertion, and muscle load. Simulated orthotic weight distributions, with total extremity loads of 0.81 kg, 1.25 kg and 2.27 kg, were evaluated along with a 0 kg control condition. Response measures included average shoulder/elbow muscle surface electromyography (sEMG) signal amplitude, quality of task completion and total rest time during performance, and Borg CR-10 scale ratings. Device weight distribution, or imposed shoulder moment, was found to have a significant effect on biceps brachii and anterior deltoid activation levels, percent task completion, total rest time, and perceived exertion ratings. Results suggest that heavier upper-extremity orthotics could cause undesirable effects in terms of muscle loading, performance and exertion; such adverse effects could potentially lead to lack of use during patient's rehabilitation.