The United States Food and Drug Administration (FDA) has issued an alert concerning all automated endoscope reprocessors manufactured by Custom Ultrasonics.
In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors (AERs) from health care facilities due to the firm's continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. FDA is recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
As part of the FDA's ongoing investigation into infections associated with reprocessed medical devices and AER devices used for cleaning and disinfection, the FDA has been reviewing the validation test methods and performance data for all AER manufacturers. To date, Custom Ultrasonics has not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.
The FDA's most recent inspection of the Custom Ultrasonics' facility in April 2015 documented continued violations. Violations include the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. The identified violations could result in an increased risk of infection transmission.
The FDA recommends that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative reprocessing methods as soon as possible. Facilities are advised to:
For details, please refer to the FDA websites:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm472462.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm472686.htm
Posted on 16 November 2015