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13 février, 2007 19:53
FDA Advises Against Use of Custom Ultrasonics' Endoscope Washers/Disinfectors
Yael Waknine
February 8, 2007 — The US Food and Drug Administration (FDA) has notified healthcare professionals against the use of flexible endoscope washers/disinfectors (System 83 Plus and System Plus 83 Mini-flex, made by Custom Ultrasonics, Inc).
The devices are considered a potential health hazard because improperly cleaned and disinfected endoscopes can be a source of pathogen transmission between patients, according to an alert sent yesterday from MedWatch, the FDA's safety information and adverse event reporting program. No adverse events related to the endoscope washers/disinfectors have been reported thus far.
The company has signed a consent decree of permanent injunction, agreeing to cease device manufacture and distribution until its manufacturing methods and controls meet FDA regulations. The firm also agreed to develop and implement adequate medical device reporting procedures.
In the interim, healthcare professionals are advised to discontinue use of the cleaning/disinfection devices if another product is available, and to contact the firm for more information. Alternatively, appropriate protocols may be followed to manually wash and disinfect the endoscope. Continued use of the devices should only be undertaken after weighing the associated risks and benefits.
Adverse events potentially related to use of the endoscope washers/disinfectors should be reported to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at
http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.|
Yael Waknine is a freelance writer for Medscape. |
