HAVING MY SAY
Last of a two-part series
Have surgical infection rates decreased with the addition of modular instruments?
by James Schneiter I
n Part I of this two-part series we looked at how a number of surgical instru- ment companies introduced ”modular” instruments that could be disassembled for internal cleaning during processing. The concept was intended to reduce the risk of a surgical infection caused by an instrument that remains contaminated with bioburden and debris after processing.
The manufacturers of modular instru- ments claim that once you’ve disassembled an instrument, you can visualize the bioburden inside of the instrument and manually remove it during processing. As was explored in Part I, the human eye is NOT capable of seeing microscopic bacte- ria and biofi lm on the surface of a surgical instrument. Both AAMI and the Healthcare Sterile Processing Association (HSPA and formerly IAHCSMM) have long been aware of the limitations and dangers of relying on ”visual” inspection to insure the removal of bioburden and debris from instruments during processing.
AAMI’s ST 79 on cleaning IFUs clearly states, “Visual inspection alone may not be sufficient for assessing the efficacy of cleaning processes.” ST79 goes on to state, “The use of methods that are able to measure organic residues that are not detectable using visual inspection should be considered in facility cleaning policy and procedures.”1
HSPA points out in its CRCST Self-Study
Lesson Plan, “Understanding Biofilm,” “Even with the use of most visual enhanc- ing tools, microorganisms will still not be seen. To help solve this problem, tests have been developed to help verify that cleaning quality standards have been attained. These tests include protein tests and adenosine triphosphate (ATP) bioluminescence tests, both of which test for residual soils, and which might also be suggestive of biofi lm formation.”2
As followers of #IFUcan have learned, the only way to ensure clean, sterile, moisture- free surgical instruments on every process- ing cycle is only to use instruments whose cleaning and sterilization IFUs have been validated using AAMI and FDA testing
protocols. Presently, there is no brand, make or style of modular instruments available whose cleaning and sterilization IFUs have been validated using AAMI and FDA vali- dation testing protocols.
The personnel at The Joint Commission (TJC) have also been very concerned about the problems associated with reprocessing modular instruments. Their concerns start in the O.R. where pre-treating at point-of-use prior to transport is often lacking, or simply non-existent. TJC was so concerned that in January 2011 the organization revised the guidelines for its inspection teams in the operating rooms. Specifi cally, the revised TC guidelines read as follows:
Point-of-use preparation: “Some typical point-of-use shortcuts that have been observed in operating rooms are: Not unlocking instruments; not disas- sembling instruments; not wiping off gross material and body fl uids during procedures not moistening or pre-treating instruments before transporting them for sterile process- ing; and not returning instruments to their proper containers.”3
Based on TJC’s January 2011 inspection guidelines, it is obvious that the failure of O.R. personnel to disassemble and manually prepare modular instruments for transport is a major concern/problem. An even greater concern/problem exists once modular instruments arrive in CS/SPD for decontamination, cleaning and steriliza- tion if they are not properly disassembled, cleaned and properly reassembled. One of the many problems with modular instruments is that most are not labeled as ”modular,” and as such O.R., CS and SPD personnel don’t disassemble them for processing. In fairness to O.R., CS and SPD personnel, most modular instruments look just like conventional, non-modular instruments. When modular instruments are not disassembled during processing, bioburden and debris quickly accumulates within the instrument. This accumulation of bioburden and debris can increase the risk of a surgical infection caused by the
58 June 2022 • HEALTHCARE PURCHASING NEWS •
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contamination that remains trapped inside of the instrument. Another signifi cant problem with modu- lar instruments that are re-assembled prior to sterilization is that residual moisture can remain trapped inside of the instrument after the sterilization cycle. This greatly increases the risk of an instrument contami- nated with waterborne pathogens being returned to surgery. To avoid this problem, you should only use instruments whose sterilization IFUs have been validated to return moisture-free instruments after the sterilization cycle. This signifi cantly reduces the risk of a surgical infection caused by water-borne pathogens and it also reduces the potential for rust to form within the instrument.
Next to infecting a patient with a contami- nated instrument, the second most impor- tant concern for the surgeon is the tactile feel and response of the instrument coupled with the bite force that can be applied to the jaw. To be easily disassembled and re- assembled, modular instruments are not built with the same tight tolerances that conventional, non-modular instruments are built to. That is why no modular design will ever be able to match the tactile feel, response and bite force of a conventional, non-modular surgical instrument. In summary, there are no studies that document lower infection rates with the use of modular instruments. Additionally, there are no brands, makes or styles of modular instruments whose cleaning and sterilization IFUs have ever been validated using AAMI and FDA validation testing protocols. Given the time and effort required to manually decontaminate and clean a non- validated modular instrument (several min- utes) vs. a simple fl ush with a conventional, flushable instrument (several seconds) whose IFUs have been validated, you have to question why a facility would continue to purchase and use non-validated modu- lar instruments. If your facility isn’t using instruments whose cleaning and sterilization IFUs have been validated using AAMI and FDA validation testing protocols, you have no way of insuring clean, sterile, moisture-
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