Loaner instrumentation: processing the unknown

AORN Journal,  March, 2007  by Thomas G. Winthrop,  Barbara A. Sion,  Clifford Gaines

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All staff members were educated about the project including personnel working off-shifts. This was of particular importance because, in theory, those sets coming in later in the day had a higher probability of being contaminated because they were more likely to have been used in a procedure at another facility earlier that same day. The pressure to meet deadlines for delivery to another facility may increase the risk of less-than-optimal decontamination.

Of the 139 sets tested during the two months, 23 (16.5%) tested positive for blood residue. Even more informative was that of the 23 contaminated sets, 22 were hand-delivered by vendor representatives and only one set was sent from a main vendor processing facility. Six sets were visibly contaminated.

LOANER INSTRUMENTATION ISSUES

Three issues became apparent during the project. First, although loaner instrumentation is considered contaminated until it is processed by the receiving institution, it is unacceptable to release an instrument from the user institution if it has not been properly decontaminated, for example if a hasty flash sterilization has been performed in the OR or the instruments have simply been rinsed off in the OR decontamination room and given back to a waiting vendor representative. This is a major infection control concern that affects not only hospital organizations but vendors and ancillary personnel who may inadvertently come into contact with possibly contaminated instruments.

Second, the level of quality assurance in the decontamination process at each institution participating in loaner instrument acquisition must be assessed to determine if there is an ongoing quality assurance program checking the efficacy of the decontamination process. The Joint Commission has not mandated specific tests to determine the efficacy of the decontamination process; however, technology has advanced enough to produce reliable, cost-effective methods for testing the decontamination process. Working with the research and education sections of the vendor supplying the facility with enzymatic solutions for both the OR and central processing department enabled central processing department personnel to formulate an approach to quality testing of the decontamination process at a reasonable cost.

Central processing department personnel at Walter Reed Army Medical Center monitor the efficacy of the decontamination process weekly. A recent publication by the Association for the Advancement of Medical Instrumentation outlined the need to validate the decontamination process both for the manufacturer and central processing departments. (2,3) This validation process includes

* testing water Ph,

* testing the temperature for both cold and hot water cycles,

* checking ultrasonic equipment and instrument lumens, and

* checking for blood residue at the end of the decontamination process for both index washers and ultrasonic equipment.

Third, loaner instrumentation concerns affect not only the central processing department but also the OR, as loaner instruments may be delivered to the OR and flash-sterilized without going through a decontamination process when they are needed in an emergency. This may be more prevalent with smaller loan companies that do not possess sufficient inventory to assure timely delivery. The issue then becomes one of enforcing existing standard operating procedures (SOPs) that should require all loaner instrumentation to be processed through the central processing department, especially if the set contains implants that require a spore test before use.