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CO2 absorbents were introduced into anesthesia practice in 1924 and are essential when using a circle system to minimize waste by reducing fresh gas flow to allow exhaled anesthetic agents to be rebreathed. For many years, absorbent formulations consisted of calcium hydroxide combined with strong bases like sodium and potassium hydroxide. When Sevoflurane and Desflurane were introduced, the potential for toxicity (compound A and CO, respectively) due to the interaction of these agents with absorbents became apparent. Studies demonstrated that strong bases added to calcium hydroxide were the cause of the toxicity, but that by eliminating potassium hydroxide and reducing the concentration of sodium hydroxide to

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.

The purpose of this position paper is to define the scope of perioperative ultrasound (US), review the current status of US training practices during anesthesiology residency, and suggest the recommendations for current and future trainees on how to obtain perioperative US proficiency. We define per

Sevoflurane is currently available in the United States from two manufacturers: Ultane (Abbott Laboratories, Inc.) and a generic product, Sevoflurane Inhalation Anesthetic (Baxter Healthcare Corp.). These products are rated therapeutically equivalent by the Food and Drug Administration, but there are some differences. Ultane is made in a single-step synthetic process and generic sevoflurane is manufactured using a three-step process. Ultane contains >300 ppm water and generic sevoflurane contains < or =130 ppm water. Ultane is supplied in a plastic polyethylene naphthalate polymer bottle, while generic sevoflurane is supplied in lacquer-lined aluminum bottles. The manufacturing processes and impurities, sevoflurane degradation resulting from Lewis acid reactions, and suitability of nonglass containers for sevoflurane are discussed.

Various alkali (e.g., soda lime) convert sevoflurane to CF2=C(CF3)OCH2F, a vinyl ether called "Compound A, " whose toxicity raises concerns regarding the safe administration of sevoflurane via rebreathing circuits. In the present investigation, we measured the sevoflurane degradation and output of Compound A caused by standard (13% water) Baralyme brand absorbent and standard (15% water) soda lime, and Baralyme and soda lime having various water contents (including no water). We used a flow-through system, applying a gas flow rate relative to absorbent volume that roughly equaled the rate/volume found in clinical practice. Both absorbents, at similar water contents, temperatures, and sevoflurane concentrations, produced roughly equal concentrations of Compound A. Dry and nearly dry absorbents produced less Compound A early in exposure to sevoflurane, and more later, than standard absorbents. Increases in temperature and sevoflurane concentration increased output of Compound A. Both absorbents, especially when dry, also destroyed Compound A, the concentration exiting from absorbent resulting from a complex sum of production and destruction. We conclude that the variability of concentrations of Compound A found in clinical practice may be largely explained by the inflow rate used (i.e., by rebreathing), sevoflurane concentration, and absorbent temperature and dryness. The effect of dryness is complex, with fresh dry absorbent destroying Compound A as it is made, and with dry absorbent that has been exposed to sevoflurane for a period of time providing a sometimes unusually high output of Compound A.