ASP—EVOTECH Endoscope Cleaner and Reprocessors: May Not Detect an Improper Endoscope Connection
May 27, 2015 | Strategic Insights for Health System
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In a May 7, 2015, Urgent Medical Device Field Safety Corrective Action letter submitted by ECRI Institute member hospitals, ASP states that the above ECRs may not detect an improper endoscope connection on 2 channels, potentially passing the cycle without cancellation if a scope is disconnected. ASP also states that a fault condition on the interface board may cause an anomaly in some cycles, preventing the above ECRs from detecting improper connections of channels 3 or 4 and allowing the cycle to complete without canceling. The above ECRs are susceptible to this problem if...