FDA announces recall of certain MRI systems
BIOMEDICAL // The Food and Drug Administration (FDA) recently announced a Class I recall of all GE Healthcare magnetic resonance imaging (MRI) systems with superconducting magnets. According to the notice, there are 12,968 of the MRI systems, including 5,708 in the United States. In a Feb. 4 announcement, GE Healthcare stated that it had initiated a “voluntary field corrective action” for all GE MRI systems with superconducting magnets manufactured since 1985, because it found that some systems in India had been modified by service personnel or equipment users to disable the magnet rundown unit.
Joint Commission advises hospitals on e-cigarettes
FACILITIES // An item in the Feb. 11 edition of the Joint Commission Online newsletter advised hospitals to review and adjust their current smoking policies to avoid e-cigarette hazards. “According to the Centers for Disease Control and Prevention, electronic or e-cigarettes have been identified as the cause of fires in the United States and in Britain,” the Joint Commission stated. “Consequently, organizations need to be aware of the possible safety threats caused by these devices and be prepared to deal with patients, visitors and staff who may light up an e-cigarette on facility premises.”
Feds issue guidance for reprocessed devices
Infection prevention // The Food and Drug Administration (FDA) recently issued final guidance for makers of reusable duodenoscopes and other reprocessed medical devices aimed at assuring that their cleaning and disinfection or sterilization instructions consistently reduce microbial contamination. In addition, the Centers for Disease Control and Prevention issued an interim protocol for health care facilities wishing to use routine culturing to assess the adequacy of duodenoscope reprocessing. The FDA said manufacturers seeking to bring to market certain reusable devices such as duodenoscopes, bronchoscopes and endoscopes should submit for review their data validating the effectiveness of their reprocessing methods and instructions.
AHE to offer certification program for technicians
Environmental services // The American Hospital Association’s Association for the Healthcare Environment is developing a certification curriculum for environmental services technicians that hospitals and other health care facilities can use for training. AHE will teach hospital and other health care personnel to conduct the Certified Healthcare Environmental Services Technician program at their facilities. The program will focus on critical thinking, ethics and technical skills, and include a behavioral assessment as well as a written component.
FDA publishes guidance on small-bore connectors
Biomedical // The Food and Drug Administration (FDA) recently published final guidance for small-bore connectors used in enteral applications. It provides recommendations to manufacturers, FDA reviewers and other entities involved in manufacturing devices that contain small-bore connectors designed for enteral feeding, as well as those submitting or reviewing premarket notification submissions [510(k)s] for these devices. Small-bore connectors provide a mechanism for the connection between a variety of medical devices including those with enteral and nonenteral (e.g., intravenous) applications. The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients.
