Q Over the past year there have been countless media headlines of virtually thousands of patients who have been potentially exposed to harmful pathogens, HBV, HIV and the like following endoscopic procedures where it was discovered scopes were not adequately cleaned. I find this extremely alarming yet I recognize that failures in processing equipment or protocols could occur at any time in any hospital. As the manager of sterile processing I have implemented a cleaning verification QA program for all items and processes conducted in SPD, however the nurse manager of our endoscopy unit does not believe there is a need to institute such a program in the Endo unit. She feels that her staff is very attentive and feels confident that the AER, manual cleaning processes and standards she enforces are superior. She blatantly stated she would not add another step such as cleaning verification into the protocol until it was required by regulations. Do you have any advice on how I could possibly influence her on the importance of implementing a QA cleaning verification process in the GI unit?

A Having the best of facilities, equipment, and staff are indeed critical but as you noted equipment and processes can still fail and often without detection. I have heard from hospitals that have implemented cleaning verification testing for their endoscopes, that they discovered that 20 – 40%, and in one case as high as 75%, of "cleaned" processed scopes tested positive for blood residuals. A Quality Assurance program provides confidence and proof on the efficacy of procedures and protocols. The cleaning verification testing of the endoscopes made the invisible visible, and allowed these hospitals to make moderate adjustments in processing procedures to render quality results which could be documented by the testing results. There are very simple endoscope testing tools available, such as a swab probe test that can detect residual blood and/or protein soil in the scope’s channels (figure 1), or a dip strip test which can detect residuals of protein, hemoglobin or carbohydrates from water that is flushed through the scope’s channels (figure 2). You may share the following information with the nurse manager of your endoscopy unit which supports the monitoring of the cleaning process of flexible endoscopes.

Figure 1	Figure 2

• Section 10.2 and AAMI ANNEX D states "… processing personnel are increasingly aware of the need to control and standardize the steps taken to ensure the sterility of devices for patient use. Because disinfection and sterilization cannot be assured unless the cleaning process is successful, professionals in the field ought to seek out whatever means are available and practical to verify this function. A quality system would call for monitoring and documenting decontamination processing parameters, whether the process is accomplished by hand or mechanically…." (Section 7.7.5)