Intermediate Update of “Investigation Plan – Forensic Engineering Investigation of Scope-X32 Contamination”

The Forensic Engineering Investigation team could quickly establish that within the Utilize phase:

• the Set Up step has always been done properly,
• the Use step has always been done properly,
• the Discontinue step did not play a role in this situation,
• the Verify steps right before and after Use could be improved: the hospital could check more often whether the scope is really clean and whether it needs maintenance,
• The Maintain/Repair step should be carefully checked, because this is what hypotheses HL1, HL2 and HC1 are about. (You can find the hypotheses in the unit containing the Investigation Plan, but we have repeated these at the end of this document for your convenience. So you don’t have to leave this page.)

Figure 1: Life-Cycle phases and steps of a technical system. The Develop and Produce phase will in this case be considered as a single phase (“cause at manufacturer”).

We will also have to check whether anything was wrong with the product or with the instructions coming from the manufacturer, because of hypothesis HC2. But we will not investigate in what step within the Develop and/or Produce phase such issues originated. We consider the develop and Produce phase as a single phase and as “Cause at Manufacturer”. We will only point out if anything and what was wrong and leave the rest to the manufacturer. For example, if we find out that a part of the ERCP-endoscope was not made as it should be, we leave it up to the manufacturer to check whether the fault was in the design or in the production.

Hypotheses about location of persistence:

HL1)     The bacteria were left behind in the working channel of Scope X-32.

HL2)     The bacteria were left behind somewhere on or in the tip of Scope X-32.

Hypotheses about cause of persistence:

HC1)     Something was wrong with how the manual cleaning of the ERCP-endoscopes was done.

HC2)     Something was wrong with the ERCP-endoscope itself.