FDA updates bronchoscope cleaning guidelines

The FDA released new guidelines today for cleaning and reprocessing flexible bronchoscopes to prevent infections associated with improperly cleaned units. Bronchoscopes must undergo reprocessing between uses, with broncoschopes specifically positioned to “pose a greater likelihood of microbial transmission and represent a high risk of infection if they are not adequately reprocessed,” according to the FDA. The new guidelines, meant to avoid outbreaks of infections that can spread hospital-wide, include strict adherence to manufacturer reprocessing instructions. The Agency said it was critically important that all staff not skip steps in cleaning, only use manufacturer-specified cleaning accessories, high level disinfectants, enzymatic cleaning agents and detergents along manufacturer guidelines. The federal watchdog advised health professionals using the devices to immediately remove any units that did not pass a leak test or shows visible signs of damage, and to follow manufacturer’s recommendations for preventive maintenance and repair. The agency also stipulated that handlers should implement a “comprehensive reprocessing quality control program,” containing written procedures for monitoring, training and adherence, as well as documentation for all items and steps in the reprocessing procedure. The agency concluded that reprocesses brochoscopes should be stored in a “manner that will minimize the likelihood of contamination or collectio...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Sterilization / Calibration Source Type: news