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...
Publication date: Available online 21 May 2019Source: Brazilian Journal of Anesthesiology (English Edition)Author(s): Laurent Becuwe, Jean-Christian Sleth, Yann-Erwan Favennec, Gilles Candelier
ConclusionIntrathecal (S)-(+)-Ketoprofen caused dose-dependent neurohistopathological changes in rats on days 3 and 7 after injection, suggesting that (S)-(+)-Ketoprofen should not be intrathecally administered.ResumoJustificativa e objetivosA administração intratecal de anti-inflamatórios não esteroides é mais eficaz no tratamento da dor pós-operatória. A Anti-inflamatórios não esteroides, como o (S)-(+)-cetoprofeno, pode ser eficaz em doses intratecais inferiores às parenterais; a segurança pré-clínica relativa à possí...
Authors: Paneta M, Waring WS Abstract Introduction Intravenous lipid emulsion (ILE) administration is capable of reversing the acute cardiac and neurological toxicity caused by local anaesthetic agents. In recent years, ILE has also been explored as a potential antidote for cardiotoxicity caused by non-anaesthetic agents too. Areas covered The potential mechanisms, safety and efficacy of this approach are considered. Data were sought from published reports listed in PubMed and EMBASE, and abstracts of meetings of the North American Congress of Clinical Toxicology and European Association of Poisons Centres and Clin...
CONCLUSIONS: This retrospective study indicates that preoperative WSCE before emergency surgery is a useful tool for predicting the presence of Hinchey III-IV in patients with colorectal perforation. PMID: 31104697 [PubMed - in process]
CA-2 opening in FL PM for details
I read True-Dat's reviews of Riverside County anesthesia groups with great interest. I thank him (or her) for his review. I figure I'd follow his lead--though I don't worry about being found out, so I'll give you the straight dope without fear. I moved to Southern California late in my career, and couldn't find any reliable info on individual groups. Some sucked in a fashion I wouldn't have believed possible--many of them are still (years later) running the same pleading ads on Gaswork... OC/LA Groups (Sanitized Version)
I've had it come up a few times where I didn't consent pre-op for TAP block but surgery takes an unexpected course and now they have an unanticipated abdominal incision and the patient really could benefit from a TAP block prior to emergence at this point. Is it reasonable to perform the block? They are so safe, I do them under GA anyway, and the benefits if the person has significant chronic pain issues would be potentially great. I don't want to have to wait until they're awake and in... TAP block consent
Condition: Kidney Calculi Intervention: Procedure: general anesthesia Sponsor: Seoul National University Hospital Completed
Condition: Perioperative Stress Intervention: Sponsor: University of Pecs Recruiting
Condition: Residual Paralysis, Post Anesthesia Intervention: Other: Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex Sponsor: University of Washington Not yet recruiting