FDA頒布更新支氣管鏡清潔指導＿2015

FDA updates bronchoscope cleaning guidelines SEPTEMBER 17, 2015 BY FINK DENSFORD LEAVE A COMMENTFDAThe 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 collection and retention of moisture," again according to manufacturer guidelines. And while the agency said the risk of infection with bronchoscopes was significant, it specified that the risk was not as high as the transmission risk in reprocessed duodenoscopes. In August, the FDA published warning letters it sent earlier that month to the 3 largest makers of endoscopes on the U.S. market, cautioning the companies about violations found during spring inspections at plants in the U.S. and Japan. The inspections followed a string of deadly "superbug" infections attributed to duodenoscopes made by Olympus (TYO:7733),Fujifilm Holdings (TSE:4901) and Hoya's (TYO:7741) Pentax subsidiary. The devices are used for a procedure called endoscopic retrograde cholangiopancreatography, in which a reusable tube-like camera is inserted into the throat of a patient. More than 500,000 ERCPs using the devices are performed in the U.S. annually. Hospitals in Connecticut, Virginia, California and Washington state all reported superbug outbreaks in February and March, some of which led to patients' deaths.