October 9, 2015 | By: Calevir
On September 17, 2015 the FDA issued a safety communication on “Infections Associated with Reprocessed Flexible Bronchoscopes”, following its earlier communication about similar concerns with duodenoscopes/endoscopes.
This alert is to reinforce the following highlights of the report, encouraging healthcare
providers to review processes and implement steps to ensure the safety of patients:
The complete report is available here.
The earlier published FDA communications addressed concerns about:
Complete information from the FDA on these concerns are available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm434871.htm and http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm.
MITIGATION STRATEGIES TO CONSIDER
RESOURCES TO TAKE ACTION
CDC/FDA Health Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices: http://emergency.cdc.gov/han/han00383.asp.
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The Center for Patient Safety believes that collaboration and sharing are the best ways to drive improvement. We strive to provide the right solutions and resources to improve healthcare safety and quality.