Abstract

A new requirement from The Joint Commission (JC) is that flexible and rigid endoscopes must be included in a clinical engineering (CE) department’s medical equipment inventory. The primary justification for this, according to George Mills, senior engineer at the JC, is that endoscopes are considered to be diagnostic equipment. CE departments do not have to maintain or service endoscopes, however. Those processes do not have to change from how they are currently provided. Keep in mind that, according to EC.02.04.03, EP 3, “These activities are documented.” The JC is concerned about cross-contamination from improperly maintained endoscopes. This concern is well placed. In November 2009, the U.S. Food and Drug Administration (FDA), Centers for Disease Control (CDC), and the Department of Veterans Affairs (VA) issued a joint safety communication called “Preventing CrossContamination in Endoscope Processing.”1 In its “Top Ten Health Technology Hazards for 2010,” ECRI Institute lists cross-contamination from flexible endoscopes as number one.2 What is interesting is that FDA, CDC, VA, and ECRI focus specifically on flexible endoscopes when it comes to concern for cross-contamination. The JC’s requirement for inventorying endoscopes is for flexible and rigid endoscopes. Organizing this information in order to make sense of the situation: • Rigid and flexible endoscopes are diagnostic equipment. • Therefore, they have to be included in the medical equipment inventory. • Items in the medical equipment inventory have to be maintained.  They don’t necessarily have to be maintained by the clinical engineering department.  They can be maintained by another department or by an outside service organization.  Maintenance has to be documented. • The primary reason for the greater concern about endoscopes is cross-contamination.  Cross-contamination is, in fact, a serious concern with flexible endoscopes (as noted by FDA, CDC, VA, and ECRI).  There is no mention of an issue with crosscontamination from rigid endoscopes.  The JC has no requirement for preventing crosscontamination from endoscopes. Endoscopes in Your Inventory: Is There a Disconnect?

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