Part of the mission of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration is to facilitate medical device innovation. Therefore, CDRH plays an important role in helping its stakeholders such as manufacturers, health care professionals, patients, patient advocates, academia, and other government agencies navigate the regulatory landscape for medical devices. This is particularly important for innovative physiological closed-loop controlled (PCLC) devices used in critical care environments, such as intensive care units, emergency settings, and battlefield environments. CDRH’s current working definition of a PCLC medical device is a medical device that incorporates physiological sensor(s) for automatic manipulation of a physiological variable through actuation of therapy that is conventionally made by a clinician. These emerging devices enable automatic therapy delivery and may have the potential to revolutionize the standard of care by ensuring adequate and timely therapy delivery with improved performance in high workload and high-stress environments. For emergency response and military applications, automatic PCLC devices may play an important role in reducing cognitive overload, minimizing human error, and enhancing medical care during surge scenarios (ie, events that exceed the capability of the normal medical infrastructure). CDRH held an open public workshop on October 13 and 14, 2015 with the aim of fostering an open discussion on design, implementation, and evaluation considerations associated with PCLC devices used in critical care environments. CDRH is currently developing regulatory recommendations and guidelines that will facilitate innovation for PCLC devices. This article highlights the contents of the white paper that was central to the workshop and focuses on the ensuing discussions regarding the engineering, clinical, and human factors considerations. (Anesth Analg 2018;126:1916–25)
The aim of this systematic review is to evaluate the impact of personal protective equipment (PPE) on medical device use during public health emergency responses. We conducted a systematic literature search of peer-reviewed journals in PubMed, Web of Science, and EBSCO databases. Twenty-nine of 92 articles published between 1984 and 2015 met the inclusion criteria for the review. Although many medical device use impacts were reported, they predominantly fell into 3 categories: airway management, drug administration, and diagnostics and monitoring. Chemical, biological, radiological, and nuclear (CBRN)-PPE increased completion times for emergency clinical procedures by as much as 130% and first attempt failure rates by 35% (anesthetist) versus 55% (non-anesthetist). Effects of CBRN-PPE use depend on device, CBRN-PPE level, and clinician experience and training. Continuous clinical training of responders in CBRN-PPE and device modifications can improve safety and effectiveness of medical device use during public health emergency response.
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