Report: FDA plans reorganized “ super office ” for device regulation

The FDA is planning a new “super office” for its Center for Devices and Radiological Health department and the soon-to-be created Office of Product Evolution and Quality, according to a Regulatory Affairs Professionals Society report. The new office will aim to support a new dynamic and overcome existing separations of functionality within the FDA to create “more organic connections and information sharing,” CDRH head Jeffrey Shuren said, according to the report. The change comes as the federal watchdog looks to shift its monitoring to taking into account the total product lifecycle of medical devices, RAPS reports, and will fold four previously separate offices into a single entity. “We’re taking technologies that we put into different offices and move away from a branch structure to instead have teams focused on a specific set of technologies,” Shuren said, according to the report. Technologies will be separated into six separate departments, with each focusing on a set of devices. Ophthalmic, anesthetic, respiratory, ENT and dental devices will make up the first division, cardiovascular devices will make up the second, and reproductive, gastro-renal, urological, general hospital devices and human factors will make up the third. The fourth division will focus on surgical and infection control devices, the fifth on neurological and physical medicine devices and the last will focus entirely on orthopedic devices, according to the repo...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Center for Devices and Radiological Health (CDRH) Source Type: news

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This article uses emerging research to update the 2010 advisory from the American Society of Regional Anesthesia and Pain Medicine. This practice advisory provides recommendations from recently published articles.
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editor’s Picks Source Type: research
The objective of this comprehensive consensus statement was to provide practical and independent advice to physicians for treating and managing spinal anesthesia-induced maternal hypotension in both resource-rich and resource-poor environments. This clinical best practices summary was necessary as there has been much variation in the methods used to manage spinal anesthesia-induced hypotension during cesarean section, and maternal hypotension increases risks to both maternal and fetal/neonatal health. While generalized recommendations have been made for the management of this problem by professional organizations, the auth...
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editor’s Picks Source Type: research
(Int J Obstet Anesth. 2018;33:23–31) Ephedrine and phenylephrine have both been used to prevent and treat the spinal hypotension that is common during cesarean delivery. When compared with phenylephrine, ephedrine is associated with greater fetal acidosis in healthy parturients. However, there are limited data regarding the relative efficacy of these 2 drugs for managing hypotension in women with fetal compromise. The present trial examined the effects of bolus ephedrine versus phenylephrine for the treatment of spinal hypotension in women with severe preeclampsia and a nonreassuring fetal heart tracing who were und...
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editor’s Picks Source Type: research
(Anaesthesia. 2018;73:23–31) Minimally invasive cardiac output monitors have been used in parturients to assess the hemodynamic effects of spinal anesthesia and the commonly used vasopressors phenylephrine and ephedrine. However, studies utilizing these devices have been performed mostly in healthy parturients, with data lacking for those with severe preeclampsia. This randomized study’s objective was to compare the cardiac output response to phenylephrine or ephedrine administered for spinal hypotension during cesarean delivery in women with severe early-onset preeclampsia as well as to measure the stroke vol...
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editor’s Picks Source Type: research
This article examined common themes (relating to consent, checking the block, managing intraoperative pain, and professionalism) that emerged from an analysis of these claims and highlighted the lessons to be learned for practicing anesthesiologists.
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
(Anesth Analg. 2018;126:1109–1111) Although meaningful progress has been made in reducing maternal mortality, the Millennium Development Goal of a 75% reduction in maternal mortality is still to be met, with many of the deaths occurring in low- and middle-income countries (LMICs). The authors of the present editorial discussed Global Surgery 2030, which was commissioned by the Lancet and published in 2015, to identify barriers to safe obstetric surgery, training anesthesia providers, providing regional versus general anesthesia, and the use of cesarean delivery in low-income countries (LICs).
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
(Am J Obstet Gynecol. 2018;218(1):1–18) Delayed umbilical cord clamping may benefit preterm infants by increasing the volume of blood transferred to the neonate as well as allowing time for physiological transition, which may result in improved outcomes. The effects of delayed cord clamping are still unclear and an updated systematic review was needed. This systematic review included randomized controlled trials (RCTs) though July 31, 2017 in order to evaluate the effects of delayed clamping without cord milking compared to early clamping in reducing mortality in preterm infants.
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
(Am J Obstet Gynecol. 2018;218(1):98–102) The United States Food and Drug Administration has warned against the use of general anesthetics and sedation medications for>3 hours in pregnant women in the third trimester and children younger than 3 years old. The anesthetics agents listed included midazolam, propofol, and inhalational anesthetics (isoflurane, sevoflurane, and desflurane). They claim these agents may affect the development of children’s brains.
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
This study aimed to evaluate the effect of aspirin in preventing preeclampsia at term and preterm in relation to gestational age at onset of treatment as well as the therapeutic dose.
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
(Int J Obstet Anesth. 2018;33:53–56) Anesthesiologists face a dilemma when pregnant women with lower back tattoos request epidural analgesia during labor, as clear guidelines have not been established regarding the performance of epidural procedures through a tattoo on the lower back. In the United States ∼25% of people between the ages of 18 and 50 report having a tattoo. The opinions of anesthesiologists vary widely as to how to approach this scenario. In surveys performed addressing the issue, 40% of survey respondents indicated they would not perform an epidural technique through a lumbar tattoo and 70% repo...
Source: Obstetric Anesthesia Digest - Category: Anesthesiology Tags: Editorials and Reviews Source Type: research
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