Log in to search using one of your social media accounts:

 

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

Related Links:

With the current trend toward ambulatory joint replacements, it is important to identify the approach to postoperative analgesia which best balances comfort and mobility. Adductor canal blocks provide analgesia after unicondylar knee replacement and can be performed with either an infusion catheter [adductor canal block catheter (ACB-C)] or as a single-shot injection [adductor canal block single-shot injection (ACB-SS)]. We conducted a retrospective analysis comparing the perceived quality of analgesia achieved by the 2 techniques, hypothesizing that patients receiving ACB-Cs would have less opioid consumption and lower pa...
Source: Techniques in Orthopaedics - Category: Orthopaedics Tags: Special Technical Articles Source Type: research
The Latarjet procedure is well known to be technically challenging, with an incidence of neurological complications ranging from 1.8% to 20.6%. Recently, intraoperative neuromonitoring has been used to define the stages of the Latarjet when the nerves are at the highest risk. Our objective is to present short-term neurological outcomes and technique of using a biphasic handheld nerve stimulator. We retrospectively evaluated the charts of all patients who had undergone a Latarjet procedure by the senior author once we began using the biphasic handheld intraoperative nerve stimulator. Data collection included age, sex, numbe...
Source: Techniques in Orthopaedics - Category: Orthopaedics Tags: Special Technical Articles Source Type: research
Condition:   Prostate Cancer Interventions:   Drug: Dexmedetomidine;   Other: Without dexmedetomidine Sponsor:   Asan Medical Center Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Conditions:   Pain, Postoperative;   Chronic Postoperative Pain Interventions:   Procedure: QLB;   Device: PCA;   Procedure: GA;   Drug: Oxycodone;   Drug: Sevoflurane;   Drug: Fentanyl;   Drug: Rocuronium Sponsors:   Medical University of Lublin;   Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów;   Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Pediatric ALL Intervention:   Drug: Propofol Sponsor:   Indonesia University Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
The study has taken three years and included identifying and investigating every case of life-threatening anaphylaxis that occurred in NHS hospitals during one year – from three million anaesthetics. The findings are wide-ranging and often unexpected, highlighting new trends in the drugs causing anaphylaxis and the need for changes to hospital procedures and training, combined with better reporting and investigation of incidents.
Source: Current Awareness Service for Health (CASH) - Category: Consumer Health News Source Type: news
The practice of operating room (OR) clinicians - nurses, surgeons, and anesthetists - is fundamentally about preserving life. Some patients, however, die in the OR. Clinicians are therefore vulnerable to moral and emotional trauma. In this paper, we discus...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Economics of Injury and Safety, PTSD, Injury Outcomes Source Type: news
This study...
Source: SafetyLit - Category: International Medicine & Public Health Tags: Alcohol and Other Drugs Source Type: news
How do abuse-deterrent opioid formulations work--and are they effective? This review details the mechanisms and pharmacology of 10 abuse-deterrent formulations currently approved in the US.Anesthesiology
Source: Medscape Today Headlines - Category: Consumer Health News Tags: Pharmacist Journal Article Source Type: news
Conclusion Our results suggest that irregularly shaped surfaces in operating rooms may require enhanced covering, cleaning, and monitoring protocols compared to more regularly shaped surfaces.
Source: American Journal of Infection Control - Category: Infectious Diseases Source Type: research
More News: Anesthesia | Anesthesiology | Brain | Cardiology | Cardiovascular | Gastroenterology | Heart | Hospitals | Medical Devices | Neurology | Opthalmology | Organic | Orthopaedics | Respiratory Medicine | Urology & Nephrology