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Twenty-five of these MDRs were reported to the FDA in 2015.Additionally, several hospitals within the SHEA membership are starting to report patients with past cardiothoracic surgery developing an infection due to Mycobacterium chimaera, an infection not typically found in humans.
chimaera based on how the fan on the heater-cooler unit aerosolized the organism into the air.
According to ICH Q2B, stability of analytical solutions is a typical method variation that should be assessed during "Robustness testings" during validation of an analytical method.
The resulting "use by" or expiry dates should be documented according to an internal SOP.
The "Guide to Inspections of Blood Banks" is a consolidation of information previously provided in the Blood Bank Inspection Checklist and Report, and the Instruction Booklet for Blood Bank Inspection Checklist and Report, FDA-2609.
This guide, which provides the most updated interpretation of certain regulations and guidelines, was prepared by the FDA, Office of Regulatory Affairs and the Center for Biologics Evaluation and Research.
Note: This document is reference material for investigators and other FDA personnel.
The document does not bind FDA, and does no confer any rights, privileges, benefits, or immunities for or on any person(s).In 2016, FDA advised health care professionals and patients not to use liquid docusate drug products manufactured at Pharma Techs Davie, Florida, facility after being implicated in CDCs public health investigation.These products were labeled and distributed by multiple companies, including Rugby.Although the agency, at the time of this publication, is in the process of revising the regulations on blood and blood products, it will take some time before such revisions are in effect.The current guide provides interim inspectional direction.March 2, 2016The following information was developed by the Society for Healthcare Epidemiology of America (SHEA) to raise awareness among healthcare providers of the possible association between Mycobacterium chimaera infections and use of heater-cooler devices.